A Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702

A Phase 2, 12-Week, Randomized, Placebo-Controlled Study to Evaluate the Antiinflammatory Effects of VX-702 When Administered Concomitantly With Methotrexate

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00395577

Enrollment

120

Registered

2006-11-03

Start date

2006-11-30

Completion date

2007-07-31

Last updated

2007-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

The purpose of this study is to assess the safety and effects of VX-702 in subjects with moderate to severe rheumatoid arthritis and who are taking the drug methotrexate.

Interventions

DRUGVX-702

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Adult patients 18 to 75 years of age with active RA * Must have been taking MTX for at least 6 months * No concurrent DMARD treatment (other than a stable dose of MTX)

Exclusion criteria

* Planned major surgery (e.g., joint replacement) within the duration of the treatment period of the study * Treated with intra-articular injections of corticosteroids within 28 days prior to Day 1

Design outcomes

Primary

Measure	Time frame
To evaluate the effects of VX-702 administered with concomitant methotrexate (MTX), and MTX alone	—

Secondary

Measure	Time frame
To evaluate the safety and tolerability of VX-702 administered with concomitant MTX, and MTX alone	—

Countries

Bulgaria, Croatia, Poland, Russia, Serbia and Montenegro, Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026