Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06581328
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohns Disease in the Community Setting
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 4 Study Evaluating Moderate to Severely Active Ulcerative Colitis or Crohns Disease and the Use of Vedolizumab Subcutaneous Within a Community Setting
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PANORAMA
Brief Summary:
Ulcerative Colitis UC and Crohns Disease CD are long-term conditions in the gut that can cause diarrhea swelling inflammation bleeding from the anus and belly pain The main aim of this study is to check for how many participants with UC and CD signs and symptoms disappear after 35 months 14 weeks of treatment with Vedolizumab this is called remission
Participants will be treated with Vedolizumab for approximately 1 year 50 weeks During the first 15 months 6 weeks participants will receive Vedolizumab as an infusion in the vein called intravenously After this participants will receive Vedolizumab as an injection under the skin called subcutaneously for the rest of the treatment Participants for whom the treatment does not seem to work well after 35 months 14 weeks will stop treatment with Vedolizumab and can change to another treatment and also there will be additional required visits at 6 months 26 weeks and at 1 year 52 weeks All participants will be checked again 45 months 18 weeks after their last treatment with Vedolizumab
During the study participants will visit their study clinic several times
Participants will be treated with Vedolizumab for approximately 1 year 50 weeks During the first 15 months 6 weeks participants will receive Vedolizumab as an infusion in the vein called intravenously After this participants will receive Vedolizumab as an injection under the skin called subcutaneously for the rest of the treatment Participants for whom the treatment does not seem to work well after 35 months 14 weeks will stop treatment with Vedolizumab and can change to another treatment and also there will be additional required visits at 6 months 26 weeks and at 1 year 52 weeks All participants will be checked again 45 months 18 weeks after their last treatment with Vedolizumab
During the study participants will visit their study clinic several times
Detailed Description:
None
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