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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Participants with a diagnosis of moderate to severe Ulcerative colitis (UC).
  • - Participants initiating upadacitinib at the clinician's discretion as part of their routine clinical care; the decision to administer upadacitinib must be made prior to and independent of recruitment into the study.
  • - Participants prescribed upadacitinib in accordance with the approved local label.
  • - Participants able to understand and communicate with the investigator and comply with the requirements of the study.
  • - Participants willing to continue with study documentation after cessation of upadacitinib.
  • - Participants willing and able to participate in the collection of patient-reported data via cloud based mobile application using the provided smart device (iPhone).

Exclusion Criteria:

  • - Participants with any contraindication to upadacitinib.
  • - Participants previously exposed to upadacitinib in a clinical trial.
  • - Participants currently participating in interventional research (not including noninterventional study, postmarketing observational study (PMOS), or registry participation).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05494606
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

AbbVie
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

ABBVIE INC.
Principal Investigator Affiliation AbbVie
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Argentina, Australia, Germany, Russian Federation
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis
Study Website: View Trial Website
Arms & Interventions

Arms

: Participants receiving upadacitinib

Participants receiving upadacitinib for moderate to severe Ulcerative colitis (UC) in real-world practice.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina

Status

Not yet recruiting

Address

Hospital Britanico de Buenos Aires /ID# 249605

Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, 1280

Blacktown Hospital /ID# 248354, Blacktown, New South Wales, Australia

Status

Not yet recruiting

Address

Blacktown Hospital /ID# 248354

Blacktown, New South Wales, 2148

Nepean Hospital /ID# 248351, Kingswood, New South Wales, Australia

Status

Not yet recruiting

Address

Nepean Hospital /ID# 248351

Kingswood, New South Wales, 2747

North Mackay, Queensland, Australia

Status

Not yet recruiting

Address

Coral Sea Clinical Research institute /ID# 248352

North Mackay, Queensland, 4740

Austin Health /ID# 249133, Heidelberg, Victoria, Australia

Status

Not yet recruiting

Address

Austin Health /ID# 249133

Heidelberg, Victoria, 3084

The Royal Melbourne Hospital /ID# 248353, Parkville, Victoria, Australia

Status

Not yet recruiting

Address

The Royal Melbourne Hospital /ID# 248353

Parkville, Victoria, 3050

Dr. Heil /ID# 248273, Andernach, Germany

Status

Not yet recruiting

Address

Dr. Heil /ID# 248273

Andernach, , 56626

Krankenhaus Waldfriede /ID# 248307, Berlin-Zehlendorf, Germany

Status

Not yet recruiting

Address

Krankenhaus Waldfriede /ID# 248307

Berlin-Zehlendorf, , 14163

Praxis Dr. Michael Mross /ID# 248272, Berlin, Germany

Status

Not yet recruiting

Address

Praxis Dr. Michael Mross /ID# 248272

Berlin, , 10318

Gastro Campus Research GbR /ID# 249867, Muenster, Germany

Status

Not yet recruiting

Address

Gastro Campus Research GbR /ID# 249867

Muenster, , 48159

Bettenworth & Partner /ID# 248977, Münster, Germany

Status

Recruiting

Address

Bettenworth & Partner /ID# 248977

Münster, , 48149

Krai Clinical Hospital /ID# 249238, Krasnoyarsk, Russian Federation

Status

Not yet recruiting

Address

Krai Clinical Hospital /ID# 249238

Krasnoyarsk, , 660022

Moscow, Russian Federation

Status

Not yet recruiting

Address

National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 249239

Moscow, , 123423

St. Petersburg, Russian Federation

Status

Not yet recruiting

Address

City Clinical Hospital No. 31 /ID# 249159

St. Petersburg, , 197110

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