Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    m13-740

A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects 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 : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 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

Arm Intervention/treatment
Experimental: Upadacitinib (ABT-494) Dose A
Open label dose A once daily (QD)
Drug: ABT-494
Oral use
Other Name: Upadacitinib

Experimental: Upadacitinib (ABT-494) Dose B
Open label dose B QD
Drug: ABT-494
Oral use
Other Name: Upadacitinib




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


Secondary Outcome Measures :
  1. Proportion of participants achieving Crohn's Disease Activity Index (CDAI) remission [ Time Frame: Up to Month 96 ]
    It is defined as CDAI less than 150.

  2. Proportion of participants achieving Clinical response over time [ 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.

  3. Proportion of participants achieving Inflammatory Bowel disease Questionnaire (IBDQ) remission [ Time Frame: Up to Month 96 ]
    IBDQ remission is defined as IBDQ >= 170.

  4. Proportion 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.

  5. Proportion 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

  6. Proportion of participants achieving Response [ Time Frame: Up to Month 96 ]
    It is defined as the proportion of participants achieving clinical response and endoscopic response.

  7. Proportion 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.

  8. Proportion 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.

  9. Proportion of participants achieving Endoscopic remission [ Time Frame: Up to Month 96 ]
    Endoscopic remission is based on Simplified Endoscopic Score for Crohn's disease.

  10. Proportion 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

  11. Proportion of participants achieving Clinical remission over time [ 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.



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.


Layout table for eligibility information
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 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.

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


  Show 61 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Layout table for investigator information
Study Director: AbbVie Inc. AbbVie

Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02782663     History of Changes
Other Study ID Numbers: M14-327
2015-003759-23 ( EudraCT Number )
First Posted: May 25, 2016    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
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

Layout table for additional information
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:
Layout table for MeSH terms
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