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

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00316771

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 II

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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.

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 Completion Date:	March 2008

Arms	Assigned Interventions
1: Experimental	Drug: P38 Inhibitor (4) 50mg po qd
2: Experimental	Drug: P38 Inhibitor (4) 150mg po qd
3: Experimental	Drug: P38 Inhibitor (4) 300mg po qd
4: Experimental	Drug: P38 Inhibitor (4) 25mg po bid
5: Experimental	Drug: P38 Inhibitor (4) 75mg po bid
6: Placebo Comparator	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, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	PA18439
Study First Received:	April 20, 2006
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00316771
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Folic Acid
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Methotrexate
Rheumatic Diseases

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents

Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009