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BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity

Primary Purpose

Crohn Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BI 695501
HUMIRA
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Males and females aged >=18 and =<80 years at Screening who have a diagnosis of moderate to severely active Crohn's Disease (CD), confirmed by endoscopy or radiologic evaluation, for more than 4 months with evidence of mucosal ulceration. Patients must have all of the following:

    • Crohn's Disease Activity Index (CDAI) score of >=220 and =<450
    • A diagnosis of Crohn's Disease (CD) confirmed by ileocolonoscopy during Screening
    • Presence of mucosal ulcers in at least one segment of the ileum or colon and a SES-CD score ≥7 (for patients with isolated ileal disease SES-CD score ≥4), as assessed by ileocolonoscopy and confirmed by central independent reviewer(s) before randomization

  • Anti-tumor necrosis factor (TNF) patients or patients previously treated with infliximab who had initially responded and who meet one of the following criteria:

    • Responded and developed secondary resistance due confirmed anti-infliximab anti-drug antibody formation, which caused infliximab depletion
    • Responded and became intolerant
  • Further inclusion criteria apply

Exclusion criteria:

  • Patients with ulcerative colitis or indeterminate colitis
  • Patients with symptomatic known obstructive strictures
  • Surgical bowel resection performed within 6 months prior to Screening or planned resection at any time while enrolled in the trial
  • Patients with an ostomy or ileoanal pouch
  • Patients with short bowel syndrome
  • Patients who have previously used infliximab and have never clinically responded
  • Patients who have previously received treatment with adalimumab, or who have participated in an adalimumab or adalimumab biosimilar clinical trial
  • Further exclusion criteria apply

Sites / Locations

  • Borland-Groover Clinic
  • Hope Clinical Research
  • Center for Advanced GI
  • Advance Medical Research Center
  • Advanced Research Institute, Inc
  • Doctors Clinical Research
  • Southwest Gastroenterology
  • University of Kansas Medical Center
  • MGG Group Co. Inc. / Chevy Chase Clinical Research,
  • Gastro Center of Maryland
  • Healthcare Research Network
  • Asheville Gastroenterology Associates, PA
  • Great Lakes Gastroenterology Research, LLC
  • Gastroenterology Associates, PA
  • Houston Endoscopy and Research Center
  • Biopharma Informatic, Inc, dba Research Consultants
  • Sagact, Pllc
  • Baylor Scott and White Healthcare
  • Victoria Gastroenterology
  • Gomel Regional Clinical
  • City Clinical Hospital # 10
  • Vitebsk Regional Clinical Oncology Dispensary
  • University Clinical Centre Sarajevo
  • Clinical Hospital Osijek
  • Polyclinic Bonifarm
  • Vojenska nemocnice Brno
  • Hepato-Gastroenterologie HK, s.r.o.
  • CTCenter Mave, s.r.o., Cllinical Trials Center, Olomouc
  • Gregar s.r.o.
  • PreventaMed, s.r.o.
  • University Hospital Ostrava
  • Vitkovice Hospital
  • Medicon, a.s.
  • University Hospital Na Bulovce
  • Axon Clinical, s.r.o.
  • General Hospital Pribram
  • Masaryk Hospital, Internal Department
  • Crohn Colitis Centrum Rhein Main
  • General Hospital of Athens Evangelismos
  • University General Hospital of Heraklion
  • General Hospital of Rhodes
  • Haemek Medical Center
  • Wolfson Medical Center
  • Hadassah Medical Center, Ein-Karem
  • Meir Medical Center
  • The Chaim Sheba Medical Center Tel Hashomer
  • Kaplan Medical Center
  • KLIMED Marek Klimkiewicz
  • NZOZ Centrum Medyczne KERmed
  • Medical Center Pleiades
  • Polimedica Centrum Badan
  • Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla
  • SANTA FAMILIA Centrum Badan, Profilaktyki i Leczenia
  • Clinic Medical Center; Nowa Sol
  • Ai Medical Center, private practice, Poznan
  • Gabinet Lekarski Bartosz Korczowski
  • Specialized Medical Practice. Dr med. Marek Horynski
  • Twoja Przychodnia-Szczecinskie Centrum Medyczne
  • Multidisciplinary Medical Clinic "Anthurium"
  • GUZ Reg. Clinical Hospital, Kemerovo
  • Clinical Hospital No. 24, Moscow
  • Murmansk Regional Clinical Hospital named after Bayandin
  • Reg.Clin.Hosp.n.a.Semashko
  • State Novosibirsk Regional Clinical Hospital
  • FSBSI "Scientific and Research Institute of Physiology and Basic Medicine"
  • BHI of Omsk region - Clinical Oncology Dispensary
  • SBIH City Clinical Hospital #31
  • LLC IClinic
  • Private Educational Institution of Higher Education "Medical University "REAVIZ"
  • NonState Healthcare Institution Central Clinical Hospital, Samara station JSC "Russian Railways"
  • Baltic Med,LLC Clinic BaltMed Ozerki
  • EKO-Bezopasnost, St. Petersburg
  • Clinical Medical Center Zvezdara, Belgrade
  • Military Medical Academy
  • Clinical Center Bezanijska kosa, Belgrade
  • Clinical Center Zemun
  • Clinical Center Kragujevac
  • Gazi University Medical Faculty
  • Gaziantep University Medical Faculty Sahinbey Educational Research Hospital
  • Kartal Lutfi Kirdar Research and Training Hospital
  • Kocaeli University Research and Training Hospital
  • CI Cherkasy RH of Cherkasy Reg.Council
  • CHI Prof.O.O.Shalimov Kharkiv City Clinical Hospital #2
  • Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC
  • Private Enterprise Private Manufacturing Company "Acinus"
  • Medical Center Medical Clinic Kyiv
  • Clin Hosp.8 P.L.Shupyk NMA of PGE
  • Vinnytsia M.I. Pyrogov NMU Ch of internal medicine #3
  • M.I. Pyrogov VRCH, Vinnytsia
  • Clin.Hosp#1,Zaporizhzhia
  • Royal Bournemouth and Christchurch Hospital
  • Walsall Manor Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BI 695501

HUMIRA + BI 695501

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 4
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 measurement, patients with a decrease ≥70 were responders. Percentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to non-responder imputation (NRI) and last observation carried forward (LOCF).

Secondary Outcome Measures

Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 24
The CDAI is a validated instrument to measure disease severity in 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 24 was assessed as the decrease relative to baseline measurement, patients with a decrease ≥70 were responders. Percentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to NRI and LOCF.
Percentage of Patients in Clinical Remission (CDAI <150) at Week 24
The CDAI is a validated instrument to measure disease severity in 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. Patients with CDAI <150 at Week 24 were considered as clinical remission cases. Percentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to NRI and LOCF.
Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs)
Analysis of AEs focused on treatment-emergent AEs (TEAEs). For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46. TEAEs and SAEs (including investigator-assessed trial medication-related TEAEs) and AESIs are reported. The following were considered an AESI: hepatic injury, anaphylactic reactions, serious infection and hypersensitivity reactions.
Percentage of Patients With Infections
The percentage of patients with TEAEs for infections are reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.
Percentage of Patients With Serious Infections
The percentage of patients with TEAEs for serious infections are reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.
Percentage of Patients Who Experienced Hypersensitivity Reactions
The percentage of patients with TEAEs for hypersensitivity reactions is reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.
Percentage of Patients Who Experienced Drug Induced Liver Injury (DILI)
The percentage of patients with TEAEs for DILIs is reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.
Percentage of Patients With Injection Site Reactions
The percentage of patients with TEAEs for injection site reactions is reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.

Full Information

First Posted
August 15, 2016
Last Updated
May 29, 2020
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT02871635
Brief Title
BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 28, 2016 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
May 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BI 695501
Arm Type
Experimental
Arm Title
HUMIRA + BI 695501
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
BI 695501
Intervention Type
Drug
Intervention Name(s)
HUMIRA
Primary Outcome Measure Information:
Title
Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 4
Description
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 measurement, patients with a decrease ≥70 were responders. Percentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to non-responder imputation (NRI) and last observation carried forward (LOCF).
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 24
Description
The CDAI is a validated instrument to measure disease severity in 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 24 was assessed as the decrease relative to baseline measurement, patients with a decrease ≥70 were responders. Percentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to NRI and LOCF.
Time Frame
Week 24
Title
Percentage of Patients in Clinical Remission (CDAI <150) at Week 24
Description
The CDAI is a validated instrument to measure disease severity in 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. Patients with CDAI <150 at Week 24 were considered as clinical remission cases. Percentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to NRI and LOCF.
Time Frame
at Week 24
Title
Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs)
Description
Analysis of AEs focused on treatment-emergent AEs (TEAEs). For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46. TEAEs and SAEs (including investigator-assessed trial medication-related TEAEs) and AESIs are reported. The following were considered an AESI: hepatic injury, anaphylactic reactions, serious infection and hypersensitivity reactions.
Time Frame
From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
Title
Percentage of Patients With Infections
Description
The percentage of patients with TEAEs for infections are reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.
Time Frame
From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
Title
Percentage of Patients With Serious Infections
Description
The percentage of patients with TEAEs for serious infections are reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.
Time Frame
From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
Title
Percentage of Patients Who Experienced Hypersensitivity Reactions
Description
The percentage of patients with TEAEs for hypersensitivity reactions is reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.
Time Frame
From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
Title
Percentage of Patients Who Experienced Drug Induced Liver Injury (DILI)
Description
The percentage of patients with TEAEs for DILIs is reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.
Time Frame
From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
Title
Percentage of Patients With Injection Site Reactions
Description
The percentage of patients with TEAEs for injection site reactions is reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.
Time Frame
From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Males and females aged >=18 and =<80 years at Screening who have a diagnosis of moderate to severely active Crohn's Disease (CD), confirmed by endoscopy or radiologic evaluation, for more than 4 months with evidence of mucosal ulceration. Patients must have all of the following: Crohn's Disease Activity Index (CDAI) score of >=220 and =<450 A diagnosis of Crohn's Disease (CD) confirmed by ileocolonoscopy during Screening Presence of mucosal ulcers in at least one segment of the ileum or colon and a SES-CD score ≥7 (for patients with isolated ileal disease SES-CD score ≥4), as assessed by ileocolonoscopy and confirmed by central independent reviewer(s) before randomization Anti-tumor necrosis factor (TNF) patients or patients previously treated with infliximab who had initially responded and who meet one of the following criteria: Responded and developed secondary resistance due confirmed anti-infliximab anti-drug antibody formation, which caused infliximab depletion Responded and became intolerant Further inclusion criteria apply Exclusion criteria: Patients with ulcerative colitis or indeterminate colitis Patients with symptomatic known obstructive strictures Surgical bowel resection performed within 6 months prior to Screening or planned resection at any time while enrolled in the trial Patients with an ostomy or ileoanal pouch Patients with short bowel syndrome Patients who have previously used infliximab and have never clinically responded Patients who have previously received treatment with adalimumab, or who have participated in an adalimumab or adalimumab biosimilar clinical trial Further exclusion criteria apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
Borland-Groover Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Hope Clinical Research
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Center for Advanced GI
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Advance Medical Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Advanced Research Institute, Inc
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Doctors Clinical Research
City
East Point
State/Province
Georgia
ZIP/Postal Code
30344
Country
United States
Facility Name
Southwest Gastroenterology
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7702
Country
United States
Facility Name
MGG Group Co. Inc. / Chevy Chase Clinical Research,
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Gastro Center of Maryland
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
Facility Name
Healthcare Research Network
City
Hazelwood
State/Province
Missouri
ZIP/Postal Code
63042
Country
United States
Facility Name
Asheville Gastroenterology Associates, PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Great Lakes Gastroenterology Research, LLC
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Gastroenterology Associates, PA
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Houston Endoscopy and Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
Biopharma Informatic, Inc, dba Research Consultants
City
Katy
State/Province
Texas
ZIP/Postal Code
77450
Country
United States
Facility Name
Sagact, Pllc
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Baylor Scott and White Healthcare
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Victoria Gastroenterology
City
Victoria
State/Province
Texas
ZIP/Postal Code
77904
Country
United States
Facility Name
Gomel Regional Clinical
City
Gomel
ZIP/Postal Code
246012
Country
Belarus
Facility Name
City Clinical Hospital # 10
City
Minsk
ZIP/Postal Code
220096
Country
Belarus
Facility Name
Vitebsk Regional Clinical Oncology Dispensary
City
Vitebsk
ZIP/Postal Code
210603
Country
Belarus
Facility Name
University Clinical Centre Sarajevo
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
Clinical Hospital Osijek
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
Polyclinic Bonifarm
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Vojenska nemocnice Brno
City
Brno
ZIP/Postal Code
63600
Country
Czechia
Facility Name
Hepato-Gastroenterologie HK, s.r.o.
City
Hradec Kralove
ZIP/Postal Code
50012
Country
Czechia
Facility Name
CTCenter Mave, s.r.o., Cllinical Trials Center, Olomouc
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Gregar s.r.o.
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
PreventaMed, s.r.o.
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia
Facility Name
University Hospital Ostrava
City
Ostrava-Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Vitkovice Hospital
City
Ostrava-Vitkovice
ZIP/Postal Code
703 84
Country
Czechia
Facility Name
Medicon, a.s.
City
Prague
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
University Hospital Na Bulovce
City
Praha 8
ZIP/Postal Code
27711
Country
Czechia
Facility Name
Axon Clinical, s.r.o.
City
Praha
ZIP/Postal Code
15000
Country
Czechia
Facility Name
General Hospital Pribram
City
Pribram
ZIP/Postal Code
261 01
Country
Czechia
Facility Name
Masaryk Hospital, Internal Department
City
Usti nad Labem
ZIP/Postal Code
401 13
Country
Czechia
Facility Name
Crohn Colitis Centrum Rhein Main
City
Frankfurt
ZIP/Postal Code
60594
Country
Germany
Facility Name
General Hospital of Athens Evangelismos
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
University General Hospital of Heraklion
City
Heraklion, Crete
ZIP/Postal Code
71110
Country
Greece
Facility Name
General Hospital of Rhodes
City
Rhodes
ZIP/Postal Code
85100
Country
Greece
Facility Name
Haemek Medical Center
City
Afula
ZIP/Postal Code
18101
Country
Israel
Facility Name
Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Hadassah Medical Center, Ein-Karem
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Meir Medical Center
City
Kfar-Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
The Chaim Sheba Medical Center Tel Hashomer
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
KLIMED Marek Klimkiewicz
City
Bialystok
ZIP/Postal Code
15-765
Country
Poland
Facility Name
NZOZ Centrum Medyczne KERmed
City
Bydgoszcz
ZIP/Postal Code
85231
Country
Poland
Facility Name
Medical Center Pleiades
City
Cracow
ZIP/Postal Code
30-363
Country
Poland
Facility Name
Polimedica Centrum Badan
City
Kielce
ZIP/Postal Code
25634
Country
Poland
Facility Name
Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla
City
Knurow
ZIP/Postal Code
44190
Country
Poland
Facility Name
SANTA FAMILIA Centrum Badan, Profilaktyki i Leczenia
City
Lodz
ZIP/Postal Code
90-302
Country
Poland
Facility Name
Clinic Medical Center; Nowa Sol
City
Nowa Sol
ZIP/Postal Code
67-100
Country
Poland
Facility Name
Ai Medical Center, private practice, Poznan
City
Poznan
ZIP/Postal Code
61-113
Country
Poland
Facility Name
Gabinet Lekarski Bartosz Korczowski
City
Rzeszow
ZIP/Postal Code
35302
Country
Poland
Facility Name
Specialized Medical Practice. Dr med. Marek Horynski
City
Sopot
ZIP/Postal Code
81756
Country
Poland
Facility Name
Twoja Przychodnia-Szczecinskie Centrum Medyczne
City
Szczecin
ZIP/Postal Code
71270
Country
Poland
Facility Name
Multidisciplinary Medical Clinic "Anthurium"
City
Barnaul
ZIP/Postal Code
656043
Country
Russian Federation
Facility Name
GUZ Reg. Clinical Hospital, Kemerovo
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
Clinical Hospital No. 24, Moscow
City
Moscow
ZIP/Postal Code
127015
Country
Russian Federation
Facility Name
Murmansk Regional Clinical Hospital named after Bayandin
City
Murmansk
ZIP/Postal Code
183047
Country
Russian Federation
Facility Name
Reg.Clin.Hosp.n.a.Semashko
City
Nizhniy Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
State Novosibirsk Regional Clinical Hospital
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
Facility Name
FSBSI "Scientific and Research Institute of Physiology and Basic Medicine"
City
Novosibirsk
ZIP/Postal Code
630117
Country
Russian Federation
Facility Name
BHI of Omsk region - Clinical Oncology Dispensary
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
SBIH City Clinical Hospital #31
City
Saint Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
LLC IClinic
City
Saint Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Private Educational Institution of Higher Education "Medical University "REAVIZ"
City
Samara
ZIP/Postal Code
443001
Country
Russian Federation
Facility Name
NonState Healthcare Institution Central Clinical Hospital, Samara station JSC "Russian Railways"
City
Samara
ZIP/Postal Code
443041
Country
Russian Federation
Facility Name
Baltic Med,LLC Clinic BaltMed Ozerki
City
St. Petersburg
ZIP/Postal Code
194356
Country
Russian Federation
Facility Name
EKO-Bezopasnost, St. Petersburg
City
St. Petersburg
ZIP/Postal Code
196143
Country
Russian Federation
Facility Name
Clinical Medical Center Zvezdara, Belgrade
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Military Medical Academy
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center Bezanijska kosa, Belgrade
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Clinical Center Zemun
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Gazi University Medical Faculty
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Gaziantep University Medical Faculty Sahinbey Educational Research Hospital
City
Gaziantep
ZIP/Postal Code
27310
Country
Turkey
Facility Name
Kartal Lutfi Kirdar Research and Training Hospital
City
Istanbul
ZIP/Postal Code
34890
Country
Turkey
Facility Name
Kocaeli University Research and Training Hospital
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
CI Cherkasy RH of Cherkasy Reg.Council
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
CHI Prof.O.O.Shalimov Kharkiv City Clinical Hospital #2
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC
City
Kiev
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
Private Enterprise Private Manufacturing Company "Acinus"
City
Kirovohrad
ZIP/Postal Code
25006
Country
Ukraine
Facility Name
Medical Center Medical Clinic Kyiv
City
Kyiv
ZIP/Postal Code
01601
Country
Ukraine
Facility Name
Clin Hosp.8 P.L.Shupyk NMA of PGE
City
Kyiv
ZIP/Postal Code
04201
Country
Ukraine
Facility Name
Vinnytsia M.I. Pyrogov NMU Ch of internal medicine #3
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine
Facility Name
M.I. Pyrogov VRCH, Vinnytsia
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Clin.Hosp#1,Zaporizhzhia
City
Zaporizhzhia
ZIP/Postal Code
69104
Country
Ukraine
Facility Name
Royal Bournemouth and Christchurch Hospital
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Walsall Manor Hospital
City
Walsall
ZIP/Postal Code
WS2 9PS
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34388360
Citation
Hanauer S, Liedert B, Balser S, Brockstedt E, Moschetti V, Schreiber S. Safety and efficacy of BI 695501 versus adalimumab reference product in patients with advanced Crohn's disease (VOLTAIRE-CD): a multicentre, randomised, double-blind, phase 3 trial. Lancet Gastroenterol Hepatol. 2021 Oct;6(10):816-825. doi: 10.1016/S2468-1253(21)00252-1. Epub 2021 Aug 11.
Results Reference
derived

Learn more about this trial

BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity

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