Crohn's Disease (CD)
Conditions
Keywords
Crohn's Disease, Efficacy, Safety, Tolerability, ABT-494
Brief summary
This is a open-label extension (OLE) study designed to evaluate the long-term efficacy, safety, and tolerability of Upadacitinib (ABT-494).
Interventions
DRUGABT-494
Tablet: Oral
Sponsors
AbbVie
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Remission | 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 | Up to Month 96 | Remission is defined as participants achieving clinical remission and endoscopic remission. |
| Percentage of Participants Achieving Response | Up to Month 96 | It is defined as the percentage of participants achieving clinical response and endoscopic response. |
| Percentage of Participants Achieving Clinical Remission | 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 | 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 | 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 | 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 | 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 | Up to Month 96 | Endoscopic remission is based on Simplified Endoscopic Score for Crohn's disease. |
| Percentage of Participants Achieving Endoscopic Improvement | 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 | 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 | Up to Month 96 | It is defined as CDAI less than 150. |
| Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Response | 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 | 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 | Up to Month 96 | IBDQ remission is defined as IBDQ \>= 170. |
| Percentage of Participants Achieving IBDQ Response | 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 | 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 | 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 | Up to Month 96 | Percentage of participants achieving Remission and normal C-reactive protein. Remission is defined as Clinical Remission AND Endoscopic Remission. |
Countries
Belgium, Canada, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Norway, Poland, Romania, Slovakia, Spain, United Kingdom, United States
Outcome results
None listed