NCT01649999

A Study to Evaluate the Efficacy and Safety of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects

Completed Phase 2 Last updated 21 October 2024

What this trial tests

Phase 2 trial testing peficitinib in Arthritis, Rheumatoid in 281 participants. Completed in 20 July 2013.

Timeline

1 March 2012

Primary endpoint
20 July 2013

20 July 2013

Quick facts

Lead sponsor	Astellas Pharma Inc
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	281
Start date	1 March 2012
Primary completion	20 July 2013
Estimated completion	20 July 2013
Sites	7 locations across Japan

Drugs / interventions tested

• peficitinib — full drug profile →
• Placebo

Conditions studied

• Arthritis, Rheumatoid — all drugs for Arthritis, Rheumatoid →

Sponsor

Astellas Pharma Inc — full company profile →

Who can join

Adults 20 to 75, any sex, with Arthritis, Rheumatoid. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is to evaluate the efficacy and safety of ASP015K monotherapy and to evaluate the dose-dependent response of ASP015K in moderate to severe Rheumatoid Arthritis (RA) subjects given ASP015K for 12 weeks.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy and safety of the oral Janus kinase inhibitor peficitinib (ASP015K) monotherapy in patients with moderate to severe rheumatoid arthritis in Japan: a 12-week, randomised, double-blind, placebo-controlled phase IIb study.
   Takeuchi T, Tanaka Y, Iwasaki M, Ishikura H, et al · · 2016 · cited 119× · PMID 26672064 · DOI 10.1136/annrheumdis-2015-208279
2. Janus Kinase Inhibitors Improve Disease Activity and Patient-Reported Outcomes in Rheumatoid Arthritis: A Systematic Review and Meta-Analysis of 24,135 Patients.
   Tóth L, Juhász MF, Szabó L, Abada A, et al · · 2022 · cited 35× · PMID 35163173 · DOI 10.3390/ijms23031246
3. Jakinibs of All Trades: Inhibiting Cytokine Signaling in Immune-Mediated Pathologies.
   Alexander M, Luo Y, Raimondi G, O'Shea JJ, et al · · 2021 · cited 27× · PMID 35056105 · DOI 10.3390/ph15010048
4. Safety and effectiveness of peficitinib (ASP015K) in patients with rheumatoid arthritis: interim data (22.7 months mean peficitinib treatment) from a long-term, open-label extension study in Japan, Korea, and Taiwan.
   Takeuchi T, Tanaka Y, Tanaka S, Kawakami A, et al · · 2020 · cited 18× · PMID 32164762 · DOI 10.1186/s13075-020-2125-2
5. Comparative efficacy of five approved Janus kinase inhibitors as monotherapy and combination therapy in patients with moderate-to-severe active rheumatoid arthritis: a systematic review and network meta-analysis of randomized controlled trials.
   Cai W, Tong R, Sun Y, Yao Y, et al · · 2024 · cited 17× · PMID 38725657 · DOI 10.3389/fphar.2024.1387585
6. Population pharmacokinetic analysis of peficitinib in patients with rheumatoid arthritis.
   Toyoshima J, Shibata M, Kaibara A, Kaneko Y, et al · · 2021 · cited 10× · PMID 33068028 · DOI 10.1111/bcp.14605
7. Efficacy and Safety of JAK Inhibitors for Rheumatoid Arthritis: A Meta-Analysis.
   Wang F, Tang X, Zhu M, Mao H, et al · · 2022 · cited 8× · PMID 35956078 · DOI 10.3390/jcm11154459
8. Comparative Efficacy and Safety of JAK Inhibitors in the Management of Rheumatoid Arthritis: A Network Meta-Analysis.
   Almoallim HM, Omair MA, Ahmed SA, Vidyasagar K, et al · · 2025 · cited 6× · PMID 40005992 · DOI 10.3390/ph18020178