Trial Outcomes & Findings for Study With Etanercept Focusing on Remission and Predictability of Remission in Real Life Clinical Practice (NCT NCT02202837)
NCT ID: NCT02202837
Last Updated: 2018-12-03
Results Overview
DAS28 was a measure of disease activity in participants with rheumatoid arthritis. DAS28 was calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joints count, C-reactive protein (CRP) (milligrams per liter \[mg/L\]) or erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hr\]) levels and patient global assessment (PGA) of disease activity on a 0-100 mm scale (scores ranging from 0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicated worst health condition). DAS28 score range from 0 (none) to 9.4 (extreme disease activity). DAS28 \[less than or equal to\] \<=3.2 implied low disease activity and greater than (\>) 3.2 to \<=5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28 less than (\<) 2.6 implied remission.
COMPLETED
157 participants
Month 6 up to Month 12
2018-12-03
Participant Flow
Participant milestones
| Measure |
Etanercept: First Intention
Participants with rheumatoid arthritis (RA) who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on Summary of Product Characteristics (SmPC).
|
Etanercept: Second Intention
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
|---|---|---|
|
Overall Study
STARTED
|
140
|
17
|
|
Overall Study
COMPLETED
|
87
|
12
|
|
Overall Study
NOT COMPLETED
|
53
|
5
|
Reasons for withdrawal
| Measure |
Etanercept: First Intention
Participants with rheumatoid arthritis (RA) who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on Summary of Product Characteristics (SmPC).
|
Etanercept: Second Intention
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
|---|---|---|
|
Overall Study
Enbrel treatment discontinued
|
36
|
4
|
|
Overall Study
Other
|
10
|
0
|
|
Overall Study
Lost to Follow-up
|
7
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Etanercept: First Intention
n=140 Participants
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
Etanercept: Second Intention
n=17 Participants
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
Total
n=157 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.21 years
STANDARD_DEVIATION 13.55 • n=140 Participants
|
56.16 years
STANDARD_DEVIATION 11.63 • n=17 Participants
|
56.21 years
STANDARD_DEVIATION 13.32 • n=157 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=140 Participants
|
11 Participants
n=17 Participants
|
104 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=140 Participants
|
6 Participants
n=17 Participants
|
53 Participants
n=157 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Month 6 up to Month 12Population: The completers analysis data set (CAS) consisted of all participants enrolled in study and who completed 12-month study, whether or not they missed some follow-up visits and regardless of cohort (first or second intention). Here, "N" (number of participants analyzed) signifies participants who were evaluable for this specified outcome measure.
DAS28 was a measure of disease activity in participants with rheumatoid arthritis. DAS28 was calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joints count, C-reactive protein (CRP) (milligrams per liter \[mg/L\]) or erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hr\]) levels and patient global assessment (PGA) of disease activity on a 0-100 mm scale (scores ranging from 0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicated worst health condition). DAS28 score range from 0 (none) to 9.4 (extreme disease activity). DAS28 \[less than or equal to\] \<=3.2 implied low disease activity and greater than (\>) 3.2 to \<=5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28 less than (\<) 2.6 implied remission.
Outcome measures
| Measure |
Etanercept: First Intention
n=76 Participants
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
Etanercept: Second Intention
n=10 Participants
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
|---|---|---|
|
Percentage of Participants With Disease Activity Score Based on 28-Joints Count (DAS28) Less Than (<) 2.6 at Month 6 and Maintained Till Month 12
|
43.4 percentage of participants
Interval 32.1 to 55.3
|
30.0 percentage of participants
Interval 6.67 to 65.3
|
PRIMARY outcome
Timeframe: Month 6 up to Month 12Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, "N" signifies those participants who were evaluable for this specified outcome measure.
The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, physician (evaluator) global assessment of disease (EGA) and PGA (assessed on a 0 mm \[very well\] to 10 mm \[extremely bad\] scale; higher scores indicated worst health condition) and CRP (mg/dL). SDAI total score ranged from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. SDAI \>3.4 to 11 implied low disease activity, \>11 to 26 implied moderate disease activity, \>26 implied high disease activity and \<=3.3 implied disease remission.
Outcome measures
| Measure |
Etanercept: First Intention
n=73 Participants
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
Etanercept: Second Intention
n=9 Participants
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
|---|---|---|
|
Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 at Month 6 and Maintained Till Month 12
|
13.7 percentage of participants
Interval 6.77 to 23.8
|
22.2 percentage of participants
Interval 2.81 to 60.0
|
PRIMARY outcome
Timeframe: Month 6 up to Month 12Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, "N" signifies those participants who were evaluable for this specified outcome measure.
The CDAI was the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm \[very well\] to 10 mm \[extremely bad\] scale; higher scores indicated worst health condition). CDAI total score ranged from 0-76 with higher scores indicating increased disease activity.
Outcome measures
| Measure |
Etanercept: First Intention
n=78 Participants
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
Etanercept: Second Intention
n=11 Participants
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
|---|---|---|
|
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 at Month 6 and Maintained Till Month 12
|
3.85 percentage of participants
Interval 0.8 to 10.8
|
18.2 percentage of participants
Interval 2.28 to 51.8
|
PRIMARY outcome
Timeframe: Month 6 up to Month 12Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, "N" signifies those participants who were evaluable for this specified outcome measure.
The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) \<=1; SJC (in 28 joints) \<=1; CRP\<=1 mg/dl; PGA\<=1 (assessed on a 0 mm \[very well\] to 10 mm \[extremely bad\] scale; higher scores indicated worst health condition).
Outcome measures
| Measure |
Etanercept: First Intention
n=74 Participants
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
Etanercept: Second Intention
n=9 Participants
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
|---|---|---|
|
Percentage of Participants With Remission at Month 6 and Maintained Till Month 12 Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Studies) Boolean Criterion
|
2.70 percentage of participants
Interval 0.33 to 9.42
|
0 percentage of participants
Interval 0.0 to 33.6
|
PRIMARY outcome
Timeframe: Month 6 up to Month 12Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, "N" signifies those participants who were evaluable for this specified outcome measure.
The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) \<=1; SJC (in 28 joints) \<=1 and PGA\<=1 (assessed on a 0 mm \[very well\] to 10 mm \[extremely bad\] scale; higher scores indicated worst health condition).
Outcome measures
| Measure |
Etanercept: First Intention
n=79 Participants
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
Etanercept: Second Intention
n=11 Participants
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
|---|---|---|
|
Percentage of Participants With Remission at Month 6 and Maintained Till Month 12 Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Practice) Boolean Criterion
|
11.4 percentage of participants
Interval 5.34 to 20.5
|
18.2 percentage of participants
Interval 2.28 to 51.8
|
PRIMARY outcome
Timeframe: Month 6 up to Month 12Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, "N" signifies those participants who were evaluable for this specified outcome measure.
A participant was in remission based on US7: if US7 synovitis sum score in grey-scale Ultrasonography (GSUS) =0, Power Doppler Ultrasonography (PDUS) =0 and erosion sum score in GSUS=0. US7 score is musculoskeletal ultrasonography (MKUS) composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. US7 score included MKUS examination of the following joints of the more clinically affected side: wrist, metacarpophalangeal (MCP) II and III, proximal interphalangeal (PIP) II and III, metatarsophalangeal (MTP) II and V. The joints were examined by GSUS and PDUS for synovitis. Synovitis in GSUS and PDUS was analyzed on a scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = \>=50% of the intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on a binary basis 0 and 1 where 0=no remission and remission=1.
Outcome measures
| Measure |
Etanercept: First Intention
n=3 Participants
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
Etanercept: Second Intention
n=2 Participants
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
|---|---|---|
|
Percentage of Participants With Remission Based on Seven-Joint Ultrasound (US7) Measurements at Month 6 and Maintained Till Month 12
|
0 percentage of participants
Interval 0.0 to 70.8
|
0 percentage of participants
Interval 0.0 to 84.2
|
PRIMARY outcome
Timeframe: Month 6 up to Month 12Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, "N" signifies those participants who were evaluable for this specified outcome measure.
Remission based on DAS28 + US7: DAS28 \<2.6 and US7 synovitis sum score in GSUS=0, PDUS=0 and US7 erosion sum score in GSUS=0. DAS28: SJC + TJC in 28 joints count + CRP(mg/L) or ESR(mm/hr) levels and PGA on 0-100 mm scale (0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicated worst health condition). U7 Remission: US7 synovitis sum score in GSUS=0, PDUS=0 and erosion sum score in GSUS=0. US7 score is MKUS composite scoring system which combined soft tissue lesions(synovitis) and destructive processes(erosions) in single scoring system. US7 score included MKUS examination of given joints: wrist, MCP II and III, PIP II and III, MTP II and V. Joints were examined by GSUS and PDUS for synovitis on scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = \>=50% of intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on binary basis 0 (no remission) and 1 (remission).
Outcome measures
| Measure |
Etanercept: First Intention
n=3 Participants
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
Etanercept: Second Intention
n=2 Participants
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
|---|---|---|
|
Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) in Combination With Seven-Joint Ultrasound (US7) Measurement at Month 6 and Maintained Till Month 12
|
0 percentage of participants
Interval 0.0 to 70.8
|
0 percentage of participants
Interval 0.0 to 84.2
|
SECONDARY outcome
Timeframe: Month 3, 6, 9 and 12Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, "N" signifies those participants who were evaluable for this specified outcome measure.
DAS28 was a measure of disease activity in participants with rheumatoid arthritis. DAS28 was calculated from SJC and TJC using 28 joints count, CRP (mg/L) or ESR) (mm/hr) levels and PGA of disease activity on a 0-100 mm scale (scores ranging from 0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicated worst health condition). DAS28 score range from 0 (none) to 9.4 (extreme disease activity). DAS28 \<=3.2 implied low disease activity and \> 3.2 to \<=5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28 \<2.6 implied remission.
Outcome measures
| Measure |
Etanercept: First Intention
n=86 Participants
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
Etanercept: Second Intention
n=12 Participants
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
|---|---|---|
|
Percentage of Participants With Disease Activity Score Based on 28-Joints Count (DAS28) <2.6 at Month 3, 6, 9 and 12
Month 3
|
50.0 percentage of participants
Interval 36.3 to 63.7
|
33.3 percentage of participants
Interval 7.49 to 70.1
|
|
Percentage of Participants With Disease Activity Score Based on 28-Joints Count (DAS28) <2.6 at Month 3, 6, 9 and 12
Month 6
|
56.6 percentage of participants
Interval 44.7 to 67.9
|
60.0 percentage of participants
Interval 26.2 to 87.8
|
|
Percentage of Participants With Disease Activity Score Based on 28-Joints Count (DAS28) <2.6 at Month 3, 6, 9 and 12
Month 9
|
50.9 percentage of participants
Interval 36.8 to 64.9
|
28.6 percentage of participants
Interval 3.67 to 71.0
|
|
Percentage of Participants With Disease Activity Score Based on 28-Joints Count (DAS28) <2.6 at Month 3, 6, 9 and 12
Month 12
|
51.3 percentage of participants
Interval 39.6 to 63.0
|
40.0 percentage of participants
Interval 12.2 to 73.8
|
SECONDARY outcome
Timeframe: Month 3, 6, 9 and 12Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, "N" signifies those participants who were evaluable for this specified outcome measure.
The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm \[very well\] to 10 mm \[extremely bad\] scale; higher scores indicated worst health condition) and CRP (mg/dL). SDAI total score ranged from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. SDAI \>3.4 to 11 implied low disease activity, \>11 to 26 implied moderate disease activity, \>26 implied high disease activity and \<=3.3 implied disease remission.
Outcome measures
| Measure |
Etanercept: First Intention
n=84 Participants
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
Etanercept: Second Intention
n=12 Participants
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
|---|---|---|
|
Percentage of Participants With Simplified Disease Activity Index (SDAI) <=3.3 at Month 3, 6, 9 and 12
Month 3
|
12.7 percentage of participants
Interval 5.27 to 24.5
|
12.5 percentage of participants
Interval 0.32 to 52.7
|
|
Percentage of Participants With Simplified Disease Activity Index (SDAI) <=3.3 at Month 3, 6, 9 and 12
Month 6
|
19.2 percentage of participants
Interval 10.9 to 30.1
|
44.4 percentage of participants
Interval 13.7 to 78.8
|
|
Percentage of Participants With Simplified Disease Activity Index (SDAI) <=3.3 at Month 3, 6, 9 and 12
Month 9
|
28.0 percentage of participants
Interval 16.2 to 42.5
|
14.3 percentage of participants
Interval 0.36 to 57.9
|
|
Percentage of Participants With Simplified Disease Activity Index (SDAI) <=3.3 at Month 3, 6, 9 and 12
Month 12
|
17.4 percentage of participants
Interval 9.32 to 28.4
|
11.1 percentage of participants
Interval 0.28 to 48.3
|
SECONDARY outcome
Timeframe: Month 3, 6, 9 and 12Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, "N" signifies those participants who were evaluable for this specified outcome measure.
The CDAI was the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm \[very well\] to 10 mm \[extremely bad\] scale; higher scores indicated worst health condition). CDAI total score ranged from 0-76 with higher scores indicating increased disease activity.
Outcome measures
| Measure |
Etanercept: First Intention
n=86 Participants
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
Etanercept: Second Intention
n=12 Participants
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
|---|---|---|
|
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 at Month 3, 6, 9 and 12
Month 9
|
23.2 percentage of participants
Interval 13.0 to 36.4
|
0.00 percentage of participants
Interval 0.0 to 36.9
|
|
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 at Month 3, 6, 9 and 12
Month 3
|
12.3 percentage of participants
Interval 5.47 to 22.8
|
18.2 percentage of participants
Interval 2.28 to 51.8
|
|
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 at Month 3, 6, 9 and 12
Month 6
|
7.69 percentage of participants
Interval 2.88 to 16.0
|
36.4 percentage of participants
Interval 10.9 to 69.2
|
|
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 at Month 3, 6, 9 and 12
Month 12
|
14.7 percentage of participants
Interval 7.56 to 24.7
|
10.0 percentage of participants
Interval 0.25 to 44.5
|
SECONDARY outcome
Timeframe: Month 3, 6, 9 and 12Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, "N" signifies those participants who were evaluable for this specified outcome measure.
The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) \<=1; SJC (in 28 joints) \<=1; CRP\<=1 mg/dl; PGA\<=1 (assessed on a 0 mm \[very well\] to 10 mm \[extremely bad\] scale; higher scores indicated worst health condition).
Outcome measures
| Measure |
Etanercept: First Intention
n=85 Participants
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
Etanercept: Second Intention
n=12 Participants
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
|---|---|---|
|
Percentage of Participants With Remission Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Studies) Boolean Criterion at Month 3, 6, 9 and 12
Month 3
|
5.36 percentage of participants
Interval 1.12 to 14.9
|
11.1 percentage of participants
Interval 0.28 to 48.3
|
|
Percentage of Participants With Remission Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Studies) Boolean Criterion at Month 3, 6, 9 and 12
Month 6
|
6.76 percentage of participants
Interval 2.23 to 15.1
|
11.1 percentage of participants
Interval 0.28 to 48.3
|
|
Percentage of Participants With Remission Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Studies) Boolean Criterion at Month 3, 6, 9 and 12
Month 9
|
5.88 percentage of participants
Interval 1.23 to 16.2
|
0.00 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants With Remission Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Studies) Boolean Criterion at Month 3, 6, 9 and 12
Month 12
|
9.59 percentage of participants
Interval 3.94 to 18.8
|
0.00 percentage of participants
Interval 0.0 to 30.9
|
SECONDARY outcome
Timeframe: Month 3, 6, 9 and 12Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention).
The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) \<=1; SJC (in 28 joints) \<=1 and PGA\<=1 (assessed on a 0 mm \[very well\] to 10 mm \[extremely bad\] scale; higher scores indicated worst health condition).
Outcome measures
| Measure |
Etanercept: First Intention
n=87 Participants
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
Etanercept: Second Intention
n=12 Participants
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
|---|---|---|
|
Percentage of Participants With Remission Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Practice) Boolean Criterion at Month 3, 6, 9 and 12
Month 3
|
10.6 percentage of participants
Interval 4.37 to 20.6
|
16.7 percentage of participants
Interval 2.09 to 48.4
|
|
Percentage of Participants With Remission Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Practice) Boolean Criterion at Month 3, 6, 9 and 12
Month 6
|
16.5 percentage of participants
Interval 9.06 to 26.5
|
45.5 percentage of participants
Interval 16.8 to 76.6
|
|
Percentage of Participants With Remission Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Practice) Boolean Criterion at Month 3, 6, 9 and 12
Month 9
|
26.3 percentage of participants
Interval 15.5 to 39.7
|
25.0 percentage of participants
Interval 3.19 to 65.1
|
|
Percentage of Participants With Remission Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Practice) Boolean Criterion at Month 3, 6, 9 and 12
Month 12
|
18.8 percentage of participants
Interval 10.9 to 29.0
|
18.2 percentage of participants
Interval 2.28 to 51.8
|
SECONDARY outcome
Timeframe: Month 6 and 12Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, "N" signifies those participants who were evaluable for this specified outcome measure.
A participant was in remission based on US7: if US7 synovitis sum score in GSUS =0, PDUS =0 and erosion sum score in GSUS=0. US7 score is MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. US7 score included MKUS examination of the following joints of the more clinically affected side: wrist, MCP II and III, PIP II and III, MTP II and V. The joints were examined by GSUS and PDUS for synovitis. Synovitis in GSUS and PDUS was analyzed on a scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = \>=50% of the intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on a binary basis 0 and 1 where 0=no remission and remission=1.
Outcome measures
| Measure |
Etanercept: First Intention
n=3 Participants
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
Etanercept: Second Intention
n=2 Participants
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
|---|---|---|
|
Percentage of Participants With no Signs of Ultrasound Synovitis (Ultrasound Remission) at Month 6 and 12
Month 6
|
0.00 percentage of participants
Interval 0.0 to 70.8
|
0.00 percentage of participants
Interval 0.0 to 70.8
|
|
Percentage of Participants With no Signs of Ultrasound Synovitis (Ultrasound Remission) at Month 6 and 12
Month 12
|
0.00 percentage of participants
Interval 0.0 to 70.8
|
0.00 percentage of participants
Interval 0.0 to 70.8
|
SECONDARY outcome
Timeframe: Month 6 and 12Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, "N" signifies those participants who were evaluable for this specified outcome measure.
Remission based on DAS28 + US7: DAS28 \<2.6 and US7 synovitis sum score in GSUS=0, PDUS=0 and US7 erosion sum score in GSUS=0. DAS28: SJC + TJC in 28 joints count + CRP(mg/L) or ESR(mm/hr) levels and PGA on 0-100 mm scale (0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicated worst health condition). U7 Remission: US7 synovitis sum score in GSUS=0, PDUS=0 and erosion sum score in GSUS=0. US7 score is MKUS composite scoring system which combined soft tissue lesions(synovitis) and destructive processes(erosions) in single scoring system. US7 score included MKUS examination of given joints: wrist, MCP II and III, PIP II and III, MTP II and V. Joints were examined by GSUS and PDUS for synovitis on scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = \>=50% of intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on binary basis 0 (no remission) and 1 (remission).
Outcome measures
| Measure |
Etanercept: First Intention
n=3 Participants
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
Etanercept: Second Intention
n=2 Participants
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
|---|---|---|
|
Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) in Combination With Seven-Joint Ultrasound (US7) Measurement at Month 6 and Month 12
Month 6
|
0.00 percentage of participants
Interval 0.0 to 70.8
|
0.00 percentage of participants
Interval 0.0 to 84.2
|
|
Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) in Combination With Seven-Joint Ultrasound (US7) Measurement at Month 6 and Month 12
Month 12
|
0.00 percentage of participants
Interval 0.0 to 70.8
|
0.00 percentage of participants
Interval 0.0 to 84.2
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and Month 12Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, "N" signifies those participants who were evaluable for this specified outcome measure.
DAS28 was a measure of disease activity in participants with rheumatoid arthritis. DAS28 was calculated from SJC and TJC using 28 joints count, CRP (mg/L) or ESR (mm/hr) levels and PGA of disease activity on a 0-100 mm scale (scores ranging from 0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicated worst health condition). DAS28 score range from 0 (none) to 9.4 (extreme disease activity). DAS28 \<=3.2 implied low disease activity and \> 3.2 to \<=5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28 \<2.6 implied remission.
Outcome measures
| Measure |
Etanercept: First Intention
n=86 Participants
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
Etanercept: Second Intention
n=12 Participants
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
|---|---|---|
|
Change From Baseline in Disease Activity Score Based on 28-Joints Count (DAS28) at Month 6 and 12
Baseline
|
5.06 units on a scale
Standard Deviation 1.15
|
5.32 units on a scale
Standard Deviation 1.44
|
|
Change From Baseline in Disease Activity Score Based on 28-Joints Count (DAS28) at Month 6 and 12
Change at Month 6
|
2.39 units on a scale
Standard Deviation 1.21
|
1.92 units on a scale
Standard Deviation 2.27
|
|
Change From Baseline in Disease Activity Score Based on 28-Joints Count (DAS28) at Month 6 and 12
Change at Month 12
|
2.36 units on a scale
Standard Deviation 1.29
|
1.37 units on a scale
Standard Deviation 1.01
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and Month 12Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, "N" signifies those participants who were evaluable for this specified outcome measure.
The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm \[very well\] to 10 mm \[extremely bad\] scale; higher scores indicated worst health condition) and CRP (mg/dL). SDAI total score ranged from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. SDAI \>3.4 to 11 implied low disease activity, \>11 to 26 implied moderate disease activity, \>26 implied high disease activity and \<=3.3 implied disease remission.
Outcome measures
| Measure |
Etanercept: First Intention
n=84 Participants
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
Etanercept: Second Intention
n=12 Participants
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
|---|---|---|
|
Change From Baseline in Simplified Disease Activity Index (SDAI) at Month 6 and 12
Baseline
|
32.2 units on a scale
Standard Deviation 13.67
|
35.83 units on a scale
Standard Deviation 19.86
|
|
Change From Baseline in Simplified Disease Activity Index (SDAI) at Month 6 and 12
Change at Month 6
|
21.06 units on a scale
Standard Deviation 11.17
|
19.62 units on a scale
Standard Deviation 18.80
|
|
Change From Baseline in Simplified Disease Activity Index (SDAI) at Month 6 and 12
Change at Month 12
|
20.30 units on a scale
Standard Deviation 12.49
|
12.10 units on a scale
Standard Deviation 8.29
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and Month 12Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, "N" signifies those participants who were evaluable for this specified outcome measure.
The CDAI was the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm \[very well\] to 10 mm \[extremely bad\] scale; higher scores indicated worst health condition). CDAI total score ranged from 0-76 with higher scores indicating increased disease activity.
Outcome measures
| Measure |
Etanercept: First Intention
n=86 Participants
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
Etanercept: Second Intention
n=12 Participants
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
|---|---|---|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) at Month 6 and 12
Baseline
|
31.12 units on a scale
Standard Deviation 13.15
|
34.17 units on a scale
Standard Deviation 18.96
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) at Month 6 and 12
Change at Month 6
|
20.06 units on a scale
Standard Deviation 10.46
|
15.64 units on a scale
Standard Deviation 16.64
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) at Month 6 and 12
Change at Month 12
|
18.85 units on a scale
Standard Deviation 13.04
|
13.20 units on a scale
Standard Deviation 11.71
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and Month 12Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, "N" signifies those participants who were evaluable for this specified outcome measure.
US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. GSUS is a scoring system use to determine synovitis. The joints were examined by GSUS for synovitis from a dorsal and palmar aspect. The US7 synovitis sum score in GSUS was the sum of the scores for 9 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 palmar, MCP 3 palmar, PIP 2 palmar, PIP 3 palmar, MTP 2 dorsal, MTP 5 dorsal) on a scale ranging from 0 =no synovitis to 3=severe synovitis. Total US7 GSUS score ranged from 0 (no synovitis) to 27 (severe synovitis), higher score= more synovitis.
Outcome measures
| Measure |
Etanercept: First Intention
n=4 Participants
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
Etanercept: Second Intention
n=2 Participants
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
|---|---|---|
|
Change From Baseline in Seven-Joint Ultrasound (US7) Synovitis Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12
Baseline
|
6.21 units on a scale
Standard Deviation 2.67
|
9.50 units on a scale
Standard Deviation 2.12
|
|
Change From Baseline in Seven-Joint Ultrasound (US7) Synovitis Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12
Change at Month 6
|
3.24 units on a scale
Standard Deviation 3.95
|
8.36 units on a scale
Standard Deviation 2.32
|
|
Change From Baseline in Seven-Joint Ultrasound (US7) Synovitis Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12
Change at Month 12
|
3.24 units on a scale
Standard Deviation 4.20
|
3.00 units on a scale
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and Month 12Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, "N" signifies those participants who were evaluable for this specified outcome measure.
US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. PDUS assessed the degree of synovial inflammation of the joints of both hands. The joints were examined by PDUS from a dorsal and palmar aspect. The US7 synovitis sum score in PDUS was the sum of the scores of 13 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 palmar, MCP 2 dorsal, MCP 3 palmar, MCP 3 dorsal, PIP 2 palmar, PIP 2 dorsal, PIP 3 palmar, PIP 3 dorsal, MTP 2 dorsal, MTP 5 dorsal) on a scale ranging from 0=no intraarticular color signal to 3 = \>=50% of the intraarticular area filled with color signals. Total US7 PSUS scores ranges from 0=no intraarticular color signal to 39 = \>=50% of the intraarticular area filled with color signals; higher scores= more severe disease.
Outcome measures
| Measure |
Etanercept: First Intention
n=3 Participants
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
Etanercept: Second Intention
n=2 Participants
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
|---|---|---|
|
Change From Baseline in Seven-Joint Ultrasound (US7) Synovitis Power Doppler Ultrasonography (PDUS) Score at Month 6 and 12
Baseline
|
7.90 units on a scale
Standard Deviation 3.76
|
6.50 units on a scale
Standard Deviation 7.78
|
|
Change From Baseline in Seven-Joint Ultrasound (US7) Synovitis Power Doppler Ultrasonography (PDUS) Score at Month 6 and 12
Change at Month 6
|
6.29 units on a scale
Standard Deviation 3.87
|
5.85 units on a scale
Standard Deviation 8.70
|
|
Change From Baseline in Seven-Joint Ultrasound (US7) Synovitis Power Doppler Ultrasonography (PDUS) Score at Month 6 and 12
Change at Month 12
|
6.90 units on a scale
Standard Deviation 2.81
|
0.50 units on a scale
Standard Deviation 3.54
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and Month 12Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, "N" signifies those participants who were evaluable for this specified outcome measure.
US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis and tenosynovitis/paratenonitis) and destructive processes (erosions) in a single scoring system. GSUS was a scoring system used to determine the tenosynovitis/paratenonitis. The joints were examined by GSUS from a dorsal and palmar aspect. The US7 tenosynovitis/paratenonitis sum score in GSUS was the sum of the scores for 7 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 dorsal, MCP I2 palmar, MCP 3 dorsal, MCP 3 palmar) on a scale ranging from 0 =no synovitis to 1=severe synovitis. Total US7 tenosynovitis/paratenonitis GSUS score ranged from 0 (no synovitis) to 7 (severe synovitis), higher score= more synovitis.
Outcome measures
| Measure |
Etanercept: First Intention
n=3 Participants
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
Etanercept: Second Intention
n=1 Participants
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
|---|---|---|
|
Change From Baseline in Seven-Joint Ultrasound (US7) Tenosynovitis/Paratenonitis Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12
Baseline
|
2.00 units on a scale
Standard Deviation 2.65
|
0.00 units on a scale
|
|
Change From Baseline in Seven-Joint Ultrasound (US7) Tenosynovitis/Paratenonitis Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12
Change at Month 6
|
0.50 units on a scale
Standard Deviation 0.71
|
0.00 units on a scale
|
|
Change From Baseline in Seven-Joint Ultrasound (US7) Tenosynovitis/Paratenonitis Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12
Change at Month 12
|
0.50 units on a scale
Standard Deviation 0.71
|
0.00 units on a scale
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and Month 12Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, "N" signifies those participants who were evaluable for this specified outcome measure.
US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis and tenosynovitis/paratenonitis) and destructive processes (erosions) in a single scoring system. PDUS assessed the degree of synovial inflammation of the joints of both hands. The joints were examined by PDUS from a dorsal and palmar aspect. The US7 tenosynovitis/paratenonitis sum score in PDUS was the sum of the scores for 7 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 dorsal, MCP 2 palmar, MCP 3 dorsal, MCP 3 palmar) on a scale ranging from 0 =no synovitis to 1=severe synovitis. Total US7 tenosynovitis/paratenonitis PDUS score ranged from 0 (no synovitis) to 7 (severe synovitis), higher score= more synovitis.
Outcome measures
| Measure |
Etanercept: First Intention
n=3 Participants
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
Etanercept: Second Intention
n=1 Participants
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
|---|---|---|
|
Change From Baseline in Seven-Joint Ultrasound (US7) Tenosynovitis/Paratenonitis Power Doppler Ultrasonography (PDUS) Score at Month 6 and 12
Baseline
|
0.67 units on a scale
Standard Deviation 1.15
|
0.00 units on a scale
|
|
Change From Baseline in Seven-Joint Ultrasound (US7) Tenosynovitis/Paratenonitis Power Doppler Ultrasonography (PDUS) Score at Month 6 and 12
Change at Month 6
|
1.00 units on a scale
Standard Deviation 1.41
|
0.00 units on a scale
|
|
Change From Baseline in Seven-Joint Ultrasound (US7) Tenosynovitis/Paratenonitis Power Doppler Ultrasonography (PDUS) Score at Month 6 and 12
Change at Month 12
|
1.00 units on a scale
Standard Deviation 1.41
|
0.00 units on a scale
|
SECONDARY outcome
Timeframe: Month 6 and Month 12Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, "N" signifies those participants who were evaluable for this specified outcome measure.
US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. GSUS was a scoring system used to determine the erosions. The joints were examined by GSUS for erosions from a dorsal, palmar/plantar and radial/lateral (only MCP 2 and MTP 5) aspect. The US7 erosion sum score in GSUS was the sum of the 14 following scores (MCP 2 dorsal, MCP 2 palmar, MCP 2 radial, MCP 3 dorsal, MCP 3 palmar, PIP 2 dorsal, PIP 2 palmar, PIP 3 dorsal, PIP 3 palmar, MTP 2 dorsal, MTP 2 plantar, MTP 5 dorsal, MTP 5 plantar and MTP 5 lateral) ranging from 0 to 1. Total score ranged from 0 (no erosions) to 14 (severe erosions), higher score= more erosions. The score was based on measurements made at fingers and toes and were calculated for both left and right sides, the score of the clinically most affected side.
Outcome measures
| Measure |
Etanercept: First Intention
n=3 Participants
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
Etanercept: Second Intention
n=2 Participants
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
|---|---|---|
|
Change From Baseline in Seven-Joint Ultrasound (US7) Erosion Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12
Baseline
|
0.67 units on a scale
Standard Deviation 0.58
|
5.00 units on a scale
Standard Deviation 1.41
|
|
Change From Baseline in Seven-Joint Ultrasound (US7) Erosion Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12
Change at Month 6
|
0.33 units on a scale
Standard Deviation 0.58
|
1.50 units on a scale
Standard Deviation 2.12
|
|
Change From Baseline in Seven-Joint Ultrasound (US7) Erosion Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12
Change at Month 12
|
0.33 units on a scale
Standard Deviation 0.58
|
0.50 units on a scale
Standard Deviation 0.71
|
Adverse Events
Etanercept: First Intention
Etanercept: Second Intention
Serious adverse events
| Measure |
Etanercept: First Intention
n=140 participants at risk
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
Etanercept: Second Intention
n=17 participants at risk
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
1/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
General disorders
Fatigue
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Diverticulitis
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
1/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
General disorders
Pain Chest
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
Other adverse events
| Measure |
Etanercept: First Intention
n=140 participants at risk
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
Etanercept: Second Intention
n=17 participants at risk
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Gastrointestinal disorders
Diarrhea
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
1/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Gastrointestinal disorders
Nausea
|
1.4%
2/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
General disorders
Asthenia
|
0.00%
0/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
1/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
General disorders
Fatigue
|
1.4%
2/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
General disorders
Injection site reaction
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
General disorders
Injection site erythema
|
1.4%
2/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
1/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
General disorders
Injection site pruritus
|
0.00%
0/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
1/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
General disorders
Injection site hypersensitivity
|
5.0%
7/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
11.8%
2/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
General disorders
Injection site pain
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
General disorders
Oedema
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
General disorders
Oedema peripheral
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Acute sinusitis
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Body tinea
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Bronchitis
|
1.4%
2/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Chlamydial infection
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Gingivitis
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Influenza
|
1.4%
2/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Oral herpes
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
1/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Pharyngitis
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Pneumonia
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Respiratory tract infection
|
1.4%
2/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Rhinitis
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Sinusitis
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
1/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.4%
2/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Urinary tract infection
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Viral pharyngitis
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
1/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
2.1%
3/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Nervous system disorders
Dysgeusia
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Nervous system disorders
Headache
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
1/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Nervous system disorders
Paresthesia
|
2.1%
3/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Nervous system disorders
Polyneuropathy
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Nervous system disorders
Syncope
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
1/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.4%
2/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
2.1%
3/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.1%
3/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.9%
4/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Cardiac disorders
Angina Pectoris
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Cardiac disorders
Cardiac disorder
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Eye disorders
Dry eye
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Eye disorders
Eye Irritation
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Eye disorders
Visual impairment
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Immune system disorders
Hypersensitivity
|
3.6%
5/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Investigations
Liver function test abnormal
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Investigations
Platelet count decreased
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Investigations
Weight decreased
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Investigations
White blood cell count decreased
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Psychiatric disorders
Depressive mood
|
0.71%
1/140 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/17 • From Day 1 up to 28 days after end of treatment (12 months)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER