NCT02531126CompletedPhase 3
The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC)
A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis
Source: EU CTIS (euclinicaltrials.eu) · Last updated 29 Jan 2025
Brief summary (registry, in English)
1. To evaluate the long-term safety and efficacy of RPC1063 for the treatment of all patients with moderate to severe UC 2. To evaluate the long-term efficacy of RPC1063 for the treatment of adult patients with moderate to severe UC.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 223 (actual)
- First submitted
- 19 Jul 2024
- Start date
- 16 Jul 2015
- Lead sponsor
- Celgene International II SARL
- Diseases
- Ulcerative colitis
- NCT number
- NCT02531126
- EU CT number
- 2024-514815-92-00
- EudraCT number
- 2015-001600-64
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 223
- 24 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving treatment with breast cancer resistance protein inhibitors
Other illness
- Clinically relevant cardiovascular conditions
- Liver function impairment
- Other protocol-defined inclusion/exclusion criteria apply
Who the study is looking for
- Previously participated in a trial of RPC1063 and meets the criteria for participation in the open-label extension as outlined in the prior trial
Criteria the registry did not label
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (52)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Camperdown | Australia | Unknown status |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Completed |
| Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Completed |
| Acibadem City Clinic Diagnostic And Consultation Center Tokuda EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Completed |
| Acibadem City Clinic Diagnostic And Consultation Center Ltd. Coordinator of this site? Confirm its status | Sofia | Bulgaria | Completed |
| University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Completed |
| Medical Center Medica Plus Ltd. Coordinator of this site? Confirm its status | Veliko Tirnovo | Bulgaria | Completed |
| - Coordinator of this site? Confirm its status | Vitebsk | Belarus | Unknown status |
| - Coordinator of this site? Confirm its status | Lindsay | Canada | Unknown status |
| GASTRO JeKa s.r.o. Coordinator of this site? Confirm its status | Klatovy IV | Czechia | Completed |
| Institute for Clinical and Experimental Medicine Coordinator of this site? Confirm its status | Prague | Czechia | Completed |
| Nemocnice Slany Coordinator of this site? Confirm its status | Slaný | Czechia | Completed |
| - Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | Frankfurt | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| - Coordinator of this site? Confirm its status | Osijek | Croatia | Unknown status |
| Clinfan Kft. Coordinator of this site? Confirm its status | Szekszard | Hungary | Completed |
| - Coordinator of this site? Confirm its status | Rehovot | Israel | Unknown status |
| ASST Fatebenefratelli Sacco Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Humanitas Mirasole S.p.A. Coordinator of this site? Confirm its status | Rozzano | Italy | Completed |
| - Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Wŏnju | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Chisinau | Moldova | Unknown status |
| - Coordinator of this site? Confirm its status | Chisinau | Moldova | Unknown status |
| Osrodek Badan Klinicznych CLINSANTE S C Ewa Galczak Nowak Malgorzata Trzaska Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Completed |
| Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Globe Badania Kliniczne Sp. z o.o. Coordinator of this site? Confirm its status | Klodzko | Poland | Completed |
| Centrum Opieki Zdrowotnej Orkan-Med Stec - Michalska Sp. j. Coordinator of this site? Confirm its status | Ksawerów | Poland | Completed |
| Velocity Nova Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Completed |
| Specjalistyczna Praktyka Lekarska dr med. Marek Horyński Coordinator of this site? Confirm its status | Sopot | Poland | Completed |
| GASTROMED Sp. z o.o. Coordinator of this site? Confirm its status | Torun | Poland | Completed |
| Eb Group Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Spitalul Județean de Urgență Bacău Coordinator of this site? Confirm its status | Bacau | Romania | Completed |
| Spitalul Universitar de Urgență București Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
| Memorial Healthcare International S R L Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
| Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara Coordinator of this site? Confirm its status | Timisoara | Romania | Completed |
| - Coordinator of this site? Confirm its status | Bardejov | Slovakia | Unknown status |
| - Coordinator of this site? Confirm its status | Kharkiv | Ukraine | Unknown status |
| - Coordinator of this site? Confirm its status | Vinnytsia | Ukraine | Unknown status |
| - Coordinator of this site? Confirm its status | Anaheim | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Baton Rouge | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Germantown | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Mission Hills | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Oak Lawn | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.