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AzTrials

Arthritis, RheumatoidPhase 3NCT02137226

BI 695501 Compared to Adalimumab in Patients With Active Rheumatoid Arthritis

A Phase 3 study testing BI 695501 and US-licensed Humira® in people with Arthritis, Rheumatoid, run by Boehringer Ingelheim at 138 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Arthritis, Rheumatoid
What is being tested?
BI 695501 and US-licensed Humira®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
645 participants
Where
138 sitesin 15 countries
Study dates
26 Jan 2015to 18 Oct 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients must sign and date an Informed Consent Form consistent with International Conference on Harmonisation Good Clinical Practice (ICH GCP) guidelines and local legislation prior to participation in the trial (i.e. prior to any trial procedures, which include medication washout and restrictions) and be willing to follow the protocol.
  • 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:
  • 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.
  • 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).
  • Disease modifying antirheumatic drug (DMARD) use will be restricted according to guidelines listed in the trial protocol.
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  • 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.
  • Any concomitant non-steroidal anti-inflammatory drugs (NSAIDs) must be stable for at least 2 weeks prior to Day 1.
  • 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.

Who cannot join

  • ACR functional Class IV or wheelchair/bed bound.
  • 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.
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  • 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.

Trial locations and contacts

138 sites in 15 countries.

138 sites in 15 countries

United States63 sites

  • Albuquerque Center For Rheumatology

    Albuquerque, New Mexico, 87102

  • Pinnacle Research Group, LLC

    Anniston, Alabama, 36207

  • Austin Regional Clinic

    Austin, Texas, 78731

  • Rheumatology Associates

    Birmingham, Alabama, 35205

  • Achieve Clinical Research, LLC

    Birmingham, Alabama, 35216

  • Alpine Clinical Research Center

    Boulder, Colorado, 80304

  • Orthopedic Research Institute

    Boynton Beach, Florida, 33437

  • Box Arthritis &amp;amp; Rheumatology of the Carolinas

    Charlotte, North Carolina, 28210

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida, 33765

  • NJP Clinical Research

    Clifton, New Jersey, 07012

  • Universal Clinical Research

    Coral Gables, Florida, 33134

  • Adriana Pop Moody Clinic PA

    Corpus Christi, Texas, 78404

  • Klein and Associates, M.D., P.A.

    Cumberland, Maryland, 21502

  • Metroplex Clinical Research Center

    Dallas, Texas, 75231

  • Danville Orthopedic Clinic, Incorporated

    Danville, Virginia, 24541

  • STAT Research, Incorporated

    Dayton, Ohio, 45417

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Altoona Center for Clinical Research, P.C.

    Duncansville, Pennsylvania, 16635

  • TriWest Research Associates, LLC

    El Cajon, California, 92020-4124

  • Arizona Arthritis and Rheumatology Research, PLLC

    Glendale, Arizona, 85304

  • Arthritis Education and Treatment Center

    Grand Rapids, Michigan, 49503

  • Medication Management, LLC

    Greensboro, North Carolina, 27408

  • Mountain View Clinical Research

    Greer, South Carolina, 29651

  • Accurate Clinical Management LLC

    Houston, Texas, 77004

  • Pioneer Research Solutions, Inc.

    Houston, Texas, 77008

  • Accurate Clinical Research, Incorporated

    Houston, Texas, 77034

  • Rheumatology Clinic Of Houston, P.A.

    Houston, Texas, 77070

  • Accurate Clinical Research, Incorporated

    Houston, Texas, 77084

  • Houston Rheumatology Consultants, PLLC

    Houston, Texas, 77089

  • Institute of Arthritis Research

    Idaho Falls, Idaho, 83404

  • Goldpoint Clinical Research, LLC

    Indianapolis, Indiana, 46260

  • Science and Research Institute, Inc.

    Jupiter, Florida, 33458

  • Glacier View Research Institute

    Kalispell, Montana, 59901

  • Advanced Medical Research, LLC

    La Palma, California, 90623

  • Accurate Clinical Research, Inc.

    Lincoln, Nebraska, 68516

  • ProHealth Partners

    Long Beach, California, 90808

  • Arthritis &amp;amp; Osteoporosis Associates LLP

    Lubbock, Texas, 79424

  • Anna Imperato, MD PLLC

    Manhasset, New York, 11030

  • Arizona Arthritis and Rheumatology Research, PLLC

    Mesa, Arizona, 85202

  • San Marcus Research Clinic, Inc.

    Miami, Florida, 33015

  • L&amp;amp;C Professional Medical Research Institute

    Miami, Florida, 33144

  • The Arthritis &amp;amp; Diabetes Clinic, Incorporated

    Monroe, Louisiana, 71203

  • Center for Inflammatory Disease

    Nashville, Tennessee, 37203-2032

  • Accurate Clinical Research, Incorporated

    Nassau Bay, Texas, 77058

  • Family Clinical Trials, Incorporated

    Pembroke Pines, Florida, 33026

  • Clinical Research Source, Inc.

    Perrysburg, Ohio, 43551

  • Arizona Arthritis and Rheumatology Research, PLLC

    Phoenix, Arizona, 85032-9384

  • Arizona Arthritis and Rheumatology Research, PLLC

    Phoenix, Arizona, 85037

  • PMG Research of Salisbury, LLC

    Salisbury, North Carolina, 28144

  • Heartland Research Associates, LLC

    San Antonio, Texas, 78229

  • The Permanente Medical Group

    Santa Clara, California, 95051

  • Physician Research Collaboration

    South Miami, Florida, 33143

  • Arthritis Northwest, PLLC

    Spokane, Washington, 99204

  • West Broward Rheumatology Associates, Incorporated

    Tamarac, Florida, 33321

  • Clinical Research of West Florida, Inc.

    Tampa, Florida, 33603

  • McIlwain Medical Group, PA

    Tampa, Florida, 33613

  • North MS Medical Clinics, Incorporated

    Tupelo, Mississippi, 38801

  • Inland Rheumatology Clinical Trials, Inc.

    Upland, California, 91786

  • Lovelace Scientific Resources, Incorporated

    Venice, Florida, 34292

  • Medvin Clinical Research

    Whittier, California, 90606

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67207

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27157

  • Clinical Pharmacology Study Group

    Worcester, Massachusetts, 01605

Other trials in United States

Bulgaria12 sites

  • MHAT &quot;Trimontium&quot;, OOD, Plovdiv

    Plovdiv, 4000

  • MHAT &quot;Eurohospital&quot; - Plovdiv, OOD

    Plovdiv, 4002

  • MHAT - Kaspela, EOOD

    Plovdiv, 4002

  • Medical Center &quot;Teodora&quot;, EOOD, Ruse

    Rousse, 7000

  • MHAT,Fourth Dept. of Therapeutics & Cardiology, Ruse

    Rousse, 7002

  • MHAT Shumen AD, Shumen

    Shumen, 9700

  • MHAT Lyulin

    Sofia, 1336

  • DCC 17 - Sofia EOOD

    Sofia, 1504

  • MMA HAT Sofia, Bulgaria

    Sofia, 1606

  • UMHAT Sv. Ivan Rilski EAD

    Sofia, 1612

  • DCC 'Chaika', EOOD, Varna

    Varna, 9000

  • MDHAT 'Dr. Stefan Cherkezov', AD

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Poland12 sites

  • Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk

    Bialystok, 15-099

  • Szpital Uniwersytecki nr 2 im.dr J. Biziela

    Bydgoszcz, 85-168

  • Wojewodzki Szpital Zespolony w Elblagu

    Elblag, 82-300

  • Medica Pro Familia Spolka Akcyjna, Oddzial w Gdyni

    Gdynia, 81-338

  • MCBK Iwona Czajkowska Anna Podrazka- Szczepaniak S.C.

    Grodzisk Mazowiecki, 05-825

  • Medical Centre Pratia Katowice I

    Katowice, 40-954

  • Medical Centre Pratia Krakow

    Krakow, 30-002

  • Specialist Center ALL-MED, Krakow

    Krakow, 31-023

  • Niepubliczny ZOZ, &quot;Nasz Lekarz&quot;, Lekarzy Rodzinnych z

    Torun, 87-100

  • Medical Centre Pratia Warszawa

    Warsaw, 01-868

  • Reumatika, Rheumatology Center, non-public outpatient clinic

    Warsaw, 02-653

  • Wojewodzki Szpital Specjalistyczny we Wroclawiu

    Wroclaw, 52-224

Other trials in Poland

Ukraine10 sites

  • Ivano-Frankivsk Nat. Medical University, Dept. Endocrinology

    Ivano-Frankivsk, 76018

  • L.T. Malaya Institute of Therapy AMS of Ukraine

    Kharkiv, 61039

  • CI of Healthcare Kharkiv CCH #8, Kharkiv

    Kharkiv, 61176

  • SI NSC M.D. Strazhesko Institute Cardiology of NAMSU, Kyiv

    Kyiv, 03680

  • SI D.F.Chebotariov Institute of Gerontology of NAMSU, Kyiv

    Kyiv, 04114

  • Oleksandrivska Clinical Hospital

    Kyiv, 1601

  • M.V. Sklifosovskyi Poltava RCH, Poltava

    Poltava, 36011

  • M.I. Pyrogov VRCH, Vinnytsia

    Vinnytsia, 21018

  • MCIC MC LLC Health Clinic, Vinnytsia

    Vinnytsia, 21029

  • Zaporizhzhia Regional Clinical Hospital, Zaporizhzhia

    Zaporizhzhya, 69600

Other trials in Ukraine

Russia8 sites

  • Kemerovo SMA b/o War Veterans Regional Clinical Hospital

    Kemerovo, 650000

  • Practicheskaya Meditsina Ltd

    Moscow, 115404

  • Republic Kareliya Republican Hosp. named after V.A. Baranov

    Petrozavodsk, 185019

  • Samara Regional Clinical Hospital n.a MI Kalinin, Samara

    Samara, 443095

  • Reg. Hospital for war veterans

    Saratov, 410002

  • Stavropol State Medical Academy

    Stavropol, 355017

  • Emergency Clinical Hospital n. a. N. V. Soloviev, Yaroslavl

    Yaroslavl, 150003

  • SBHI of Yaroslavl Area &quot;Clinical Hospital #3&quot;

    Yaroslavl, 150051

Other trials in Russia

Chile6 sites

  • Corporacion de Beneficencia Osorno

    Osorno, 5290000

  • Quantum Research Santiago, Puerto Varas

    Puerto Varas, 5550170

  • BIOMEDICA, Santiago

    Santiago, 7500710

  • Centro de Estudios Reumatológicos

    Santiago, 7501126

  • Centro Medico Prosalud

    Santiago, 7510047

  • CINVEC - Centro de Investigacion Clinica V Reg.,Vina del Mar

    Viña del Mar, 2570017

Other trials in Chile

Spain5 sites

  • Hospital A Coruña

    A Coruña, 15006

  • Hospital Universitario de Cruces

    Barakaldo, 48903

  • Fundación Jiménez Díaz

    Madrid, 28040

  • Hosp. Nuestra Señora de la Esperanza, Santiago de Compostela

    Santiago de Compostela, 15705

  • Hospital Clínico de Santiago

    Santiago de Compostela, 15706

Other trials in Spain

Germany4 sites

  • Rheumazentrum Prof. Dr. G. Neeck, Bad Doberan

    Bad Doberan, 18209

  • ACURA Kliniken Rheinland-Pfalz AG, Bad Kreuznach

    Bad Kreuznach, 55543

  • Kerckhoff-Klinik, Bad Nauheim

    Bad Nauheim, 61231

  • SMO.MD GmbH, Magdeburg

    Magdeburg, 39112

Other trials in Germany

Serbia4 sites

  • Institute of Rheumatology, Belgrade

    Belgrade, 11000

  • Institute for Treatment and Rehabilitation, Niska Banja

    Niška Banja, 18205

  • Clinical Center of Vojvodina

    Novi Sad, 21 000

  • General Hospital &quot;Dr Laza K. Lazarevic&quot; Sabac, Sabac

    Šabac, 15000

Other trials in Serbia

South Korea4 sites

  • Daegu Catholic University Medical Center

    Daegu, 705-718

  • Chungnam National University Hospital

    Daejeon, 301-721

  • Seoul National University Hospital

    Seoul, 110744

  • Konkuk University Medical Center

    Seoul, 143-729

Other trials in South Korea

Thailand3 sites

  • Siriraj Hospital

    Bangkoknoi, 10700

  • Songklanagarind Hospital

    Hat Yai, 90110

  • Pramongkutklao Hospital

    Rajathevee, 10400

Other trials in Thailand

Estonia2 sites

  • Pärnu Hospital, Pärnu

    Pärnu, 80010

  • Medita Kliinik OÜ, Tartu

    Tartu, 50107

Other trials in Estonia

Hungary2 sites

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klin. Kozpont

    Szeged, 6725

  • Csolnoky Ferenc Korhaz, Veszprem

    Veszprém, 8200

Other trials in Hungary

Malaysia2 sites

  • Hospital Tengku Ampuan Afzan

    Kuantan, 25100

  • Hospital Pulau Pinang

    Pulau Pinang, 10990

Other trials in Malaysia

New Zealand1 site

  • CGM Research Trust, The Princess Margaret Hospital Cantebury

    Cantebury, 8022

Other trials in New Zealand

About this study

Official title: Efficacy, Safety and Immunogenicity of BI 695501 Versus Adalimumab in Patients With Active Rheumatoid Arthritis: a Randomized, Double-blind,Parallel Arm, Multiple Dose, Active Comparator Trial

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.

Being tested
BI 695501, US-licensed Humira®
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BI 695501Drug

    BI 695501, every two weeks for 48 weeks (25 injections in total)

  • US-licensed Humira®Drug

    one injection every 2 weeks for 48 weeks (25 injections in total)

Study groups in NCT02137226
Study groupRoleWhat they receive
BI 695501Experimentalone injection every 2 weeks for 48 weeks (25 injections in total)
Receives: Drug: BI 695501
US-licensed Humira®Active comparatorone injection every 2 weeks for 48 weeks (25 injections in total)
Receives: Drug: US-licensed Humira®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Proportion of Patients Meeting the American College of Rheumatology 20% (ACR20) Response Criteria at 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.

    Measured: Week 12

  2. The Proportion of Patients Meeting ACR20 Response Criteria at 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]).

    Measured: Week 24

Secondary outcomes (2)

  1. Change From Baseline in Disease Activity Score 28 (DAS28) (Erythrocyte Sedimentation Rate [ESR]) at 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.

    Measured: Baseline, Week 12 and Week 24

  2. The Percentage of Patients With Investigator-assessed Drug-related Adverse Events (AEs) During the Treatment Phase

    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).

    Measured: From the first drug administration until 10 weeks after the last drug administration, up to 58 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2014 (estimated)
  2. Study start26 Jan 2015
  3. Primary completion3 Mar 2016
  4. Study completion18 Oct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
645 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02137226
Sponsor's protocol ID
1297.2
Other IDs
2012-002945-40
Status last verified
Dec 2017
First submitted
12 May 2014
Last updated
19 Jan 2018

Publications

  • 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.

    PubMed 39551590

  • 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.

    PubMed 39120847

  • 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.

    PubMed 36065786

  • 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.

    PubMed 33263165

  • 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.

    PubMed 32363771

  • 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.

    PubMed 29514803

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BI 695501 and US-licensed Humira® in people with Arthritis, Rheumatoid, run by Boehringer Ingelheim at 138 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 138 sites in United States, Bulgaria, Poland, Ukraine, Russia and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Proportion of Patients Meeting the American College of Rheumatology 20% (ACR20) Response Criteria at Week 12 (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02137226, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2018.

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