BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity
- Registration Number
- NCT02871635
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 147
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HUMIRA + BI 695501 BI 695501 - HUMIRA + BI 695501 HUMIRA - BI 695501 BI 695501 -
- Primary Outcome Measures
Name Time Method Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 4 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
Name Time Method Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 24 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 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 Infections From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks. 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 Who Experienced Hypersensitivity Reactions From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks. 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 With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs) From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks. 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 Serious Infections From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks. 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 With Injection Site Reactions From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks. 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.
Percentage of Patients Who Experienced Drug Induced Liver Injury (DILI) From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks. 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.
Trial Locations
- Locations (92)
MGG Group Co. Inc. / Chevy Chase Clinical Research,
🇺🇸Chevy Chase, Maryland, United States
Borland-Groover Clinic
🇺🇸Jacksonville, Florida, United States
Advance Medical Research Center
🇺🇸Miami, Florida, United States
Center for Advanced GI
🇺🇸Maitland, Florida, United States
Doctors Clinical Research
🇺🇸East Point, Georgia, United States
Advanced Research Institute, Inc
🇺🇸New Port Richey, Florida, United States
Biopharma Informatic, Inc, dba Research Consultants
🇺🇸Katy, Texas, United States
Healthcare Research Network
🇺🇸Hazelwood, Missouri, United States
Great Lakes Gastroenterology Research, LLC
🇺🇸Mentor, Ohio, United States
Gastroenterology Associates, PA
🇺🇸Greenville, South Carolina, United States
Baylor Scott and White Healthcare
🇺🇸Temple, Texas, United States
Victoria Gastroenterology
🇺🇸Victoria, Texas, United States
City Clinical Hospital # 10
🇧🇾Minsk, Belarus
Gomel Regional Clinical
🇧🇾Gomel, Belarus
Clinical Hospital Osijek
🇭🇷Osijek, Croatia
Vojenska nemocnice Brno
🇨🇿Brno, Czechia
CTCenter Mave, s.r.o., Cllinical Trials Center, Olomouc
🇨🇿Olomouc, Czechia
Gregar s.r.o.
🇨🇿Olomouc, Czechia
Hepato-Gastroenterologie HK, s.r.o.
🇨🇿Hradec Kralove, 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.
🇨🇿Praha, Czechia
Masaryk Hospital, Internal Department
🇨🇿Usti nad Labem, Czechia
University Hospital Na Bulovce
🇨🇿Praha 8, Czechia
General Hospital Pribram
🇨🇿Pribram, Czechia
General Hospital of Athens Evangelismos
🇬🇷Athens, Greece
University General Hospital of Heraklion
🇬🇷Heraklion, Crete, Greece
General Hospital of Rhodes
🇬🇷Rhodes, Greece
Crohn Colitis Centrum Rhein Main
🇩🇪Frankfurt, Germany
Wolfson Medical Center
🇮🇱Holon, Israel
Haemek Medical Center
🇮🇱Afula, Israel
The Chaim Sheba Medical Center Tel Hashomer
🇮🇱Ramat Gan, Israel
Meir Medical Center
🇮🇱Kfar-Saba, Israel
Kaplan Medical Center
🇮🇱Rehovot, Israel
NZOZ Centrum Medyczne KERmed
🇵🇱Bydgoszcz, Poland
Medical Center Pleiades
🇵🇱Cracow, Poland
KLIMED Marek Klimkiewicz
🇵🇱Bialystok, Poland
Polimedica Centrum Badan
🇵🇱Kielce, Poland
Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla
🇵🇱Knurow, Poland
SANTA FAMILIA Centrum Badan, Profilaktyki i Leczenia
🇵🇱Lodz, Poland
Clinic Medical Center; Nowa Sol
🇵🇱Nowa Sol, Poland
Gabinet Lekarski Bartosz Korczowski
🇵🇱Rzeszow, Poland
Ai Medical Center, private practice, Poznan
🇵🇱Poznan, Poland
Clinical Hospital No. 24, Moscow
🇷🇺Moscow, Russian Federation
GUZ Reg. Clinical Hospital, Kemerovo
🇷🇺Kemerovo, Russian Federation
Specialized Medical Practice. Dr med. Marek Horynski
🇵🇱Sopot, Poland
Twoja Przychodnia-Szczecinskie Centrum Medyczne
🇵🇱Szczecin, Poland
Multidisciplinary Medical Clinic "Anthurium"
🇷🇺Barnaul, Russian Federation
Reg.Clin.Hosp.n.a.Semashko
🇷🇺Nizhniy Novgorod, Russian Federation
State Novosibirsk Regional Clinical Hospital
🇷🇺Novosibirsk, Russian Federation
FSBSI "Scientific and Research Institute of Physiology and Basic Medicine"
🇷🇺Novosibirsk, Russian Federation
BHI of Omsk region - Clinical Oncology Dispensary
🇷🇺Omsk, Russian Federation
Private Educational Institution of Higher Education "Medical University "REAVIZ"
🇷🇺Samara, Russian Federation
SBIH City Clinical Hospital #31
🇷🇺Saint Petersburg, Russian Federation
NonState Healthcare Institution Central Clinical Hospital, Samara station JSC "Russian Railways"
🇷🇺Samara, Russian Federation
EKO-Bezopasnost, St. Petersburg
🇷🇺St. Petersburg, Russian Federation
Baltic Med,LLC Clinic BaltMed Ozerki
🇷🇺St. Petersburg, Russian Federation
Clinical Medical Center Zvezdara, Belgrade
🇷🇸Belgrade, Serbia
Military Medical Academy
🇷🇸Belgrade, Serbia
Clinical Center Zemun
🇷🇸Belgrade, Serbia
Gazi University Medical Faculty
🇹🇷Ankara, Turkey
Kartal Lutfi Kirdar Research and Training Hospital
🇹🇷Istanbul, Turkey
Clinical Center Bezanijska kosa, Belgrade
🇷🇸Belgrade, Serbia
Gaziantep University Medical Faculty Sahinbey Educational Research Hospital
🇹🇷Gaziantep, Turkey
Kocaeli University Research and Training Hospital
🇹🇷Kocaeli, Turkey
CI Cherkasy RH of Cherkasy Reg.Council
🇺🇦Cherkasy, Ukraine
Medical Center Medical Clinic Kyiv
🇺🇦Kyiv, Ukraine
Vinnytsia M.I. Pyrogov NMU Ch of internal medicine #3
🇺🇦Vinnytsia, Ukraine
Clin Hosp.8 P.L.Shupyk NMA of PGE
🇺🇦Kyiv, Ukraine
M.I. Pyrogov VRCH, Vinnytsia
🇺🇦Vinnytsia, Ukraine
Royal Bournemouth and Christchurch Hospital
🇬🇧Bournemouth, United Kingdom
Walsall Manor Hospital
🇬🇧Walsall, United Kingdom
CHI Prof.O.O.Shalimov Kharkiv City Clinical Hospital #2
🇺🇦Kharkiv, Ukraine
University Clinical Centre Sarajevo
🇧🇦Sarajevo, Bosnia and Herzegovina
Private Enterprise Private Manufacturing Company "Acinus"
🇺🇦Kirovohrad, Ukraine
LLC IClinic
🇷🇺Saint Petersburg, Russian Federation
Hadassah Medical Center, Ein-Karem
🇮🇱Jerusalem, Israel
Vitebsk Regional Clinical Oncology Dispensary
🇧🇾Vitebsk, Belarus
Polyclinic Bonifarm
🇭🇷Zagreb, Croatia
Clin.Hosp#1,Zaporizhzhia
🇺🇦Zaporizhzhia, Ukraine
Murmansk Regional Clinical Hospital named after Bayandin
🇷🇺Murmansk, Russian Federation
Clinical Center Kragujevac
🇷🇸Kragujevac, Serbia
Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC
🇺🇦Kiev, Ukraine
Hope Clinical Research
🇺🇸Kissimmee, Florida, United States
Southwest Gastroenterology
🇺🇸Oak Lawn, Illinois, United States
Gastro Center of Maryland
🇺🇸Columbia, Maryland, United States
Asheville Gastroenterology Associates, PA
🇺🇸Asheville, North Carolina, United States
Houston Endoscopy and Research Center
🇺🇸Houston, Texas, United States
Sagact, Pllc
🇺🇸San Antonio, Texas, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States