This Study is to Investigate the Effect of Etanercept in Early Versus Delayed Referral for Management of Rheumatoid Arthritis Patients.

Completed

• Conditions: Arthritis Rheumatoid
• Interventions: Drug: Etanercept

• Registration Number: NCT04267614
• Lead Sponsor: Pfizer

Brief Summary

This study is to investigate the effect of etanercept in early versus delayed referral for management of rheumatoid arthritis patients assessing real-world patient data entered in the Iraq National Center of Rheumatology database between May 2012 and May 2017.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-01
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-01
• Study First Submitted: 2020-02-11
• Study First Submitted QC: 2020-02-11
• Study First Posted: 2020-02-13
• Status Verified: 2022-08
• Results First Submitted: 2022-08-10
• Results First Submitted QC: 2022-08-10
• Last Update Submitted: 2022-08-10
• Results First Posted: 2023-07-07
• Last Update Posted: 2023-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1226

Inclusion Criteria

• Diagnosed RA patients.
• 18 years old and above.
• Did not receive pervious biological treatment.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Rheumatoid Arthritis (RA)	Etanercept	Patients receiving etanercept from Baghdad teaching hospital registry(Rheumatology center) from 2012 till 2017. Patients were identified as receiving early versus delayed etanercept treatment.

Primary Outcome Measures

Name	Time	Method
Disease Activity Score 28 (DAS28) at Month 12	Month 12 (from the data retrieved and observed during 1 month of this study)	DAS28 was calculated from the number of swollen joints (SJC) and painful joints (PJC) using 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 or equal to (\<=) 3.2 = low disease activity, DAS28 greater than (\>) 3.2 to 5.1 = moderate to high disease activity. Participants were grouped based on early and delayed referral to management of RA with etanercept treatment. Early referral was considered when participants were referred to management of RA from 1 to 9.9 years and delayed referral was considered when participants were referred to management of RA for \>9.9 years after diagnosis with RA.
Clinical Disease Activity Index (CDAI) Score at Month 12	Month 12 (from the data retrieved and observed during 1 month of this study)	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. Participants were grouped based on early and delayed referral to management of RA with etanercept treatment. Early referral was considered when participants were referred to management of RA from 1 to 9.9 years and delayed referral was considered when participants were referred to management of RA for \>9.9 years after diagnosis with RA.

Trial Locations

Locations (1)

Pfizer; 🇮🇶 Baghdad, Iraq