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Ten Years of Interventional Research in Systemic Sclerosis: A Systematic Mapping of Trial Registries
Author(s) -
Iudici Michele,
Bafeta Aïda,
Atal Ignacio,
Ravaud Philippe
Publication year - 2020
Publication title -
arthritis care and research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.032
H-Index - 163
eISSN - 2151-4658
pISSN - 2151-464X
DOI - 10.1002/acr.23817
Subject(s) - medicine , multiple sclerosis , medical physics , psychiatry
Objective To provide a comprehensive overview of interventional clinical trials registered in international databases and planned and conducted within the last 10 years in patients with systemic sclerosis ( SS c). Methods We searched the International Clinical Trials Registry Platform for all records on interventional clinical trials targeting patients with SS c performed since September 2007. Two reviewers selected studies according to the prespecified eligibility criteria. Information on start date, country of origin, funding sources, phase of development, study design, (planned) sample size, enrollment status, outcomes, disease complication, and treatments investigated were retrieved and summarized. Results Among the 198 eligible studies identified (122 randomized controlled trials [ RCT s; 62%]), 87 (30%) were conducted in Europe, 165 (83%) in a single country, and 81 (41%) were industry‐funded. The majority of trials investigated pharmacologic treatments (75%), mostly nonbiotherapies (57%). RCT s were mostly 2‐arm (82%) placebo‐controlled (71%) studies with a median number of patients enrolled or planned to be enrolled of 40 (interquartile range 25–77 [range 10–586]). Twenty‐one RCT s (17%) planned to enroll or enrolled >100 patients. Time to assess the primary outcome was found to be adequate in 29% to 50% of RCT s retrieved. Patients age >65 years were excluded in 14% of studies. SS c complications more frequently investigated in overall studies were skin thickness (26%), Raynaud's phenomenon/digital ulcers (24%), and interstitial lung disease (14%). Conclusion The SS c research landscape is dominated by small, short, and mainly placebo‐controlled trials, especially investigating pharmacologic treatments. Some patients’ needs continue to be neglected.