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

• Conditions: Arthritis, Rheumatoid
• Interventions: Drug: Enbrel

• Registration Number: NCT04428424
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-10
• Study First Submitted QC: 2020-06-10
• Study First Posted: 2020-06-11
• Study Start: 2020-07-05
• Primary Completion: 2020-08-30
• Study Completion: 2020-08-30
• Status Verified: 2021-08
• Results First Submitted: 2021-08-12
• Results First Submitted QC: 2021-08-12
• Last Update Submitted: 2021-08-12
• Results First Posted: 2021-09-09
• Last Update Posted: 2021-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1493

Inclusion Criteria

• Diagnosed RA patients.

  -≥18 years of age

• Did not receive previous another biological treatment

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Exclusion Criteria

• Had previous biological treatment
• Use of etanercept for less than 1 year

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with rheumatoid arthritis	Enbrel	Iraqi patients with rheumatoid arthritis that received Enbrel as treatment for disease

Primary Outcome Measures

Name	Time	Method
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)	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 measure.
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)	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.
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)	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.
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)	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.

Trial Locations

Locations (1)

Pfizer; 🇮🇶 Baghdad, Iraq