Trial Outcomes & Findings for Study To Evaluate The Response To Enbrel And The Impact Of Rheumatoid Factor(RF) And Anti-Cyclic Citrullinated Peptide(Anti-CCP) In Rheumatoid Arthritis(RA) Patients (NCT NCT04428424)

NCT ID: NCT04428424

Last Updated: 2021-09-09

Results Overview

DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (in millimeters per hour \[mm/hour\]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity). DAS28 less than equal to (\<=) 3.2 = low disease activity, DAS28 greater than (\>) 3.2 to 5.1 = moderate to high disease activity. DAS28 score in participants with positive RF and ACCP were reported in this outcome measure.

Recruitment status

COMPLETED

Target enrollment

1493 participants

Primary outcome timeframe

Month 12 visit during retrospective data collection period of approximately 7 years

Results posted on

2021-09-09

Participant Flow

Participant milestones

Participant milestones
Measure
Etanercept
Participants with rheumatoid arthritis (RA) and who received etanercept from Baghdad Teaching Hospital (Rheumatology center) from May 2012 until August 2019 were included in this study. Their data was collected from the Baghdad Teaching Hospital registry and retrospectively assessed for 1 month.
Overall Study
STARTED
1493
Overall Study
COMPLETED
1246
Overall Study
NOT COMPLETED
247

Reasons for withdrawal

Reasons for withdrawal
Measure
Etanercept
Participants with rheumatoid arthritis (RA) and who received etanercept from Baghdad Teaching Hospital (Rheumatology center) from May 2012 until August 2019 were included in this study. Their data was collected from the Baghdad Teaching Hospital registry and retrospectively assessed for 1 month.
Overall Study
Does not meet entrance criteria
132
Overall Study
Lost to Follow-up
115

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Etanercept
n=1493 Participants
Participants with RA and who received etanercept from Baghdad Teaching Hospital (Rheumatology center) from May 2012 until August 2019 were included in this study. Their data was collected from the Baghdad Teaching Hospital registry and retrospectively assessed for 1 month.
Age, Continuous
48.3 years
STANDARD_DEVIATION 11.7 • n=1493 Participants
Sex: Female, Male
Female
1234 Participants
n=1493 Participants
Sex: Female, Male
Male
259 Participants
n=1493 Participants

PRIMARY outcome

Timeframe: Month 12 visit during retrospective data collection period of approximately 7 years

Population: Analysis was performed on all participants who were included in this study. Here "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for this outcome measure for specified rows.

DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (in millimeters per hour \[mm/hour\]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity). DAS28 less than equal to (\<=) 3.2 = low disease activity, DAS28 greater than (\>) 3.2 to 5.1 = moderate to high disease activity. DAS28 score in participants with positive RF and ACCP were reported in this outcome measure.

Outcome measures

Outcome measures
Measure
Etanercept
n=1122 Participants
Participants with RA and who received etanercept from Baghdad Teaching Hospital (Rheumatology center) from May 2012 until August 2019 were included in this study. Their data was collected from the Baghdad Teaching Hospital registry and retrospectively assessed for 1 month.
Disease Activity Score 28 (DAS28) in Participants With Positive Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide (ACCP) at Last Follow-up Visit (Month 12)
Positive RF
3.13 units on a scale
Standard Deviation 1.6
Disease Activity Score 28 (DAS28) in Participants With Positive Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide (ACCP) at Last Follow-up Visit (Month 12)
Positive ACCP
3.1 units on a scale
Standard Deviation 1.58

PRIMARY outcome

Timeframe: Month 12 visit during retrospective data collection period of approximately 7 years

Population: Analysis was performed on all participants who were included in this study. Here "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for this outcome measure for specified rows.

The CDAI is the numerical sum of 4 outcome parameters: tender joint count (TJC) and SJC based on a 28-joint assessment, PGA and physician global assessment (PhGA) assessed on 0 to 10 centimeter (cm) visual analog scale (VAS); higher scores = high disease activity. CDAI total score = 0 to 76. CDAI \<= 2.8 indicates disease remission, \> 2.8 to 10 = low disease activity, \> 10 to 22 = moderate disease activity and \> 22 = high disease activity. CDAI score in participants with positive RF and ACCP were reported in this outcome measure.

Outcome measures

Outcome measures
Measure
Etanercept
n=1122 Participants
Participants with RA and who received etanercept from Baghdad Teaching Hospital (Rheumatology center) from May 2012 until August 2019 were included in this study. Their data was collected from the Baghdad Teaching Hospital registry and retrospectively assessed for 1 month.
Clinical Disease Activity Index (CDAI) Score in Participants With Positive Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide (ACCP) at Last Follow-up Visit (Month 12)
Positive RF
8.0 units on a scale
Standard Deviation 10.4
Clinical Disease Activity Index (CDAI) Score in Participants With Positive Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide (ACCP) at Last Follow-up Visit (Month 12)
Positive ACCP
8.2 units on a scale
Standard Deviation 10.9

PRIMARY outcome

Timeframe: Month 12 visit during retrospective data collection period of approximately 7 years

Population: Analysis was performed on all participants who were included in this study. Here "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for this outcome measure for specified rows.

DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (in mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity). DAS28 \<= 3.2 = low disease activity, DAS28 \> 3.2 to 5.1 = moderate to high disease activity. DAS28 score in participants with negative RF and ACCP were reported in this outcome measure.

Outcome measures

Outcome measures
Measure
Etanercept
n=439 Participants
Participants with RA and who received etanercept from Baghdad Teaching Hospital (Rheumatology center) from May 2012 until August 2019 were included in this study. Their data was collected from the Baghdad Teaching Hospital registry and retrospectively assessed for 1 month.
Disease Activity Score 28 (DAS28) in Participants With Negative Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide (ACCP) at Last Follow-up Visit (Month 12)
Negative RF
3.10 units on a scale
Standard Deviation 1.59
Disease Activity Score 28 (DAS28) in Participants With Negative Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide (ACCP) at Last Follow-up Visit (Month 12)
Negative ACCP
3.16 units on a scale
Standard Deviation 1.6

PRIMARY outcome

Timeframe: Month 12 visit during retrospective data collection period of approximately 7 years

Population: Analysis was performed on all participants who were included in this study. Here "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for this outcome measure for specified rows.

The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGA and PhGA assessed on 0 to 10 cm VAS; higher scores = high disease activity. CDAI total score = 0 to 76. CDAI \<= 2.8 indicates disease remission, \> 2.8 to 10 = low disease activity, \> 10 to 22 = moderate disease activity and \> 22 = high disease activity. CDAI score in participants with negative RF and ACCP were reported in this outcome measure.

Outcome measures

Outcome measures
Measure
Etanercept
n=439 Participants
Participants with RA and who received etanercept from Baghdad Teaching Hospital (Rheumatology center) from May 2012 until August 2019 were included in this study. Their data was collected from the Baghdad Teaching Hospital registry and retrospectively assessed for 1 month.
Clinical Disease Activity Index (CDAI) Score in Participants With Negative Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide (ACCP) at Last Follow-up Visit (Month 12)
Negative RF
7.3 units on a scale
Standard Deviation 9.0
Clinical Disease Activity Index (CDAI) Score in Participants With Negative Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide (ACCP) at Last Follow-up Visit (Month 12)
Negative ACCP
6.8 units on a scale
Standard Deviation 7.5

Adverse Events

Etanercept

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

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