A Study of P38 Inhibitor (4) Monotherapy in Patients With Active Rheumatoid Arthritis - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00303563

Purpose

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 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 Study to Compare the Effect of RO4402257 Monotherapy and Methotrexate Monotherapy on Disease Response in Patients With Active Rheumatoid Arthritis.

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 Completion Date:	December 2007

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: Placebo Comparator	Drug: Placebo po qd

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, 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

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

Show 61 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:	PA18604
Study First Received:	March 16, 2006
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00303563
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Methotrexate
Rheumatic Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009