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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 : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE May 23, 2016
First Posted Date  ICMJE May 25, 2016
Last Update Posted Date January 5, 2021
Actual Study Start Date  ICMJE May 18, 2016
Estimated Primary Completion Date September 17, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Percentage of Participants Achieving Endoscopic Remission [ Time Frame: Up to Month 96 ]
    Endoscopic remission is based on Simplified Endoscopic Score for Crohn's disease.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission [ Time Frame: Up to Month 96 ]
    IBDQ remission is defined as IBDQ >= 170.
  • 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.
  • 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
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 23, 2016)
Proportion of participants achieving Remission [ Time Frame: Up to Month 24 ]
It is defined as the proportion of participants achieving clinical remission and endoscopic remission.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2016)
  • 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.
  • 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.
  • 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.
  • 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.
  • Proportion of participants achieving Endoscopic remission [ Time Frame: Up to Month 96 ]
    Endoscopic remission is based on Simplified Endoscopic Score for Crohn's disease.
  • 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.
  • 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.
  • 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.
  • 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
  • Proportion of participants achieving Inflammatory Bowel disease Questionnaire (IBDQ) remission [ Time Frame: Up to Month 96 ]
    IBDQ remission is defined as IBDQ >= 170.
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's Disease
Official Title  ICMJE 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
Brief Summary This is a open-label extension (OLE) study designed to evaluate the long-term efficacy, safety, and tolerability of Upadacitinib (ABT-494).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease (CD)
Intervention  ICMJE Drug: ABT-494
Tablet: Oral
Other Names:
  • Upadacitinib
  • RINVOQ
Study Arms  ICMJE
  • Experimental: Upadacitinib (ABT-494) Dose A
    Open label dose A once daily (QD)
    Intervention: Drug: ABT-494
  • Experimental: Upadacitinib (ABT-494) Dose B
    Open label dose B QD
    Intervention: Drug: ABT-494
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 12, 2018)
107
Original Estimated Enrollment  ICMJE
 (submitted: May 23, 2016)
210
Estimated Study Completion Date  ICMJE September 17, 2025
Estimated Primary Completion Date September 17, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Czechia,   Denmark,   France,   Germany,   Hungary,   Israel,   Italy,   Netherlands,   New Zealand,   Norway,   Poland,   Romania,   Slovakia,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02782663
Other Study ID Numbers  ICMJE M14-327
2015-003759-23 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP