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A Study to Assess Safety and Efficacy of ASP015K in Participants With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to Methotrexate (MTX)

NCT03660059 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 385

Last updated 2024-10-21

No results posted yet for this study

Summary

The purpose of this study is to verify the superiority of ASP015K in combination with MTX or with other disease-modifying antirheumatic drugs (DMARDs) over placebo in terms of efficacy in participants with rheumatoid arthritis (RA) who had an inadequate response or intolerance to MTX, as measured by the American College of Rheumatology (ACR) 20 response rate at Week 24.

This study will also evaluate the pharmacokinetics and safety of ASP015K as well as efficacy and safety of long-term treatment with ASP015K (52 weeks).

Conditions

  • Rheumatoid Arthritis (RA)

Interventions

DRUG

Peficitinib

Oral

DRUG

Plaebo

Oral

DRUG

Disease-modifying antirheumatic drugs (DMARDs)

As necessary concomitant medications, DMARDs listed below will be administered orally unless specified. For subjects who are inadequate responders to methotrexate (MTX): MTX. For subjects who are intolerant of MTX: either of DMARDs listed; hydroxychloroquine, salazosulfapyridine, gold (injection or oral), D-penicillamine, lobenzarit, actarit, bucillamine and iguratimod.

Sponsors & Collaborators

  • Astellas Pharma China, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Astellas Pharma Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-27
Primary Completion
2021-04-01
Completion
2021-11-02

Countries

  • China
  • South Korea
  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03660059 on ClinicalTrials.gov