Radiographic progression in clinical trials in rheumatoid arthritis: a systemic literature review of trials performed by industry.

RMD Open
Yune-Jung ParkD M van der Heijde

Abstract

To summarise radiographic data in randomised controlled trials (RCTs) as part of the radiographic inhibition claim of disease-modifying antirheumatic drugs (DMARDs) approved for patients with rheumatoid arthritis (RA). A systemic literature review was performed using the Medline database from 1994 to February 2020. The results were grouped based on the scoring methods (Sharp, Genant modification, van der Heijde modification) and RA patient populations. One hundred sixty-eight publications were selected. After detailed assessment, 52 RCTs (7 methotrexate (MTX)-naive, 23 MTX inadequate response (IR), 9 DMARDs IR and 3 tumour necrosis factor-alpha inhibitors (TNFi) IR studies) were finally included. Information on patient population, scoring method used, reader reliability, statistical analyses and detailed radiographic data on baseline and change scores over multiple follow-up periods are presented. The data gathered in this review serve as a repository for the design of future trials with radiographic damage as an outcome.

References

Jan 13, 1996·BMJ : British Medical Journal·D L SackettW S Richardson
Nov 30, 2000·The New England Journal of Medicine·J M BathonB K Finck
Mar 6, 2004·Lancet·Lars KlareskogUNKNOWN TEMPO (Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes) study investigators
Nov 6, 2004·Arthritis and Rheumatism·E William St ClairUNKNOWN Active-Controlled Study of Patients Receiving Infliximab for the Treatment of Rheumatoid Arthritis of Early Onset Study Grou
Nov 29, 2011·Annals of the Rheumatic Diseases·Yoshiya TanakaUNKNOWN GO-FORTH Study Group
Jun 19, 2014·The New England Journal of Medicine·Eun Bong LeeUNKNOWN ORAL Start Investigators
Nov 6, 2014·The New England Journal of Medicine·Paul EmeryBonnie Vlahos
Oct 30, 2015·Annals of the Rheumatic Diseases·Gerd R BurmesterNina Mitchell
Feb 16, 2017·The New England Journal of Medicine·Peter C TaylorYoshiya Tanaka

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NCT00195494
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