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 |
Recruitment Status :
Completed
First Posted : June 18, 2007
Results First Posted : February 17, 2014
Last Update Posted : February 17, 2014
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Condition or disease | Intervention/treatment | Phase |
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Colitis, Ulcerative | Biological: Placebo Biological: Golimumab 100 mg Biological: Golimumab 200 mg Biological: Golimumab 400 mg Biological: Golimumab 50 mg | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1065 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis |
Study Start Date : | August 2007 |
Actual Primary Completion Date : | October 2010 |
Actual Study Completion Date : | October 2010 |
Arm | Intervention/treatment |
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Placebo Comparator: Placebo
Placebo subcutaneous injection (given under the skin by way of a needle) matching to golimumab administered at Week 0 and Week 2.
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Biological: Placebo
Placebo subcutaneous injection (given under the skin by way of a needle) matching to golimumab administered at Week 0 and Week 2. |
Experimental: Golimumab 100 mg -> 50 mg
Golimumab 100 milligram (mg) subcutaneous injection administered at Week 0 and dose is decreased to 50 mg at Week 2.
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Biological: Golimumab 100 mg
Golimumab 100 mg subcutaneous injection administered at Week 0 for Golimumab 100 mg -> 50 mg arm group and at Week 2 for Golimumab 200 mg -> 100 mg arm group. Biological: Golimumab 50 mg Golimumab 50 mg subcutaneous injection administered at Week 2 for Golimumab 100 mg -> 50 mg arm group. |
Experimental: Golimumab 200 mg -> 100 mg
Golimumab 200 mg subcutaneous injection administered at Week 0 and dose is decreased to 100 mg at Week 2.
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Biological: Golimumab 100 mg
Golimumab 100 mg subcutaneous injection administered at Week 0 for Golimumab 100 mg -> 50 mg arm group and at Week 2 for Golimumab 200 mg -> 100 mg arm group. Biological: Golimumab 200 mg Golimumab 200 mg subcutaneous injection administered at Week 0 for Golimumab 200 mg -> 100 mg arm group and at Week 2 for Golimumab 400 mg -> 200 mg arm group. |
Experimental: Golimumab 400 mg -> 200 mg
Golimumab 400 mg subcutaneous injection administered at Week 0 and dose is decreased to 200 mg at Week 2.
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Biological: Golimumab 200 mg
Golimumab 200 mg subcutaneous injection administered at Week 0 for Golimumab 200 mg -> 100 mg arm group and at Week 2 for Golimumab 400 mg -> 200 mg arm group. Biological: Golimumab 400 mg Golimumab 400 mg subcutaneous injection administered at Week 0 for Golimumab 400 mg -> 200 mg arm group. |
- Number of Participants With Clinical Response at Week 6 [ Time Frame: Baseline, Week 6 ]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.
- Number of Participants With Clinical Remission at Week 6 [ Time Frame: Week 6 ]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.
- Number of Participants With Mucosal Healing at Week 6 [ Time Frame: Week 6 ]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).
- Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 6 [ Time Frame: Baseline to Week 6 ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participants diagnosed with moderately to severely active ulcerative colitis (UC) defined by a Mayo score of 6 to 12 inclusive at Baseline (Week 0), including an endoscopic (examination of an internal part of the body with a lighted tube; looking at a part of the body with a lighted tube) subscore of greater than or equal to 2
- Participants must have biopsy results (collected at the screening endoscopy (procedure or obtained within the last year) consistent with the diagnosis of UC
- Participants either currently receiving treatment with, or have a history of failure to respond to, or tolerate, at least 1 of the following therapies: oral 5-aminosalicylate, oral corticosteroids, 6-mercaptopurine and azathioprine
- Participants with current dependency or with a history of corticosteroid dependency (i.e., an inability to successfully taper corticosteroids without a return of the symptoms of UC)
- Not have a diagnosis of active tuberculosis
- Participants with negative stool test for enteric (by way of the intestines) pathogens
Exclusion Criteria:
- Participants with prior exposure to biologic anti-tumor necrosis factor (TNF) agents
- Participants with severe extensive UC that is likely to require a colectomy (surgery to remove part or all of the colon) within 12 weeks of study entry
- Participants having UC limited to the rectum only or to less than 20 centimeter of the colon
- Presence of a stoma (an artificial permanent opening especially in the abdominal wall made in surgical procedures) or presence of a fistula
- Participants with a history of extensive colonic resection
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00487539
Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
Responsible Party: | Janssen Research & Development, LLC |
ClinicalTrials.gov Identifier: | NCT00487539 |
Other Study ID Numbers: |
CR014176 C0524T17 2006-003398-28 ( EudraCT Number ) |
First Posted: | June 18, 2007 Key Record Dates |
Results First Posted: | February 17, 2014 |
Last Update Posted: | February 17, 2014 |
Last Verified: | January 2014 |
Colitis, Ulcerative Golimumab CNTO 148 |
Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes |
Inflammatory Bowel Diseases Golimumab Antibodies, Monoclonal Tumor Necrosis Factor Inhibitors Anti-Inflammatory Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |