BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity
NCT ID: NCT02871635
Last Updated: 2020-06-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
147 participants
INTERVENTIONAL
2016-09-28
2019-05-13
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BI 695501
BI 695501
HUMIRA + BI 695501
BI 695501
HUMIRA
Interventions
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BI 695501
HUMIRA
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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Borland-Groover Clinic
Jacksonville, Florida, United States
Hope Clinical Research
Kissimmee, Florida, United States
Center for Advanced GI
Maitland, Florida, United States
Advance Medical Research Center
Miami, Florida, United States
Advanced Research Institute, Inc
New Port Richey, Florida, United States
Doctors Clinical Research
East Point, Georgia, United States
Southwest Gastroenterology
Oak Lawn, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
MGG Group Co. Inc. / Chevy Chase Clinical Research,
Chevy Chase, Maryland, United States
Gastro Center of Maryland
Columbia, Maryland, United States
Healthcare Research Network
Hazelwood, Missouri, United States
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States
Gastroenterology Associates, PA
Greenville, South Carolina, United States
Houston Endoscopy and Research Center
Houston, Texas, United States
Biopharma Informatic, Inc, dba Research Consultants
Katy, Texas, United States
Sagact, Pllc
San Antonio, Texas, United States
Baylor Scott and White Healthcare
Temple, Texas, United States
Victoria Gastroenterology
Victoria, Texas, United States
Gomel Regional Clinical
Homyel, , Belarus
City Clinical Hospital # 10
Minsk, , Belarus
Vitebsk Regional Clinical Oncology Dispensary
Vitebsk, , Belarus
University Clinical Centre Sarajevo
Sarajevo, , Bosnia and Herzegovina
Clinical Hospital Osijek
Osijek, , Croatia
Polyclinic Bonifarm
Zagreb, , Croatia
Vojenska nemocnice Brno
Brno, , Czechia
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, , Czechia
CTCenter Mave, s.r.o., Cllinical Trials Center, Olomouc
Olomouc, , Czechia
Gregar s.r.o.
Olomouc, , Czechia
PreventaMed, s.r.o.
Olomouc, , Czechia
University Hospital Ostrava
Ostrava-Poruba, , Czechia
Vitkovice Hospital
Ostrava-Vitkovice, , Czechia
Medicon, a.s.
Prague, , Czechia
Axon Clinical, s.r.o.
Prague, , Czechia
University Hospital Na Bulovce
Prague, , Czechia
General Hospital Pribram
Příbram, , Czechia
Masaryk Hospital, Internal Department
Ústí nad Labem, , Czechia
Crohn Colitis Centrum Rhein Main
Frankfurt, , Germany
General Hospital of Athens Evangelismos
Athens, , Greece
University General Hospital of Heraklion
Heraklion, Crete, , Greece
General Hospital of Rhodes
Rhodes, , Greece
Haemek Medical Center
Afula, , Israel
Wolfson Medical Center
Holon, , Israel
Hadassah Medical Center, Ein-Karem
Jerusalem, , Israel
Meir Medical Center
Kfar Saba, , Israel
The Chaim Sheba Medical Center Tel Hashomer
Ramat Gan, , Israel
Kaplan Medical Center
Rehovot, , Israel
KLIMED Marek Klimkiewicz
Bialystok, , Poland
NZOZ Centrum Medyczne KERmed
Bydgoszcz, , Poland
Polimedica Centrum Badan
Kielce, , Poland
Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla
Knurów, , Poland
Medical Center Pleiades
Krakow, , Poland
SANTA FAMILIA Centrum Badan, Profilaktyki i Leczenia
Lodz, , Poland
Clinic Medical Center; Nowa Sol
Nowa Sól, , Poland
Ai Medical Center, private practice, Poznan
Poznan, , Poland
Gabinet Lekarski Bartosz Korczowski
Rzeszów, , Poland
Specialized Medical Practice. Dr med. Marek Horynski
Sopot, , Poland
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin, , Poland
Multidisciplinary Medical Clinic "Anthurium"
Barnaul, , Russia
GUZ Reg. Clinical Hospital, Kemerovo
Kemerovo, , Russia
Clinical Hospital No. 24, Moscow
Moscow, , Russia
Murmansk Regional Clinical Hospital named after Bayandin
Murmansk, , Russia
Reg.Clin.Hosp.n.a.Semashko
Nizhny Novgorod, , Russia
State Novosibirsk Regional Clinical Hospital
Novosibirsk, , Russia
FSBSI "Scientific and Research Institute of Physiology and Basic Medicine"
Novosibirsk, , Russia
BHI of Omsk region - Clinical Oncology Dispensary
Omsk, , Russia
SBIH City Clinical Hospital #31
Saint Petersburg, , Russia
Baltic Med,LLC Clinic BaltMed Ozerki
Saint Petersburg, , Russia
EKO-Bezopasnost, St. Petersburg
Saint Petersburg, , Russia
LLC IClinic
Saint Petersburg, , Russia
Private Educational Institution of Higher Education "Medical University "REAVIZ"
Samara, , Russia
NonState Healthcare Institution Central Clinical Hospital, Samara station JSC "Russian Railways"
Samara, , Russia
Clinical Medical Center Zvezdara, Belgrade
Belgrade, , Serbia
Military Medical Academy
Belgrade, , Serbia
Clinical Center Bezanijska kosa, Belgrade
Belgrade, , Serbia
Clinical Center Zemun
Belgrade, , Serbia
Clinical Center Kragujevac
Kragujevac, , Serbia
Gazi University Medical Faculty
Ankara, , Turkey (Türkiye)
Gaziantep University Medical Faculty Sahinbey Educational Research Hospital
Gaziantep, , Turkey (Türkiye)
Kartal Lutfi Kirdar Research and Training Hospital
Istanbul, , Turkey (Türkiye)
Kocaeli University Research and Training Hospital
Kocaeli, , Turkey (Türkiye)
CI Cherkasy RH of Cherkasy Reg.Council
Cherkasy, , Ukraine
CHI Prof.O.O.Shalimov Kharkiv City Clinical Hospital #2
Kharkiv, , Ukraine
Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC
Kiev, , Ukraine
Private Enterprise Private Manufacturing Company "Acinus"
Kirovohrad, , Ukraine
Medical Center Medical Clinic Kyiv
Kyiv, , Ukraine
Clin Hosp.8 P.L.Shupyk NMA of PGE
Kyiv, , Ukraine
Vinnytsia M.I. Pyrogov NMU Ch of internal medicine #3
Vinnytsia, , Ukraine
M.I. Pyrogov VRCH, Vinnytsia
Vinnytsia, , Ukraine
Clin.Hosp#1,Zaporizhzhia
Zaporizhzhia, , Ukraine
Royal Bournemouth and Christchurch Hospital
Bournemouth, , United Kingdom
Walsall Manor Hospital
Walsall, , United Kingdom
Countries
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References
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Strand V. Summary of Research: Immunogenicity of Adalimumab Reference Product and Adalimumab-adbm in Patients with Rheumatoid Arthritis, Crohn's Disease, and Chronic Plaque Psoriasis: A Pooled Analysis of the VOLTAIRE trials. Rheumatol Ther. 2025 Aug;12(4):613-616. doi: 10.1007/s40744-025-00766-6. Epub 2025 Jun 11.
Strand V, McCabe D, Bender S. Immunogenicity of adalimumab reference product and adalimumab-adbm in patients with rheumatoid arthritis, Crohn's disease and chronic plaque psoriasis: a pooled analysis of the VOLTAIRE trials. BMJ Open. 2024 Nov 17;14(11):e081687. doi: 10.1136/bmjopen-2023-081687.
Hanauer S. Plain language summary of the VOLTAIRE-CD study in people with moderate-to-severe active Crohn's disease. Immunotherapy. 2022 Dec;14(17):1353-1359. doi: 10.2217/imt-2022-0129. Epub 2022 Dec 13.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-000612-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1297.4
Identifier Type: -
Identifier Source: org_study_id
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