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24-week Study With Open Label Extension of VX-509, an Oral JAK3 Inhibitor, in Subjects Taking Methotrexate

NCT01590459 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 359

Last updated 2015-11-20

No results posted yet for this study

Summary

This study is designed to evaluate the safety and efficacy of VX-509, an oral JAK3 inhibitor, for treatment of subjects with active RA who have had an inadequate response to Methotrexate.

Conditions

Interventions

DRUG

VX-509

50 mg oral tablet

DRUG

VX-509 matching placebo

0 mg oral tablet

Sponsors & Collaborators

Principal Investigators

  • Ali Ashrafzadeh, MD, FACR · Quintiles, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States
  • Argentina
  • Bulgaria
  • Czechia
  • Estonia
  • Germany
  • Hungary
  • Mexico
  • Poland
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT01590459 on ClinicalTrials.gov