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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
Centocor, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Early Rheumatoid Arthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 7, 2005
    Last Updated
    May 18, 2011
    Sponsor
    Centocor, Inc.
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    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
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    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

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    A Safety and Efficacy Study for Infliximab (Remicade) With Methotrexate in Patients With Early Rheumatoid Arthritis

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