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

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 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:

MedlinePlus related topics: Rheumatoid Arthritis

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, 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
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

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

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Locations

United States, Alabama

Aniston, Alabama, United States, 36207
United States, Arizona

Scottsdale, Arizona, United States, 85251

Tucson, Arizona, United States, 85704

Tucson, Arizona, United States, 85712
United States, California

Escondido, California, United States, 92025

Loma Linda, California, United States, 92357
United States, Connecticut

Stamford, Connecticut, United States, 06905
United States, Illinois

Morton Grove, Illinois, United States, 60053
United States, Indiana

South Bend, Indiana, United States, 46601
United States, Kansas

Wichita, Kansas, United States, 67207
United States, Kentucky

Louisville, Kentucky, United States, 40292
United States, Louisiana

New Orleans, Louisiana, United States, 70115
United States, North Carolina

Belmont, North Carolina, United States, 28012
United States, Oregon

Bend, Oregon, United States, 97701
United States, Pennsylvania

Danville, Pennsylvania, United States, 17822

Lancaster, Pennsylvania, United States, 17604
United States, South Carolina

Charleston, South Carolina, United States, 29407
United States, Tennessee

Knoxville, Tennessee, United States, 37909

Memphis, Tennessee, United States, 38104

Nashville, Tennessee, United States, 37203
United States, Texas

Amarillo, Texas, United States, 79106

Dallas, Texas, United States, 75235
Canada, Alberta

Edmonton, Alberta, Canada, T5M 0H4
Canada, Nova Scotia

Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario

Ottawa, Ontario, Canada, K2G 6E2

Toronto, Ontario, Canada, M5T 2S8
Croatia

Rijeka, Croatia, 51000

Split, Croatia, 21000
Czech Republic

Ceské Budejovice, Czech Republic, 370 01

Praha, Czech Republic, 128 50

Terezin, Czech Republic, 411 55

Zlin, Czech Republic, 760 01
France

Brest, France, 29609

Corbeil-essonnes, France, 91106

Montpellier, France, 34295

Paris, France, 75014

Rouen, France, 76031
Italy

Brescia, Italy, 25123

Genova, Italy, 16132

Pavia, Italy, 27100

Roma, Italy, 00161
Mexico

Guadalajara, Mexico, 44620

Guadalajara, Mexico, 44340

Mexico City, Mexico, 06700
Romania

Brasov, Romania, 500366

Bucharest, Romania, 020125
Serbia

Belgrade, Serbia, 11000
South Africa

Bloemfontein, South Africa, 9301

Johannesburg, South Africa, 1619

Pretoria, South Africa, 0002
Spain

Barcelona, Spain, 08035

Granada, Spain, 18014

Jerez de La Frontera, Spain, 11407

La Coruna, Spain, 15006

Madrid, Spain, 28040

Oviedo, Spain, 33006

Palma de Mallorca, Spain, 07007

Sevilla, Spain, 41013
Taiwan

Kaohsiung, Taiwan, 833

Taoyuan, Taiwan, 333

Tapei, Taiwan, 114

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00303563 History of Changes
Other Study ID Numbers:	PA18604
Study First Received:	March 16, 2006
Last Updated:	May 13, 2009
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

ClinicalTrials.gov processed this record on May 16, 2013