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:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00299546
First received: March 3, 2006
Last updated: January 27, 2014
Last verified: January 2014
Results First Received: May 21, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Arthritis, Rheumatoid
Interventions: Drug: Placebo
Biological: Golimumab 50 mg
Biological: Golimumab 100 mg

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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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.
Total Total of all reporting groups

Baseline Measures
    Group 1: Placebo     Group 2: Golimumab 50 mg     Group 3: Golimumab 100 mg     Total  
Number of Participants  
[units: participants]
  155     153     153     461  
Age  
[units: years]
Mean ± Standard Deviation
  54.8  ± 13.07     53.9  ± 11.47     53.7  ± 12.26     54.1  ± 12.27  
Gender  
[units: participants]
       
Female     132     113     122     367  
Male     23     40     31     94  



  Outcome Measures
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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
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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.


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