NCT04428424

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

Completed Results posted Last updated 9 September 2021

What this trial tests

trial testing Enbrel in Arthritis, Rheumatoid in 1,493 participants. Completed in 30 August 2020.

Timeline

5 July 2020

Primary endpoint
30 August 2020

30 August 2020

Quick facts

Lead sponsor	Pfizer
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,493
Start date	5 July 2020
Primary completion	30 August 2020
Estimated completion	30 August 2020
Sites	1 location across Iraq

Drugs / interventions tested

• Enbrel (etanercept) — full drug profile →

Conditions studied

• Arthritis, Rheumatoid — all drugs for Arthritis, Rheumatoid →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Arthritis, Rheumatoid. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

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 m

Positive RF

Group	Value	95% CI
Etanercept	3.13	± 1.6

Positive ACCP

Group	Value	95% CI
Etanercept	3.1	± 1.58

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

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.

Positive RF

Group	Value	95% CI
Etanercept	8.0	± 10.4

Positive ACCP

Group	Value	95% CI
Etanercept	8.2	± 10.9

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

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.

Negative RF

Group	Value	95% CI
Etanercept	3.10	± 1.59

Negative ACCP

Group	Value	95% CI
Etanercept	3.16	± 1.6

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

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.

Negative RF

Group	Value	95% CI
Etanercept	7.3	± 9.0

Negative ACCP

Group	Value	95% CI
Etanercept	6.8	± 7.5

Sponsor's own description

This study is to evaluate available local data in Iraqi patients with rheumatoid arthritis on Enbrel treatment with regards to the impact of Rheumatoid factor and Anti-cyclic citrullinated peptide using data from the Baghdad Teaching Hospital registry.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Citrullination in the pathology of inflammatory and autoimmune disorders: recent advances and future perspectives.
   Ciesielski O, Biesiekierska M, Panthu B, Soszyński M, et al · · 2022 · cited 107× · PMID 35079870 · DOI 10.1007/s00018-022-04126-3