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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02782663
Recruitment Status : Active, not recruiting
First Posted : May 25, 2016
Last Update Posted : September 10, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

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

Condition or disease Intervention/treatment Phase
Crohn's Disease (CD) Drug: ABT-494 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects With Crohn's Disease
Actual Study Start Date : May 18, 2016
Estimated Primary Completion Date : September 17, 2025
Estimated Study Completion Date : September 17, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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Arm Intervention/treatment
Experimental: Upadacitinib (ABT-494) Dose A
Open label dose A once daily (QD)
 Drug: ABT-494
Tablet: Oral
Other Names:
  • Upadacitinib
  • RINVOQ
Experimental: Upadacitinib (ABT-494) Dose B
Open label dose B QD
 Drug: ABT-494
Tablet: Oral
Other Names:
  • Upadacitinib
  • RINVOQ


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Achieving Remission [ Time Frame: Up to Month 96 ]
    It is defined as the percentage of participants achieving clinical remission and endoscopic remission.

  2. Percentage of Participants in Remission at Week 0 Who Maintain Remission [ Time Frame: Up to Month 96 ]
    Remission is defined as participants achieving clinical remission and endoscopic remission.

  3. Percentage of Participants Achieving Response [ Time Frame: Up to Month 96 ]
    It is defined as the percentage of participants achieving clinical response and endoscopic response.

  4. Percentage of Participants Achieving Clinical Remission [ Time Frame: Up to Month 96 ]
    Clinical remission is defined based on the patient reported outcomes: average daily stool frequency and average daily abdominal pain.

  5. Percentage of Participants Achieving Modified Clinical Remission [ Time Frame: Up to Month 96 ]
    Clinical remission is defined as change from baseline in the patient reported outcomes: average daily stool frequency and average daily abdominal pain.

  6. Percentage of Participants Achieving Enhanced Clinical Response [ Time Frame: Up to Month 96 ]
    Enhanced clinical response is defined as change from baseline in the patient reported outcomes: average daily stool frequency and average daily abdominal pain.

  7. Percentage of Participants Achieving Clinical Response [ Time Frame: Up to Month 96 ]
    Clinical response is defined as change from baseline in the patient reported outcomes: average daily stool frequency and average daily abdominal pain.

  8. Percentage of Participants Achieving Endoscopic Remission [ Time Frame: Up to Month 96 ]
    Endoscopic remission is based on Simplified Endoscopic Score for Crohn's disease.

  9. Percentage of Participants in Endoscopic Remission at Week 0 Who Maintain Endoscopic Remission [ Time Frame: Up to Month 96 ]
    Endoscopic remission is based on Simplified Endoscopic Score for Crohn's disease.

  10. Percentage of Participants Achieving Endoscopic Improvement [ Time Frame: Up to Month 96 ]
    Endoscopic improvement is based on changes from baseline on the Simplified Endoscopic Score for Crohn's disease or endoscopic remission.

  11. Percentage of Participants Achieving Endoscopic Response [ Time Frame: Up to Month 96 ]
    Endoscopic response is based on changes from baseline on the Simplified Endoscopic Score for Crohn's disease.

  12. Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Remission [ Time Frame: Up to Month 96 ]
    It is defined as CDAI less than 150.

  13. Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Response [ Time Frame: Up to Month 96 ]
    CDAI response is defined as a reduction in CDAI by >= 70 from baseline of Study M13-740.

  14. Percentage of Participants Achieving Enhanced CDAI Response [ Time Frame: Up to Month 96 ]
    Enhanced CDAI response is defined as reduction in CDAI by >= 100 from baseline of Study M13-740.

  15. Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission [ Time Frame: Up to Month 96 ]
    IBDQ remission is defined as IBDQ >= 170.

  16. Percentage of Participants Achieving IBDQ Response [ Time Frame: Up to Month 96 ]
    IBDQ response is defined as an increase in IBDQ score >= 16 point from Baseline of Study M13-740.

  17. Percentage of Participants Taking Steroids at Baseline (of Study M13-740) Who Are Steroid-Free [ Time Frame: Up to Month 96 ]
    Percentage of participants taking steroids at Baseline (of Study M13-740) who are steroid-free

  18. Percentage of Participants Taking Steroids at Baseline (of Study M13-740) Who Are Steroid-Free for At Least 90 Days and Achieve Remission [ Time Frame: Up to Month 96 ]
    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

  19. Percentage of Participants Achieving Remission and Normal C-Reactive Protein [ Time Frame: Up to Month 96 ]
    Percentage of participants achieving Remission and normal C-reactive protein. Remission is defined as Clinical Remission AND Endoscopic Remission.


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 to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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): NCT02782663


Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02782663    
Other Study ID Numbers: M14-327
2015-003759-23 ( EudraCT Number )
First Posted: May 25, 2016    Key Record Dates
Last Update Posted: September 10, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
URL: https://vivli.org/ourmember/abbvie/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Crohn's Disease
Efficacy
Safety
Tolerability
ABT-494
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
 Upadacitinib
Janus Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents