BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity
Public ClinicalTrials.gov record NCT02871635. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
BI 695501 Versus Humira® in Patients With Active Crohn's Disease: a Randomized, Double-blind, Multicenter, Parallel Group, Exploratory Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02871635
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 147 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 28, 2016 (Actual)
- Primary completion
- Apr 30, 2019 (Actual)
- Completion
- May 13, 2019 (Actual)
- Last update posted
- Jun 4, 2020
2016 – 2019
United States locations
- U.S. sites
- 19
- U.S. states
- 10
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Borland-Groover Clinic | Jacksonville | Florida | 32256 | — |
| Hope Clinical Research | Kissimmee | Florida | 34741 | — |
| Center for Advanced GI | Maitland | Florida | 32751 | — |
| Advance Medical Research Center | Miami | Florida | 33155 | — |
| Advanced Research Institute, Inc | New Port Richey | Florida | 34653 | — |
| Doctors Clinical Research | East Point | Georgia | 30344 | — |
| Southwest Gastroenterology | Oak Lawn | Illinois | 60453 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160-7702 | — |
| MGG Group Co. Inc. / Chevy Chase Clinical Research, | Chevy Chase | Maryland | 20815 | — |
| Gastro Center of Maryland | Columbia | Maryland | 21045 | — |
| Healthcare Research Network | Hazelwood | Missouri | 63042 | — |
| Asheville Gastroenterology Associates, PA | Asheville | North Carolina | 28801 | — |
| Great Lakes Gastroenterology Research, LLC | Mentor | Ohio | 44060 | — |
| Gastroenterology Associates, PA | Greenville | South Carolina | 29615 | — |
| Houston Endoscopy and Research Center | Houston | Texas | 77079 | — |
| Biopharma Informatic, Inc, dba Research Consultants | Katy | Texas | 77450 | — |
| Sagact, Pllc | San Antonio | Texas | 78229 | — |
| Baylor Scott and White Healthcare | Temple | Texas | 76508 | — |
| Victoria Gastroenterology | Victoria | Texas | 77904 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 73 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02871635, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 4, 2020 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02871635 live on ClinicalTrials.gov.