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A Study of the Safety and Efficacy of Golimumab in Subjects With Active Ankylosing Spondylitis

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.
ClinicalTrials.gov Identifier: NCT00265083
Recruitment Status : Completed
First Posted : December 14, 2005
Results First Posted : July 13, 2009
Last Update Posted : July 19, 2013
Sponsor:
Collaborator:
Schering-Plough
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 Spondylitis, Ankylosing
Interventions Biological: golimumab
Biological: Golimumab (CNTO 148); placebo
Enrollment 356
Recruitment Details 356 patients were randomly assigned to treatment groups at 42 sites (17 in North America, 16 in Europe and 9 in Asia). Consent was obtained from the first patient on 13 Dec 2005. The last patient completed the final visit of the 24-week reporting period on 15 May 2007. The last patient completed the final visit of the 5-year period on 17 Jan 2012.
Pre-assignment Details  
Arm/Group Title Group 1: Placebo Group 2: Golimumab 50 mg Group 3: Golimumab 100 mg
Hide Arm/Group Description Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg. Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg. Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
Period Title: Overall Study
Started 78 138 [1] 140
Completed 61 96 [1] 98
Not Completed 17 42 42
Reason Not Completed
Adverse Event             5             13             15
Lost to Follow-up             3             4             4
Unsatisfactory therapeutic effect             8             13             14
Not specified             1             12             9
[1]
One patient did not receive study agent.
Arm/Group Title Group I: Placebo Group II: Golimumab 50 mg Group III: Golimumab 100 mg Total
Hide Arm/Group Description Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg. Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg. Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs. Total of all reporting groups
Overall Number of Baseline Participants 78 138 140 356
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 78 participants 138 participants 140 participants 356 participants
40.6  (12.71) 39.2  (12.46) 38.6  (11.30) 39.3  (12.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 138 participants 140 participants 356 participants
Female
23
  29.5%
36
  26.1%
42
  30.0%
101
  28.4%
Male
55
  70.5%
102
  73.9%
98
  70.0%
255
  71.6%
1.Primary Outcome
Title Assessment in Ankylosing Spondylitis 20 Responders at Week 14
Hide Description Number of patients who achieved a 20% improvement and at least 1 absolute improvement on a 0 to 10 cm scale from baseline to Week 14 in at least 3 of the 4 domains: patient global, total back pain, function or inflammation.
Time Frame Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT). Patients considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing ASAS components at Week 14 were imputed by Last Observation Carried Forward (LOCF) unless all ASAS components are missing in which case considered non-responders.
Arm/Group Title Group I: Placebo Group II: Golimumab 50 mg Group III: Golimumab 100 mg Combined: Groups II & III
Hide Arm/Group Description:
Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
Overall Number of Participants Analyzed 78 138 140 278
Measure Type: Number
Unit of Measure: Participants
17 82 84 166
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Combined: Groups II & III
Comments Null hypothesis: No difference in ASAS 20 response comparing Groups I vs II and Groups I vs III. The sample size of 75 patients (pts) in placebo and 135 pts per active group will provide >=99% power to detect a difference in ASAS 20 response between treatment groups at alpha=0.05, assuming 50% of pts with screening CRP<1.5mg/dL, and the difference in ASAS 20 response of 10-27.5% in pts with screening CRP<1.5mg/dL and 32.5-45% in pts with screening CRP>=1.5mg/dL, between Groups I vs II or III.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The positive test is defined if the comparison between combined golimumab and placebo is significant (p-value <0.05), and at least one of the pair-wise comparisons is also significant (p-value <0.05).
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel with stratification: screening CRP level (<=1.5mg/dL, >1.5mg/dL)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Group II: Golimumab 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel with stratification: screening CRP level (<=1.5mg/dL, >1.5mg/dL)
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Group III: Golimumab 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel with stratification: screening CRP level (<=1.5mg/dL, >1.5mg/dL)
2.Secondary Outcome
Title Assessment in Ankylosing Spondylitis 20 Responders at Week 24
Hide Description Number of patients who achieved a 20% improvement and at least 1 absolute improvement on a 0 to 10 cm scale from baseline to Week 24 at least 3 of the 4 domains: patient global, total back pain, function or inflammation.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT. Patients (pts) considered non-responder if used any pre-specified prohibited medications or discontinued SC study agent due to lack of efficacy. Missing ASAS components were imputed by LOCF unless all ASAS components are missing in which case considered non-responders. Wk 16 ASAS response was used for pts with change in study treatment.
Arm/Group Title Group I: Placebo Group II: Golimumab 50 mg Group III: Golimumab 100 mg Combined: Groups II & III
Hide Arm/Group Description:
Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
Overall Number of Participants Analyzed 78 138 140 278
Measure Type: Number
Unit of Measure: P a r t i c ip an t s
18 77 92 169
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Combined: Groups II & III
Comments Null hypothesis: No difference in ASAS 20 response comparing Groups I vs. II and Groups I vs. III.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The positive test is defined if the comparison between combined golimumab and placebo is significant (p-value <0.05), and at least one of the pair-wise comparisons is also significant (p-value <0.05).
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel with stratification: screening CRP level (<=1.5mg/dL, >1.5mg/dL)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Group II: Golimumab 50 mg
Comments Null hypothesis: no difference in ASAS 20 response between Group II and Group I.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel with stratification: screening CRP level (<=1.5mg/dL, >1.5mg/dL)
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Group III: Golimumab 100 mg
Comments Null hypothesis: no difference in ASAS 20 response between Group III and Group I.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel with stratification: screening CRP level (<=1.5mg/dL, >1.5mg/dL)
3.Secondary Outcome
Title Summary of Change From Baseline in Bath Ankylosing Spondylitis Functional Index at Week 14
Hide Description The Bath Ankylosing Spondylitis Functional Index (BASFI) is calculated as the mean of 10 VAS, each of length 0 to 10 cm. Eight of the scales relate to functional capacity of patients while the other 2 relate to a patient’s ability to cope with everyday life. Change from baseline is Wk 14 value minus baseline value.
Time Frame From Baseline to Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT). Patients considered non-change from baseline in BASFI if used any pre-specified prohibited medications or discontinued SC study agent due to lack of efficacy. Missing value of change from baseline in BASFI at Week 14 was imputed by Last Observation Carried Forward (LOCF).
Arm/Group Title Group I: Placebo Group II: Golimumab 50 mg Group III: Golimumab 100 mg Combined: Groups II & III
Hide Arm/Group Description:
Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
Overall Number of Participants Analyzed 78 138 140 278
Median (Inter-Quartile Range)
Unit of Measure: Change from baseline in BASFI Index
0.095
(-1.050 to 1.120)
-1.375
(-3.130 to -0.120)
-1.495
(-2.985 to -0.060)
-1.420
(-3.070 to -0.080)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Combined: Groups II & III
Comments Null hypothesis: No difference in change from baseline in BASFI comparing Groups I vs. II and Groups I vs. III.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The positive test is defined if the comparison between combined golimumab and placebo is significant (p-value <0.05), and at least one of the pair-wise comparisons is also significant (p-value <0.05).
Method ANOVA on van der Waerden normal scores
Comments ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Group II: Golimumab 50 mg
Comments Null hypothesis: no difference in BASFI between Group II and Group I.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA on van der Waerden normal scores
Comments ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Group III: Golimumab 100 mg
Comments Null hypothesis: no difference in BASFI between Group III and Group I.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA on van der Waerden normal scores
Comments ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.
4.Secondary Outcome
Title Summary of Change From Baseline in Bath Ankylosing Spondylitis Metrology Index at Week 14
Hide Description The Bath Ankylosing Spondylitis Metrology Index (BASMI) is the sum of scores comprised of 5 measures (0=mild, 1=moderate & 2=severe): Tragus-to-wall; Lumbar flexion; Cervical rotation; Lumbar side flexion; Intermalleolar distance. BASMI ranges from 0 to 10. Change from baseline is Wk 14 value minus baseline value.
Time Frame From Baseline to Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT). Patients considered non-change from baseline in BASMI if used any pre-specified prohibited medications or discontinued SC study agent due to lack of efficacy. Missing value of change from baseline in BASMI at Week 14 was imputed by Last Observation Carried Forward (LOCF).
Arm/Group Title Group I: Placebo Group II: Golimumab 50 mg Group III: Golimumab 100 mg Combined: Groups II & III
Hide Arm/Group Description:
Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
Overall Number of Participants Analyzed 78 138 140 278
Mean (Standard Deviation)
Unit of Measure: Change from baseline in BASMI Index
-0.28  (1.015) -0.36  (1.112) -0.49  (1.296) -0.43  (1.208)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Combined: Groups II & III
Comments Null hypothesis: No difference in change from baseline in BASMI comparing Groups I vs. II and Groups I vs. III.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.288
Comments The positive test is defined if the comparison between combined golimumab and placebo is significant at the 0.05, and at least one of the pair-wise comparisons is also significant at the 0.05.
Method ANOVA on van der Waerden normal scores
Comments ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Group II: Golimumab 50 mg
Comments Null hypothesis: no difference in BASMI between Group II and Group I.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.444
Comments [Not Specified]
Method ANOVA on van der Waerden normal scores
Comments ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group I: Placebo, Group III: Golimumab 100 mg
Comments Null hypothesis: no difference in BASMI between Group III and Group I.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.247
Comments [Not Specified]
Method ANOVA on van der Waerden normal scores
Comments ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.
Time Frame Up to 5 years (end of study)
Adverse Event Reporting Description The number of participants reported at risk for adverse events (AEs) in each treatment (tx) group is based on actual tx received during the study and may differ from the number of participants who started tx in the study. Participants may be counted more than once in the analysis of AEs if they received tx at more than one dose level in the study.
 
Arm/Group Title Group 1: Golimumab 50 mg Group 2: Golimumab 100 mg Group 3: Golimumab 50 and 100 mg
Hide Arm/Group Description Subjects who were treated with Golimumab and received Golimumab 50 mg injections only. Subjects who were treated with Golimumab and received Golimumab 100 mg injections only. Subjects who were treated with Golimumab and received at least one injection of both Golimumab 50 mg and Golimumab 100 mg.
All-Cause Mortality
Group 1: Golimumab 50 mg Group 2: Golimumab 100 mg Group 3: Golimumab 50 and 100 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1: Golimumab 50 mg Group 2: Golimumab 100 mg Group 3: Golimumab 50 and 100 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   27/158 (17.09%)   26/118 (22.03%)   19/77 (24.68%) 
Blood and lymphatic system disorders       
Anaemia * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Cardiac disorders       
Angina Unstable * 1  0/158 (0.00%)  1/118 (0.85%)  0/77 (0.00%) 
Cardiac Failure * 1  0/158 (0.00%)  0/118 (0.00%)  1/77 (1.30%) 
Coronary Artery Disease * 1  0/158 (0.00%)  0/118 (0.00%)  1/77 (1.30%) 
Hypertensive Heart Disease * 1  0/158 (0.00%)  0/118 (0.00%)  1/77 (1.30%) 
Myocardial Infarction * 1  1/158 (0.63%)  0/118 (0.00%)  1/77 (1.30%) 
Congenital, familial and genetic disorders       
Atrial Septal Defect * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Cryptorchism * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Gastrointestinal disorders       
Abdominal Pain * 1  2/158 (1.27%)  0/118 (0.00%)  0/77 (0.00%) 
Abdominal Pain Upper * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Crohn's Disease * 1  0/158 (0.00%)  0/118 (0.00%)  1/77 (1.30%) 
Diverticulum Intestinal * 1  0/158 (0.00%)  0/118 (0.00%)  1/77 (1.30%) 
Duodenal Ulcer * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Enterocolitis * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Gastrooesophageal Reflux Disease * 1  0/158 (0.00%)  0/118 (0.00%)  2/77 (2.60%) 
Ileus * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Inguinal Hernia * 1  0/158 (0.00%)  0/118 (0.00%)  1/77 (1.30%) 
Intestinal Perforation * 1  0/158 (0.00%)  0/118 (0.00%)  1/77 (1.30%) 
Lower Gastrointestinal Haemorrhage * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Malocclusion * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Mouth Haemorrhage * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Oesophageal Stenosis * 1  0/158 (0.00%)  1/118 (0.85%)  0/77 (0.00%) 
Pancreatitis * 1  0/158 (0.00%)  0/118 (0.00%)  1/77 (1.30%) 
Small Intestinal Obstruction * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Subileus * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
General disorders       
Chest Pain * 1  0/158 (0.00%)  2/118 (1.69%)  0/77 (0.00%) 
Device Occlusion * 1  0/158 (0.00%)  1/118 (0.85%)  0/77 (0.00%) 
Generalised Oedema * 1  0/158 (0.00%)  0/118 (0.00%)  1/77 (1.30%) 
Hepatobiliary disorders       
Biliary Colic * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Cholelithiasis * 1  2/158 (1.27%)  0/118 (0.00%)  0/77 (0.00%) 
Hepatic Steatosis * 1  0/158 (0.00%)  1/118 (0.85%)  0/77 (0.00%) 
Hepatitis * 1  0/158 (0.00%)  1/118 (0.85%)  0/77 (0.00%) 
Hepatitis Toxic * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Infections and infestations       
Anal Abscess * 1  0/158 (0.00%)  0/118 (0.00%)  1/77 (1.30%) 
Bursitis Infective * 1  0/158 (0.00%)  0/118 (0.00%)  1/77 (1.30%) 
Cellulitis * 1  0/158 (0.00%)  1/118 (0.85%)  0/77 (0.00%) 
Cellulitis Staphylococcal * 1  0/158 (0.00%)  0/118 (0.00%)  1/77 (1.30%) 
Clostridial Infection * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Coccidioidomycosis * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Device Related Infection * 1  0/158 (0.00%)  1/118 (0.85%)  0/77 (0.00%) 
Diverticulitis * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Furuncle * 1  0/158 (0.00%)  1/118 (0.85%)  0/77 (0.00%) 
Herpes Zoster * 1  0/158 (0.00%)  1/118 (0.85%)  0/77 (0.00%) 
Infectious Mononucleosis * 1  0/158 (0.00%)  1/118 (0.85%)  0/77 (0.00%) 
Lyme Disease * 1  0/158 (0.00%)  1/118 (0.85%)  0/77 (0.00%) 
Otitis Media Chronic * 1  0/158 (0.00%)  1/118 (0.85%)  0/77 (0.00%) 
Pelvic Inflammatory Disease * 1  0/158 (0.00%)  0/118 (0.00%)  1/77 (1.30%) 
Pneumonia * 1  1/158 (0.63%)  1/118 (0.85%)  2/77 (2.60%) 
Post Procedural Infection * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Pulmonary Tuberculosis * 1  0/158 (0.00%)  1/118 (0.85%)  0/77 (0.00%) 
Pyelonephritis * 1  0/158 (0.00%)  0/118 (0.00%)  1/77 (1.30%) 
Sepsis * 1  0/158 (0.00%)  1/118 (0.85%)  0/77 (0.00%) 
Staphylococcal Infection * 1  0/158 (0.00%)  1/118 (0.85%)  0/77 (0.00%) 
Tonsillitis * 1  0/158 (0.00%)  0/118 (0.00%)  1/77 (1.30%) 
Urosepsis * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Injury, poisoning and procedural complications       
Cervical Vertebral Fracture * 1  0/158 (0.00%)  0/118 (0.00%)  1/77 (1.30%) 
Clavicle Fracture * 1  0/158 (0.00%)  1/118 (0.85%)  0/77 (0.00%) 
Contusion * 1  0/158 (0.00%)  0/118 (0.00%)  1/77 (1.30%) 
Excoriation * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Face Injury * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Hand Fracture * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Humerus Fracture * 1  1/158 (0.63%)  1/118 (0.85%)  0/77 (0.00%) 
Injury * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Laceration * 1  0/158 (0.00%)  1/118 (0.85%)  0/77 (0.00%) 
Ligament Rupture * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Ligament Sprain * 1  0/158 (0.00%)  2/118 (1.69%)  0/77 (0.00%) 
Meniscus Lesion * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Post Procedural Haemorrhage * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Rib Fracture * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Road Traffic Accident * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Scapula Fracture * 1  0/158 (0.00%)  1/118 (0.85%)  0/77 (0.00%) 
Metabolism and nutrition disorders       
Dehydration * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Hypoglycaemia * 1  0/158 (0.00%)  0/118 (0.00%)  1/77 (1.30%) 
Musculoskeletal and connective tissue disorders       
Ankylosing Spondylitis * 1  1/158 (0.63%)  2/118 (1.69%)  1/77 (1.30%) 
Arthralgia * 1  0/158 (0.00%)  2/118 (1.69%)  1/77 (1.30%) 
Arthritis * 1  0/158 (0.00%)  1/118 (0.85%)  0/77 (0.00%) 
Back Pain * 1  2/158 (1.27%)  0/118 (0.00%)  1/77 (1.30%) 
Intervertebral Disc Protrusion * 1  1/158 (0.63%)  1/118 (0.85%)  0/77 (0.00%) 
Joint Swelling * 1  0/158 (0.00%)  1/118 (0.85%)  0/77 (0.00%) 
Knee Deformity * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Muscle Spasms * 1  0/158 (0.00%)  1/118 (0.85%)  0/77 (0.00%) 
Osteoarthritis * 1  3/158 (1.90%)  1/118 (0.85%)  3/77 (3.90%) 
Prognathism * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Rotator Cuff Syndrome * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Spinal Osteoarthritis * 1  0/158 (0.00%)  1/118 (0.85%)  0/77 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Anogenital Warts * 1  0/158 (0.00%)  0/118 (0.00%)  1/77 (1.30%) 
Basal Cell Carcinoma * 1  0/158 (0.00%)  1/118 (0.85%)  1/77 (1.30%) 
Lymphoma * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Pancreatic Carcinoma * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Nervous system disorders       
Cervicobrachial Syndrome * 1  0/158 (0.00%)  1/118 (0.85%)  0/77 (0.00%) 
Hypoaesthesia * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Migraine * 1  0/158 (0.00%)  1/118 (0.85%)  1/77 (1.30%) 
Multiple Sclerosis * 1  0/158 (0.00%)  1/118 (0.85%)  0/77 (0.00%) 
Paraesthesia * 1  0/158 (0.00%)  1/118 (0.85%)  0/77 (0.00%) 
Psychiatric disorders       
Alcohol Abuse * 1  0/158 (0.00%)  1/118 (0.85%)  0/77 (0.00%) 
Bipolar I Disorder * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Depression * 1  0/158 (0.00%)  2/118 (1.69%)  2/77 (2.60%) 
Hallucination * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Mania * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Mental Disorder * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Suicidal Ideation * 1  0/158 (0.00%)  0/118 (0.00%)  1/77 (1.30%) 
Suicide Attempt * 1  1/158 (0.63%)  0/118 (0.00%)  1/77 (1.30%) 
Renal and urinary disorders       
Calculus Ureteric * 1  0/158 (0.00%)  1/118 (0.85%)  0/77 (0.00%) 
Nephrolithiasis * 1  0/158 (0.00%)  1/118 (0.85%)  0/77 (0.00%) 
Reproductive system and breast disorders       
Cystocele * 1  0/158 (0.00%)  1/118 (0.85%)  0/77 (0.00%) 
Endometriosis * 1  0/158 (0.00%)  0/118 (0.00%)  1/77 (1.30%) 
Rectocele * 1  0/158 (0.00%)  1/118 (0.85%)  0/77 (0.00%) 
Uterine Prolapse * 1  0/158 (0.00%)  1/118 (0.85%)  1/77 (1.30%) 
Respiratory, thoracic and mediastinal disorders       
Asthma * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Dyspnoea * 1  0/158 (0.00%)  0/118 (0.00%)  1/77 (1.30%) 
Epistaxis * 1  0/158 (0.00%)  0/118 (0.00%)  1/77 (1.30%) 
Pleural Effusion * 1  0/158 (0.00%)  0/118 (0.00%)  2/77 (2.60%) 
Pulmonary Embolism * 1  0/158 (0.00%)  0/118 (0.00%)  1/77 (1.30%) 
Snoring * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Skin and subcutaneous tissue disorders       
Pustular Psoriasis * 1  0/158 (0.00%)  1/118 (0.85%)  0/77 (0.00%) 
Social circumstances       
Pregnancy of Partner * 1  0/158 (0.00%)  1/118 (0.85%)  0/77 (0.00%) 
Surgical and medical procedures       
Female Sterilisation * 1  1/158 (0.63%)  0/118 (0.00%)  0/77 (0.00%) 
Vascular disorders       
Aortic Dissection * 1  0/158 (0.00%)  0/118 (0.00%)  1/77 (1.30%) 
Haematoma * 1  0/158 (0.00%)  1/118 (0.85%)  0/77 (0.00%) 
Hypertension * 1  0/158 (0.00%)  1/118 (0.85%)  0/77 (0.00%) 
*
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%
Group 1: Golimumab 50 mg Group 2: Golimumab 100 mg Group 3: Golimumab 50 and 100 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   147/158 (93.04%)   113/118 (95.76%)   76/77 (98.70%) 
Eye disorders       
Dry Eye * 1  1/158 (0.63%)  3/118 (2.54%)  4/77 (5.19%) 
Iritis * 1  7/158 (4.43%)  7/118 (5.93%)  3/77 (3.90%) 
Uveitis * 1  7/158 (4.43%)  10/118 (8.47%)  0/77 (0.00%) 
Gastrointestinal disorders       
Abdominal Discomfort * 1  2/158 (1.27%)  5/118 (4.24%)  5/77 (6.49%) 
Abdominal Pain * 1  8/158 (5.06%)  4/118 (3.39%)  2/77 (2.60%) 
Abdominal Pain Lower * 1  2/158 (1.27%)  0/118 (0.00%)  4/77 (5.19%) 
Abdominal Pain Upper * 1  12/158 (7.59%)  9/118 (7.63%)  5/77 (6.49%) 
Dental Caries * 1  2/158 (1.27%)  6/118 (5.08%)  1/77 (1.30%) 
Diarrhoea * 1  22/158 (13.92%)  16/118 (13.56%)  11/77 (14.29%) 
Dyspepsia * 1  10/158 (6.33%)  11/118 (9.32%)  2/77 (2.60%) 
Gastritis * 1  8/158 (5.06%)  4/118 (3.39%)  1/77 (1.30%) 
Nausea * 1  16/158 (10.13%)  24/118 (20.34%)  9/77 (11.69%) 
Toothache * 1  3/158 (1.90%)  7/118 (5.93%)  3/77 (3.90%) 
Vomiting * 1  9/158 (5.70%)  8/118 (6.78%)  4/77 (5.19%) 
General disorders       
Chest Pain * 1  7/158 (4.43%)  4/118 (3.39%)  5/77 (6.49%) 
Fatigue * 1  25/158 (15.82%)  30/118 (25.42%)  10/77 (12.99%) 
Injection Site Erythema * 1  8/158 (5.06%)  12/118 (10.17%)  10/77 (12.99%) 
Injection Site Swelling * 1  3/158 (1.90%)  3/118 (2.54%)  5/77 (6.49%) 
Oedema Peripheral * 1  8/158 (5.06%)  7/118 (5.93%)  4/77 (5.19%) 
Pyrexia * 1  13/158 (8.23%)  11/118 (9.32%)  4/77 (5.19%) 
Hepatobiliary disorders       
Hepatic Steatosis * 1  3/158 (1.90%)  8/118 (6.78%)  2/77 (2.60%) 
Immune system disorders       
Seasonal Allergy * 1  4/158 (2.53%)  4/118 (3.39%)  4/77 (5.19%) 
Infections and infestations       
Bronchitis * 1  17/158 (10.76%)  12/118 (10.17%)  10/77 (12.99%) 
Cellulitis * 1  7/158 (4.43%)  6/118 (5.08%)  2/77 (2.60%) 
Ear Infection * 1  2/158 (1.27%)  7/118 (5.93%)  1/77 (1.30%) 
Gastroenteritis * 1  9/158 (5.70%)  8/118 (6.78%)  2/77 (2.60%) 
Gastroenteritis Viral * 1  1/158 (0.63%)  6/118 (5.08%)  2/77 (2.60%) 
Herpes Zoster * 1  3/158 (1.90%)  4/118 (3.39%)  6/77 (7.79%) 
Influenza * 1  10/158 (6.33%)  13/118 (11.02%)  10/77 (12.99%) 
Lower Respiratory Tract Infection * 1  1/158 (0.63%)  4/118 (3.39%)  4/77 (5.19%) 
Nasopharyngitis * 1  49/158 (31.01%)  44/118 (37.29%)  27/77 (35.06%) 
Oral Herpes * 1  8/158 (5.06%)  5/118 (4.24%)  6/77 (7.79%) 
Pharyngitis * 1  9/158 (5.70%)  7/118 (5.93%)  3/77 (3.90%) 
Rhinitis * 1  9/158 (5.70%)  6/118 (5.08%)  4/77 (5.19%) 
Sinusitis * 1  18/158 (11.39%)  19/118 (16.10%)  13/77 (16.88%) 
Tooth Abscess * 1  4/158 (2.53%)  4/118 (3.39%)  4/77 (5.19%) 
Tooth Infection * 1  6/158 (3.80%)  7/118 (5.93%)  0/77 (0.00%) 
Upper Respiratory Tract Infection * 1  60/158 (37.97%)  42/118 (35.59%)  26/77 (33.77%) 
Urinary Tract Infection * 1  6/158 (3.80%)  13/118 (11.02%)  7/77 (9.09%) 
Vaginal Infection * 1  2/158 (1.27%)  0/118 (0.00%)  4/77 (5.19%) 
Viral Infection * 1  1/158 (0.63%)  1/118 (0.85%)  4/77 (5.19%) 
Vulvovaginal Mycotic Infection * 1  3/158 (1.90%)  7/118 (5.93%)  1/77 (1.30%) 
Injury, poisoning and procedural complications       
Contusion * 1  6/158 (3.80%)  4/118 (3.39%)  6/77 (7.79%) 
Laceration * 1  2/158 (1.27%)  8/118 (6.78%)  3/77 (3.90%) 
Ligament Sprain * 1  9/158 (5.70%)  4/118 (3.39%)  1/77 (1.30%) 
Investigations       
Alanine Aminotransferase Increased * 1  21/158 (13.29%)  20/118 (16.95%)  5/77 (6.49%) 
Aspartate Aminotransferase Increased * 1  14/158 (8.86%)  12/118 (10.17%)  6/77 (7.79%) 
Blood Glucose Increased * 1  2/158 (1.27%)  5/118 (4.24%)  4/77 (5.19%) 
Weight Increased * 1  7/158 (4.43%)  7/118 (5.93%)  4/77 (5.19%) 
Metabolism and nutrition disorders       
Hypercholesterolaemia * 1  2/158 (1.27%)  6/118 (5.08%)  1/77 (1.30%) 
Musculoskeletal and connective tissue disorders       
Ankylosing Spondylitis * 1  9/158 (5.70%)  4/118 (3.39%)  5/77 (6.49%) 
Arthralgia * 1  37/158 (23.42%)  28/118 (23.73%)  23/77 (29.87%) 
Back Pain * 1  36/158 (22.78%)  31/118 (26.27%)  16/77 (20.78%) 
Bone Pain * 1  8/158 (5.06%)  3/118 (2.54%)  1/77 (1.30%) 
Bursitis * 1  5/158 (3.16%)  5/118 (4.24%)  6/77 (7.79%) 
Joint Swelling * 1  8/158 (5.06%)  5/118 (4.24%)  6/77 (7.79%) 
Muscle Spasms * 1  8/158 (5.06%)  5/118 (4.24%)  5/77 (6.49%) 
Musculoskeletal Pain * 1  19/158 (12.03%)  9/118 (7.63%)  10/77 (12.99%) 
Musculoskeletal Stiffness * 1  3/158 (1.90%)  11/118 (9.32%)  5/77 (6.49%) 
Myalgia * 1  6/158 (3.80%)  10/118 (8.47%)  2/77 (2.60%) 
Neck Pain * 1  16/158 (10.13%)  12/118 (10.17%)  12/77 (15.58%) 
Pain in Extremity * 1  21/158 (13.29%)  14/118 (11.86%)  10/77 (12.99%) 
Rotator Cuff Syndrome * 1  0/158 (0.00%)  3/118 (2.54%)  5/77 (6.49%) 
Nervous system disorders       
Dizziness * 1  10/158 (6.33%)  9/118 (7.63%)  8/77 (10.39%) 
Headache * 1  29/158 (18.35%)  28/118 (23.73%)  20/77 (25.97%) 
Hypoaesthesia * 1  8/158 (5.06%)  6/118 (5.08%)  7/77 (9.09%) 
Migraine * 1  1/158 (0.63%)  6/118 (5.08%)  5/77 (6.49%) 
Paraesthesia * 1  7/158 (4.43%)  8/118 (6.78%)  3/77 (3.90%) 
Psychiatric disorders       
Depression * 1  5/158 (3.16%)  7/118 (5.93%)  4/77 (5.19%) 
Insomnia * 1  5/158 (3.16%)  9/118 (7.63%)  5/77 (6.49%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  30/158 (18.99%)  19/118 (16.10%)  18/77 (23.38%) 
Dyspnoea * 1  7/158 (4.43%)  6/118 (5.08%)  6/77 (7.79%) 
Nasal Congestion * 1  3/158 (1.90%)  5/118 (4.24%)  7/77 (9.09%) 
Oropharyngeal Pain * 1  21/158 (13.29%)  12/118 (10.17%)  7/77 (9.09%) 
Productive Cough * 1  14/158 (8.86%)  8/118 (6.78%)  4/77 (5.19%) 
Respiratory Tract Congestion * 1  0/158 (0.00%)  2/118 (1.69%)  4/77 (5.19%) 
Rhinorrhoea * 1  14/158 (8.86%)  6/118 (5.08%)  4/77 (5.19%) 
Upper Respiratory Tract Congestion * 1  5/158 (3.16%)  3/118 (2.54%)  5/77 (6.49%) 
Skin and subcutaneous tissue disorders       
Alopecia * 1  4/158 (2.53%)  6/118 (5.08%)  5/77 (6.49%) 
Dermatitis Contact * 1  2/158 (1.27%)  1/118 (0.85%)  5/77 (6.49%) 
Dry Skin * 1  1/158 (0.63%)  1/118 (0.85%)  5/77 (6.49%) 
Eczema * 1  5/158 (3.16%)  5/118 (4.24%)  7/77 (9.09%) 
Hyperhidrosis * 1  3/158 (1.90%)  3/118 (2.54%)  6/77 (7.79%) 
Night Sweats * 1  4/158 (2.53%)  8/118 (6.78%)  4/77 (5.19%) 
Pruritus * 1  11/158 (6.96%)  7/118 (5.93%)  7/77 (9.09%) 
Rash * 1  17/158 (10.76%)  16/118 (13.56%)  8/77 (10.39%) 
Vascular disorders       
Hypertension * 1  14/158 (8.86%)  15/118 (12.71%)  6/77 (7.79%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 14.1
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.
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.
Generally, the only disclosure restriction on the PI is that the sponsor has 60 days to review results communications prior to public release and can embargo communications regarding trial results for a period that does not exceed 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title: Director, Clinical Research
Organization: Centocor Research and Development, Inc.
Phone: 1-800-457-6399
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00265083     History of Changes
Other Study ID Numbers: CR006337
C0524T09 ( Other Identifier: Centocor )
First Submitted: December 12, 2005
First Posted: December 14, 2005
Results First Submitted: May 21, 2009
Results First Posted: July 13, 2009
Last Update Posted: July 19, 2013