An Observational Study to Assess Change in Disease Activity and Adverse Events of Upadacitinib in Adult Participants With Moderate to Severe Ulcerative Colitis (UC) in Real-World Practice (NCT05494606)
Prospective Real World Study Of Upadacitinib in Ulcerative Colitis (PROFUNDUS)
🩺 Plain-English Summary (8th-Grade Level)
Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Participants with UC have mucosal inflammation starting in the rectum that can extend continuously to proximal segments of the colon. This study will assess how safe and effective upadacitinib is in treating adult participants with moderate to severe ulcerative colitis (UC). Adverse events and change in disease activity will be assessed. Upadacitinib is a drug approved for the treatment of Ulcerative colitis (UC). All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 1000 adult participants will be enrolled worldwide. Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 3 years. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.
Who can join: Review the eligibility criteria below.
Location: Gedyt /ID# 249611 — Ciudad Autonoma de Buenos Aire, Buenos Aires F.D.
Age range: 18 Years to 75 Years
📋 "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 (153 Sites)
Showing the first 25 of 153 sites.
- Gedyt /ID# 249611 — Ciudad Autonoma de Buenos Aire, Buenos Aires F.D.
- Hospital Britanico de Buenos Aires /ID# 249605 — Ciudad Autonoma de Buenos Aire, Buenos Aires F.D.
- Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 249612 — Córdoba,
- Blacktown Hospital /ID# 248354 — Blacktown, New South Wales
- Nepean Hospital /ID# 248351 — Kingswood, New South Wales
- Coral Sea Clinical Research institute /ID# 248352 — North Mackay, Queensland
- Austin Health /ID# 249133 — Heidelberg, Victoria
- The Royal Melbourne Hospital /ID# 248353 — Parkville, Victoria
- University of Calgary /ID# 259183 — Calgary, Alberta
- Gastroenterology and Internal Medicine Research Institution /ID# 251463 — Edmonton, Alberta
- Dr. J Siffledeen Profess Pract /ID# 256903 — Edmonton, Alberta
- Six08 Gastroenterology /ID# 259452 — Lethbridge, Alberta
- Dr. Sundeep Singh, Inc /ID# 251471 — Kelowna, British Columbia
- The Moncton Hospital /ID# 257337 — Moncton, New Brunswick
- Barrie GI Associates /ID# 264978 — Barrie, Ontario
- Hamilton Health Sciences - McMaster University Medical Centre /ID# 256819 — Hamilton, Ontario
- London Health Sciences Center- University Hospital /ID# 258472 — London, Ontario
- West GTA Endoscopy /ID# 263221 — Mississauga, Ontario
- Scott Shulman Medicine Professional Corporation /ID# 256826 — North Bay, Ontario
- Toronto Immune and Digestive Health Institute Inc /ID# 256827 — North York, Ontario
- Toronto Digestive Disease Associates /ID# 258914 — Vaughan, Ontario
- CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 260528 — Montreal, Quebec
- Royal Victoria Hospital / McGill University Health Centre /ID# 258470 — Montreal, Quebec
- Diex Recherche Québec /ID# 262796 — Québec, Quebec
- Iscare Klinické Centrum /ID# 259811 — Prague, Praha 9
💰 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
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- 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
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Explore by condition: All Ulcerative Colitis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.