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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00303563
Recruitment Status : Completed
First Posted : March 17, 2006
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

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 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 or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: P38 Inhibitor (4) Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : April 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Percentage of patients with ACR 20 response [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Percentage of patients with ACR 50/70 response. [ Time Frame: Week 12 ]
  2. Change in ACR core set, DAS 28, FACIT-F fatigue assessment, AEs, laboratory parameters. [ Time Frame: Throughout study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00303563

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Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT00303563     History of Changes
Other Study ID Numbers: PA18604
First Posted: March 17, 2006    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

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