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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: March 16, 2006
Last updated: February 1, 2016
Last verified: February 2016
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 adult patients with active rheumatoid arthritis. Patients will be randomized to receive one of 3 doses of P38 Inhibitor (4) or methotrexate. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

Condition Intervention Phase
Rheumatoid Arthritis
Drug: P38 Inhibitor (4)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Study to Compare the Effect of RO4402257 Monotherapy and Methotrexate Monotherapy on Disease Response in Patients With Active Rheumatoid Arthritis.

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of patients with ACR 20 response [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients with ACR 50/70 response. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change in ACR core set, DAS 28, FACIT-F fatigue assessment, AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 204
Study Start Date: April 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: P38 Inhibitor (4)
50mg po qd
Experimental: 2 Drug: P38 Inhibitor (4)
150mg po qd
Experimental: 3 Drug: P38 Inhibitor (4)
300mg po qd
Placebo Comparator: 4 Drug: Placebo
po qd


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00303563

  Show 61 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00303563     History of Changes
Other Study ID Numbers: PA18604 
Study First Received: March 16, 2006
Last Updated: February 1, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on February 07, 2016