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Expanded Access to Risankizumab

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ClinicalTrials.gov Identifier: NCT03914261
Expanded Access Status : No longer available
First Posted : April 16, 2019
Last Update Posted : May 24, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:
This is an expanded access program (EAP) for eligible participants with Crohn's Disease (CD). This program is designed to provide access to risankizumab, prior to approval by the local regulatory agency, to patients with the highest unmet need and an urgent need for treatment, where risankizumab may prolong survival, prevent occurrence of clinical events associated with significant morbidity and/or mortality, or stabilize a progressive debilitating disease. Availability will depend on a review of the eligibility of the patient and local approval status of risankizumab for CD. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Condition or disease Intervention/treatment
Crohn's Disease Ulcerative Colitis (UC) Drug: Risankizumab

Study Design
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Study Type : Expanded Access
Expanded Access Type : Individual Patients
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Expanded Access to Risankizumab

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Interventions
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Intervention Details:
  • Drug: Risankizumab
    Tablet
    Other Names:
    • ABBV-066
    • BI 655066
Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers:   No
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914261


Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03914261    
Other Study ID Numbers: C19-882
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: May 24, 2022
Last Verified: May 2022
Keywords provided by AbbVie:
Expanded Access
Pre-approval Access
Compassionate Use
 Special Access Program
Named Patient Basis
Special Access Scheme
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases