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

Pfizer1,226 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,226

Conditions

Arthritis Rheumatoid

Interventions

EtanerceptDRUG

Patients who received etanercept for RA

Eligibility

Sex: ALLMin age: 0 Years

Medical Language ↔ Plain English

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

Locations (1)

Pfizer

Baghdad, Iraq

Outcomes

Primary Outcomes

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.

Time frame: Month 12 (from the data retrieved and observed during 1 month of this study)

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.

Time frame: Month 12 (from the data retrieved and observed during 1 month of this study)

Data from ClinicalTrials.gov

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