Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00488774
Status:
TERMINATED
Last Update Posted:
2013-06-14
First Post:
2007-06-18
Brief Title:
An Efficacy and Safety Study of Golimumab in Participants With Ulcerative Colitis
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
A Phase 23 Multicenter Randomized Placebo-controlled Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy Administered Intravenously in Subjects With Moderately to Severely Active Ulcerative Colitis
Status:
TERMINATED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Protocol was cancelled by company based on overall efficacy no safety concern
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 effects good and bad of golimumab CNTO 148 therapy in participants with active ulcerative colitis UC sores in the colon
Detailed Description:
This is a randomized study medication assigned by chance double-blind neither the Physician nor the participant know about the study medication placebo-controlled an inactive substance a pretend treatment with no drug in it that is compared in a clinical trial with a drug to test if the drug has a real effect parallel-group a medical research study comparing the response in 2 or more groups of participants receiving different interventions treatments study to evaluate an appropriate intravenous through a vein in the arm golimumab induction dose and to demonstrate the safety and efficacy of intravenous induction dosing with golimumab in participants with moderately to severely active UC At Week 6 participants will be asked to participate in an additional 1-year maintenance study Participants not entering the 1-year golimumab maintenance study will be evaluated for safety at Week 16 The duration of study will be 6 weeks for participants who enter the 1-year golimumab maintenance study and 16 weeks for participant who do not enter the 1-year golimumab maintenance studyThere are 2 parts in this study Part 1 is Phase 2 dose-ranging portion of study Participants enrolled in Part 1 will receive a single intravenous infusion of either matching placebo for golimumab or 1 milligram mg per kilogramkg 2 mg per kg or 4 mg per kg of golimumab Part 2 of the study is called dose-confirming and newly enrolled participants will receive same doses studied in Part 1 until the doses for Part 2 are selected and Phase 3 begins At the time that the final doses are selected all newly enrolled participants will receive 1 of the selected doses or matching placebo this is the start of the Phase 3 portion of the study Participants will primarily be assessed using Mayo Score it is a score developed for measuring disease activity Participants safety and quality of life will also 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 |
|---|---|---|---|
| 2006-003397-94 | OTHER | Janssen Research Development LLC | None |
| C0524T16 | OTHER | None | None |