Phase 2 Clinical Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702

A 12-Week, Double-Blind, Randomized, Parallel Group, Placebo Controlled Study of Two Doses of VX-702 in Subjects With Moderate to Severe Rheumatoid Arthritis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00205478

Enrollment

300

Registered

2005-09-20

Start date

2005-06-30

Completion date

2006-02-28

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 clinical activity and safety of two doses of VX-702 compared to placebo in subjects with moderate to severe Rheumatoid Arthritis.

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

* Adults with active rheumatoid arthritis for greater than 6 months and evidence of inflammation.

Exclusion criteria

* Subjects who have conditions precluding the use of cytokine inhibitors or subjects who require DMARDs other than hydroxychloroquine or sulfasalazine are excluded.

Design outcomes

Primary

Measure	Time frame
The primary endpoint for the study is the ACR20 response at Week 12.	—

Secondary

Measure	Time frame
The ACR50 and ACR70 responses at 12 weeks will also be assessed as well as other measures.	—

Countries

Bulgaria, Croatia, Czechia, Poland, Russia, Serbia and Montenegro, Slovakia, Slovenia, Ukraine

Outcome results

None listed

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