Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis (RA) (NCT NCT03823391)
NCT ID: NCT03823391
Last Updated: 2021-07-19
Results Overview
The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a visual analog scale \[VAS\] from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0.96 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2021-07-19
Participant Flow
Participants with moderately to severely active rheumatoid arthritis (RA) on background methotrexate (MTX) were enrolled at 14 sites in the United States and Puerto Rico, Poland, Hungary, and Israel.
Participants were randomly assigned in a 2:1 ratio to either ABBV-3373 or adalimumab. Randomization was stratified by current use of systemic glucocorticoid (≤ 7.5 mg/d prednisone equivalent) for treatment of RA at Baseline (yes/no) and prior exposure to non-anti-tumor necrosis factor (TNF) biologics or targeted synthetic disease-modifying antirheumatic drugs (DMARDs) for less than 3 months and terminated not due to lack of efficacy or intolerance (yes/no).
Participant milestones
| Measure |
Adalimumab
Participants were administered placebo to ABBV-3373 by intravenous (IV) infusion and 80 mg adalimumab by subcutaneous injection every other week (EOW) for 12 weeks. After 12 weeks, participants received 80 mg adalimumab subcutaneously EOW until Week 22.
|
ABBV-3373 Followed by Placebo
Participants were administered 100 mg ABBV-3373 by intravenous infusion and placebo to adalimumab by subcutaneous injection every other week for 12 weeks. After 12 weeks, participants received placebo to adalimumab EOW until Week 22.
|
|---|---|---|
|
Period 1: Week 1 to Week 12
STARTED
|
17
|
31
|
|
Period 1: Week 1 to Week 12
COMPLETED
|
17
|
31
|
|
Period 1: Week 1 to Week 12
NOT COMPLETED
|
0
|
0
|
|
Period 2: Weeks 12 to Week 24
STARTED
|
17
|
31
|
|
Period 2: Weeks 12 to Week 24
COMPLETED
|
15
|
30
|
|
Period 2: Weeks 12 to Week 24
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Adalimumab
Participants were administered placebo to ABBV-3373 by intravenous (IV) infusion and 80 mg adalimumab by subcutaneous injection every other week (EOW) for 12 weeks. After 12 weeks, participants received 80 mg adalimumab subcutaneously EOW until Week 22.
|
ABBV-3373 Followed by Placebo
Participants were administered 100 mg ABBV-3373 by intravenous infusion and placebo to adalimumab by subcutaneous injection every other week for 12 weeks. After 12 weeks, participants received placebo to adalimumab EOW until Week 22.
|
|---|---|---|
|
Period 2: Weeks 12 to Week 24
Adverse Event
|
1
|
1
|
|
Period 2: Weeks 12 to Week 24
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis (RA)
Baseline characteristics by cohort
| Measure |
Adalimumab
n=17 Participants
Participants were administered placebo to ABBV-3373 by IV infusion and 80 mg adalimumab by subcutaneous injection EOW for 12 weeks. After 12 weeks, participants received 80 mg adalimumab subcutaneously EOW until Week 22.
|
ABBV-3373 Followed by Placebo
n=31 Participants
Participants were administered 100 mg ABBV-3373 by IV infusion and placebo to adalimumab by subcutaneous injection EOW for 12 weeks. After 12 weeks, participants received placebo to adalimumab EOW until Week 22.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.0 years
STANDARD_DEVIATION 10.21 • n=99 Participants
|
52.8 years
STANDARD_DEVIATION 13.14 • n=107 Participants
|
53.2 years
STANDARD_DEVIATION 12.08 • n=206 Participants
|
|
Age, Customized
< 40 years
|
0 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Age, Customized
40 to 65 years
|
13 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Age, Customized
≥ 65 years
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
16 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Duration of RA Symptoms
|
5.9 years
STANDARD_DEVIATION 3.22 • n=99 Participants
|
8.0 years
STANDARD_DEVIATION 8.73 • n=107 Participants
|
7.2 years
STANDARD_DEVIATION 7.29 • n=206 Participants
|
|
Duration of RA Diagnosis
|
3.5 years
STANDARD_DEVIATION 3.09 • n=99 Participants
|
5.0 years
STANDARD_DEVIATION 6.02 • n=107 Participants
|
4.5 years
STANDARD_DEVIATION 5.19 • n=206 Participants
|
|
Baseline Use of Systemic Glucocorticoids
Yes
|
5 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Baseline Use of Systemic Glucocorticoids
No
|
12 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Prior Exposure to Non-anti-TNF or Targeted Synthetic DMARDs
Yes
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Prior Exposure to Non-anti-TNF or Targeted Synthetic DMARDs
No
|
17 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Disease Activity Score 28 C-reactive protein (DAS28[CRP])
|
5.6 units on a scale
STANDARD_DEVIATION 0.71 • n=99 Participants
|
5.6 units on a scale
STANDARD_DEVIATION 0.92 • n=107 Participants
|
5.6 units on a scale
STANDARD_DEVIATION 0.84 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Participants in the full analysis set with non-missing Baseline and at least one post-baseline value are included in the analyses.
The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a visual analog scale \[VAS\] from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0.96 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
Outcome measures
| Measure |
Adalimumab
n=17 Participants
Participants were administered placebo to ABBV-3373 by IV infusion and 80 mg adalimumab by subcutaneous injection EOW for 12 weeks.
|
ABBV-3373
n=31 Participants
Participants were administered 100 mg ABBV-3373 by IV infusion and placebo to adalimumab by subcutaneous injection EOW for 12 weeks.
|
|---|---|---|
|
Change From Baseline to Week 12 in Disease Activity Score (DAS) 28 (C-reactive Protein [CRP])
|
-2.51 score on a scale
Standard Error 0.293
|
-2.65 score on a scale
Standard Error 0.215
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Participants in the full analysis set with non-missing Baseline and at least one post-baseline value were included in the analyses.
The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient Global Assessment of Disease Activity and Physician Global Assessment of Disease Activity both measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 76 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity.
Outcome measures
| Measure |
Adalimumab
n=17 Participants
Participants were administered placebo to ABBV-3373 by IV infusion and 80 mg adalimumab by subcutaneous injection EOW for 12 weeks.
|
ABBV-3373
n=31 Participants
Participants were administered 100 mg ABBV-3373 by IV infusion and placebo to adalimumab by subcutaneous injection EOW for 12 weeks.
|
|---|---|---|
|
Change From Baseline to Week 12 in Clinical Disease Activity Index (CDAI)
|
-26.30 score on a scale
Standard Error 2.656
|
-27.99 score on a scale
Standard Error 1.955
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Participants in the full analysis set with non-missing Baseline and at least one post-baseline value were included in the analyses.
The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), Patient Global Assessment of Disease Activity and Physician Global Assessment of Disease Activity both measured on a VAS from 0-10 cm and level of CRP (in mg/dL; normal \< 1 mg/dL). The SDAI has a range from 0 to 86, with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity.
Outcome measures
| Measure |
Adalimumab
n=17 Participants
Participants were administered placebo to ABBV-3373 by IV infusion and 80 mg adalimumab by subcutaneous injection EOW for 12 weeks.
|
ABBV-3373
n=31 Participants
Participants were administered 100 mg ABBV-3373 by IV infusion and placebo to adalimumab by subcutaneous injection EOW for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Simplified Disease Activity Index (SDAI)
|
-27.42 score on a scale
Standard Error 2.659
|
-28.50 score on a scale
Standard Error 1.961
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Participants in the full analysis set with non-missing Baseline and at least one post-baseline value were included in the analyses.
The DAS28 (ESR) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and ESR (in mm/hr). Scores on the DAS28 (ESR) range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline indicates improvement in disease activity.
Outcome measures
| Measure |
Adalimumab
n=17 Participants
Participants were administered placebo to ABBV-3373 by IV infusion and 80 mg adalimumab by subcutaneous injection EOW for 12 weeks.
|
ABBV-3373
n=31 Participants
Participants were administered 100 mg ABBV-3373 by IV infusion and placebo to adalimumab by subcutaneous injection EOW for 12 weeks.
|
|---|---|---|
|
Change From Baseline to Week 12 in DAS28 (Erythrocyte Sedimentation Rate [ESR])
|
-2.55 score on a scale
Standard Error 0.344
|
-2.76 score on a scale
Standard Error 0.254
|
SECONDARY outcome
Timeframe: Week 12Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom DAS28 data were missing at Week 12 were considered non-responders.
The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0.96 to approximately 10, where higher scores indicate more disease activity. A DAS28 (CRP) score less than or equal to 3.2 indicates low disease activity.
Outcome measures
| Measure |
Adalimumab
n=17 Participants
Participants were administered placebo to ABBV-3373 by IV infusion and 80 mg adalimumab by subcutaneous injection EOW for 12 weeks.
|
ABBV-3373
n=31 Participants
Participants were administered 100 mg ABBV-3373 by IV infusion and placebo to adalimumab by subcutaneous injection EOW for 12 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28 (CRP) at Week 12
|
58.8 percentage of participants
Interval 39.2 to 78.5
|
54.8 percentage of participants
Interval 40.1 to 69.5
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: 1. ≥ 50% improvement in 68-tender joint count; 2. ≥ 50% improvement in 66-swollen joint count; and 3. ≥ 50% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Outcome measures
| Measure |
Adalimumab
n=17 Participants
Participants were administered placebo to ABBV-3373 by IV infusion and 80 mg adalimumab by subcutaneous injection EOW for 12 weeks.
|
ABBV-3373
n=31 Participants
Participants were administered 100 mg ABBV-3373 by IV infusion and placebo to adalimumab by subcutaneous injection EOW for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
|
64.7 percentage of participants
Interval 45.6 to 83.8
|
51.6 percentage of participants
Interval 36.8 to 66.4
|
Adverse Events
Period 1: ABBV-3373
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
Period 1: Adalimumab
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Period 2: ABBV-3773 / Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Period 2: Adalimumab / Adalimumab
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Period 1: ABBV-3373
n=31 participants at risk
Participants received 100 mg ABBV-3373 by intravenous infusion EOW and placebo to adalimumab by subcutaneous injection EOW for 12 weeks.
|
Period 1: Adalimumab
n=17 participants at risk
Participants received 80 mg adalimumab by subcutaneous injection EOW and placebo to ABBV-3373 by intravenous infusion EOW for 12 weeks.
|
Period 2: ABBV-3773 / Placebo
n=30 participants at risk
Participants received placebo to adalimumab by subcutaneous injection EOW from Week 12 to Week 24.
|
Period 2: Adalimumab / Adalimumab
n=16 participants at risk
Participants continued to receive 80 mg adalimumab by subcutaneous injection EOW from Week 12 to Week 24.
|
|---|---|---|---|---|
|
General disorders
NON-CARDIAC CHEST PAIN
|
3.2%
1/31 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/17 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/30 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/16 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
Immune system disorders
ANAPHYLACTIC SHOCK
|
3.2%
1/31 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/17 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/30 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/16 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
Infections and infestations
BREAST ABSCESS
|
0.00%
0/31 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/17 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/30 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/31 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/17 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/30 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
Infections and infestations
PNEUMONIA
|
3.2%
1/31 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/17 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/30 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/16 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
3.2%
1/31 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/17 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/30 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/16 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
Other adverse events
| Measure |
Period 1: ABBV-3373
n=31 participants at risk
Participants received 100 mg ABBV-3373 by intravenous infusion EOW and placebo to adalimumab by subcutaneous injection EOW for 12 weeks.
|
Period 1: Adalimumab
n=17 participants at risk
Participants received 80 mg adalimumab by subcutaneous injection EOW and placebo to ABBV-3373 by intravenous infusion EOW for 12 weeks.
|
Period 2: ABBV-3773 / Placebo
n=30 participants at risk
Participants received placebo to adalimumab by subcutaneous injection EOW from Week 12 to Week 24.
|
Period 2: Adalimumab / Adalimumab
n=16 participants at risk
Participants continued to receive 80 mg adalimumab by subcutaneous injection EOW from Week 12 to Week 24.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.00%
0/31 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/17 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/30 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
Eye disorders
PERIORBITAL SWELLING
|
0.00%
0/31 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/17 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/30 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.00%
0/31 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/30 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/16 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
Gastrointestinal disorders
MOUTH SWELLING
|
0.00%
0/31 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/17 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/30 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/31 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/17 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/30 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
General disorders
INFUSION SITE BRUISING
|
0.00%
0/31 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/30 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/16 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
General disorders
INJECTION SITE PRURITUS
|
0.00%
0/31 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/17 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/30 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/31 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/17 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/30 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
General disorders
PYREXIA
|
0.00%
0/31 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/17 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/30 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.00%
0/31 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/17 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/30 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
Immune system disorders
TYPE I HYPERSENSITIVITY
|
0.00%
0/31 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/30 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/16 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
Infections and infestations
BRONCHITIS
|
3.2%
1/31 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/17 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/30 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/31 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/30 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/16 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/31 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
10.0%
3/30 • Number of events 3 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
12.5%
2/16 • Number of events 2 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
Infections and infestations
ORAL HERPES
|
0.00%
0/31 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/30 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/31 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/17 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
3.3%
1/30 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/31 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/17 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
6.7%
2/30 • Number of events 2 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
6.5%
2/31 • Number of events 2 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
11.8%
2/17 • Number of events 2 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
3.3%
1/30 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
Investigations
BLOOD PRESSURE INCREASED
|
0.00%
0/31 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/30 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/16 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.00%
0/31 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/17 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/30 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
Investigations
MYCOPLASMA TEST POSITIVE
|
0.00%
0/31 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/17 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/30 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/31 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/30 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/16 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/31 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/17 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
3.3%
1/30 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/31 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/30 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/16 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/31 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/17 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/30 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
|
0.00%
0/31 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/17 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
10.0%
3/30 • Number of events 3 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/16 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
Nervous system disorders
HEADACHE
|
6.5%
2/31 • Number of events 2 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/30 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.00%
0/31 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/30 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/16 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
Nervous system disorders
SCIATICA
|
0.00%
0/31 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/17 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/30 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIAL HYPERREACTIVITY
|
0.00%
0/31 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/30 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/16 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/31 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/17 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/30 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/31 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/30 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
6.2%
1/16 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/31 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
5.9%
1/17 • Number of events 1 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/30 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
0.00%
0/16 • From first dose of study drug up to 70 days after last dose; the treatment duration was 12 weeks in each period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER