BI 695501 Compared to Adalimumab in Patients With Active Rheumatoid Arthritis
- Conditions
- Arthritis, Rheumatoid
- Interventions
- Drug: BI 695501Drug: US-licensed Humira®
- Registration Number
- NCT02137226
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Primary Objective:
The primary objective of this trial is to establish an equivalence in efficacy between BI 695501 and US-licensed Humira® in patients with active Rheumatoid arthritis based on a statistical comparison of the proportion of patients meeting American College of Rheumatology 20% (ACR20) response rate at Week 12 and ACR20 response rate at Week 24 between BI 695501 and US-licensed Humira®.
Secondary Objectives:
The secondary objectives of this trial are to compare the efficacy, safety and immunogenicity of BI 695501 and US-licensed Humira® in patients with active RA including those undergoing the transition from US-licensed Humira® to BI 695501 after 24 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 645
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 695501 BI 695501 one injection every 2 weeks for 48 weeks (25 injections in total) US-licensed Humira® US-licensed Humira® one injection every 2 weeks for 48 weeks (25 injections in total)
- Primary Outcome Measures
Name Time Method The Proportion of Patients Meeting the American College of Rheumatology 20% (ACR20) Response Criteria at Week 12 Week 12 The proportion of patients meeting the ACR20 response criteria was assessed. A patient had an ACR20 response if all of the following occurred: A ≥ 20 % improvement in the swollen joint count (66 joints), A ≥ 20 % improvement in the tender joint count (68 joints), A ≥ 20 % improvement in at least three of the following assessments: Patient's assessment of pain, Patient's global assessment of disease activity (equivalent to the General Health component of the Disease Activity Score (DAS)), Physician's global assessment of disease activity, Patient's assessment of physical function, as measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI) Acute phase reactant (C-reactive protein (CRP)).The Full Analysis Set contained all enrolled patients who were randomized to trial drug and who received at least one dose of trial drug and had all efficacy measures relevant for the co-primary efficacy endpoints measured at baseline and at least once post- baseline.
The Proportion of Patients Meeting ACR20 Response Criteria at Week 24 Week 24 ACR20 at Week 12 and Week 24 are standard outcome criteria that are widely accepted for regulatory purposes to demonstrate efficacy in treating the signs and symptoms of Rheumatoid arthritis (RA). The proportion of patients meeting the ACR20 response criteria was assessed at Week 12 and Week 24 to provide a robust comparison with US-licensed Humira® data. A patient had an ACR20 response if all of the following occurred: A ≥ 20 % improvement in the swollen joint count (66 joints), A ≥ 20 % improvement in the tender joint count (68 joints), A ≥ 20 % improvement in at least three of the following assessments: Patient's assessment of pain, Patient's global assessment of disease activity (equivalent to the General Health component of the Disease Activity Score (\[DAS\]), Physician's global assessment of disease activity, Patient's assessment of physical function, as measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI) Acute phase reactant (C-reactive protein \[CRP\]).
- Secondary Outcome Measures
Name Time Method Change From Baseline in Disease Activity Score 28 (DAS28) (Erythrocyte Sedimentation Rate [ESR]) at Week 12 and Week 24 Baseline, Week 12 and Week 24 The DAS28 (ESR) score was derived using the following formulae:
DAS28 (ESR) = 0.56\*√(TJC28) + 0.28\*√(SJC28) + 0.014\*(GH) + 0.7\*ln(ESR)
Where:
* TJC28 = 28 joint count for tenderness
* SJC28 = 28 joint count for swelling
* Ln (ESR) = natural logarithm of ESR
* GH = General Health component of the DAS (patient's global assessment of disease activity). DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity. Actual number of patient analysed (N) is mean number of subjects in the analysis set with DAS28(ESR) results computable across the multiply imputed data sets. It is 319.6, 317.1 for week 12 and 313.9, 315.1 for week 24 for BI 695501 and US-licensed Humira® respectively.The Percentage of Patients With Investigator-assessed Drug-related Adverse Events (AEs) During the Treatment Phase From the first drug administration until 10 weeks after the last drug administration, up to 58 weeks The analysis of AEs was based on the concept of treatment-emergent AEs (TEAEs). Thus, all AEs with an onset after the first dose of trial drug up to a period of ten weeks after the last dose of trial drug were assigned to the current treatment for evaluation. Investigator-assessed drug related AEs were AEs with a relationship to drug ticked "yes" according to the Investigator. Overall results are presented from Day 1 up to Week 58 and are based on the initial randomization groups. The comparison therefore focuses on patients who received BI 695501 continuously versus patients who received Humira® continuously for the long term assessment of safety. One patient was initially treated with Humira and discontinued prior to Week 24. This patient was mistakenly re randomized to BI 695501 but not treated. For safety this was counted in Humira not re-randomized group (as treated), and for other analysis sets, this patient was counted in the Humira to BI 695501 group (as randomized).
Trial Locations
- Locations (131)
North MS Medical Clinics, Incorporated
🇺🇸Tupelo, Mississippi, United States
Glacier View Research Institute
🇺🇸Kalispell, Montana, United States
Accurate Clinical Research, Inc.
🇺🇸Lincoln, Nebraska, United States
Anna Imperato, MD PLLC
🇺🇸Manhasset, New York, United States
Metroplex Clinical Research Center
🇺🇸Dallas, Texas, United States
Accurate Clinical Research, Incorporated
🇺🇸Nassau Bay, Texas, United States
MHAT "Eurohospital" - Plovdiv, OOD
🇧🇬Plovdiv, Bulgaria
Medita Kliinik OÜ, Tartu
🇪🇪Tartu, Estonia
Wojewodzki Szpital Zespolony w Elblagu
🇵🇱Elblag, Poland
M.I. Pyrogov VRCH, Vinnytsia
🇺🇦Vinnytsia, Ukraine
Niepubliczny ZOZ, "Nasz Lekarz", Lekarzy Rodzinnych z
🇵🇱Torun, Poland
San Marcus Research Clinic, Inc.
🇺🇸Miami, Florida, United States
L&C Professional Medical Research Institute
🇺🇸Miami, Florida, United States
Goldpoint Clinical Research, LLC
🇺🇸Indianapolis, Indiana, United States
Heartland Research Associates, LLC
🇺🇸San Antonio, Texas, United States
Houston Rheumatology Consultants, PLLC
🇺🇸Houston, Texas, United States
Accurate Clinical Management LLC
🇺🇸Houston, Texas, United States
Pioneer Research Solutions, Inc.
🇺🇸Houston, Texas, United States
Rheumatology Clinic Of Houston, P.A.
🇺🇸Houston, Texas, United States
ProHealth Partners
🇺🇸Long Beach, California, United States
Medical Centre Pratia Warszawa
🇵🇱Warszawa, Poland
Lovelace Scientific Resources, Incorporated
🇺🇸Venice, Florida, United States
Hospital Universitario de Cruces
🇪🇸Barakaldo, Spain
Institute of Rheumatology, Belgrade
🇷🇸Belgrade, Serbia
Reg. Hospital for war veterans
🇷🇺Saratov, Russian Federation
Republic Kareliya Republican Hosp. named after V.A. Baranov
🇷🇺Petrozavodsk, Russian Federation
Emergency Clinical Hospital n. a. N. V. Soloviev, Yaroslavl
🇷🇺Yaroslavl, Russian Federation
MHAT Lyulin
🇧🇬Sofia, Bulgaria
Rheumatology Associates
🇺🇸Birmingham, Alabama, United States
Pinnacle Research Group, LLC
🇺🇸Anniston, Alabama, United States
TriWest Research Associates, LLC
🇺🇸El Cajon, California, United States
Arizona Arthritis and Rheumatology Research, PLLC
🇺🇸Phoenix, Arizona, United States
Advanced Medical Research, LLC
🇺🇸La Palma, California, United States
The Permanente Medical Group
🇺🇸Santa Clara, California, United States
Inland Rheumatology Clinical Trials, Inc.
🇺🇸Upland, California, United States
Medvin Clinical Research
🇺🇸Whittier, California, United States
Alpine Clinical Research Center
🇺🇸Boulder, Colorado, United States
Orthopedic Research Institute
🇺🇸Boynton Beach, Florida, United States
Family Clinical Trials, Incorporated
🇺🇸Pembroke Pines, Florida, United States
Science and Research Institute, Inc.
🇺🇸Jupiter, Florida, United States
McIlwain Medical Group, PA
🇺🇸Tampa, Florida, United States
West Broward Rheumatology Associates, Incorporated
🇺🇸Tamarac, Florida, United States
Physician Research Collaboration
🇺🇸South Miami, Florida, United States
Institute of Arthritis Research
🇺🇸Idaho Falls, Idaho, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
The Arthritis & Diabetes Clinic, Incorporated
🇺🇸Monroe, Louisiana, United States
Klein and Associates, M.D., P.A.
🇺🇸Cumberland, Maryland, United States
Clinical Pharmacology Study Group
🇺🇸Worcester, Massachusetts, United States
Arthritis Education and Treatment Center
🇺🇸Grand Rapids, Michigan, United States
NJP Clinical Research
🇺🇸Clifton, New Jersey, United States
Albuquerque Center For Rheumatology
🇺🇸Albuquerque, New Mexico, United States
Box Arthritis & Rheumatology of the Carolinas
🇺🇸Charlotte, North Carolina, United States
Altoona Center for Clinical Research, P.C.
🇺🇸Duncansville, Pennsylvania, United States
Austin Regional Clinic
🇺🇸Austin, Texas, United States
Mountain View Clinical Research
🇺🇸Greer, South Carolina, United States
Adriana Pop Moody Clinic PA
🇺🇸Corpus Christi, Texas, United States
Arthritis & Osteoporosis Associates LLP
🇺🇸Lubbock, Texas, United States
Medical Center "Teodora", EOOD, Ruse
🇧🇬Ruse, Bulgaria
Danville Orthopedic Clinic, Incorporated
🇺🇸Danville, Virginia, United States
Arthritis Northwest, PLLC
🇺🇸Spokane, Washington, United States
MHAT "Trimontium", OOD, Plovdiv
🇧🇬Plovdiv, Bulgaria
MHAT - Kaspela, EOOD
🇧🇬Plovdiv, Bulgaria
MHAT,Fourth Dept. of Therapeutics & Cardiology, Ruse
🇧🇬Ruse, Bulgaria
UMHAT Sv. Ivan Rilski EAD
🇧🇬Sofia, Bulgaria
MMA HAT Sofia, Bulgaria
🇧🇬Sofia, Bulgaria
MDHAT 'Dr. Stefan Cherkezov', AD
🇧🇬Veliko Tarnovo, Bulgaria
Corporacion de Beneficencia Osorno
🇨🇱Osorno, Chile
Quantum Research Santiago, Puerto Varas
🇨🇱Puerto Varas, Chile
BIOMEDICA, Santiago
🇨🇱Santiago, Chile
Centro de Estudios Reumatológicos
🇨🇱Santiago, Chile
CINVEC - Centro de Investigacion Clinica V Reg.,Vina del Mar
🇨🇱Viña del Mar, Chile
Rheumazentrum Prof. Dr. G. Neeck, Bad Doberan
🇩🇪Bad Doberan, Germany
Kerckhoff-Klinik, Bad Nauheim
🇩🇪Bad Nauheim, Germany
ACURA Kliniken Rheinland-Pfalz AG, Bad Kreuznach
🇩🇪Bad Kreuznach, Germany
Csolnoky Ferenc Korhaz, Veszprem
🇭🇺Veszprem, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klin. Kozpont
🇭🇺Szeged, Hungary
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Hospital Tengku Ampuan Afzan
🇲🇾Kuantan, Malaysia
CGM Research Trust, The Princess Margaret Hospital Cantebury
🇳🇿Cantebury, New Zealand
Medica Pro Familia Spolka Akcyjna, Oddzial w Gdyni
🇵🇱Gdynia, Poland
Medical Centre Pratia Krakow
🇵🇱Krakow, Poland
Wojewodzki Szpital Specjalistyczny we Wroclawiu
🇵🇱Wroclaw, Poland
Reumatika, Rheumatology Center, non-public outpatient clinic
🇵🇱Warszawa, Poland
Clinical Center of Vojvodina
🇷🇸Novi Sad, Serbia
Samara Regional Clinical Hospital n.a MI Kalinin, Samara
🇷🇺Samara, Russian Federation
Stavropol State Medical Academy
🇷🇺Stavropol, Russian Federation
Institute for Treatment and Rehabilitation, Niska Banja
🇷🇸Niska Banja, Serbia
Fundación Jiménez Díaz
🇪🇸Madrid, Spain
Hospital A Coruña
🇪🇸La Coruña, Spain
Hosp. Nuestra Señora de la Esperanza, Santiago de Compostela
🇪🇸Santiago de Compostela, Spain
Siriraj Hospital
🇹🇭Bangkoknoi, Thailand
Ivano-Frankivsk Nat. Medical University, Dept. Endocrinology
🇺🇦Ivano-Frankivsk, Ukraine
Songklanagarind Hospital
🇹🇭Hat Yai, Thailand
Pramongkutklao Hospital
🇹🇭Rajathevee, Thailand
L.T. Malaya Institute of Therapy AMS of Ukraine
🇺🇦Kharkiv, Ukraine
M.V. Sklifosovskyi Poltava RCH, Poltava
🇺🇦Poltava, Ukraine
Zaporizhzhia Regional Clinical Hospital, Zaporizhzhia
🇺🇦Zaporizhzhia, Ukraine
PMG Research of Salisbury, LLC
🇺🇸Salisbury, North Carolina, United States
Clinical Research of West Florida, Inc.
🇺🇸Tampa, Florida, United States
Universal Clinical Research
🇺🇸Coral Gables, Florida, United States
Achieve Clinical Research, LLC
🇺🇸Birmingham, Alabama, United States
STAT Research, Incorporated
🇺🇸Dayton, Ohio, United States
Medication Management, LLC
🇺🇸Greensboro, North Carolina, United States
Wake Forest University School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
Center for Inflammatory Disease
🇺🇸Nashville, Tennessee, United States
Clinical Research Source, Inc.
🇺🇸Perrysburg, Ohio, United States
Hospital Clínico de Santiago
🇪🇸Santiago de Compostela, Spain
SMO.MD GmbH, Magdeburg
🇩🇪Magdeburg, Germany
Practicheskaya Meditsina Ltd
🇷🇺Moscow, Russian Federation
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Kemerovo SMA b/o War Veterans Regional Clinical Hospital
🇷🇺Kemerovo, Russian Federation
SBHI of Yaroslavl Area "Clinical Hospital #3"
🇷🇺Yaroslavl, Russian Federation
DCC 17 - Sofia EOOD
🇧🇬Sofia, Bulgaria
DCC 'Chaika', EOOD, Varna
🇧🇬Varna, Bulgaria
Centro Medico Prosalud
🇨🇱Santiago, Chile
Pärnu Hospital, Pärnu
🇪🇪Pärnu, Estonia
MCBK Iwona Czajkowska Anna Podrazka- Szczepaniak S.C.
🇵🇱Grodzisk Mazowiecki, Poland
CI of Healthcare Kharkiv CCH #8, Kharkiv
🇺🇦Kharkiv, Ukraine
SI NSC M.D. Strazhesko Institute Cardiology of NAMSU, Kyiv
🇺🇦Kyiv, Ukraine
Oleksandrivska Clinical Hospital
🇺🇦Kyiv, Ukraine
MHAT Shumen AD, Shumen
🇧🇬Shumen, Bulgaria
Hospital Pulau Pinang
🇲🇾Pulau Pinang, Malaysia
Medical Centre Pratia Katowice I
🇵🇱Katowice, Poland
Specialist Center ALL-MED, Krakow
🇵🇱Krakow, Poland
General Hospital "Dr Laza K. Lazarevic" Sabac, Sabac
🇷🇸Sabac, Serbia
MCIC MC LLC Health Clinic, Vinnytsia
🇺🇦Vinnytsia, Ukraine
Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
🇵🇱Bialystok, Poland
Szpital Uniwersytecki nr 2 im.dr J. Biziela
🇵🇱Bydgoszcz, Poland
SI D.F.Chebotariov Institute of Gerontology of NAMSU, Kyiv
🇺🇦Kyiv, Ukraine