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A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433

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: NCT03345823
Recruitment Status : Enrolling by invitation
First Posted : November 17, 2017
Last Update Posted : May 21, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Upadacitinib Drug: Placebo for Upadacitinib Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 747 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Crohn's Disease Who Completed the Studies M14-431 or M14-433
Actual Study Start Date : March 21, 2018
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : April 24, 2027

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: Group A - Arm A
This is a maintenance group with 52 weeks which includes participants who achieved clinical response to upadacitinib dose A in studies M14-431 and M14-433 and will receive dose B.
 Drug: Upadacitinib
Oral; Tablet
Other Names:
  • ABT-494
  • RINVOQ
Experimental: Group A - Arm B
This is a maintenance group with 52 weeks which includes participants who achieved clinical response to upadacitinib dose A in studies M14-431 and M14-433 and will receive dose C.
 Drug: Upadacitinib
Oral; Tablet
Other Names:
  • ABT-494
  • RINVOQ
Experimental: Group A- Arm C
This is a maintenance group with 52 weeks which includes participants who achieved clinical response to upadacitinib dose A in studies M14-431 and M14-433 and will receive placebo.
 Drug: Placebo for Upadacitinib
Oral; Tablet
Experimental: Group B - Arm A
This is a long-term extension group with 240 weeks which includes participants who complete group A and will receive dose B.
 Drug: Upadacitinib
Oral; Tablet
Other Names:
  • ABT-494
  • RINVOQ
Experimental: Group B - Arm B
This is a long-term extension group with 240 weeks which includes participants who complete group A and will receive dose C.
 Drug: Upadacitinib
Oral; Tablet
Other Names:
  • ABT-494
  • RINVOQ
Experimental: Group B - Arm C
This is a long-term extension group with 240 weeks which includes participants who complete group A.
 Drug: Placebo for Upadacitinib
Oral; Tablet


Outcome Measures
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Primary Outcome Measures :
  1. Sub-Study 1: Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) [ Time Frame: Week 52 ]
    Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.

  2. Sub-Study 1: Percentage of Participants with Endoscopic Response [ Time Frame: Week 52 ]
    Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) from Baseline.

  3. Sub-Study 2: Number of Participants with Adverse Events [ Time Frame: Through Week 240 ]
    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. For more details on adverse events please see the Adverse Event section.


Secondary Outcome Measures :
  1. Sub-Study 1: Percentage of Participants with Clinical Remission per Patient-Reported Outcomes (PROs) [ Time Frame: Week 52 ]
    Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.

  2. Sub-Study 1: Percentage of Participants Achieving Clinical Response 100 (CR-100) [ Time Frame: Week 52 ]
    Decrease of at least 100 points in CDAI from Baseline.

  3. Sub-Study 1: Percentage of Participants who Discontinue Corticosteroid Use at Least 90 Days Prior to Week 52 and Achieve Clinical Remission, in Participants Taking Corticosteroids at Baseline. [ Time Frame: Week 52 ]
    This is assessed in participants taking corticosteroids at Baseline. Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score.

  4. Sub-Study 1: Percentage of Participants with Clinical Remission per CDAI and Endoscopic Remission [ Time Frame: Week 52 ]
    Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score. Endoscopic remission is defined per SES-CD.

  5. Sub-Study 1: Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) [ Time Frame: Through Week 52 ]
    CDAI remission is defined as CDAI < 150.

  6. Sub-Study 1: Percentage of Participants with Endoscopic Remission [ Time Frame: Week 52 ]
    Endoscopic remission is defined per Simplified Endoscopic Score for Crohn's Disease (SES-CD).

  7. Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Baseline (Week 0) to Week 52 ]
    The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.

  8. Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) [ Time Frame: Baseline (Week 0) to Week 52 ]
    The FACIT-F questionnaire was developed to assess fatigue.

  9. Sub-Study 1: Percentage of Participants with Hospitalizations due to Crohn's Disease (CD) [ Time Frame: Week 52 ]
    This is assessed by reviewing participant's hospitalization data.

  10. Sub-Study 1: Percentage of Participants with Resolution of Extra-Intestinal Manifestation (EIMs) , in Participants with EIMs at Baseline [ Time Frame: Week 52 ]
    EIMs are defined as manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.


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:

For Substudy 1:

  • Participant who receive double-blind treatment in Study M14-431 or Study M14-433 and achieve clinical response.
  • 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 receive open-label upadacitinib Dose B in Study M14-431 and achieve clinical response.
  • Participant completes study procedures in the parent study/substudy.

Exclusion Criteria:

For Sub-studies 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 of Study M14-430 that in the investigator's judgment makes the subject unsuitable for this study.
  • Participant with any active or chronic recurring infections based on the investigator's assessment that makes the subject an unsuitable candidate for the study. Subjects with ongoing infections undergoing treatment may be enrolled BUT NOT dosed until the infection treatment has been completed and the infection is cured, 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).
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): NCT03345823


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:

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03345823    
Other Study ID Numbers: M14-430
2017-001225-41 ( EudraCT Number )
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020
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 and 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: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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 (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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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:
Upadacitinib
ABT-494
Extension Study
Efficacy
 Safety
Crohn's Disease
Maintenance Study
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