title: Clinical trials in rheumatoid arthritis: a status report from the ClinicalTrials.gov website.
abstract: The aims of this study are to describe the characteristics of clinical trials in rheumatoid arthritis (RA) listed in ClinicalTrials.gov and examine existing trends in study design, funding sources, outcomes, and drugs under investigation. We conducted a survey of ongoing clinical trials in RA registered in the ClinicalTrials.gov website. We used the advanced search option and applied the following inclusion criteria, "rheumatoid arthritis", "open studies", "interventional", and "adults 18 years or older". Of 127 eligible trials, 53.5% of the studies were either phase 3 or 4, and 40.2% were phase 1, 2, and 2/3. Two-thirds of the trials were randomized (70.9%), and over half were, in addition, double-blinded (53.5%) and placebo-controlled (53.5%). Universities were listed as the primary sponsor for 18.9% of the trials and pharmaceutical industry for 73.2%. Majority of the trials were multi-center studies (93%) conducted outside the United States (54.3%). The most frequently used endpoint was drug efficacy (54.3%) followed by drug safety (25.2%). Most industry-funded trials were open for less than 12 months, whereas most university-funded trials were open for more than 24 months (58% each). Biologic therapies were the focus of most trials in the registry (78.5%). Randomized, double-blinded, placebo-controlled, phase 3 and 4 trials form the majority of ongoing clinical trials in RA. The preponderance of industry funding of RA trials and the short duration of such trials are troubling trends which need to be addressed.
authors.affiliation: Department of Medicine, St. Luke's Hospital, St. Louis, MO, USA.
authors.forename: Jisna R
authors.initials: JR
authors.lastname: Paul
authors.forename: Prabha
authors.initials: P
authors.lastname: Ranganathan
mesh_terms: D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000628:therapy*; D002986:Clinical Trials as Topic / Q000191:economics / Q000941:ethics / Q000639:trends*; D016265:Conflict of Interest; D004345:Drug Industry / Q000191:economics / Q000941:ethics / Q000639:trends; D019317:Evidence-Based Medicine / Q000639:trends; D005380:Financing, Government / Q000941:ethics / Q000639:trends; D019538:Health Care Surveys; D006801:Humans; D020407:Internet / Q000639:trends*; D012042:Registries; D012107:Research Design / Q000639:trends*; D012109:Research Support as Topic / Q000941:ethics / Q000639:trends; D013997:Time Factors; D016896:Treatment Outcome; D014495:Universities / Q000191:economics / Q000941:ethics / Q000639:trends