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A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's Disease
A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's Disease

NCT02782663

CompletedPhase 2

Sponsor: AbbVie

Conditions: Crohn's Disease (CD)

Interventions: ABT-494

Countries: United States, Belgium, Canada, Czechia, Denmark, France, Germany, Hungary

This is a open-label extension (OLE) study designed to evaluate the long-term efficacy, safety, and tolerability of Upadacitinib (ABT-494).

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Participant must have completed Study M13-740 through Week 52.
* If female, participant must be postmenopausal, surgically sterile or on using a birth control method.

Exclusion Criteria:

* For any reason participant is considered by the investigator to be an unsuitable candidate
* Female participant with a positive pregnancy test at Baseline or who is considering becoming pregnant during the study.
* Participant is not in compliance with prior and concomitant medication requirements and procedures throughout Study M13-740.
Locations (61)
  • La Jolla, California, United States
  • San Francisco, California, United States
  • Gainesville, Florida, United States
  • Hollywood, Florida, United States
  • Inverness, Florida, United States
  • Macon, Georgia, United States
  • Marietta, Georgia, United States
  • Topeka, Kansas, United States
  • Louisville, Kentucky, United States
  • Annapolis, Maryland, United States
  • Towson, Maryland, United States
  • Chesterfield, Michigan, United States
  • Rochester, Minnesota, United States
  • Kansas City, Missouri, United States
  • St Louis, Missouri, United States
  • Lake Success, New York, United States
  • New York, New York, United States
  • Chapel Hill, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Tulsa, Oklahoma, United States
  • Southlake, Texas, United States
  • Southlake, Texas, United States
  • Orem, Utah, United States
  • Charlottesville, Virginia, United States
  • Seattle, Washington, United States
  • Seattle, Washington, United States
  • Milwaukee, Wisconsin, United States
  • Liège, Liege, Belgium
  • Edmonton, Alberta, Canada
  • Vancouver, British Columbia, Canada
  • + 31 more on CT.gov