An Efficacy and Safety Study of CNTO 148 Subcutaneous Injection Compared With Placebo in Patients With Active Rheumatoid Arthritis

This study has been completed.
Sponsor:
Collaborator:
Centocor BV
Information provided by:
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00207714
First received: September 13, 2005
Last updated: October 16, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: Golimumab
Drug: MTX
Drug: Placebo
Drug: Infliximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    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]).


Secondary Outcome Measures:
  • Summary of ACR-N, Index of Improvement at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    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.


Enrollment: 172
Study Start Date: November 2003
Study Completion Date: February 2006
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Golimumab (CNTO 148) with Methotrexate (MTX) 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
Experimental: Infliximab with MTX Drug: MTX
Type=exact, unit=mg/ml, number= 10, 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
Placebo Comparator: Placebo with MTX 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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00207714

Sponsors and Collaborators
Centocor, Inc.
Centocor BV
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

No publications provided by Centocor, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: DIRECTOR CLINICAL RESEARCH, Janssen R&D US
ClinicalTrials.gov Identifier: NCT00207714     History of Changes
Other Study ID Numbers: CR005263, C0524T02
Study First Received: September 13, 2005
Results First Received: May 21, 2009
Last Updated: October 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:
Rheumatoid Arthritis
CNTO 148
Methotrexate
Joint pain
Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Infliximab
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics

ClinicalTrials.gov processed this record on September 16, 2014