Condition: Crohn's Disease · Sponsor: AbbVie
Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.
A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
Inclusion Criteria: For Substudy 1: * Participant who achieve clinical response in Study M14-431 or Study M14-433. * Participant completes study procedures in the parent study. The final endoscopy for Studies M14-431 or M14-433 may be missing, if the endoscopy cannot be performed during the COVID-19 pandemic. For Substudy 2: * Participant completes Substudy 1. The Week 52 endoscopy may be missing, if the endoscopy cannot be performed during the COVID-19 pandemic. * Participant who achieved clinical response at the time described in the protocol and completes study procedures in the parent study/ substudy. Exclusion Criteria: For Substudies 1 and 2: * Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study. * Participant who has a known hypersensitivity to upadacitinib or its excipients, or had an adverse event during Studies M14-431 and M14-433 or Substudy 1 or 2 of Study M14-430 that in the investigator's judgment makes the participant unsuitable for this study. * Participant at the final visit of M14-431 or M14-433 with any active or chronic recurring infections based on the investigator's assessment that makes the participant an unsuitable candidate for the study. Participants with serious infections undergoing treatment may be enrolled BUT NOT dosed until the infection treatment has been completed and the infection is resolved, based on the investigator's assessment. * Participants with high grade colonic dysplasia or malignancy diagnosed at the endoscopy performed at the final visit of Studies M14-431, M14-433 or Substudy 1 of Study M14-430 (Week 52).
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| East View Medical Research, LLC /ID# 171132 | Mobile, Alabama, United States | — |
| CB Flock Research Corporation /ID# 166239 | Mobile, Alabama, United States | — |
| Delsol Research Management, Ll /Id# 170164 | Chandler, Arizona, United States | — |
| Duplicate_HonorHealth Research Institute - Shea /ID# 164725 | Scottsdale, Arizona, United States | — |
| Duplicate_Arizona Arthritis & Rheumatology Research, PLLC /ID# 164702 | Sun City, Arizona, United States | — |
| Southern California Res. Ctr. /ID# 169653 | Coronado, California, United States | — |
| Citrus Valley Gastroenterology /ID# 166230 | Covina, California, United States | — |
| Hoag Memorial Hosp Presbyterian /ID# 222538 | Irvine, California, United States | — |
| UC San Diego Health System /ID# 164763 | La Jolla, California, United States | — |
| United Medical Doctors /ID# 207458 | Los Alamitos, California, United States | — |
| Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164640 | Los Angeles, California, United States | — |
| Facey Medical Foundation /ID# 203138 | Mission Hills, California, United States | — |
+ 454 more locations — full list on the registry record.
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