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Trial record 10 of 387 for:    Ankylosing Spondylitis

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

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ClinicalTrials.gov Identifier: NCT01248793
Recruitment Status : Completed
First Posted : November 25, 2010
Results First Posted : June 28, 2012
Last Update Posted : March 20, 2013
Sponsor:
Information provided by (Responsible Party):
Centocor, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Ankylosing Spondylitis
Interventions Drug: Placebo
Drug: Golimumab
Drug: Golimumab (placebo group)
Enrollment 213

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group I: Placebo Group II: Golimumab 50 mg
Hide Arm/Group Description 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 Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48
Period Title: Overall Study
Started 105 108
Completed 101 102
Not Completed 4 6
Reason Not Completed
Lost to Follow-up             0             1
Adverse Event             1             1
Protocol Violation             0             1
Withdrawal by Subject             3             3
Arm/Group Title Group I: Placebo Group II: Golimumab 50 mg Total
Hide Arm/Group Description 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 Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48 Total of all reporting groups
Overall Number of Baseline Participants 105 108 213
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 105 participants 108 participants 213 participants
30.6  (8.60) 30.5  (10.27) 30.5  (9.46)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants 108 participants 213 participants
Female
18
  17.1%
18
  16.7%
36
  16.9%
Male
87
  82.9%
90
  83.3%
177
  83.1%
1.Primary Outcome
Title Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 14
Hide Description Number of patients who achieved a >= 20% improvement in ankylosing spondylitis symptoms, including back pain, function, and inflammation
Time Frame Week 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment
Arm/Group Title Group I: Placebo Group II: Golimumab 50 mg
Hide Arm/Group Description:
Placebo subcutaneous (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 20 if early escape
Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20
Overall Number of Participants Analyzed 105 108
Measure Type: Number
Unit of Measure: Participants
26 53
2.Secondary Outcome
Title Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 24
Hide Description Number of patients who achieved a >= 20% improvement in ankylosing spondylitis symptoms, including back pain, function, and inflammation
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment
Arm/Group Title Group I: Placebo Group II: Golimumab 50 mg
Hide Arm/Group Description:
Placebo subcutaneous (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 20 if early escape
Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20
Overall Number of Participants Analyzed 105 108
Measure Type: Number
Unit of Measure: Participants
24 54
3.Secondary Outcome
Title Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14
Hide Description BASFI is a participant’s self-assessment, represented as a mean (Visual Analogue Scale [Score]; 0 cm [easy] to 10 cm [impossible]) of 10 questions, 8 of which relate to the participant’s functional anatomy and 2 of which relate to a participant’s ability to cope with everyday life. A negative change from baseline indicates improvement.
Time Frame Baseline and Week 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment
Arm/Group Title Group I: Placebo Group II: Golimumab 50 mg
Hide Arm/Group Description:
Placebo subcutaneous (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 20 if early escape
Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20
Overall Number of Participants Analyzed 105 108
Mean (Standard Deviation)
Unit of Measure: Score on a scale
0.113  (2.0967) -1.262  (2.5698)
4.Secondary Outcome
Title Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 14
Hide Description BASMI is a combined score of 5 components of spine flexibility, ranging from 0 (least impairment) to 10 (most impairment). A negative change from baseline indicates improvement.
Time Frame Baseline and Week 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment
Arm/Group Title Group I: Placebo Group II: Golimumab 50 mg
Hide Arm/Group Description:
Placebo subcutaneous (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 20 if early escape
Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20
Overall Number of Participants Analyzed 105 108
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-0.19  (0.718) -0.42  (0.906)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo -> Golimumab 50 mg Golimumab 50 mg
Hide Arm/Group Description Placebo SC injections every 4 weeks from Week 0 to Week 12 and early escape to receive Golimumab 50 mg SC injection every 4 weeks from Week 16 to Week 20; or Placebo SC injections every 4 weeks from Week 0 to Week 20 and crossed over to receive Golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48
All-Cause Mortality
Placebo -> Golimumab 50 mg Golimumab 50 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo -> Golimumab 50 mg Golimumab 50 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   2/103 (1.94%)   4/108 (3.70%) 
Eye disorders     
Uveitis * 1  0/103 (0.00%)  1/108 (0.93%) 
Gastrointestinal disorders     
Enteritis * 1  1/103 (0.97%)  0/108 (0.00%) 
Infections and infestations     
Tuberculous Pleurisy * 1  1/103 (0.97%)  0/108 (0.00%) 
Injury, poisoning and procedural complications     
Tibia Fracture * 1  0/103 (0.00%)  1/108 (0.93%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Ovarian Epithelial Cancer * 1  0/103 (0.00%)  1/108 (0.93%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis * 1  0/103 (0.00%)  1/108 (0.93%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo -> Golimumab 50 mg Golimumab 50 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   37/103 (35.92%)   33/108 (30.56%) 
Infections and infestations     
Upper Respiratory Tract Infection * 1  23/103 (22.33%)  24/108 (22.22%) 
Investigations     
Alanine Aminotransferase Increased * 1  7/103 (6.80%)  7/108 (6.48%) 
Liver Function Test Abnormal * 1  10/103 (9.71%)  5/108 (4.63%) 
Transaminases Increased * 1  6/103 (5.83%)  4/108 (3.70%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 14.1
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.
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 )
First Submitted: November 24, 2010
First Posted: November 25, 2010
Results First Submitted: May 25, 2012
Results First Posted: June 28, 2012
Last Update Posted: March 20, 2013