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
Overview
- Phase
- Phase 2
- Intervention
- ABT-494
- Conditions
- Crohn's Disease (CD)
- Sponsor
- AbbVie
- Enrollment
- 107
- Locations
- 61
- Primary Endpoint
- Percentage of Participants Achieving Remission
- Status
- Completed
- Last Updated
- 9 months ago
Overview
Brief Summary
This is a open-label extension (OLE) study designed to evaluate the long-term efficacy, safety, and tolerability of Upadacitinib (ABT-494).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participant must have completed Study M13-740 through Week
- •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.
Arms & Interventions
Upadacitinib (ABT-494) Dose B
Open label dose B QD
Intervention: ABT-494
Upadacitinib (ABT-494) Dose A
Open label dose A once daily (QD)
Intervention: ABT-494
Outcomes
Primary Outcomes
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 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 Inflammatory Bowel Disease Questionnaire (IBDQ) Remission
Time Frame: Up to Month 96
IBDQ remission is defined as IBDQ \>= 170.
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 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 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 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.
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 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 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 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 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 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 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) 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 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