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An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis

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: NCT00487539
Recruitment Status : Completed
First Posted : June 18, 2007
Results First Posted : February 17, 2014
Last Update Posted : February 17, 2014
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Colitis, Ulcerative
Interventions Biological: Placebo
Biological: Golimumab 100 mg
Biological: Golimumab 200 mg
Biological: Golimumab 400 mg
Biological: Golimumab 50 mg
Enrollment 1065
Recruitment Details  
Pre-assignment Details Participants were assigned to Placebo, Golimumab 100 mg->50 mg, Golimumab 200 mg->100 mg and Golimumab 400 mg->200 mg groups for dose selection. Efficacy results were reported for only newly enrolled participants assigned to Placebo, Golimumab 200 mg->100 mg and Golimumab 400 mg->200 mg groups after dose-selection as per planned analysis.
Arm/Group Title Placebo Golimumab 100 mg -> 50 mg Golimumab 200 mg -> 100 mg Golimumab 400 mg -> 200 mg
Hide Arm/Group Description Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2. This dosing regimen was selected for the efficacy analysis (only in newly enrolled participants following dose-selection, as per planned analysis). Golimumab 100 milligram (mg) subcutaneous injection was administered at Week 0 and dose was decreased to 50 mg at Week 2. Golimumab 200 mg subcutaneous injection was administered at Week 0 and the dose was decreased to 100 mg at Week 2. This dosing regimen was selected for the efficacy analysis (only in newly enrolled participants following dose-selection, as per planned analysis). Golimumab 400 mg subcutaneous injection was administered at Week 0 and the dose was decreased to 200 mg at Week 2. This dosing regimen was selected for the efficacy analysis (only in newly enrolled participants following dose-selection, as per planned analysis).
Period Title: Overall Study
Started 331 72 331 331
Completed 324 69 328 327
Not Completed 7 3 3 4
Reason Not Completed
Adverse Event             3             2             1             1
Unsatisfactory therapeutic effect             1             0             0             1
Other             3             1             2             2
Arm/Group Title Placebo Golimumab 100 mg -> 50 mg Golimumab 200 mg -> 100 mg Golimumab 400 mg -> 200 mg Total
Hide Arm/Group Description Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2. Golimumab 100 milligram (mg) subcutaneous injection was administered at Week 0 and dose was decreased to 50 mg at Week 2. Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2. Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2. Total of all reporting groups
Overall Number of Baseline Participants 331 72 331 331 1065
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 331 participants 72 participants 331 participants 331 participants 1065 participants
39  (13.04) 40.9  (12.19) 40  (13.54) 40.7  (13.75) 40  (13.37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 331 participants 72 participants 331 participants 331 participants 1065 participants
Female
156
  47.1%
32
  44.4%
151
  45.6%
130
  39.3%
469
  44.0%
Male
175
  52.9%
40
  55.6%
180
  54.4%
201
  60.7%
596
  56.0%
1.Primary Outcome
Title Number of Participants With Clinical Response at Week 6
Hide Description Clinical response is defined as decrease from baseline in Mayo score by greater than or equal to 30 percent and greater than or equal to 3, with either a decrease from baseline in rectal bleeding sub-score of greater than or equal to 1 or a rectal bleeding sub-score of 0 or 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis population included all the participants who were randomly assigned to the study after the dose selection.
Arm/Group Title Placebo Golimumab 200 mg -> 100 mg Golimumab 400 mg -> 200 mg
Hide Arm/Group Description:
Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.
Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.
Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
Overall Number of Participants Analyzed 251 253 257
Measure Type: Number
Unit of Measure: Participants
76 129 141
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Golimumab 200 mg -> 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Golimumab 400 mg -> 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Clinical Remission at Week 6
Hide Description Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis population included all the participants who were randomly assigned to the study after the dose selection.
Arm/Group Title Placebo Golimumab 200 mg -> 100 mg Golimumab 400 mg -> 200 mg
Hide Arm/Group Description:
Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.
Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.
Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
Overall Number of Participants Analyzed 251 253 257
Measure Type: Number
Unit of Measure: Participants
16 45 46
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Golimumab 200 mg -> 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Golimumab 400 mg -> 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Mucosal Healing at Week 6
Hide Description Mucosal healing is determined from the endoscopy sub-score of the Mayo score. Mucosal healing is defined as an endoscopy sub-score of 0 or 1. Higher score indicates higher severity of disease. Endoscopy sub-score ranges from 0 (normal or inactive disease) to 3 (severe disease; spontaneous bleeding and ulceration).
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis population included all the participants who were randomly assigned to the study after the dose selection.
Arm/Group Title Placebo Golimumab 200 mg -> 100 mg Golimumab 400 mg -> 200 mg
Hide Arm/Group Description:
Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.
Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.
Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
Overall Number of Participants Analyzed 251 253 257
Measure Type: Number
Unit of Measure: Participants
72 107 116
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Golimumab 200 mg -> 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0014
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Golimumab 400 mg -> 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 6
Hide Description The IBDQ is used to measure disease specific quality of life on a 32 Likert-scaled items questionnaire. The IBDQ scale contains 4 component subscales: bowel symptoms, systemic symptoms, emotional function and social function with scores ranging from 10 to 70, 5 to 35, 12 to 84 and 5 to 35 respectively and the total score ranges from 32 to 224. Higher scores indicate better health related quality of life.
Time Frame Baseline to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis population included all the participants who were randomly assigned to the study after the dose selection. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Placebo Golimumab 200 mg -> 100 mg Golimumab 400 mg -> 200 mg
Hide Arm/Group Description:
Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.
Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.
Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
Overall Number of Participants Analyzed 250 252 255
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
Baseline 129.6  (32.61) 131.7  (33.93) 127.2  (33.90)
Change at Week 6 14.8  (31.25) 27.0  (33.72) 26.9  (34.28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Golimumab 200 mg -> 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments on the van der Waerden normal scores
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Golimumab 400 mg -> 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments on the van der Waerden normal scores
Time Frame 6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study.
Adverse Event Reporting Description The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -> 200 mg group.
 
Arm/Group Title Placebo Golimumab 100 mg -> 50 mg Golimumab 200 mg -> 100 mg Golimumab 400 mg -> 200 mg
Hide Arm/Group Description Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2. Golimumab 100 milligram (mg) subcutaneous injection was administered at Week 0 and dose was decreased to 50 mg at Week 2. Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2. Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
All-Cause Mortality
Placebo Golimumab 100 mg -> 50 mg Golimumab 200 mg -> 100 mg Golimumab 400 mg -> 200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo Golimumab 100 mg -> 50 mg Golimumab 200 mg -> 100 mg Golimumab 400 mg -> 200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   20/330 (6.06%)   3/71 (4.23%)   10/331 (3.02%)   15/332 (4.52%) 
Blood and lymphatic system disorders         
Anaemia * 1  2/330 (0.61%)  0/71 (0.00%)  3/331 (0.91%)  0/332 (0.00%) 
Gastrointestinal disorders         
Abdominal Pain * 1  0/330 (0.00%)  0/71 (0.00%)  0/331 (0.00%)  1/332 (0.30%) 
Abdominal Pain Upper * 1  0/330 (0.00%)  0/71 (0.00%)  1/331 (0.30%)  0/332 (0.00%) 
Colitis Ulcerative * 1  8/330 (2.42%)  1/71 (1.41%)  3/331 (0.91%)  7/332 (2.11%) 
Nausea * 1  1/330 (0.30%)  0/71 (0.00%)  0/331 (0.00%)  0/332 (0.00%) 
Vomiting * 1  0/330 (0.00%)  0/71 (0.00%)  0/331 (0.00%)  1/332 (0.30%) 
General disorders         
Adverse Drug Reaction * 1  1/330 (0.30%)  0/71 (0.00%)  0/331 (0.00%)  0/332 (0.00%) 
Pyrexia * 1  0/330 (0.00%)  0/71 (0.00%)  1/331 (0.30%)  1/332 (0.30%) 
Infections and infestations         
Anal Abscess * 1  1/330 (0.30%)  0/71 (0.00%)  0/331 (0.00%)  1/332 (0.30%) 
Brain Abscess * 1  0/330 (0.00%)  0/71 (0.00%)  0/331 (0.00%)  1/332 (0.30%) 
Bronchitis * 1  0/330 (0.00%)  0/71 (0.00%)  0/331 (0.00%)  1/332 (0.30%) 
Candidiasis * 1  1/330 (0.30%)  0/71 (0.00%)  0/331 (0.00%)  0/332 (0.00%) 
Cellulitis * 1  0/330 (0.00%)  0/71 (0.00%)  0/331 (0.00%)  1/332 (0.30%) 
Cytomegalovirus Infection * 1  0/330 (0.00%)  1/71 (1.41%)  0/331 (0.00%)  0/332 (0.00%) 
Enterocolitis Infectious * 1  1/330 (0.30%)  0/71 (0.00%)  0/331 (0.00%)  0/332 (0.00%) 
Gastroenteritis * 1  0/330 (0.00%)  0/71 (0.00%)  1/331 (0.30%)  0/332 (0.00%) 
Gastroenteritis Viral * 1  0/330 (0.00%)  0/71 (0.00%)  0/331 (0.00%)  1/332 (0.30%) 
Haematoma Infection * 1  1/330 (0.30%)  0/71 (0.00%)  0/331 (0.00%)  0/332 (0.00%) 
Herpes Simplex * 1  1/330 (0.30%)  0/71 (0.00%)  0/331 (0.00%)  0/332 (0.00%) 
Pneumonia * 1  1/330 (0.30%)  0/71 (0.00%)  1/331 (0.30%)  0/332 (0.00%) 
Rectal Abscess * 1  0/330 (0.00%)  0/71 (0.00%)  0/331 (0.00%)  1/332 (0.30%) 
Viral Infection * 1  1/330 (0.30%)  0/71 (0.00%)  0/331 (0.00%)  0/332 (0.00%) 
Injury, poisoning and procedural complications         
Ankle Fracture * 1  0/330 (0.00%)  1/71 (1.41%)  0/331 (0.00%)  0/332 (0.00%) 
Fall * 1  0/330 (0.00%)  1/71 (1.41%)  0/331 (0.00%)  0/332 (0.00%) 
Investigations         
Haemoglobin Decreased * 1  0/330 (0.00%)  0/71 (0.00%)  1/331 (0.30%)  0/332 (0.00%) 
Volume Blood Decreased * 1  0/330 (0.00%)  0/71 (0.00%)  0/331 (0.00%)  1/332 (0.30%) 
Metabolism and nutrition disorders         
Dehydration * 1  2/330 (0.61%)  0/71 (0.00%)  0/331 (0.00%)  0/332 (0.00%) 
Malnutrition * 1  1/330 (0.30%)  0/71 (0.00%)  0/331 (0.00%)  0/332 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthropathy * 1  1/330 (0.30%)  0/71 (0.00%)  0/331 (0.00%)  0/332 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Carcinoma in Situ * 1  0/330 (0.00%)  0/71 (0.00%)  0/331 (0.00%)  1/332 (0.30%) 
Colon Cancer * 1  0/330 (0.00%)  0/71 (0.00%)  0/331 (0.00%)  1/332 (0.30%) 
Thyroid Cancer * 1  1/330 (0.30%)  0/71 (0.00%)  0/331 (0.00%)  0/332 (0.00%) 
Nervous system disorders         
Demyelination * 1  0/330 (0.00%)  0/71 (0.00%)  0/331 (0.00%)  1/332 (0.30%) 
Dizziness * 1  0/330 (0.00%)  0/71 (0.00%)  0/331 (0.00%)  1/332 (0.30%) 
Headache * 1  0/330 (0.00%)  0/71 (0.00%)  0/331 (0.00%)  1/332 (0.30%) 
Ischaemic Stroke * 1  0/330 (0.00%)  0/71 (0.00%)  0/331 (0.00%)  1/332 (0.30%) 
Respiratory, thoracic and mediastinal disorders         
Chronic Obstructive Pulmonary Disease * 1  0/330 (0.00%)  0/71 (0.00%)  0/331 (0.00%)  1/332 (0.30%) 
Lung Infiltration * 1  0/330 (0.00%)  0/71 (0.00%)  0/331 (0.00%)  1/332 (0.30%) 
Skin and subcutaneous tissue disorders         
Erythema Nodosum * 1  3/330 (0.91%)  0/71 (0.00%)  0/331 (0.00%)  0/332 (0.00%) 
Rash Macular * 1  1/330 (0.30%)  0/71 (0.00%)  0/331 (0.00%)  0/332 (0.00%) 
Vascular disorders         
Deep Vein Thrombosis * 1  1/330 (0.30%)  0/71 (0.00%)  0/331 (0.00%)  0/332 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 13.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo Golimumab 100 mg -> 50 mg Golimumab 200 mg -> 100 mg Golimumab 400 mg -> 200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   61/330 (18.48%)   18/71 (25.35%)   54/331 (16.31%)   55/332 (16.57%) 
Blood and lymphatic system disorders         
Anaemia * 1  6/330 (1.82%)  2/71 (2.82%)  8/331 (2.42%)  5/332 (1.51%) 
Gastrointestinal disorders         
Abdominal Pain * 1  5/330 (1.52%)  1/71 (1.41%)  2/331 (0.60%)  7/332 (2.11%) 
Colitis Ulcerative * 1  7/330 (2.12%)  1/71 (1.41%)  4/331 (1.21%)  2/332 (0.60%) 
Nausea * 1  6/330 (1.82%)  1/71 (1.41%)  3/331 (0.91%)  12/332 (3.61%) 
General disorders         
Injection Site Erythema * 1  0/330 (0.00%)  3/71 (4.23%)  5/331 (1.51%)  4/332 (1.20%) 
Pyrexia * 1  7/330 (2.12%)  2/71 (2.82%)  5/331 (1.51%)  10/332 (3.01%) 
Infections and infestations         
Nasopharyngitis * 1  12/330 (3.64%)  2/71 (2.82%)  13/331 (3.93%)  8/332 (2.41%) 
Oral Herpes * 1  1/330 (0.30%)  2/71 (2.82%)  2/331 (0.60%)  0/332 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  7/330 (2.12%)  0/71 (0.00%)  3/331 (0.91%)  6/332 (1.81%) 
Back Pain * 1  2/330 (0.61%)  2/71 (2.82%)  1/331 (0.30%)  1/332 (0.30%) 
Nervous system disorders         
Headache * 1  17/330 (5.15%)  5/71 (7.04%)  11/331 (3.32%)  15/332 (4.52%) 
Psychiatric disorders         
Insomnia * 1  3/330 (0.91%)  2/71 (2.82%)  1/331 (0.30%)  1/332 (0.30%) 
Respiratory, thoracic and mediastinal disorders         
Cough * 1  9/330 (2.73%)  0/71 (0.00%)  3/331 (0.91%)  3/332 (0.90%) 
Skin and subcutaneous tissue disorders         
Rash * 1  5/330 (1.52%)  2/71 (2.82%)  2/331 (0.60%)  3/332 (0.90%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 13.0
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.
12 months after study ends, Sponsor will be provided with a copy of the materials at least 45 days prior to submission, with details of proposed date, journal or conference name of publication & it will have 30 days post receipt to send a written request that the publication be delayed on the basis it exposes intellectual property that requires propriety protection but it will be only for 60 days after which Investigator will be free to publish. The participation of Sponsor will be acknowledged.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director
Organization: Janssen Research & Development
Phone: 215-793-7540
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT00487539    
Other Study ID Numbers: CR014176
C0524T17
2006-003398-28 ( EudraCT Number )
First Submitted: June 14, 2007
First Posted: June 18, 2007
Results First Submitted: April 29, 2013
Results First Posted: February 17, 2014
Last Update Posted: February 17, 2014