An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis
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| ClinicalTrials.gov Identifier: NCT00487539 |
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Recruitment Status :
Completed
First Posted : June 18, 2007
Results First Posted : February 17, 2014
Last Update Posted : February 17, 2014
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Sponsor:
Janssen Research & Development, LLC
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Janssen Research & Development, LLC
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| 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 |
Participant Flow
| 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 |
|---|---|---|---|---|
 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 |
Baseline Characteristics
| Arm/Group Title | Placebo | Golimumab 100 mg -> 50 mg | Golimumab 200 mg -> 100 mg | Golimumab 400 mg -> 200 mg | Total | |
|---|---|---|---|---|---|---|
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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 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| 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) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 331 participants | 72 participants | 331 participants | 331 participants | 1065 participants | |
| Female |
156 47.1%
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32 44.4%
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151 45.6%
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130 39.3%
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469 44.0%
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| Male |
175 52.9%
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40 55.6%
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180 54.4%
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201 60.7%
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596 56.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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
| Name/Title: | Senior Director |
| Organization: | Janssen Research & Development |
| Phone: | 215-793-7540 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |