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Infliximab Plus Methotrexate for the Treatment of Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00269867
First received: December 22, 2005
Last updated: November 3, 2014
Last verified: November 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety [ Time Frame: up to Week 54 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: December 22, 2005
Last Updated: November 3, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Antibodies
Antibodies, Monoclonal
Immunoglobulins
Infliximab
Methotrexate
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents

ClinicalTrials.gov processed this record on November 27, 2014