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

Arthritis Rheumatoid Clinical Trial

Official title:

Clinical Outcomes of Early Versus Delayed Management of Iraqi Patients With Rheumatoid Arthritis With Etanercept

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04267614
• Other study ID #: B1801411
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: August 2022
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1226
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis Rheumatoid
• Arthritis, Rheumatoid

Intervention

Drug:
• Etanercept
Patients who received etanercept for RA

Locations

Country	Name	City	State
Iraq	Pfizer	Baghdad

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean Change From Baseline in DAS28 at Month 12	DAS28 was calculated from the SJC and PJC using 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. 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. Baseline was defined as Day 0 before receiving etanercept.	Baseline, Month 12 (from the data retrieved and observed during 1 month of this study)
Other	Mean Change From Baseline in CDAI Score at Month 12	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. 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. Baseline was defined as Day 0 before receiving etanercept.	Baseline, Month 12 (from the data retrieved and observed during 1 month of this study)
Primary	Disease Activity Score 28 (DAS28) at Month 12	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.	Month 12 (from the data retrieved and observed during 1 month of this study)
Primary	Clinical Disease Activity Index (CDAI) Score at Month 12	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.	Month 12 (from the data retrieved and observed during 1 month of this study)