Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Spectrum of Clinical Research in Juvenile Idiopathic Arthritis: a Cross-Sectional Analysis of Registered Studies in Clinicaltrials.gov and Clinicaltrialsregister.eu

Version 1 : Received: 14 October 2021 / Approved: 18 October 2021 / Online: 18 October 2021 (11:00:57 CEST)

How to cite: Lehmann, R.; Ries, M. Spectrum of Clinical Research in Juvenile Idiopathic Arthritis: a Cross-Sectional Analysis of Registered Studies in Clinicaltrials.gov and Clinicaltrialsregister.eu. Preprints 2021, 2021100241 (doi: 10.20944/preprints202110.0241.v1). Lehmann, R.; Ries, M. Spectrum of Clinical Research in Juvenile Idiopathic Arthritis: a Cross-Sectional Analysis of Registered Studies in Clinicaltrials.gov and Clinicaltrialsregister.eu. Preprints 2021, 2021100241 (doi: 10.20944/preprints202110.0241.v1).

Abstract

Management of Juvenile idiopathic arthritis (JIA) has improved tremendously in recent years due to the introduction of new drug therapies but remains complex also in terms of non-pharmaceutical issues. In order to determine the direction of scientific progress by characterizing the current spectrum of ongoing clinical research in JIA, we analyzed all ongoing studies in the field of JIA registered in clinicaltrials.gov and clinicaltrialsregister.eu concerning sponsoring, enrollment, duration, localization, and particularly objectives. Close of database was 7 January 2021. After identifying doubled-registered studies, N=72 went into further analysis. Of these, 61.1% were academia-sponsored and 37.5% by pharma industry. The majority of studies was of interventional type (77.8%), while others (22.2%) were observational. Median planned enrollments were 100 participants (interventional studies) and 175 participants (observational studies), respectively. Duration differed remarkably from one month to more than 15 years with a median of 42.5 months. 61.1% of studies were located in a single country, 38.9% were in several. Europe and North America clearly dominated study localizations. Study objectives were DMARDs (56.9%), followed by diagnostics and disease activity measurement (18.1%), and medication other than DMARD (12.5%), besides others. Studies on DMARDs were mainly sponsored by industry, predominantly interventional studies on established and novel biologics, with several on specific issues like systemic JIA and others. The spectrum of registered studies is currently centered on drug therapy and diagnostics, while other issues in JIA play a subordinated role.

Keywords

Juvenile idiopathic arthritis, JIA, Research registry, Clinical trial, DMARD

Subject

MEDICINE & PHARMACOLOGY, Pediatrics

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