MedTrace Logo

A Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate

NCT01554696 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 379

Last updated 2025-05-29

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of ASP015K in moderate to severe rheumatoid arthritis subjects who are methotrexate-inadequate responders (MTX-IR).

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

peficitinib

oral

DRUG

Placebo

oral

DRUG

methotrexate

oral

Sponsors & Collaborators

  • Astellas Pharma Inc

    lead INDUSTRY

Principal Investigators

  • Senior Medical Director Director · Astellas Pharma Global Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-06
Primary Completion
2014-02-11
Completion
2014-02-11

Countries

  • United States
  • Belgium
  • Bulgaria
  • Colombia
  • Czechia
  • Hungary
  • Mexico
  • Poland

Study Locations

More Related Trials

Entities

Drugs

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 NCT01554696 on ClinicalTrials.gov