Status:

COMPLETED

A Study of P38 Inhibitor (4) Monotherapy in Patients With Active Rheumatoid Arthritis

Lead Sponsor:

Hoffmann-La Roche

Conditions:

Rheumatoid Arthritis

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

This 4 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of P38 Inhibitor (4) (50, 150 or 300mg po qd) monotherapy versus methotrexate monotherapy in adul...

Eligibility Criteria

Inclusion

  • adult patients \>18 years of age, with active RA;
  • receiving treatment for RA on an outpatient basis;
  • females of child-bearing potential, or nonsterilized males with partners of child-bearing potential, must use reliable contraception during, and for 4 weeks after, the study.

Exclusion

  • major surgery within 8 weeks prior to screening;
  • rheumatic autoimmune disease or inflammatory joint disease other than RA;
  • treatment with methotrexate within 8 weeks of baseline;
  • concurrent use of DMARDs, including anti-TNF or other biologic therapy for RA.

Key Trial Info

Start Date :

April 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2007

Estimated Enrollment :

204 Patients enrolled

Trial Details

Trial ID

NCT00303563

Start Date

April 1 2006

End Date

December 1 2007

Last Update

November 2 2016

Active Locations (61)

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Page 1 of 16 (61 locations)

1

Anniston, Alabama, United States, 36207

2

Scottsdale, Arizona, United States, 85251

3

Tucson, Arizona, United States, 85704

4

Tucson, Arizona, United States, 85712