CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 519 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/NCT02305849
NCT02305849Phase 3Completed

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

Astellas Pharma Inc·interventional·Posted Dec 3, 2014·Updated Oct 28, 2024

In Brief

A Phase 3 clinical trial evaluating Peficitinib, Placebo, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 519 participants across 146 sites.

Detailed Summary

The objective of this study was to verify the efficacy of ASP015K versus placebo administrated in combination with methotrexate (MTX) over placebo in terms of efficacy in participants with rheumatoid arthritis (RA) who had an inadequate response to MTX

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 3, 2014
Enrollment StartJul 25, 2014
Primary CompletionJun 20, 2017
Study CompletionNov 28, 2017
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 11.6 years ago

Interventions

Peficitinibdrug

oral tablet

Placebodrug

oral tablet

Methotrexatedrug

Oral tablet/capsule