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Trial record 1 of 1 for:    NCT00207714
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An Efficacy and Safety Study of CNTO 148 Subcutaneous Injection Compared With Placebo in Patients With Active Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00207714
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : August 7, 2012
Last Update Posted : October 18, 2012
Sponsor:
Collaborator:
Centocor BV
Information provided by:
Centocor, Inc.

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 21, 2005
Results First Submitted Date  ICMJE May 21, 2009
Results First Posted Date  ICMJE August 7, 2012
Last Update Posted Date October 18, 2012
Study Start Date  ICMJE November 2003
Actual Primary Completion Date February 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2012)
Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16 [ Time Frame: Week 16 ]
ACR 20 response is a decrease of at least 20 per cent in both tender and swollen joint count and in 3 to 5 assessments (participant's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]).
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Improvement in signs and symptoms, as measured by proportion of subjects achieving an ACR 20 response at week 16
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2012)
Summary of ACR-N, Index of Improvement at Week 16 [ Time Frame: Week 16 ]
The ACR-N index of improvement is the minimum of the following: 1) the percent decrease from baseline in tender joint counts; 2) the percent decrease from baseline in swollen joint counts; 3) the median percent decrease from baseline for the following: a. Patient's assessment of pain as measured on a 10 cm visual assessment scale (0-10, 10 worst pain) Patient's global assessment of disease activity (VAS 0-10); c. Physician's global assessment of disease activity (VAS 0-10) d. Physical function as measured by the Health Assessment Questionnaire; e. C-Reactive Protein measurement.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
The percentage ACR improvement from baseline at week 16; safety; PK/PD parameters
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Efficacy and Safety Study of CNTO 148 Subcutaneous Injection Compared With Placebo in Patients With Active Rheumatoid Arthritis
Official Title  ICMJE A Randomized, Double-blind, Dose-ranging Trial of CNTO 148 Subcutaneous Injection Compared With Placebo in Subjects With Active Rheumatoid Arthritis Despite Treatment With Methotrexate
Brief Summary Multicenter, randomized, double-blind, placebo-controlled, 5-arm, dose-ranging study to assess the efficacy of subcutaneous injections of Golimumab (CNTO 148), 50 or 100 mg, at either 2- or 4- week intervals in subjects with active RA despite MTX therapy.
Detailed Description

This is an experimental medical research study. The purpose of this study is to determine if Golimumab is safe and effective in the treatment of rheumatoid arthritis.

Subjects will receive subcutaneous injections of either 50 or 100 mg Golimumab or placebo every two or four weeks or an infusion of infliximab at week 20, 22, 28, 36, 44 for 48 weeks

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: Golimumab
    Type=exact, unit=mg/ml, number= 50 to 100 , form=powder for solution for infusion, route=sub cutaneous.
  • Drug: MTX
    Type=exact, unit=mg/ml, number= 10, form=powder for solution for infusion, route=sub cutaneous
  • Drug: Placebo
    Type=exact, unit=mg/ml, form=powder for solution for infusion, route=sub cutaneous
  • Drug: Infliximab
    Type=exact, unit=mg/ml number= 10, form=powder for solution for infusion, route=sub cutaneous
Study Arms  ICMJE
  • Experimental: Golimumab (CNTO 148) with Methotrexate (MTX)
    Interventions:
    • Drug: Golimumab
    • Drug: MTX
  • Experimental: Infliximab with MTX
    Interventions:
    • Drug: MTX
    • Drug: Infliximab
  • Placebo Comparator: Placebo with MTX
    Interventions:
    • Drug: MTX
    • Drug: Placebo
Publications * Kay J, Matteson EL, Dasgupta B, Nash P, Durez P, Hall S, Hsia EC, Han J, Wagner C, Xu Z, Visvanathan S, Rahman MU. Golimumab in patients with active rheumatoid arthritis despite treatment with methotrexate: a randomized, double-blind, placebo-controlled, dose-ranging study. Arthritis Rheum. 2008 Apr;58(4):964-75. doi: 10.1002/art.23383. Erratum in: Arthritis Rheum. 2010 Nov;62(11):3518.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 28, 2012)
172
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
197
Actual Study Completion Date  ICMJE February 2006
Actual Primary Completion Date February 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of RA according to the American College of Rheumatology criteria for at least 3 months prior to screening
  • Have active Rheumatoid Arthritis at the time of screening and at baseline, as defined by 6 or more swollen joints and 6 or more tender joints and additional laboratory criteria

Exclusion Criteria:

  • Have other inflammatory diseases, including but not limited to ankylosing spondylitis, systemic lupus erythematosus, Lyme disease
  • Received disease-modifying antirheumatic drugs ([DMARDs] eg, D penicillamine, hydroxychloroquine, chloroquine, oral or parenteral gold, interleukin [IL]-1 receptor antagonist [anakinra], azathioprine, sulphasalazine, agents other than MTX) within 4 weeks prior to the first study dose
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00207714
Other Study ID Numbers  ICMJE CR005263
C0524T02 ( Other Identifier: Centocor )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party DIRECTOR CLINICAL RESEARCH, Janssen R&D US
Study Sponsor  ICMJE Centocor, Inc.
Collaborators  ICMJE Centocor BV
Investigators  ICMJE
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
PRS Account Centocor, Inc.
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP