A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting (NCT06581328)
A Phase 4 Study Evaluating Moderate to Severely Active Ulcerative Colitis or Crohn's Disease and the Use of Vedolizumab Subcutaneous Within a Community Setting
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Gastro Health — Birmingham, Alabama
Age range: 18 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (101 Sites)
Showing the first 25 of 101 sites.
- Gastro Health — Birmingham, Alabama
- East View Medical Research — Mobile, Alabama
- AZ Gastro Care — Chandler, Arizona
- Spectrum Research Institute LLC — Gilbert, Arizona
- GI Alliance- Sun City — Sun City, Arizona
- UAMS Health Gastroenterology Clinic — Little Rock, Arkansas
- Gastroenterology and Liver Institute — Escondido, California
- Inland Empire Gastroenterology — Murrieta, California
- United Clinical Research Institute — Murrieta, California
- Digestive Health Institute — Newport Beach, California
- Knowledge Research Center — Orange, California
- Medical Associates Research Group, Inc. — San Diego, California
- Peak Gastroenterology Associates — Colorado Springs, Colorado
- Rocky Mountain Endocopy Centers LLC — Littleton, Colorado
- Access Research Institute — Brooksville, Florida
- Gastro Florida — Clearwater, Florida
- Doral Medical Research, LLC — Hialeah, Florida
- Digestive and Liver Center of Florida, P.A. — Kissimmee, Florida
- Gastro Health Research - Miami — Miami, Florida
- The Clinical Trials Network CTNX LLC — Orange City, Florida
- Endoscopic Research, Inc. — Orlando, Florida
- Orlando Health-Orlando Regional Medical Center — Orlando, Florida
- Digestive and Liver Center of Florida — Orlando, Florida
- Gastro Health Research - Pensacola — Pensacola, Florida
- West Central Gastroenterology d/b/a Gastro Florida — Pinellas Park, Florida
📞 Contact the Study Coordinator
Phone: (877) 825-3327
Email: medinfoUS@takeda.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Ulcerative Colitis
- A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001) — Dothan, Alabama
- Pharmacokinetics of IFX and TNF Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis — San Diego, California
- A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis and Their Infants — Eden Prairie, Minnesota
- CP101 for the Treatment of Ulcerative Colitis — Boston, Massachusetts
- A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis — Los Angeles, California
- Angiographic Delivery of AD-MSC for Ulcerative Colitis — Rochester, Minnesota
Explore by condition: All Ulcerative Colitis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.