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A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Rheumatoid Arthritis.

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ClinicalTrials.gov Identifier: NCT00036387
Recruitment Status : Completed
First Posted : May 10, 2002
Last Update Posted : May 19, 2011
Information provided by:
Centocor, Inc.

May 9, 2002
May 10, 2002
May 19, 2011
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The proportion of patients with serious infections occurring over the first 22 weeks of the trial
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Complete list of historical versions of study NCT00036387 on ClinicalTrials.gov Archive Site
The proportion of patients with infections & atypical/opportunistic infections. The duration of most frequently reported infections. Proportion of patients achieving ACR 20 criteria at 22 weeks. Effect of 1.5 mg/kg dose increment in reducing disease
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A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Rheumatoid Arthritis.
A Randomized, Double-blind Trial of the Safety of Anti-TNF Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Rheumatoid Arthritis on Standard Disease-modifying Anti-Rheumatic Drug Background Therapy.
The purpose of this study is to evaluate the safety and effectiveness of Infliximab (Remicade) in patients with Rheumatoid Arthritis. Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce the pain of rheumatoid arthritis.

This is a randomized (patients are assigned different treatments based on chance), double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage) trial of the safety of anti-tumor necrosis factor (TNF) chimeric monoclonal antibody (Infliximab) in combination with methotrexate (MTX) compared to methotrexate alone in patients with rheumatoid arthritis on standard disease-modifying anti-rheumatic drug background therapy. The purpose of the study is to better understand the safety and occurrence of infections in patients treated with either placebo or 3 mg/kg and 10 mg/kg of infliximab in combination with methotrexate (MTX).

Patients will receive infusions of either placebo or 3 to 10mg/kg Infliximab at weeks 0, 2, 6, and 14 then every 8 weeks through week 46.

Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures. Patients will receive 3 to10mg/kg Infliximab (Remicade) or placebo via infusion at weeks 0, 2, 6, and 14 then every 8 weeks through week 46.

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Arthritis, Rheumatoid
Drug: Infliximab
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
November 2003
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Inclusion Criteria:

  • Patients must have a diagnosis of Rheumatoid Arthritis at least 3 months before screening
  • If the patient is of childbearing potential, must have been using adequate birth control measures
  • Patients must be receiving MTX for =3 months before randomization and at a stable dose(=25 mg/week) for =4 weeks before randomization

Exclusion Criteria:

  • Patients must not be pregnant, nursing, or planning a pregnancy within 18 months of enrollment
  • Patients must not have rheumatic disease other than Rheumatoid Arthritis or had any systemic inflammatory condition
  • Patients must not be confined to a wheelchair
  • Patients must not be treated with any approved or investigational biologic agent except for approved vaccines for immunizations
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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United States
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Centocor, Inc.
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Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
Centocor, Inc.
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP