CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 509 enrolled
Drug / intervention
Peficitinib +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02308163
NCT02308163Phase 3Completed

Phase 3 Study of ASP015K - A Randomized, Double-blind, Placebo-controlled Confirmatory Study of the Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis Who Had an Inadequate Response to DMARDs

Astellas Pharma Inc·interventional·Posted Dec 4, 2014·Updated Oct 28, 2024

In Brief

A Phase 3 clinical trial evaluating Peficitinib, Placebo, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 509 participants across 153 sites in 3 countries.

Detailed Summary

The objective of this study was to verify the superiority of ASP015K alone or in combination with disease-modifying antirheumatic drugs (DMARDs) over placebo in terms of efficacy in participants with rheumatoid arthritis (RA) who had an inadequate response to DMARDs

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan, South Korea, Taiwan
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 4, 2014
Enrollment StartAug 8, 2014
Primary CompletionJan 23, 2017
Study CompletionNov 22, 2017
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 11.6 years ago

Interventions

Peficitinibdrug

oral

Placebodrug

oral

Etanerceptbiological

subcutaneous injection