BI 695501 Compared to Adalimumab in Patients With Active Rheumatoid Arthritis
NCT ID: NCT02137226
Last Updated: 2018-01-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
645 participants
INTERVENTIONAL
2015-01-26
2016-10-18
Brief Summary
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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.
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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
one injection every 2 weeks for 48 weeks (25 injections in total)
BI 695501
BI 695501, every two weeks for 48 weeks (25 injections in total)
US-licensed Humira®
one injection every 2 weeks for 48 weeks (25 injections in total)
US-licensed Humira®
one injection every 2 weeks for 48 weeks (25 injections in total)
Interventions
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BI 695501
BI 695501, every two weeks for 48 weeks (25 injections in total)
US-licensed Humira®
one injection every 2 weeks for 48 weeks (25 injections in total)
Eligibility Criteria
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Inclusion Criteria
* Male or female participants, between 18 and 80 years of age, who have a diagnosis of moderately to severely active Rheumatoid arthritis for at least 6 months as defined by at least six swollen joints (66 joint count) and at least six tender joints (68 joint count) at Screening and Baseline (Day 1), and either an Erythrocyte sedimentation rate of \>28 mm/hour OR a C-reactive protein (CRP) level \>1.0 mg/dL (normal: \<0.4 mg/dL) at Screening. Patients must currently be receiving methotrexate (MTX) therapy.
* Current treatment for Rheumatoid arthritis on an outpatient basis:
1. Must be receiving and tolerating oral or parenteral MTX therapy at a dose of 15 to 25 mg per week (dose may be as low as 10 mg per week if the patient is unable to tolerate a higher dose) for at least 12 weeks immediately prior to Day 1. The dose and administration route should remain stable for at least 4 weeks prior to Day 1 until Week 24. After Week 24 the administration route can be changed at the investigator's discretion. Patients receiving a lower dose of MTX (10 to 14 mg/week) should be doing so as a result of a documented history of intolerance to higher doses of MTX.
2. Patients must be willing to receive oral folic acid (at least 5 mg/week or as per local practice) or folinic acid (at least 1 mg/week or as per local practice) or equivalent during the entire trial (mandatory comedication for MTX treatment).
3. Disease modifying antirheumatic drug (DMARD) use will be restricted according to guidelines listed in the trial protocol.
4. If receiving current treatment with oral corticosteroids (other than intra-articular or parenteral), the dose must not exceed 10 mg/day prednisolone or equivalent. During the 4 weeks prior to Baseline (Day 1) the dose must remain stable.
5. Any concomitant non-steroidal anti-inflammatory drugs (NSAIDs) must be stable for at least 2 weeks prior to Day 1.
6. Patients may be taking oral hydroxychloroquine provided that the dose is not greater than 400 mg/day or chloroquine provided that the dose is not greater than 250 mg/day. These doses must have been stable for a minimum of 12 weeks prior to Day 1. The hydroxychloroquine or chloroquine treatment will need to be continued at a stable dose with the same formulation until the end of the trial.
* For participants of reproductive potential (males and females), a reliable means of contraception has to be used throughout trial participation(acceptable methods of birth control include for example birth control pills, intrauterine devices \[IUDs\], surgical sterilization, vasectomized partner and double barrier method.. All patients (males and females of child-bearing potential) must also agree to use an acceptable method of contraception for 6 months following completion or discontinuation from the trial medication.
Exclusion Criteria
* Primary or secondary immunodeficiency, including known history of HIV infection, or a positive test at Screening.
* History of Tuberculosis, latent Tuberculosis, or positive purified protein derivative test or interferon gamma-releasing assay .
* Known clinically significant coronary artery disease or significant cardiac arrhythmias or severe congestive heart failure, or interstitial lung disease.
* Previous treatment with \>=2 biologic agents.
* Previous treatment with adalimumab or adalimumab biosimilar.
* Current treatment or previous treatment with leflunomide within 8 weeks.
* History of a severe allergic reaction or anaphylactic reaction to a biological agent or history of hypersensitivity to adalimumab or any component of the trial drug.
* History of cancer including solid tumors, hematologic malignancies, and carcinoma in situ.
* Has evidence of positive serology for Hepatitis B virus or Hepatitis C virus
* Receipt of a live/attenuated vaccine within 12 weeks prior to the Screening Visit. Patients who are expecting to receive any live virus or bacterial vaccinations during the trial, or up to 3 months after the last dose of trial drug.
* Any treatment that, in the opinion of the investigator, may place the patient at unacceptable risk during the trial.
* Patients with a significant disease other than Rheumatoid arthritis and/or a significant uncontrolled disease (such as, but not limited to, nervous system, renal, hepatic, endocrine, or gastrointestinal disorders). A significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the trial, or (ii) influence the results of the trial, or (iii) cause concern regarding the patient's ability to participate in the trial.
* Premenopausal, sexually active women who are pregnant or nursing, or are of child-bearing potential and not practicing an acceptable method of birth control, or do not plan to continue practicing an acceptable method of birth control throughout the trial.
* History of, or current, inflammatory joint disease other than Rheumatoid arthritis or other systemic autoimmune disorder.
* Diagnosis of juvenile idiopathic arthritis, and/or Rheumatoid arthritis before age 16.
* Any planned surgical procedure within 12 weeks prior to the Screening Visit or for the duration of the trial.
* Known active infection of any kind (excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with intravenous anti infectives within 4 weeks of the Screening Visit or completion of oral anti-infectives within 2 weeks of the Screening Visit.
* History of deep space/tissue infection within 52 weeks of the Screening Visit.
* History of serious infection or opportunistic infection in the last 2 years.
* Any neurological, vascular or systemic disorder that might affect any of the efficacy assessments.
* Currently active alcohol or drug abuse or history of alcohol or drug abuse within 2 years of the Screening Visit.
* Treatment with intravenous Gamma Globulin or the Prosorba® Column within 6 months of the Screening Visit.
* Treatment with intravenous, intramuscular, intra-articular and parenteral corticosteroids within 6 weeks prior to Day 1 or throughout the trial.
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>1.5 times upper limit of normal.
* Hemoglobin \<8.0 g/dL.
* Platelets \<100,000/µL.
* Leukocyte count \<4000/µL.
* Creatinine clearance \<60 mL/min.
* Patients who are currently participating in another clinical trial or who have been participating in another clinical trial with another investigational drug within a minimum of 12 weeks or five half-lives (whichever is longer) of the drug prior to Day 1.
* Patients with a history of any clinically significant adverse reaction to murine or chimeric proteins.
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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Pinnacle Research Group, LLC
Anniston, Alabama, United States
Rheumatology Associates
Birmingham, Alabama, United States
Achieve Clinical Research, LLC
Birmingham, Alabama, United States
Arizona Arthritis and Rheumatology Research, PLLC
Glendale, Arizona, United States
Arizona Arthritis and Rheumatology Research, PLLC
Mesa, Arizona, United States
Arizona Arthritis and Rheumatology Research, PLLC
Phoenix, Arizona, United States
Arizona Arthritis and Rheumatology Research, PLLC
Phoenix, Arizona, United States
TriWest Research Associates, LLC
El Cajon, California, United States
Advanced Medical Research, LLC
La Palma, California, United States
ProHealth Partners
Long Beach, 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
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States
Universal Clinical Research
Coral Gables, Florida, United States
Science and Research Institute, Inc.
Jupiter, Florida, United States
San Marcus Research Clinic, Inc.
Miami, Florida, United States
L&amp;C Professional Medical Research Institute
Miami, Florida, United States
Family Clinical Trials, Incorporated
Pembroke Pines, Florida, United States
Physician Research Collaboration
South Miami, Florida, United States
West Broward Rheumatology Associates, Incorporated
Tamarac, Florida, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, United States
McIlwain Medical Group, PA
Tampa, Florida, United States
Lovelace Scientific Resources, Incorporated
Venice, Florida, United States
Institute of Arthritis Research
Idaho Falls, Idaho, United States
Goldpoint Clinical Research, LLC
Indianapolis, Indiana, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
The Arthritis &amp; 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
Henry Ford Health System
Detroit, Michigan, United States
Arthritis Education and Treatment Center
Grand Rapids, Michigan, United States
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
NJP Clinical Research
Clifton, New Jersey, United States
Albuquerque Center For Rheumatology
Albuquerque, New Mexico, United States
Anna Imperato, MD PLLC
Manhasset, New York, United States
Box Arthritis &amp; Rheumatology of the Carolinas
Charlotte, North Carolina, United States
Medication Management, LLC
Greensboro, North Carolina, United States
PMG Research of Salisbury, LLC
Salisbury, North Carolina, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
STAT Research, Incorporated
Dayton, Ohio, United States
Clinical Research Source, Inc.
Perrysburg, Ohio, United States
Altoona Center for Clinical Research, P.C.
Duncansville, Pennsylvania, United States
Mountain View Clinical Research
Greer, South Carolina, United States
Center for Inflammatory Disease
Nashville, Tennessee, United States
Austin Regional Clinic
Austin, Texas, United States
Adriana Pop Moody Clinic PA
Corpus Christi, Texas, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
Accurate Clinical Management LLC
Houston, Texas, United States
Pioneer Research Solutions, Inc.
Houston, Texas, United States
Accurate Clinical Research, Incorporated
Houston, Texas, United States
Rheumatology Clinic Of Houston, P.A.
Houston, Texas, United States
Accurate Clinical Research, Incorporated
Houston, Texas, United States
Houston Rheumatology Consultants, PLLC
Houston, Texas, United States
Arthritis &amp; Osteoporosis Associates LLP
Lubbock, Texas, United States
Accurate Clinical Research, Incorporated
Nassau Bay, Texas, United States
Heartland Research Associates, LLC
San Antonio, Texas, United States
Danville Orthopedic Clinic, Incorporated
Danville, Virginia, United States
Arthritis Northwest, PLLC
Spokane, Washington, United States
MHAT "Trimontium", OOD, Plovdiv
Plovdiv, , Bulgaria
MHAT "Eurohospital" - Plovdiv, OOD
Plovdiv, , Bulgaria
MHAT - Kaspela, EOOD
Plovdiv, , Bulgaria
Medical Center "Teodora", EOOD, Ruse
Rousse, , Bulgaria
MHAT,Fourth Dept. of Therapeutics & Cardiology, Ruse
Rousse, , Bulgaria
MHAT Shumen AD, Shumen
Shumen, , Bulgaria
MHAT Lyulin
Sofia, , Bulgaria
DCC 17 - Sofia EOOD
Sofia, , Bulgaria
MMA HAT Sofia, Bulgaria
Sofia, , Bulgaria
UMHAT Sv. Ivan Rilski EAD
Sofia, , Bulgaria
DCC 'Chaika', EOOD, Varna
Varna, , 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
Centro Medico Prosalud
Santiago, , Chile
CINVEC - Centro de Investigacion Clinica V Reg.,Vina del Mar
Viña del Mar, , Chile
Pärnu Hospital, Pärnu
Pärnu, , Estonia
Medita Kliinik OÜ, Tartu
Tartu, , Estonia
Rheumazentrum Prof. Dr. G. Neeck, Bad Doberan
Bad Doberan, , Germany
ACURA Kliniken Rheinland-Pfalz AG, Bad Kreuznach
Bad Kreuznach, , Germany
Kerckhoff-Klinik, Bad Nauheim
Bad Nauheim, , Germany
SMO.MD GmbH, Magdeburg
Magdeburg, , Germany
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klin. Kozpont
Szeged, , Hungary
Csolnoky Ferenc Korhaz, Veszprem
Veszprém, , Hungary
Hospital Tengku Ampuan Afzan
Kuantan, , Malaysia
Hospital Pulau Pinang
Pulau Pinang, , Malaysia
CGM Research Trust, The Princess Margaret Hospital Cantebury
Cantebury, , New Zealand
Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
Bialystok, , Poland
Szpital Uniwersytecki nr 2 im.dr J. Biziela
Bydgoszcz, , Poland
Wojewodzki Szpital Zespolony w Elblagu
Elblag, , Poland
Medica Pro Familia Spolka Akcyjna, Oddzial w Gdyni
Gdynia, , Poland
MCBK Iwona Czajkowska Anna Podrazka- Szczepaniak S.C.
Grodzisk Mazowiecki, , Poland
Medical Centre Pratia Katowice I
Katowice, , Poland
Medical Centre Pratia Krakow
Krakow, , Poland
Specialist Center ALL-MED, Krakow
Krakow, , Poland
Niepubliczny ZOZ, "Nasz Lekarz", Lekarzy Rodzinnych z
Torun, , Poland
Medical Centre Pratia Warszawa
Warsaw, , Poland
Reumatika, Rheumatology Center, non-public outpatient clinic
Warsaw, , Poland
Wojewodzki Szpital Specjalistyczny we Wroclawiu
Wroclaw, , Poland
Kemerovo SMA b/o War Veterans Regional Clinical Hospital
Kemerovo, , Russia
Practicheskaya Meditsina Ltd
Moscow, , Russia
Republic Kareliya Republican Hosp. named after V.A. Baranov
Petrozavodsk, , Russia
Samara Regional Clinical Hospital n.a MI Kalinin, Samara
Samara, , Russia
Reg. Hospital for war veterans
Saratov, , Russia
Stavropol State Medical Academy
Stavropol, , Russia
Emergency Clinical Hospital n. a. N. V. Soloviev, Yaroslavl
Yaroslavl, , Russia
SBHI of Yaroslavl Area "Clinical Hospital #3"
Yaroslavl, , Russia
Institute of Rheumatology, Belgrade
Belgrade, , Serbia
Institute for Treatment and Rehabilitation, Niska Banja
Niška Banja, , Serbia
Clinical Center of Vojvodina
Novi Sad, , Serbia
General Hospital "Dr Laza K. Lazarevic" Sabac, Sabac
Šabac, , Serbia
Daegu Catholic University Medical Center
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Hospital A Coruña
A Coruña, , Spain
Hospital Universitario de Cruces
Barakaldo, , Spain
Fundación Jiménez Díaz
Madrid, , Spain
Hosp. Nuestra Señora de la Esperanza, Santiago de Compostela
Santiago de Compostela, , Spain
Hospital Clínico de Santiago
Santiago de Compostela, , Spain
Siriraj Hospital
Bangkoknoi, , Thailand
Songklanagarind Hospital
Hat Yai, , Thailand
Pramongkutklao Hospital
Rajathevee, , Thailand
Ivano-Frankivsk Nat. Medical University, Dept. Endocrinology
Ivano-Frankivsk, , Ukraine
L.T. Malaya Institute of Therapy AMS of Ukraine
Kharkiv, , Ukraine
CI of Healthcare Kharkiv CCH #8, Kharkiv
Kharkiv, , Ukraine
SI NSC M.D. Strazhesko Institute Cardiology of NAMSU, Kyiv
Kyiv, , Ukraine
SI D.F.Chebotariov Institute of Gerontology of NAMSU, Kyiv
Kyiv, , Ukraine
Oleksandrivska Clinical Hospital
Kyiv, , Ukraine
M.V. Sklifosovskyi Poltava RCH, Poltava
Poltava, , Ukraine
M.I. Pyrogov VRCH, Vinnytsia
Vinnytsia, , Ukraine
MCIC MC LLC Health Clinic, Vinnytsia
Vinnytsia, , Ukraine
Zaporizhzhia Regional Clinical Hospital, Zaporizhzhia
Zaporizhzhia, , Ukraine
Countries
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References
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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.
Strand V, Bender S, McCabe D. Effects of Adalimumab-adbm Versus Adalimumab Reference Product on Patient-Reported Outcomes in Rheumatoid Arthritis: Results from VOLTAIRE-RA. Rheumatol Ther. 2024 Oct;11(5):1291-1302. doi: 10.1007/s40744-024-00687-w. Epub 2024 Aug 9.
Cohen SB, Lee EC. Plain language summary of the VOLTAIRE-RA in patients with moderate-to-severe rheumatoid arthritis. Immunotherapy. 2022 Oct;14(15):1183-1190. doi: 10.2217/imt-2022-0106. Epub 2022 Sep 6.
Huizinga TWJ, Torii Y, Muniz R. Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity. Rheumatol Ther. 2021 Mar;8(1):41-61. doi: 10.1007/s40744-020-00259-8. Epub 2020 Dec 1.
Kang J, Eudy-Byrne RJ, Mondick J, Knebel W, Jayadeva G, Liesenfeld KH. Population pharmacokinetics of adalimumab biosimilar adalimumab-adbm and reference product in healthy subjects and patients with rheumatoid arthritis to assess pharmacokinetic similarity. Br J Clin Pharmacol. 2020 Nov;86(11):2274-2285. doi: 10.1111/bcp.14330. Epub 2020 Jun 11.
Cohen SB, Alonso-Ruiz A, Klimiuk PA, Lee EC, Peter N, Sonderegger I, Assudani D. Similar efficacy, safety and immunogenicity of adalimumab biosimilar BI 695501 and Humira reference product in patients with moderately to severely active rheumatoid arthritis: results from the phase III randomised VOLTAIRE-RA equivalence study. Ann Rheum Dis. 2018 Jun;77(6):914-921. doi: 10.1136/annrheumdis-2017-212245. Epub 2018 Mar 7.
Other Identifiers
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2012-002945-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1297.2
Identifier Type: -
Identifier Source: org_study_id
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