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A Study of the Safety and Efficacy of Golimumab (CNTO 148) in Subjects With Active Rheumatoid Arthritis Previously Treated With Biologic Anti-TNFa Agent(s)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00299546
First Posted: March 7, 2006
Last Update Posted: February 27, 2014
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.
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Centocor, Inc.
Results First Submitted: May 21, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Arthritis, Rheumatoid
Interventions: Drug: Placebo
Biological: Golimumab 50 mg
Biological: Golimumab 100 mg

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 461 participants were enrolled at 86 sites in North America, Europe, Australia and New Zealand.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Group 1: Placebo Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); Golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; Golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
Group 2: Golimumab 50 mg Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); Golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
Group 3: Golimumab 100 mg Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.

Participant Flow:   Overall Study
    Group 1: Placebo   Group 2: Golimumab 50 mg   Group 3: Golimumab 100 mg
STARTED   155   153   153 
COMPLETED   55   61   67 
NOT COMPLETED   100   92   86 
Death                3                2                0 
Lost to Follow-up                2                2                5 
Adverse Event                37                22                27 
Unsatisfactory therapeutic effect                34                39                34 
Not specified                24                26                19 
Not treated                0                1                1 



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   American College of Rheumatology (ACR) 20 Response at Week 14.   [ Time Frame: Week 14 ]

2.  Secondary:   American College of Rheumatology (ACR) 50 Response at Week 14   [ Time Frame: Week 14 ]

3.  Secondary:   Disease Activity Index Score 28 (DAS 28) (Using C-reactive Protein) Response at Week 14   [ Time Frame: Week 14 ]

4.  Secondary:   American College of Rheumatology (ACR) 20 at Week 24   [ Time Frame: From Baseline to Week 24 ]

5.  Secondary:   Health Assessment Questionnaire (HAQ) Score at Week 24   [ Time Frame: From Baseline to Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The count of patients with any nonserious adverse events (NAE) excludes patients who only had NAE that occurred in <= 5% of patients. This information may vary from existing approved labeling and publications due to the requirement of this website.


  More Information