Pfizer
Baghdad, Iraq
NCT Number: NCT04267614
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.
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Notify Me0 year and older
All sexes
Observational
Baghdad, Iraq
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients who received etanercept for RA
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Month 12 (from the data retrieved and observed during 1 month of this study)
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.
Time frame: Baseline, Month 12 (from the data retrieved and observed during 1 month of this study)
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.
Pfizer
Industry
Clinical Outcomes of Early Versus Delayed Management of Iraqi Patients With Rheumatoid Arthritis With Etanercept
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