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A Study of P38 Inhibitor (4) in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00316771
First received: April 20, 2006
Last updated: September 18, 2012
Last verified: September 2012
History of Changes
  Purpose

This 6 arm study will evaluate the efficacy and safety of different doses of P38 Inhibitor (4) in patients with RA currently having an inadequate clinical response to methotrexate. Patients will be randomized to receive P38 Inhibitor (4) (50,150 or 300 qd po,and 25 or 75 bid po) or placebo, and will remain on the stable dose of 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, Placebo-controlled, Study to Determine the Efficacy and Safety of 5 Dose Regimens of RO4402257 in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy.

Resource links provided by NLM:

U.S. FDA Resources

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, HAQ disability index, SF-36, withdrawals, AEs, lab parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 374
Study Start Date: November 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (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
Experimental: 4 Drug: P38 Inhibitor (4)
25mg po bid
Experimental: 5 Drug: P38 Inhibitor (4)
75mg po bid
Placebo Comparator: 6 Drug: Placebo
po bid

  Eligibility

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

Inclusion Criteria:

  • adult patients >=18 years of age;
  • active rheumatoid arthritis;
  • current inadequate clinical response to methotrexate.

Exclusion Criteria:

  • receiving any other disease-modifying anti-rheumatic drug, with the exception of hydroxychloroquine or chloroquine.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316771

  Show 115 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00316771     History of Changes
Other Study ID Numbers: PA18439
Study First Received: April 20, 2006
Last Updated: September 18, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013