A Study of the Safety and Effectiveness of CNTO 148 (Golimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (CR014179)
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Purpose
The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis
| Condition | Intervention | Phase |
|---|---|---|
|
Ulcerative Colitis |
Biological: Golimumab, placebo Biological: golimumab, placebo Biological: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis |
- Evaluate the efficacy and safety of maintenance regimens of CNTO 148 (golimumab) in maintaining clinical response through Week 54 [ Time Frame: Week 54 ] [ Designated as safety issue: Yes ]
- Evaluate the efficacy of CNTO 148 (golimumab) in maintaining clinical remission and mucosal healing at weeks 30 and 54, and in achieving clinical remission and eliminating corticosteroid use at Week 54. [ Time Frame: Weeks 30 and 54 ] [ Designated as safety issue: No ]
| Enrollment: | 1228 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | February 2015 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 001
Placebo 3 subcutaneous (SC) injections every 4 weeks through Week 52; golimumab - Could receive 100 mg SC injections every 4 weeks through Week 52
|
Biological: Placebo
3 SC injections every 4 weeks through week 52; golimumab - Could receive 100 mg sc injections every 4 weeks through wk 52
|
|
Experimental: 003
Golimumab, placebo 1 SC injection of 100 mg every 4 weeks though Week 52; placebo - 2 SC injections every 4 weeks though Week 52; golimumab - Could receive SC injections of 100 or 200 mg every 4 weeks through Week 52
|
Biological: Golimumab, placebo
1 sc injection of 100 mg every 4 weeks though week 52; placebo - 2 sc injections every 4 weeks though week 52; golimumab - Could receive sc injections of 100 or 200 mg every 4 weeks through week 52
|
|
Experimental: 002
Golimumab, placebo 1 SC injection of 50 mg every 4 weeks through Week 52; placebo - 2 SC every 4 weeks through Week 52; golimumab - Could receive SC injections of 50 or 100 mg every 4 weeks through Week 52
|
Biological: golimumab, placebo
1 subcutaneous injection of 50mg every 4 weeks through week 52; placebo - 2 SC every 4 weeks through week 52; golimumab - Could receive sc injections of 50 or 100 mg every 4 weeks through week 52
|
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 CNTO 148 (golimumab) maintenance therapy administered subcutaneously (under the skin) in patients with active ulcerative colitis who have participated in C0524T16 (CR014176) or C0524T17 (CR014179). Approximately 1350 patients will take part in the study at approximately 300 centers. Following participation in one of the previous 6-week induction studies, patients will be eligible to participate in this maintenance study that will last up to 54 weeks. On completing this study, patients will have the opportunity to continue to receive study medication in a study extension that will last up to approximately 3 years. If a patient discontinues at any time during the maintenance study or the study extension, they will be asked to return for a follow up visit 16 weeks after their last dose of study medication. Patients who discontinue prior to Week 54 will be contacted for follow-up colectomy information within 1 year of entering the study.Patients whose ulcerative colitis symptoms improved with CNTO 148 (golimumab) treatment in either the C0524T16 (CR014176) or C0524T17 (CR014179) study will be equally assigned to one of three maintenance treatment groups and will receive subcutaneous injections of either placebo or CNTO 148 (golimumab), 50mg or 100mg at Week 0 and every 4 weeks thereafter through Week 52. Patients whose ulcerative colitis symptoms improved with placebo treatment in either the C0524T16 (CR014176) or C0524T17 (CR014179) study will continue to receive placebo in the maintenance study.Patients entering one of the above-mentioned treatments who have an increase in their ulcerative colitis symptoms will be eligible for a dose adjustment of study medication (up to 200 mg of CNTO 148 (golimumab)). If the patient's symptoms improve after 4 treatments at the adjusted dose, they will be eligible to continue receiving study medication thereafter through Week 52. If their symptoms do not improve, they will be discontinued from receiving further study medication and will return for a final visit 16 weeks after their last dose of study medication.Patients whose ulcerative colitis symptoms did NOT improve with either CNTO 148 (golimumab) or placebo treatment in either the C0524T16 (CR014176) or C0524T17 (CR014179) study will be eligible to receive 100mg of CNTO 148 (golimumab) every 4 weeks through Week 12. If the patient's symptoms improve during this time, they will be eligible to continue to receive 100mg of CNTO 148 (golimumab) every 4 weeks thereafter through Week 52. If the patient's symptoms do not improve, they will be discontinued from receiving further CNTO 148 (golimumab) treatment, and return for a final visit 16 weeks after their last dose of study medication.This entire study is "blinded." This means that neither the patient nor the study doctor will know which treatment the patient has received. The overall purpose of this trial is to determine if treatment with CNTO 148 (golimumab) is better than treatment with placebo in controlling a patient's ulcerative colitis. Patients will receive multiple subcutaneous (under the skin) injections of placebo or a total dose of CNTO 148 (golimumab), 50mg, 100mg, or 200mg, every 4 weeks through Week 52.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Have received all study agent administrations and completed the Week 6 Mayo score evaluation in one of the induction studies of CNTO 148 (golimumab) for (UC) Ulcerative Colitis (CR014176, CR014179)
Exclusion Criteria:
- Had changes to concomitant UC medications since Week 0 of an induction study (CR014176, CR014179)
Contacts and Locations
Show 308 Study Locations| Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
More Information
No publications provided
| Responsible Party: | Janssen Research & Development, LLC |
| ClinicalTrials.gov Identifier: | NCT00488631 History of Changes |
| Other Study ID Numbers: | CR014179, 2006-003399-37, C0524T18 |
| Study First Received: | June 18, 2007 |
| Last Updated: | December 21, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Janssen Research & Development, LLC:
|
Ulcerative Colitis injection |
Additional relevant MeSH terms:
|
Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Colonic Diseases Intestinal Diseases Inflammatory Bowel Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013