Crohn's Disease
Conditions
Keywords
Upadacitinib, ABT-494, Extension Study, Efficacy, Safety, Crohn's Disease, Maintenance Study
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.
Interventions
DRUGUpadacitinib
Oral; Tablet
Oral; Tablet
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
For Substudy 1: * Participant who achieve clinical response in Study M14-431 or Study M14-433. * 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 achieved clinical response at the time described in the protocol and completes study procedures in the parent study/ substudy.
Exclusion criteria
For Substudies 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 or 2 of Study M14-430 that in the investigator's judgment makes the participant unsuitable for this study. * Participant at the final visit of M14-431 or M14-433 with any active or chronic recurring infections based on the investigator's assessment that makes the participant an unsuitable candidate for the study. Participants with serious infections undergoing treatment may be enrolled BUT NOT dosed until the infection treatment has been completed and the infection is resolved, 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sub-Study 1: Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) | Week 52 | Clinical remission per CDAI is defined as CDAI \<150. |
| Sub-Study 1: Percentage of Participants with Endoscopic Response | Week 52 | Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) from Baseline. |
| Number of Participants with Adverse Events | Through Week 240 | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant 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 participant 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
| Measure | Time frame | Description |
|---|---|---|
| Sub-Study 1: Percentage of Participants without Corticosteroid use for Crohn's Disease Among All Participants | Week 52 | This is assessed in participants not taking corticosteroids at least 90 days prior to Week 52 and achieved clinical remission per CDAI. Clinical remission is defined as CDAI \<150. |
| Sub-Study 1: Percentage of Participants with Clinical Remission per CDAI and Endoscopic Remission | Week 52 | Clinical remission per CDAI is defined as CDAI \<150. Endoscopic remission is defined per SES-CD. |
| Sub-Study 1: Percentage of Participants with Clinical Remission per CDAI | Through Week 52 | Clinical remission per CDAI is defined as CDAI \<150 (as measured by the percentage of participants with clinical remission at Week 52 among those with clinical remission at Week 0). |
| Sub-Study 1: Percentage of Participants who Discontinue Corticosteroid Use for Crohn's Disease at Least 90 Days Prior to Week 52 and Achieve Clinical Remission, in Participants Taking Corticosteroids at Baseline. | 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. |
| Sub-Study 1: Percentage of Participants with Clinical Remission per Patient-Reported Outcomes (PROs) | Week 52 | Clinical remission is defined based on average daily stool frequency (SF) AND average daily abdominal pain (AP) score. |
| Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | Baseline (Week 0) to Week 52 | The FACIT-F questionnaire was developed to assess fatigue. |
| Sub-Study 1: Percentage of Participants with Hospitalizations due to Crohn's Disease (CD) | Up to Week 52 | This is assessed by reviewing participant's hospitalization data. |
| Sub-Study 1: Percentage of Participants with Resolution of Extra-Intestinal Manifestation (EIMs) , in Participants with EIMs at Baseline | 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. |
| Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) | Baseline (Week 0) to Week 52 | The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease. |
| Sub-Study 1: Percentage of Participants Achieving Clinical Response 100 (CR-100) | Week 52 | Decrease of at least 100 points in CDAI from Baseline. |
| Sub-Study 1: Percentage of Participants with Endoscopic Remission | Week 52 | Endoscopic remission is defined per Simplified Endoscopic Score for Crohn's Disease (SES-CD). |
Countries
Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Egypt, Estonia, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
Outcome results
None listed