Infliximab Plus Methotrexate for the Treatment of Rheumatoid Arthritis
NCT ID: NCT00269867
Last Updated: 2014-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
428 participants
INTERVENTIONAL
1997-03-31
2000-03-31
Brief Summary
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Detailed Description
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Patients will be treated with either infliximab or matching placebo.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Matching placebo will be adminstered at Week 0, 2, 6 and every 4 weeks up to Week 54.
Placebo
Matching placebo will be adminstered at Week 0, 2, 6 and every 4 weeks up to Week 54.
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.
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.
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.
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.
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.
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.
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.
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.
Interventions
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Placebo
Matching placebo will be adminstered at Week 0, 2, 6 and every 4 weeks up to Week 54.
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Centocor, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Centocor, Inc. Clinical Trial
Role: STUDY_DIRECTOR
Centocor, Inc.
References
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Lipsky PE, van der Heijde DM, St Clair EW, Furst DE, Breedveld FC, Kalden JR, Smolen JS, Weisman M, Emery P, Feldmann M, Harriman GR, Maini RN; Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group. Infliximab and methotrexate in the treatment of rheumatoid arthritis. Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group. N Engl J Med. 2000 Nov 30;343(22):1594-602. doi: 10.1056/NEJM200011303432202.
Mack ME, Hsia E, Aletaha D. Comparative Assessment of the Different American College of Rheumatology/European League Against Rheumatism Remission Definitions for Rheumatoid Arthritis for Their Use as Clinical Trial End Points. Arthritis Rheumatol. 2017 Mar;69(3):518-528. doi: 10.1002/art.39945.
Other Identifiers
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CR006259
Identifier Type: -
Identifier Source: org_study_id
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