A Study Evaluating Safety and Efficacy of CNTO 148 Subcutaneous Injection Compared With Placebo in Subjects With Active Rheumatoid Arthritis - Full Text View

Sponsors and Collaborators:	Centocor, Inc. Centocor BV
Information provided by:	Centocor, Inc.
ClinicalTrials.gov Identifier:	NCT00207714

Purpose

Multicenter, randomized, double-blind, placebo-controlled, 5-arm, dose-ranging study to assess the efficacy of subcutaneous injections of CNTO 148, 50 or 100 mg, at either 2- or 4- week intervals in subjects with active RA despite MTX therapy.

Condition	Intervention	Phase
Arthritis, Rheumatoid	Drug: golimumab, infliximab	Phase III

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Infliximab Golimumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Dose-Ranging Trial of CNTO 148 Subcutaneous Injection Compared With Placebo in Subjects With Active Rheumatoid Arthritis Despite Treatment With Methotrexate.

Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:

Improvement in signs and symptoms, as measured by proportion of subjects achieving an ACR 20 response at week 16

Secondary Outcome Measures:

The percentage ACR improvement from baseline at week 16; safety; PK/PD parameters

Estimated Enrollment:	197
Study Start Date:	November 2003
Estimated Study Completion Date:	February 2006

Detailed Description:

This is an experimental medical research study. The purpose of this study is to determine if CNTO 148 is safe and effective in the treatment of rheumatoid arthritis.

Subjects will receive subcutaneous injections of either 50 or 100 mg CNTO 148 or placebo every two or four weeks or an infusion of infliximab at week 20, 22, 28, 36, 44 for 48 weeks

Eligibility

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

Criteria

Inclusion Criteria:

Diagnosis of RA according to the American College of Rheumatology criteria for at least 3 months prior to screening
Have active Rheumatoid Arthritis at the time of screening and at baseline, as defined by 6 or more swollen joints and 6 or more tender joints and additional laboratory criteria

Exclusion Criteria:

Have other inflammatory diseases, including but not limited to ankylosing spondylitis, systemic lupus erythematosus, Lyme disease
Received disease-modifying antirheumatic drugs ([DMARDs] eg, D penicillamine, hydroxychloroquine, chloroquine, oral or parenteral gold, interleukin [IL]-1 receptor antagonist [anakinra], azathioprine, sulphasalazine, agents other than MTX) within 4 weeks prior to the first study dose

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00207714

Sponsors and Collaborators

Centocor, Inc.

Centocor BV

Investigators

Study Director:

Centocor, Inc. Clinical Trial

Centocor, Inc.

More Information

Publications indexed to this study:

Kay J, Matteson EL, Dasgupta B, Nash P, Durez P, Hall S, Hsia EC, Han J, Wagner C, Xu Z, Visvanathan S, Rahman MU. Golimumab in patients with active rheumatoid arthritis despite treatment with methotrexate: a randomized, double-blind, placebo-controlled, dose-ranging study. Arthritis Rheum. 2008 Apr;58(4):964-75.

Study ID Numbers:	CR005263
Study First Received:	September 13, 2005
Last Updated:	October 19, 2007
ClinicalTrials.gov Identifier:	NCT00207714
Health Authority:	United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:

Rheumatoid Arthritis

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Infliximab
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Methotrexate
Rheumatic Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immune System Diseases
Therapeutic Uses
Gastrointestinal Agents

Antirheumatic Agents
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009