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Trial record 1 of 1 for:    " NCT00269867"
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Infliximab Plus Methotrexate for the Treatment of Rheumatoid Arthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00269867
First Posted: December 26, 2005
Last Update Posted: November 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centocor, Inc.
  Purpose
The purpose of this study is to evaluate the safety and effectiveness of infliximab (an anti-TNF chimeric monoclonal antibody [cA2]) in patients with active Rheumatoid Arthritis, despite methotrexate treatment.

Condition Intervention Phase
Rheumatoid Arthritis Drug: Placebo Drug: Infliximab 3 mg/kg Drug: Infliximab 10 mg/kg Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled, Double-Blinded, Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment

Resource links provided by NLM:


Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • Change from baseline in ACR20 response at week 30; Change in modified van der Heijde-Sharp Score [ Time Frame: Baseline and Week 30 ]

Secondary Outcome Measures:
  • safety [ Time Frame: up to Week 54 ]

Enrollment: 428
Study Start Date: March 1997
Study Completion Date: March 2000
Primary Completion Date: March 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Matching placebo will be adminstered at Week 0, 2, 6 and every 4 weeks up to Week 54.
Drug: Placebo
Matching placebo will be adminstered at Week 0, 2, 6 and every 4 weeks up to Week 54.
Experimental: Infliximab 3 mg/kg every 8 weeks
Infliximab 3 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2, 6 and every 8 weeks up to Week 52.
Drug: Infliximab 3 mg/kg
Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 3 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2, 6 and every 8 weeks or every 4 weeks up to Week 52.
Other Name: anti-TNF chimeric monoclonal antibody (cA2)
Experimental: Infliximab 3 mg/kg every 4 weeks
Infliximab 3 mg/kg will be administered as infusion at Week 0, 2, 6 and every 4 weeks up to Week 52.
Drug: Infliximab 3 mg/kg
Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 3 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2, 6 and every 8 weeks or every 4 weeks up to Week 52.
Other Name: anti-TNF chimeric monoclonal antibody (cA2)
Experimental: Infliximab 10 mg/kg every 8 weeks
Infliximab 10 mg/kg will be administered as infusion at Week 0, 2, 6 and every 8 weeks up to Week 52.
Drug: Infliximab 10 mg/kg
Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 3 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2, 6 and every 8 weeks or every 4 weeks up to Week 52.
Other Name: anti-TNF chimeric monoclonal antibody (cA2)
Experimental: Infliximab 10 mg/kg every 4 weeks
Infliximab 3 mg/kg will be administered as infusion at Week 0, 2, 6 and every 4 weeks up to Week 52.
Drug: Infliximab 10 mg/kg
Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 3 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2, 6 and every 8 weeks or every 4 weeks up to Week 52.
Other Name: anti-TNF chimeric monoclonal antibody (cA2)

Detailed Description:

This is a placebo-controlled, double-blinded, randomized clinical study to evaluate the safety and effectiveness of infliximab in patients with active Rheumatoid Arthritis, despite methotrexate treatment. Infliximab is an anti-TNF chimeric monoclonal antibody (cA2). The primary measures of effectiveness include the change from baseline in American College of Rheumatology (ACR20) response at week 30, and the change in the modified van der Heijde Sharp Score. The ACR20 Responder Index a composite of clinical, laboratory, and functional measures and the van der Heijde-Sharp (vdH-S) scoring method is a method of rating structural damage in patients..

Patients will be treated with either infliximab or matching placebo.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with active Rheumatoid Arthritis despite treatment with methotrexate
  • Diagnosed with Rheumatoid Arthritis at least 6 months prior to screening
  • Having active disease at the time of screening and pre-infusion as defined by having at least 6 or more swollen joints and 6 or more tender joints
  • Using methotrexate for at least 3 months prior to study enrollment

Exclusion Criteria:

  • Patients having any systemic inflammatory condition
  • Having Lyme disease or a rheumatic disease other than Rheumatoid Arthritis
  • Who have used Disease-Modifying Antirheumatic Drugs (DMARDs) other than methotrexate within 4 weeks prior to screening
  • Who have used corticosteroids within 4 weeks prior to screening
  • Having received previous administration of infliximab
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00269867


Sponsors and Collaborators
Centocor, Inc.
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

Publications:
Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00269867     History of Changes
Other Study ID Numbers: CR006259
First Submitted: December 22, 2005
First Posted: December 26, 2005
Last Update Posted: November 4, 2014
Last Verified: November 2014

Keywords provided by Centocor, Inc.:
Rheumatoid Arthritis
infliximab
methotrexate

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