Clinical Trials in Italy / NCT03345823
Active, not recruiting
Phase 3
A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433
NCT03345823 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Crohn's Disease
Investigational drug(s) / intervention(s)
Upadacitinib →Placebo for Upadacitinib
Upadacitinib: Oral; Tablet
Placebo for Upadacitinib: Oral; Tablet
Study 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.
Eligibility
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).
Primary outcome measure(s)
- 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.
Trial sites (466)
| Facility | City | Region | Status |
|---|---|---|---|
| East View Medical Research, LLC /ID# 171132 | Mobile | Alabama | |
| CB Flock Research Corporation /ID# 166239 | Mobile | Alabama | |
| Delsol Research Management, Ll /Id# 170164 | Chandler | Arizona | |
| Duplicate_HonorHealth Research Institute - Shea /ID# 164725 | Scottsdale | Arizona | |
| Duplicate_Arizona Arthritis & Rheumatology Research, PLLC /ID# 164702 | Sun City | Arizona | |
| Southern California Res. Ctr. /ID# 169653 | Coronado | California | |
| Citrus Valley Gastroenterology /ID# 166230 | Covina | California | |
| Hoag Memorial Hosp Presbyterian /ID# 222538 | Irvine | California | |
| UC San Diego Health System /ID# 164763 | La Jolla | California | |
| United Medical Doctors /ID# 207458 | Los Alamitos | California | |
| Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164640 | Los Angeles | California | |
| Facey Medical Foundation /ID# 203138 | Mission Hills | California | |
| United Medical Doctors - Murrieta /ID# 164602 | Murrieta | California | |
| Medical Assoc Research Grp /ID# 169704 | San Diego | California | |
| UCSF Medical Center - Mount Zion /ID# 202372 | San Francisco | California | |
| Univ of California San Francis /ID# 164653 | San Francisco | California | |
| Care Access Research /ID# 167765 | San Pablo | California | |
| Peak Gastroenterology Associates, PC /ID# 170166 | Colorado Springs | Colorado | |
| Delta Waves, Inc. /ID# 164656 | Colorado Springs | Colorado | |
| Western States Clinical Res /ID# 164625 | Wheat Ridge | Colorado | |
| Gastroenterology Center of Connecticut /ID# 164614 | Hamden | Connecticut | |
| Advanced Research - Coral Springs /ID# 218019 | Coral Springs | Florida | |
| Encore Borland-Groover Clinical Research /Id# 203500 | Jacksonville | Florida | |
| Ctr for Advanced Gastroenterol /ID# 165306 | Maitland | Florida | |
| Crystal Pharmacology Research /ID# 166118 | Miami | Florida | |
| Coral Research Clinic /ID# 164604 | Miami | Florida | |
| Advanced Research Institute, Inc /ID# 164601 | New Port Richey | Florida | |
| Endoscopic Research, Inc. /ID# 206139 | Orlando | Florida | |
| Omega Research Group /ID# 203482 | Orlando | Florida | |
| Duplicate_Clinical Research of West Florida, Inc /ID# 205828 | Tampa | Florida | |
| Duplicate_Clinical Research of West Florida, Inc /ID# 208119 | Tampa | Florida | |
| Clinical Research Trials of Florida, Inc. /ID# 203486 | Tampa | Florida | |
| Duplicate_AdventHealth Tampa /ID# 171181 | Tampa | Florida | |
| Gastroenterology Associates of Central Georgia, LLC /ID# 165492 | Macon | Georgia | |
| Gastroenterology Consultants, P.C /ID# 218218 | Roswell | Georgia | |
| Atlanta Gastroenterology Spec /ID# 164698 | Suwanee | Georgia | |
| Treasure Valley Medical Research /ID# 215030 | Boise | Idaho | |
| Duplicate_Rush University Medical Center /ID# 165470 | Chicago | Illinois | |
| Duplicate_University of Chicago Medicine /ID# 165509 | Chicago | Illinois | |
| DuPage Medical Group /ID# 205320 | Downers Grove | Illinois |
+ 426 more sites — see the full list on the official registry below.
On this site
📄 Rinvoq (upadacitinib) drug profile →More AbbVie trials in Italy
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03345823 on ClinicalTrials.gov ↗ ← All trials in Italy