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Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing Spondylitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT01248793
First received: November 24, 2010
Last updated: March 14, 2013
Last verified: March 2013
Results First Received: May 25, 2012  
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: Ankylosing Spondylitis
Interventions: Drug: Placebo
Drug: Golimumab
Drug: Golimumab (placebo group)

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Group I: Placebo Placebo SC injections every 4 weeks from Week 0 to Week 20(unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48 if early escape; Golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 if not early escape
Group II: Golimumab 50 mg Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48

Participant Flow:   Overall Study
    Group I: Placebo   Group II: Golimumab 50 mg
STARTED   105   108 
COMPLETED   101   102 
NOT COMPLETED   4   6 
Lost to Follow-up                0                1 
Adverse Event                1                1 
Protocol Violation                0                1 
Withdrawal by Subject                3                3 



  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 I: Placebo Placebo SC injections every 4 weeks from Week 0 to Week 20(unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48 if early escape; Golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 if not early escape
Group II: Golimumab 50 mg Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48
Total Total of all reporting groups

Baseline Measures
   Group I: Placebo   Group II: Golimumab 50 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 105   108   213 
Age 
[Units: Years]
Mean (Standard Deviation)
 30.6  (8.60)   30.5  (10.27)   30.5  (9.46) 
Gender 
[Units: Participants]
     
Female   18   18   36 
Male   87   90   177 


  Outcome Measures
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1.  Primary:   Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 14   [ Time Frame: Week 14 ]

2.  Secondary:   Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 24   [ Time Frame: Week 24 ]

3.  Secondary:   Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14   [ Time Frame: Baseline and Week 14 ]

4.  Secondary:   Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 14   [ Time Frame: Baseline and Week 14 ]


  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
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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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Associate Director, Clinical Research
Organization: Janssen Research & Development
phone: 610-500-3369


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT01248793     History of Changes
Other Study ID Numbers: CR015916
C0524T29 ( Other Identifier: Centocor )
Study First Received: November 24, 2010
Results First Received: May 25, 2012
Last Updated: March 14, 2013
Health Authority: United States: Institutional Review Board