Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00488631
Status:
COMPLETED
Last Update Posted:
2016-04-26
First Post:
2007-06-18
Brief Title:
An Efficacy and Safety Study of Golimumab CNTO 148 in Participants With Moderately to Severely Active Ulcerative Colitis
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the safety and efficacy of golimumab administered subcutaneously under the skin injections in maintenance therapy
Detailed Description:
This was a Phase 3 multicenter conducted in more than one center placebo-controlled an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial double-blind neither the Physician nor the participant know about the study medication parallel-group a medical research study comparing the response in 2 or more groups of participants receiving different interventions randomized-withdrawal study Participants who were in clinical response to golimumab at Week 6 in induction study C0524T16 NCT00488774 or C0524T17 NCT00487539 will be randomly assigned in a 111 ratio at Week 0 of this study to receive 1 of the following maintenance treatment regimens administered subcutaneously every 4 weeks through Week 52 placebo golimumab 50 mg or golimumab 100 mg Participants who were in clinical response to placebo and participants who were not in clinical response to golimumab or placebo at Week 6 in induction study C0524T16 NCT00488774 or C0524T17 NCT00487539 will not be randomly assigned but will be eligible to be enrolled in the study ie the nonrandomized group and received the following treatment regimens placebo golimumab 100 mg and golimumab 100 mg Dose adjustment will be done for participants who were in clinical response to golimumab or placebo during induction studies C0524T16 NCT00488774 or C0524T17 NCT00487539 but lose clinical response during maintenance study C0524T18 NCT00488631 On completing this study participant will have the opportunity to continue to receive study medication in a study extension that will last up to approximately 3 years Efficacy will be primarily evaluated by assessing the clinical response using Mayo Score Participants safety will be monitored throughout the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| C0524T18 | OTHER | Janssen Research Development LLC | None |
| 2006-003399-37 | EUDRACT_NUMBER | None | None |