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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:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00299546
First received: March 3, 2006
Last updated: September 12, 2012
Last verified: September 2012
History of Changes
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; golimumab
Biological: golimumab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
101 investigative sites received study agent and 86 sites enrolled patients (obtained informed consent) in this study. Sixty sites were in North America and 41 were in Europe/Australia/New Zealand. Consent was obtained from the first patient on 21 Feb 2006 and the last patient completed the 24-week reporting period on 26 Sep 2007.

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 I: 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 adjust from 50 to 100 mg.
Group II: 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 adjust from 50 to 100 mg.
Group III: Golimumab 100 mg Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.

Participant Flow:   Overall Study
    Group I: Placebo     Group II: Golimumab 50 mg     Group III: Golimumab 100 mg  
STARTED     155     153     153  
COMPLETED     124 [1]   141 [1]   139 [1]
NOT COMPLETED     31     12     14  
Adverse Event                 10                 4                 2  
Unsastisfactory therapeutic effect                 11                 6                 5  
Lost to Follow-up                 0                 0                 2  
Death                 1                 0                 0  
Not specified                 9                 2                 5  
[1] Indicates number of patients who continued subcutaneous study agent at Wk 24



  Baseline Characteristics
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Reporting Groups
  Description
Group I: 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 adjust from 50 to 100 mg.
Group II: 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 adjust from 50 to 100 mg.
Group III: Golimumab 100 mg Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
Total Total of all reporting groups

Baseline Measures
    Group I: Placebo     Group II: Golimumab 50 mg     Group III: Golimumab 100 mg     Total  
Number of Participants  
[units: participants]
 		  155     153     153     461  
Age [1]
[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  
[1] >= 18 years



  Outcome Measures
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1.  Primary:   American College of Rheumatology 20 Response at Week 14.   [ Time Frame: Week 14 ]
  Show Outcome Measure 1

2.  Secondary:   American College of Rheumatology 50 Response at Week 14   [ Time Frame: Week 14 ]
  Show Outcome Measure 2

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

4.  Secondary:   American College of Rheumatology 20 at Week 24   [ Time Frame: From Baseline to Week 24 ]
  Show Outcome Measure 4

5.  Secondary:   Health Assessment Questionnaire Score at Week 24   [ Time Frame: From Baseline to Week 24 ]
  Hide Outcome Measure 5

Measure Type Secondary
Measure Title Health Assessment Questionnaire Score at Week 24
Measure Description Improvement from baseline in Health Assessment Questionnaire (HAQ) score at Week (Wk) 24. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area based on the worst score from the questions that pertain to that task. The HAQ score is determined by the average of the 8 scores; HAQ ranges from 0 to 3.
Time Frame From Baseline to Week 24  
Safety Issue No  

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.
Intent to treat (ITT). Missing scores were imputed by Last Observation Carried Forward (LOCF). Week 16 scores were used for subjects with change in study treatment.

Reporting Groups
  Description
Group I: 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 adjust from 50 to 100 mg.
Group II: 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 adjust from 50 to 100 mg.
Group III: Golimumab 100 mg Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
Combined: Groups II & III Combined Group II (golimumab 50 mg) and Group III (golimumab 100 mg).

Measured Values
    Group I: Placebo     Group II: Golimumab 50 mg     Group III: Golimumab 100 mg     Combined: Groups II & III  
Number of Participants Analyzed  
[units: participants]
 		  155     153     153     306  
Health Assessment Questionnaire Score at Week 24  
[units: scores on a scale]
Median ( Inter-Quartile Range ) 		  0.0000  
  ( -0.2500 to 0.2500 )   		  0.2500  
  ( 0.0000 to 0.5000 )   		  0.2500  
  ( 0.0000 to 0.5000 )   		  0.2500  
  ( 0.0000 to 0.5000 )  


Statistical Analysis 1 for Health Assessment Questionnaire Score at Week 24
Groups [1] Group I: Placebo vs. Combined: Groups II & III
Method [2] ANOVA on van der Waerden normal scores.
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Null hypothesis: No difference in improvement of HAQ score from baseline at Wk 24 between Group I: Placebo and Combined: Groups II and III at 0.05 level of significance.
[2] Other relevant information, such as adjustments or degrees of freedom:
  Stratified by baseline Methotrexate (MTX).
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  A positive test is concluded if there is a significant difference between combined golimumab and placebo groups and at least one of the pair-wise comparisons at 0.05 level.

Statistical Analysis 2 for Health Assessment Questionnaire Score at Week 24
Groups [1] Group I: Placebo vs. Group II: Golimumab 50 mg
Method [2] ANOVA on van der Waerden normal scores.
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Null hypothesis: No difference in improvement from baseline in HAQ score at Wk 24 between Group I: Placebo and Group II: 50 mg.
[2] Other relevant information, such as adjustments or degrees of freedom:
  Stratified by baseline MTX.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Test was preformed because Group I: Placebo was significantly different from Group II: 50 mg.

Statistical Analysis 3 for Health Assessment Questionnaire Score at Week 24
Groups [1] Group I: Placebo vs. Group III: Golimumab 100 mg
Method [2] ANOVA on van der Waerden normal scores.
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Null hypothesis: No difference in improvement from baseline in HAQ score at Wk 24 between Group I: Placebo and Group III: 100 mg.
[2] Other relevant information, such as adjustments or degrees of freedom:
  Stratified by baseline MTX.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Test was preformed because Group I: Placebo was significantly different from Group III: 100 mg.




  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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.  


Results Point of Contact:  
Name/Title: Associate Director Clinical Research
Organization: Centocor Research & Development, Inc.
phone: 1-800-457-6399


No publications provided by Centocor, Inc.

Publications automatically indexed to this study:


Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00299546     History of Changes
Other Study ID Numbers: CR006334, C0524T11
Study First Received: March 3, 2006
Results First Received: May 21, 2009
Last Updated: September 12, 2012
Health Authority: United States: Food and Drug Administration