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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003759-23 | EudraCT Number |
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This is a open-label extension (OLE) study designed to evaluate the long-term efficacy, safety, and tolerability of Upadacitinib (ABT-494).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Upadacitinib (ABT-494) Dose A | Experimental | Open label dose A once daily (QD) |
|
| Upadacitinib (ABT-494) Dose B | Experimental | Open label dose B QD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-494 | Drug | Tablet: Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Remission | It is defined as the percentage of participants achieving clinical remission and endoscopic remission. | Up to Month 96 |
| Percentage of Participants in Remission at Week 0 Who Maintain Remission | Remission is defined as participants achieving clinical remission and endoscopic remission. | Up to Month 96 |
| Percentage of Participants Achieving Response | It is defined as the percentage of participants achieving clinical response and endoscopic response. | Up to Month 96 |
| Percentage of Participants Achieving Clinical Remission | Clinical remission is defined based on the patient reported outcomes: average daily stool frequency and average daily abdominal pain. | Up to Month 96 |
| Percentage of Participants Achieving Modified Clinical Remission | Clinical remission is defined as change from baseline in the patient reported outcomes: average daily stool frequency and average daily abdominal pain. | Up to Month 96 |
| Percentage of Participants Achieving Enhanced Clinical Response | Enhanced clinical response is defined as change from baseline in the patient reported outcomes: average daily stool frequency and average daily abdominal pain. | Up to Month 96 |
| Percentage of Participants Achieving Clinical Response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego Health System /ID# 150041 | La Jolla | California | 92037 | United States | ||
| Univ California, San Francisco /ID# 149987 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34968730 | Derived | D'Haens G, Panes J, Louis E, Lacerda A, Zhou Q, Liu J, Loftus EV Jr. Upadacitinib Was Efficacious and Well-tolerated Over 30 Months in Patients With Crohn's Disease in the CELEST Extension Study. Clin Gastroenterol Hepatol. 2022 Oct;20(10):2337-2346.e3. doi: 10.1016/j.cgh.2021.12.030. Epub 2021 Dec 27. |
| Label | URL |
|---|---|
| This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses. | View source |
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AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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Clinical response is defined as change from baseline in the patient reported outcomes: average daily stool frequency and average daily abdominal pain.
| Up to Month 96 |
| Percentage of Participants Achieving Endoscopic Remission | Endoscopic remission is based on Simplified Endoscopic Score for Crohn's disease. | Up to Month 96 |
| Percentage of Participants in Endoscopic Remission at Week 0 Who Maintain Endoscopic Remission | Endoscopic remission is based on Simplified Endoscopic Score for Crohn's disease. | Up to Month 96 |
| Percentage of Participants Achieving Endoscopic Improvement | Endoscopic improvement is based on changes from baseline on the Simplified Endoscopic Score for Crohn's disease or endoscopic remission. | Up to Month 96 |
| Percentage of Participants Achieving Endoscopic Response | Endoscopic response is based on changes from baseline on the Simplified Endoscopic Score for Crohn's disease. | Up to Month 96 |
| Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Remission | It is defined as CDAI less than 150. | Up to Month 96 |
| Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Response | CDAI response is defined as a reduction in CDAI by >= 70 from baseline of Study M13-740. | Up to Month 96 |
| Percentage of Participants Achieving Enhanced CDAI Response | Enhanced CDAI response is defined as reduction in CDAI by >= 100 from baseline of Study M13-740. | Up to Month 96 |
| Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission | IBDQ remission is defined as IBDQ >= 170. | Up to Month 96 |
| Percentage of Participants Achieving IBDQ Response | IBDQ response is defined as an increase in IBDQ score >= 16 point from Baseline of Study M13-740. | Up to Month 96 |
| Percentage of Participants Taking Steroids at Baseline (of Study M13-740) Who Are Steroid-Free | Percentage of participants taking steroids at Baseline (of Study M13-740) who are steroid-free | Up to Month 96 |
| Percentage of Participants Taking Steroids at Baseline (of Study M13-740) Who Are Steroid-Free for At Least 90 Days and Achieve Remission | Percentage of participants taking steroids at Baseline (of Study M13-740) who are steroid-free for at least 90 days over time and achieve Remission | Up to Month 96 |
| Percentage of Participants Achieving Remission and Normal C-Reactive Protein | Percentage of participants achieving Remission and normal C-reactive protein. Remission is defined as Clinical Remission AND Endoscopic Remission. | Up to Month 96 |
| San Francisco |
| California |
| 94143-2204 |
| United States |
| Duplicate_University of Florida - Archer /ID# 150033 | Gainesville | Florida | 32610 | United States |
| The Ctr for Gastro Disorders /ID# 150012 | Hollywood | Florida | 33021 | United States |
| Nature Coast Clinical Research - Inverness /ID# 149975 | Inverness | Florida | 34452-4717 | United States |
| Gastroenterology Associates of Central Georgia, LLC /ID# 149870 | Macon | Georgia | 31201 | United States |
| GI Specialists of GA, PC /ID# 150015 | Marietta | Georgia | 30060 | United States |
| Cotton O'Neil Clinical Research Center, Digestive Health /ID# 149900 | Topeka | Kansas | 66606 | United States |
| Duplicate_University of Louisville /ID# 149884 | Louisville | Kentucky | 40202 | United States |
| Investigative Clinical Research /ID# 149886 | Annapolis | Maryland | 21401 | United States |
| Charm City Research Group /ID# 150040 | Towson | Maryland | 21204 | United States |
| Clin Res Inst of Michigan, LLC /ID# 150008 | Chesterfield | Michigan | 48047 | United States |
| Mayo Clinic - Rochester /ID# 149894 | Rochester | Minnesota | 55905-0001 | United States |
| Kansas City Research Institute /ID# 149888 | Kansas City | Missouri | 64131 | United States |
| Washington University-School of Medicine /ID# 149899 | St Louis | Missouri | 63110 | United States |
| NYU Langone Long Island Clinical Research Associates /ID# 149976 | Lake Success | New York | 11042 | United States |
| Weill Cornell Medicine/NYP /ID# 149895 | New York | New York | 10021-4872 | United States |
| Univ NC Chapel Hill /ID# 149982 | Chapel Hill | North Carolina | 27514-4220 | United States |
| University Of Cincinnati Medical Center /ID# 149977 | Cincinnati | Ohio | 45219 | United States |
| Options Health Research, LLC /ID# 150010 | Tulsa | Oklahoma | 74104 | United States |
| Texas Digestive Disease Consultants - Southlake /ID# 149869 | Southlake | Texas | 76092 | United States |
| Texas Digestive Disease Consultants - Southlake /ID# 149989 | Southlake | Texas | 76092 | United States |
| Aspen Clinical Research /ID# 150020 | Orem | Utah | 84058 | United States |
| University of Virginia /ID# 149881 | Charlottesville | Virginia | 22908 | United States |
| Virginia Mason Hospital & Medical Center /ID# 150042 | Seattle | Washington | 98101 | United States |
| University of Washington /ID# 149988 | Seattle | Washington | 98109 | United States |
| Wisconsin Center for Advanced Research /ID# 149863 | Milwaukee | Wisconsin | 53215 | United States |
| Duplicate_CHU de Liege /ID# 149912 | Liège | 4000 | Belgium |
| University of Alberta Hospital /ID# 149873 | Edmonton | Alberta | T6G 2B7 | Canada |
| University of British Columbia (UBC) - Gordon and Leslie Diamond Health Care Ce /ID# 149876 | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Duplicate_(G.I.R.I.) GI Research Institute Foundation /ID# 149878 | Vancouver | British Columbia | V6Z 2K5 | Canada |
| Toronto Digestive Disease Associates /ID# 149877 | Vaughan | Ontario | L4L 4Y7 | Canada |
| Disc_Royal Victoria Hospital / McGill University Health Centre /ID# 149871 | Montreal | Quebec | H4A 3J1 | Canada |
| Hepato-Gastroenterologie HK, s.r.o. /ID# 149882 | Hradec Králové | 500 12 | Czechia |
| Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 149890 | Hvidovre | Capital Region | 2650 | Denmark |
| Duplicate_Aarhus University Hospital /ID# 149919 | Aarhus N | Central Jutland | 8200 | Denmark |
| CHRU Nancy - Hopitaux de Brabois /ID# 149896 | Vandœuvre-lès-Nancy | Meurthe-et-Moselle | 54500 | France |
| CHRU Lille - Hopital Claude Huriez /ID# 149897 | Lille | Nord | 59037 | France |
| CHU Amiens-Picardie Site Sud /ID# 149921 | Amiens | Somme | 80054 | France |
| Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 149936 | Kiel | Schleswig-Holstein | 24105 | Germany |
| DRK Kliniken Berlin Westend /ID# 149905 | Berlin | 14050 | Germany |
| Medizinisches Versorgungszentrum Portal 10 /ID# 149930 | Münster | 48155 | Germany |
| Magyar Elhizastudomanyi Kozpont Kft. /ID# 149907 | Budapest | 1124 | Hungary |
| Yitzhak Shamir Medical Center /ID# 149943 | Ẕerifin | Central District | 70300 | Israel |
| The Chaim Sheba Medical Center /ID# 149945 | Ramat Gan | Tel Aviv | 5265601 | Israel |
| Rabin Medical Center /ID# 149942 | Petah Tikva | 4941492 | Israel |
| University of Catanzaro /ID# 149927 | Catanzaro | Calabria | 88100 | Italy |
| Duplicate_IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 149958 | Bologna | Emilia-Romagna | 40138 | Italy |
| Amsterdam UMC, locatie AMC /ID# 149932 | Amsterdam | North Holland | 1105 AZ | Netherlands |
| Universitair Medisch Centrum Utrecht /ID# 149933 | Utrecht | 3584 CX | Netherlands |
| Dunedin Hospital /ID# 149964 | Otago | Otago | 9016 | New Zealand |
| Lovisenberg Diakonale Sykehus /ID# 149967 | Oslo | 0440 | Norway |
| Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 149978 | Warsaw | Masovian Voivodeship | 02-507 | Poland |
| Santa Sp. z o.o. Santa Familia Centrum Badan, Profilaktyki i Leczenia /ID# 149979 | Lodz | Łódź Voivodeship | 90-302 | Poland |
| Cabinet Particular Policlinic Algomed /ID# 149993 | Timișoara | 300002 | Romania |
| Duplicate_KM Management, spol. s.r.o. /ID# 149949 | Nitra | Nitra Region | 949 01 | Slovakia |
| Gastro I., s.r.o. /ID# 149948 | Prešov | Presov | 080 01 | Slovakia |
| Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 149996 | Ferrol | A Coruna | 15405 | Spain |
| Hospital Universitario La Paz /ID# 149997 | Madrid | 28046 | Spain |
| Oxford University Hospitals NHS Foundation Trust /ID# 149963 | Oxford | Oxfordshire | OX3 9DU | United Kingdom |
| Duplicate_Manchester University NHS Foundation Trust /ID# 150006 | Manchester | M13 9WL | United Kingdom |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 7, 2026 |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C000613732 | upadacitinib |
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