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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.

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

MedlinePlus related topics:   Juvenile Rheumatoid Arthritis    Rheumatoid Arthritis   

Drug Information available for:   Methotrexate    Infliximab   

U.S. FDA Resources

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

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


A Randomized, Double-blind Study of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab) in Combination with Methotrexate for the Treatment of Subjects with Polyarticular Juvenile Rheumatoid Arthritis  This link exits the ClinicalTrials.gov site
 
/A Randomized, Double-blind Study of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab) in Combination with Methotrexate for the Treatment of Subjects with Polyarticular Juvenile Rheumatoid Arthriti  This link exits the ClinicalTrials.gov site
 
/A Randomized, Double-blind Study of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab) in Combination with Methotrexate for the Treatment of Subjects with Polyarticular Juvenile Rheumatoid Arthriti  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CR004774
First Received:   May 9, 2002
Last Updated:   June 7, 2008
ClinicalTrials.gov Identifier:   NCT00036374
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:
Antibodies, Monoclonal
Antibodies
Autoimmune Diseases
Arthritis, Juvenile Rheumatoid
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 November 30, 2008




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