A Study of Vedolizumab in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) in the Community Setting
Condition(s) studied
Investigational drug(s) / intervention(s)
Vedolizumab IV: Vedolizumab IV infusion
Vedolizumab SC: Vedolizumab SC injection
Study summary
Ulcerative Colitis (UC) and Crohn's 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 3.5 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 1.5 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 3.5 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 4.5 months (18 weeks) after their last treatment with Vedolizumab.
During the study, participants will visit their study clinic several times.
Eligibility
Primary outcome measure(s)
- Percentage of CD Participants With 2-item Patient-reported Outcome Measure (PRO-2) Remission at Week 14 — At Week 14
PRO-2 remission is defined as 7-day average of very soft or liquid stool frequency (SF) less than and equal to (\<=) 2.8, 7-day average of abdominal pain (AP) score \<= 1.0, and neither worse than baseline. - Percentage of UC Participants With PRO-2 Remission at Week 14 — At Week 14
PRO-2 remission is defined as Mayo rectal bleeding sub-score of 0 and stool frequency sub-score \<=1.
Trial sites (101)
| Facility | City | Region | Status |
|---|---|---|---|
| Gastro Health | Birmingham | Alabama | Recruiting |
| East View Medical Research | Mobile | Alabama | Recruiting |
| AZ Gastro Care | Chandler | Arizona | Recruiting |
| Spectrum Research Institute LLC | Gilbert | Arizona | Recruiting |
| GI Alliance- Sun City | Sun City | Arizona | Recruiting |
| UAMS Health Gastroenterology Clinic | Little Rock | Arkansas | Withdrawn |
| Gastroenterology and Liver Institute | Escondido | California | Recruiting |
| Inland Empire Gastroenterology | Murrieta | California | Withdrawn |
| United Clinical Research Institute | Murrieta | California | Recruiting |
| Digestive Health Institute | Newport Beach | California | Withdrawn |
| Knowledge Research Center | Orange | California | Withdrawn |
| Medical Associates Research Group, Inc. | San Diego | California | Withdrawn |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | Recruiting |
| Rocky Mountain Endocopy Centers LLC | Littleton | Colorado | Recruiting |
| Access Research Institute | Brooksville | Florida | Recruiting |
| Gastro Florida | Clearwater | Florida | Recruiting |
| Doral Medical Research, LLC | Hialeah | Florida | Withdrawn |
| Digestive and Liver Center of Florida, P.A. | Kissimmee | Florida | Recruiting |
| Gastro Health Research - Miami | Miami | Florida | Recruiting |
| Endoscopic Research, Inc. | Orlando | Florida | Recruiting |
| Orlando Health-Orlando Regional Medical Center | Orlando | Florida | Recruiting |
| Digestive and Liver Center of Florida | Orlando | Florida | Withdrawn |
| Gastro Health Research - Pensacola | Pensacola | Florida | Recruiting |
| West Central Gastroenterology d/b/a Gastro Florida | Pinellas Park | Florida | Recruiting |
| Digestive Healthcare of Georgia | Atlanta | Georgia | Recruiting |
| AGA GA Research LLC | Atlanta | Georgia | Recruiting |
| Atlanta Center for Gastroenterology, P.C. | Decatur | Georgia | Withdrawn |
| Yapp, Rockford M.D. (Private Practice) | Downers Grove | Illinois | Recruiting |
| GI Alliance - Glenview | Glenview | Illinois | Recruiting |
| Gastroenterology and Internal Medicine Specialists, SC | Lake Barrington | Illinois | Recruiting |
| Suburban Gastroenterology | Naperville | Illinois | Withdrawn |
| GI Partners of Illinois - Southwest Gastroenterology | Oak Lawn | Illinois | Recruiting |
| Rockford Gastroenterology Associates, Ltd. | Rockford | Illinois | Recruiting |
| Springfield Clinic | Springfield | Illinois | Recruiting |
| Riverview Health | Westfield | Indiana | Recruiting |
| Hutchinson Clinic | Hutchinson | Kansas | Recruiting |
| Tri-State Gastroenterology Associates | Crestview Hills | Kentucky | Recruiting |
| Baton Rouge General Medical Center - Bluebonnet Campus | Baton Rouge | Louisiana | Recruiting |
| Combined Gastro LLC | Lafayette | Louisiana | Recruiting |
| GI Alliance | Metairie | Louisiana | Recruiting |
+ 61 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06581328 on ClinicalTrials.gov ↗ ← All trials in the USA