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NCT02871635 · ClinicalTrials.gov registry record · Phase 3
BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity
A Phase 3 study of Crohn Disease, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 147
- Enrollment target
- 20
- Study locations
NCT02871635: Completed Phase 3 study of Crohn Disease, sponsored by Boehringer Ingelheim.
NCT02871635 is a Phase 3 study of Crohn Disease that has completed, run by Boehringer Ingelheim. The registered enrollment target is 147 participants, below the 203-participant average among 71 other Crohn Disease trials with a reported enrollment target (28% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02871635, a Phase 3 study of Crohn Disease, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 147 participants
- Enrollment target
- 20
- Study locations
Study Summary
Primary Objective: The primary objective of this trial is to compare the clinical efficacy of BI 695501 with EU-approved Humira® in patients with active Crohn's disease (CD). Secondary Objectives: The secondary objectives of this trial are to compare the efficacy and safety of BI 695501 with EU-approved Humira® across the induction and maintenance phases.
Primary Outcome
The Crohn's Disease Activity Index (CDAI) is a validated instrument to measure disease severity in Crohn's Disease (CD). The CDAI score is a sum of the 8 factors (number of liquid stools, abdominal pain, general well-being, extra-intestinal complications, antidiarrheal drugs, abdominal mass, hematocrit and body weight) after adjustment with a weighting factor. Higher CDAI scores indicating more active disease. The CDAI decrease at Week 4 was assessed as the decrease relative to baseline measure
Conditions Studied
Interventions
- DRUG BI 695501
- DRUG HUMIRA
Study Locations (20)
Florida
- Borland-Groover Clinic - Jacksonville
- Hope Clinical Research - Kissimmee
- Center for Advanced GI - Maitland
- Advance Medical Research Center - Miami
- Advanced Research Institute, Inc - New Port Richey
Texas
- Houston Endoscopy and Research Center - Houston
- Biopharma Informatic, Inc, dba Research Consultants - Katy
- Sagact, Pllc - San Antonio
- Baylor Scott and White Healthcare - Temple
- Victoria Gastroenterology - Victoria
Maryland
- MGG Group Co. Inc. / Chevy Chase Clinical Research, - Chevy Chase
- Gastro Center of Maryland - Columbia
Georgia
- Doctors Clinical Research - East Point
Illinois
- Southwest Gastroenterology - Oak Lawn
Kansas
- University of Kansas Medical Center - Kansas City
Missouri
- Healthcare Research Network - Hazelwood
North Carolina
- Asheville Gastroenterology Associates, PA - Asheville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 147 participants |
| Start Date | 2016-09-28 |
| Est. Completion | 2019-05-13 |
| Phase | Phase 3 |
What the finished NCT02871635 record still lists
NCT02871635 is an interventional study that assigns participants to a tested intervention. The registered 147 participants enrollment target is mid-sized for trials with a published cap, below the 203-participant average among 71 other Crohn Disease trials with a reported enrollment target (28% lower).
The record links to 1 condition, with Crohn Disease appearing as the primary indexed condition, and to 2 interventions - of which BI 695501 is the first listed.
NCT02871635 names 20 study sites across 11 states, led by Florida, Texas, Maryland.
Frequently Asked Questions
What is clinical trial NCT02871635 about?
NCT02871635 is a clinical study titled "BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity". Primary Objective: The primary objective of this trial is to compare the clinical efficacy of BI 695501 with EU-approved Humira® in patients with active Crohn's disease (CD). Secondary Objectives: The secondary objectives of this trial are to compare the efficacy and safety of BI 695501 with EU-a...
What is the current status of trial NCT02871635?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 147 participants. The study started on 2016-09-28. Estimated completion is 2019-05-13.
What conditions does trial NCT02871635 study?
This clinical trial studies the following conditions: Crohn Disease.
What interventions are being tested in trial NCT02871635?
The interventions under investigation include: BI 695501 (DRUG), HUMIRA (DRUG).
Who is sponsoring clinical trial NCT02871635?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02871635 being conducted?
This trial has 20 study locations across Florida, Georgia, Illinois, Kansas, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02871635's enrollment target sits among peer trials
147 28th of 71 higher than 44 of 71 other Crohn Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn 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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