Tracking Information
Start Date ICMJE | January 2007 |
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Estimated Primary Completion Date | October 2010 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: December 21, 2007) | Part 1:Evaluate the dose response; Select SC induction regimen(s) of CNTO 148 (golimumab), based on safety and efficacy; Part 2:Evaluate the safety and efficacy of SC induction regimens of CNTO 148 (golimumab) in inducing clinical response at Week 6. [ Time Frame: Part I: Week 6, Part II: Week 6 ] [ Designated as safety issue: Yes ] |
Original Primary Outcome Measures ICMJE (submitted: June 14, 2007) | Part 1:Evaluate the dose response; Select SC induction regimen(s) of CNTO 148 (golimumab), based on safety and efficacy; Part 2:Evaluate the safety and efficacy of SC induction regimens of CNTO 148 (golimumab) in inducing clinical response at Week 6. |
Change History | Complete list of historical versions of study NCT00487539 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: December 21, 2007) | Evaluate the efficacy of SC induction regimens of CNTO 148 (golimumab) in inducing clinical remission, mucosal healing, improving disease-specific health-related quality of life at Week 6. [ Time Frame: Part II: Week 6 ] [ Designated as safety issue: No ] |
Original Secondary Outcome Measures ICMJE (submitted: June 14, 2007) | Evaluate the efficacy of SC induction regimens of CNTO 148 (golimumab) in inducing clinical remission, mucosal healing, improving disease-specific health-related quality of life at Week 6. |
Descriptive Information
Brief Title ICMJE | A Study of the Safety and Effectiveness of CNTO 148 (Golimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (CR014176) |
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Official Title ICMJE | 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 |
Brief Summary | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis. |
Detailed Description | CNTO 148 (golimumab) is a type of tumor necrosis factor (TNF) inhibitor. TNF is a naturally occurring substance in the body and this substance may cause long-term inflammation. CNTO 148 (golimumab) may help treat this disease by blocking the activity of TNF in the body and reducing the symptoms of ulcerative colitis(UC).This study will assess the safety and effectiveness of subcutaneously (under the skin) administered CNTO 148 (golimumab) and determine if there is a reduction of signs and symptoms (such as diarrhea and rectal bleeding) in patients with active ulcerative colitis. The effect of subcutaneously (SC) administered CNTO 148 (golimumab) on the quality of life in patients with ulcerative colitis will also be assessed. About 676 patients will take part in the study at approximately 150 centers.Participation in the study will last for six weeks. At week 6, patients will be asked to participate in an additional 54-week maintenance study and a long-term extension study (CR014188) that will last approximately 3 years. If the patient chooses not to participate in the maintenance study, their participation in this study will extend 16 weeks after the last dose of study medication.There are two parts to this study. Part 1 is called "dose-ranging" and will enroll 176 patients. Patients enrolled in Part 1 will be equally assigned to subcutaneous (under the skin) injections at Week 0 of either placebo, or a total dose of CNTO 148 (golimumab), 100mg, 200mg, or 400mg followed by injections at Week 2 of either placebo, or total dose of CNTO 148 (golimumab) 50mg, 100mg, or 200mg, respectively.Part 2 of this study is called "dose confirming" and will enroll 500 patients. Patients will be equally assigned to the same doses as studied in Part 1 until the doses for Part 2 are selected. At the time that the final doses are selected, all newly enrolled patients will be equally assigned to one of the selected doses or placebo. This entire study is "blinded." This means that neither the patient nor the study doctor will know which treatment the patient received. The overall purpose of this trial is to determine if treatment with CNTO 148 (golimumab) is better than treatment with placebo in reducing a patient's ulcerative colitis signs and symptoms. Patients will receive multiple injections (under the skin) for a total dose of 0, 100, 200 or 400 mgCNTO 148 at Week 0 followed a total dose of 0, 50, 100 or 200 mg CNTO 148 (golimumab), respectively, at Week 2. |
Study Phase | Phase II, Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Ulcerative Colitis |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 676 | ||||
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Estimated Completion Date | January 2011 | ||||
Estimated Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Australia, Austria, Belgium, Bulgaria, Canada, Denmark, France, Germany, Hungary, India, Israel, Japan, Latvia, Lithuania, Netherlands, Poland, Romania, Russian Federation, Serbia, Slovakia, Sweden, Ukraine, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00487539 | ||||
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Responsible Party | Assoc Director Clinical Research, Centocor Inc. | ||||
Study ID Numbers ICMJE | CR014176, C0524T17, EudraCT No: 2006-003398-28 | ||||
Study Sponsor ICMJE | Centocor, Inc. | ||||
Collaborators ICMJE | Schering-Plough | ||||
Investigators ICMJE |
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Information Provided By | Centocor, Inc. |