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A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Juvenile Rheumatoid Arthritis
This study has been completed.
First Received: May 9, 2002   Last Updated: June 7, 2008   History of Changes
Sponsored by: Centocor, Inc.
Information provided by: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00036374
  Purpose

The purpose of this study is to evaluate the effectiveness and safety of infliximab (Remicade) in patients with Juvenile Rheumatoid Arthritis (JRA).


Condition Intervention Phase
Rheumatoid Arthritis, Juvenile
Drug: Infliximab
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Double-Blind Trial of Anti-TNF Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate for the Treatment of Patients With Polyarticular Juvenile Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • The proportion of patients with improvements in the Juvenile Rheumatoid Arthritis core set criteria at Week 14 in the placebo group with that in the 3 mg/kg infliximab plus concomitant methotrexate therapy group.

Secondary Outcome Measures:
  • To evaluate pharmacokinetics (rate of movement in the body and then the clearance)of infliximab over a maximum time period of 52 wks; to evaluate the safety profile of infliximab in patients with JRA

Study Start Date: October 2001
Study Completion Date: December 2006
Detailed Description:

The purpose of this study is to determine if infliximab in combination with methotrexate is safe and effective in the treatment of patients with juvenile rheumatoid arthritis. The second purpose of this study is to see how children's bodies react to the combination of study drug and methotrexate. Patients will receive either infliximab at 3 mg/kg for 44 weeks or, placebo for 14 weeks followed by infliximab at 6 mg/kg for 30 weeks. Patients who complete the original study are eligible for additional treatment with 3 to 6 mg/kg of infliximab every 8 weeks for up to three years. 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 either infliximab at 3 mg/kg for 44 weeks or, placebo for 14 weeks followed by infliximab at 6 mg/kg for 30 weeks. Patients who complete the original study are eligible for additional treatment with 3 to 6 mg/kg of infliximab every 8 weeks for up to three years

  Eligibility

Ages Eligible for Study:   4 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients must have a diagnosis of juvenile rheumatoid arthritis (JRA) with polyarticular JRA for at least 6 months, systemic JRA with a polyarticular course and no systemic symptoms (including fever, rash,hepatosplenomegaly, and serositis) for 1 year prior to study entry, or pauciarticular JRA with a polyarticular course for at least 6 months prior to study entry. The patient should have had at least 6 months of persistent synovitis before screening
  • The patient must have at least 5 joints with active arthritis (ie, presence of swelling, or if no swelling is present, limitation of motion accompanied by pain, tenderness, or both) at the time of enrollment, with at least 3 of these active joints having limitation of motion accompanied by pain, tenderness, or both
  • The patient must be at least 4 years of age, but less than 18 years (ie, after the 4th but before the 18th birthday), with onset of disease before age 16

Exclusion Criteria:

  • Patient must not be pregnant, nursing, or planning a pregnancy within 6 months after the last study infusion
  • Patient must not be incapacitated, largely or wholly bedridden, or confined to a wheelchair, or have little or no ability for age-appropriate self care
  • Patient must not have a rheumatic disease other than JRA or any current systemic inflammatory condition (for example, Lyme disease,fibromyalgia, enthesitis-related arthritis, psoriatic arthritis, systemic lupuserythematosus, infectious or reactive arthritis, Reiter's syndrome, or parvovirus infection)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00036374

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

Additional Information:
Publications:
Study ID Numbers: CR004774
Study First Received: May 9, 2002
Last Updated: June 7, 2008
ClinicalTrials.gov Identifier: NCT00036374     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:
remicade
Infliximab
Methotrexate
Juvenile rheumatoid arthritis

Study placed in the following topic categories:
Anti-Inflammatory Agents
Arthritis, Juvenile Rheumatoid
Autoimmune Diseases
Infliximab
Joint Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Antibodies, Monoclonal
Antibodies
Musculoskeletal Diseases
Arthritis
Connective Tissue Diseases
Methotrexate
Antirheumatic Agents
Immunoglobulins

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Arthritis, Juvenile Rheumatoid
Autoimmune Diseases
Immune System Diseases
Infliximab
Joint Diseases
Gastrointestinal Agents
Arthritis, Rheumatoid
Rheumatic Diseases
Pharmacologic Actions
Musculoskeletal Diseases
Arthritis
Therapeutic Uses
Connective Tissue Diseases
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on July 02, 2009