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NCT03345836 · ClinicalTrials.gov registry record · Phase 3
A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy
A Phase 3 study of Crohn's Disease, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 624
- Enrollment target
- 20
- Study locations
NCT03345836: Completed Phase 3 study of Crohn's Disease, sponsored by AbbVie.
NCT03345836 is a Phase 3 study of Crohn's Disease that has completed, run by AbbVie. The registered enrollment target is 624 participants, below the 2,389-participant average among 105 other Crohn's Disease trials with a reported enrollment target (74% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03345836, a Phase 3 study of Crohn's Disease, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 624 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).
Primary Outcome
The CDAI was used to evaluate the activity of Crohn's disease. Clinical remission per CDAI is defined as CDAI \<150. The CDAI is calculated on the basis of a one-week evaluation of 8 items: frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Total score ranges from 0 to about 600. Higher CDAI scores indicate more severe dise
Conditions Studied
Interventions
- DRUG Upadacitinib
- DRUG Matching Placebo for Upadacitinib
Study Locations (20)
California
- Southern California Res. Ctr. /ID# 169654 - Coronado
- Citrus Valley Gastroenterology /ID# 166201 - Covina
- United Medical Doctors /ID# 207452 - Los Alamitos
- Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164887 - Los Angeles
- Facey Medical Foundation /ID# 203137 - Mission Hills
- United Medical Doctors - Murrieta /ID# 164845 - Murrieta
- Ucsd /Id# 164679 - San Diego
- Medical Assoc Research Grp /ID# 169705 - San Diego
- UCSF Center for Colitis and Crohn's Disease /ID# 202373 - San Francisco
- Univ of California San Francis /ID# 164843 - San Francisco
- Care Access Research /ID# 167766 - San Pablo
Arizona
- Delsol Research Management, Ll /Id# 170179 - Chandler
- HonorHealth Research Institute - Shea /ID# 164734 - Scottsdale
- Arizona Arthritis & Rheumatology Research, PLLC /ID# 203891 - Sun City
Colorado
- Peak Gastroenterology Associates, PC /ID# 170181 - Colorado Springs
- Delta Waves, Inc. /ID# 164872 - Colorado Springs
- Duplicate_Western States Clinical Research, Inc. /ID# 164895 - Wheat Ridge
Alabama
- East View Medical Research, LLC /ID# 171133 - Mobile
- CB Flock Research Corporation /ID# 166220 - Mobile
Connecticut
- Medical Research Center of CT /ID# 164829 - Hamden
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 624 participants |
| Start Date | 2017-11-29 |
| Est. Completion | 2021-08-11 |
| Phase | Phase 3 |
What the finished NCT03345836 record still lists
NCT03345836 is an interventional study that assigns participants to a tested intervention. The registered 624 participants enrollment target is mid-sized for trials with a published cap, below the 2,389-participant average among 105 other Crohn's Disease trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 2 interventions - of which Upadacitinib is the first listed.
NCT03345836 names 20 study sites across 5 states, led by California, Arizona, Colorado.
Frequently Asked Questions
What is clinical trial NCT03345836 about?
NCT03345836 is a clinical study titled "A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy". The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).
What is the current status of trial NCT03345836?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 624 participants. The study started on 2017-11-29. Estimated completion is 2021-08-11.
What conditions does trial NCT03345836 study?
This clinical trial studies the following conditions: Crohn's Disease.
What interventions are being tested in trial NCT03345836?
The interventions under investigation include: Upadacitinib (DRUG), Matching Placebo for Upadacitinib (DRUG).
Who is sponsoring clinical trial NCT03345836?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03345836 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Crohn's Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03345836's enrollment target sits among peer trials
624 21st of 105 higher than 85 of 105 other Crohn's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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