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A 12-week Study of 4 Doses of VX-509 in Subjects With Active Rheumatoid Arthritis

NCT01052194 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2012-12-13

No results posted yet for this study

Summary

This study is designed to evaluate safety and assess initial efficacy of VX-509, a JAK3 inhibitor, for treatment of subjects with active RA. This study will assess the clinical response of 4 doses of VX-509 compared to placebo when administered for 12 weeks to patients with active RA. The study will also evaluate the safety and tolerability of VX-509 compared to placebo when administered for 12 weeks to subjects with active RA.

Conditions

Interventions

DRUG

Placebo

tablet, placebo b.i.d. for 12 weeks

DRUG

VX-509

tablets, 25mg b.i.d. for 12 weeks

DRUG

VX-509

tablet, 50 mg b.i.d. for 12 weeks

DRUG

VX-509

tablet, 100 mg b.i.d. for 12 weeks

DRUG

VX-509

tablet, 150 mg b.i.d. for 12 weeks

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Vertex Pharmaceuticals Incorporated

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States
  • Belgium
  • Croatia
  • Germany
  • Hungary
  • Poland
  • Puerto Rico
  • Romania
  • Russia
  • Serbia

Study Locations

More Related Trials

Entities

Drugs
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 NCT01052194 on ClinicalTrials.gov