A Safety and Efficacy Study for Infliximab (Remicade) With Methotrexate in Patients With Early Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Infliximab
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Early Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria: Diagnosis of rheumatoid arthritis for at least 3 months and less than or equal to 3 years before screening Active disease at the time of screening and pre-infusion of the drug Exclusion Criteria: Pregnant, nursing, or planning a pregnancy within 18 months of enrollment Incapacitated, largely or wholly bedridden, or confined to a wheelchair, or had little or no ability for self care Rheumatic disease other than rheumatoid arthritis or any current systemic inflammatory condition
Sites / Locations
Outcomes
Primary Outcome Measures
Improvement from baseline in clinical signs and symptoms, prevention of structural damage, and prevention of physical disability evaluated at week 54.
Secondary Outcome Measures
Safety assessments throughout the study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00236028
Brief Title
A Safety and Efficacy Study for Infliximab (Remicade) With Methotrexate in Patients With Early Rheumatoid Arthritis
Official Title
A Randomized, Double-blind, Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate Compared With Methotrexate Alone for the Treatment of Patients With Early Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
April 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Centocor, Inc.
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of infliximab (Remicade) in patients with early rheumatoid arthritis.
Detailed Description
This is a randomized, multicenter, double-blind, active-treatment-controlled, three-arm, parallel study of chronic treatment with infliximab. This study will determine whether infliximab, at two different doses (3 mg/kg or 6 mg/kg) in combination with methotrexate (MTX), reduces the signs and symptoms (such as joint pain, swelling and stiffness) of rheumatoid arthritis. The study will also compare their effect on slowing down the joint damage associated with rheumatoid arthritis. Additional information on the safety of infliximab treatment will be obtained. The study will last for about 1 year. Patients will receive methotrexate and total of eight intravenous infusions of the study medication (Infliximab or placebo) spaced out over the first year. After the final infusion of study medication, several follow-up visits are to be made. Patients will receive methotrexate (start at 7.5mg/wk, increased to 20mg/wk by week8) and intravenous infusions of the study medication (Infliximab 3 or 6mg/kg, or placebo) at week 0, 2, and 6, and every 8 weeks thereafter through week 46.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Early Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
607 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Infliximab
Primary Outcome Measure Information:
Title
Improvement from baseline in clinical signs and symptoms, prevention of structural damage, and prevention of physical disability evaluated at week 54.
Secondary Outcome Measure Information:
Title
Safety assessments throughout the study.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of rheumatoid arthritis for at least 3 months and less than or equal to 3 years before screening
Active disease at the time of screening and pre-infusion of the drug
Exclusion Criteria:
Pregnant, nursing, or planning a pregnancy within 18 months of enrollment
Incapacitated, largely or wholly bedridden, or confined to a wheelchair, or had little or no ability for self care
Rheumatic disease other than rheumatoid arthritis or any current systemic inflammatory condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Centocor, Inc. Clinical Trial
Organizational Affiliation
Centocor, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
16948115
Citation
Visvanathan S, Wagner C, Smolen J, St Clair EW, Hegedus R, Baker D, Keenan G. IgG and IgM anticardiolipin antibodies following treatment with infliximab plus methotrexate in patients with early rheumatoid arthritis. Arthritis Rheum. 2006 Sep;54(9):2840-4. doi: 10.1002/art.22054.
Results Reference
background
PubMed Identifier
17552048
Citation
Visvanathan S, Marini JC, Smolen JS, Clair EW, Pritchard C, Shergy W, Pendley C, Baker D, Bala M, Gathany T, Han J, Wagner C. Changes in biomarkers of inflammation and bone turnover and associations with clinical efficacy following infliximab plus methotrexate therapy in patients with early rheumatoid arthritis. J Rheumatol. 2007 Jul;34(7):1465-74. Epub 2007 Jun 1.
Results Reference
result
PubMed Identifier
17444589
Citation
Visvanathan S, Keenan GF, Baker DG, Levinson AI, Wagner CL. Response to pneumococcal vaccine in patients with early rheumatoid arthritis receiving infliximab plus methotrexate or methotrexate alone. J Rheumatol. 2007 May;34(5):952-7. Epub 2007 Apr 15.
Results Reference
result
PubMed Identifier
16508926
Citation
Smolen JS, Van Der Heijde DM, St Clair EW, Emery P, Bathon JM, Keystone E, Maini RN, Kalden JR, Schiff M, Baker D, Han C, Han J, Bala M; Active-Controlled Study of Patients Receiving Infliximab for the Treatment of Rheumatoid Arthritis of Early Onset (ASPIRE) Study Group. Predictors of joint damage in patients with early rheumatoid arthritis treated with high-dose methotrexate with or without concomitant infliximab: results from the ASPIRE trial. Arthritis Rheum. 2006 Mar;54(3):702-10. doi: 10.1002/art.21678.
Results Reference
result
PubMed Identifier
27696724
Citation
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.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=142&filename=CR003124_CSR.pdf
Description
A Randomized, Double-blind, Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab) in Combination with Methotrexate Compared with Methotrexate Alone for the Treatment of Patients with Early Rheumatoid Arthritis
Learn more about this trial
A Safety and Efficacy Study for Infliximab (Remicade) With Methotrexate in Patients With Early Rheumatoid Arthritis
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