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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02760407
Other study ID # CL04041023
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 6, 2016
Est. completion date November 5, 2019

Study information

Verified date September 2023
Source R-Pharm
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study was to determine how effective and safe the study drug Olokizumab was in patients with Rheumatoid Arthritis (RA) who had been already receiving but not fully responding to treatment with methotrexate (MTX). The primary objective of this study was to evaluate the efficacy of OKZ 64 mg administered subcutaneously (SC) once every 2 weeks (q2w) or once every 4 weeks (q4w) relative to placebo in subjects with moderately to severely active RA inadequately controlled by MTX therapy. The secondary objective was to evaluate the efficacy of OKZ relative to adalimumab in subjects with moderately to severely active RA inadequately controlled by MTX therapy.


Description:

The goal of this Phase III study was to assess the efficacy, safety and tolerability of OKZ in subjects with moderately to severely active RA who had responded inadequately to MTX. The primary endpoint of the trial was at Week 12. Olokizumab was expected to reduce the disease activity and improve physical function. The study was expected to provide safety information in a large group of subjects over at least a 24 week period. This study included a 4-week Screening Period, a double-blind Treatment Period from Week 0 to Week 24, and a Safety Follow-Up Period from Week 24 to Week 44. Subjects were assessed for eligibility to enter the study during the 4-week Screening Period. A total of 1575 subjects were planned to be randomly assigned to 1 of 4 treatment groups in a 2:2:2:1 ratio (450, 450, 450, and 225 subjects per group, respectively): 1. Olokizumab 64 mg q4w: SC injection of OKZ 64 mg q4w (alternating with SC injection of placebo q4w to maintain blinding) + MTX 2. Olokizumab 64 mg q2w: SC injection of OKZ 64 mg q2w + MTX 3. Adalimumab 40 mg q2w: SC injection of adalimumab 40 mg q2w + MTX 4. Placebo: SC injection of placebo q2w + MTX Throughout the double-blind Treatment Period, all subjects were required to remain on a stable dose of background MTX with a stable route of administration. Concomitant treatment with folic acid was required for all subjects. The last dose of study treatment (OKZ, adalimumab, or placebo) was at Week 22 in all groups. Following Visit 2 (randomization; Week 0), subjects returned to the study site at least every 2 weeks through Week 24 for response and safety assessments. At Week 14, subjects who had not improved by at least 20% in both swollen and tender joint counts were classified as nonresponders and were administered sulfasalazine and/or hydroxychloroquine as rescue medication in addition to the assigned treatment. After completion of the 24-week double-blind Treatment Period, subjects either rolled over into the long-term open-label extension (OLE) study or entered the Safety Follow-Up Period. During the Safety Follow-Up Period, subjects returned for visits +4, +8, and +22 weeks after the last dose of study treatment. Subjects who had discontinued randomized treatment prematurely were required to come for the End of Treatment (EoT) Visit 2 weeks after the last study treatment administration and then continue with the scheduled study visits. Adverse events (AEs) were assessed throughout the study (starting when the subject signed the informed consent form) and evaluated using the Common Terminology Criteria for Adverse Events Version 4.0. There was ongoing monitoring of safety events, including laboratory findings, by the Sponsor or the Sponsor's designee. In addition, safety was assessed throughout the study by an independent Data Safety Monitoring Board and potential major adverse cardiac events were evaluated by an independent Cardiovascular Adjudication Committee. The study was conducted at 208 sites across 18 countries globally (in US, European Union (EU),United Kingdom (UK), Russian Federation, Asia, Latin America).


Recruitment information / eligibility

Status Completed
Enrollment 1648
Est. completion date November 5, 2019
Est. primary completion date August 2, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subjects willing and able to sign informed consent - Subjects must have a diagnosis of adult onset RA classified by ACR/EULAR 2010 revised classification criteria for RA for at least 12 weeks prior to Screening. (If the subject was diagnosed according to ACR 1987 criteria previously, the Investigator may classify the subject per ACR 2010 retrospectively, using available source data) - Inadequate response to treatment with oral, SC, or intramuscular MTX (defined as a subject with at least 12 weeks of exposure prior to Screening and with either absence of any documented clinically significant response, or documented initial clinical response with subsequent loss of that response or partial response) for at least 12 weeks prior to Screening at a dose of 15 to 25 mg/week (or =10 mg/week if intolerant to higher doses). The dose and route of administering MTX had to have been stable for at least 6 weeks prior to Screening. A lower dose of MTX (=7.5 mg/week) was permitted for subjects enrolled in the Republic of Korea, consistent with local clinical practice. - Subjects must be willing to take folic acid or equivalent throughout the study. - Subjects must have moderately to severely active RA disease as defined by all of the following: - =6 tender joints (68 joint count) at Screening and baseline; and - =6 swollen joints (66 joint count) at Screening and baseline; and - CRP above the normal range (ULN) at Screening based on the central laboratory results. Exclusion Criteria: - Diagnosis of any other inflammatory arthritis or systemic rheumatic disease (eg, gout, psoriatic or reactive arthritis, Crohn's disease, Lyme disease, juvenile idiopathic arthritis, or systemic lupus erythematosus). However, subjects could have secondary Sjogren's syndrome or hypothyroidism. - Subjects who are Steinbrocker class IV functional capacity (incapacitated, largely or wholly bed-ridden or confined to a wheelchair, with little or no self-care) - Prior exposure to any licensed or investigational compound directly or indirectly targeting IL 6 or IL 6R (including tofacitinib or other Janus kinases and spleen tyrosine kinase [SYK] inhibitors) - Prior treatment with cell depleting therapies including anti CD20 or investigational agents (e.g., CAMPATH, anti CD4, anti CD5, anti CD3, and anti CD19) - Prior use of bDMARDs - Use of parenteral and/or intra-articular glucocorticoids within 4 weeks prior to baseline - Use of oral glucocorticoids greater than 10 mg/day prednisone (or equivalent) or change in dosage within 2 weeks prior to baseline - Prior documented history of no response to hydroxychloroquine and sulfasalazine - Prior use of cDMARDs (other than MTX) within the following windows prior to baseline (cDMARDs should not be discontinued to facilitate a subject's participation in the study, but should instead have been previously discontinued as part of a subject's medical management of RA): 1. 4 weeks for sulfasalazine, azathioprine, cyclosporine, hydroxychloroquine, chloroquine, gold, penicillamine, minocycline, or doxycycline 2. 12 weeks for leflunomide unless the subject has completed the following elimination procedure at least 4 weeks prior to baseline: Cholestyramine at a dosage of 8 grams 3 times daily for at least 24 hours, or activated charcoal at a dosage of 50 grams 4 times daily for at least 24 hours 3. 24 weeks for cyclophosphamide - Vaccination with live vaccines in the 6 weeks prior to baseline or planned vaccination with live vaccines during the study - Participation in any other investigational drug study within 30 days or 5 times the terminal half-life of the investigational drug, whichever is longer, prior to baseline - Other treatments for RA (e.g., Prosorba Device/Column) within 6 months prior to baseline - Use of intra-articular hyaluronic acid injections within 4 weeks prior to baseline - Use of non-steroidal anti-inflammatory drugs (NSAIDs) on unstable dose or switching of NSAIDs within 2 weeks prior to baseline - Previous participation in this study (randomized) or another study of OKZ - Subjects with concurrent acute or chronic viral hepatitis B or C infection as detected by blood tests at Screening(e.g., positive for hepatitis B surface antigen [HBsAg], total hepatitis B core antibody [anti-HBc], or hepatitis C virus antibody [HCV Ab]). Subjects who are are positive for hepatitis B surface antibodies (anti-HBs), but negative for HBsAg and anti-HBc, will be eligible - Subjects with human immunodeficiency virus (HIV) infection - Subjects with: 1. Suspected or confirmed current active TB disease or a history of active TB disease 2. Close contact (i.e., sharing the same household or other enclosed environment, such as a social gathering place, workplace, or facility, for extended periods during the day) with an individual with active TB within 1.5 years prior to Screening - Concurrent malignancy or a history of malignancy within the last 5 years (with the exception of successfully treated carcinoma of the cervix in situ and successfully treated basal cell carcinoma and squamous cell carcinoma not less than 1 year prior to Screening [and no more than 3 excised skin cancers within the last 5 years prior to Screening]) - Subjects with any infection requiring oral antibiotic or antiviral therapy in the 2 weeks prior to Screening or at baseline, injectable anti-infective therapy in the last 4 weeks prior to baseline, or serious or recurrent infection with history of hospitalization in the 6 months prior to baseline - Subjects with evidence of disseminated herpes zoster infection, zoster encephalitis, meningitis, or other non-self-limited herpes zoster infections in the 6 months prior to baseline - Subjects with planned surgery during the study or surgery = 4 weeks prior to Screening and from which the subject has not fully recovered, as judged by the Investigator - Subjects with diverticulitis or other symptomatic GI conditions that might predispose the subject to perforations, including subjects with history of such predisposing conditions (e.g., diverticulitis, GI perforation, or ulcerative colitis) - Pre-existing central nervous system demyelinating disorders (e.g., multiple sclerosis and optic neuritis) - History of chronic alcohol or drug abuse as judged by the Investigator - Female subjects who are pregnant, currently lactating, have lactated within the last 12 weeks, or who are planning to become pregnant during the study or within 6 months of last dose of study treatment - Female subjects of childbearing potential (unless permanent cessation of menstrual periods, determined retrospectively after a woman has experienced 12 months of natural amenorrhea as defined by the amenorrhea with underlying status (e.g., correlative age) or 6 months of natural amenorrhea with documented serum follicle-stimulating hormone levels >40 mIU/mL and estradiol <20 pg/mL) who are not willing to use a highly effective method of contraception during the study and for at least 6 months after the last administration of study treatment OR Male subjects with partners of childbearing potential not willing to use a highly effective method of contraception during the study and for at least 3 months after the last administration of study treatment. - Subjects with a known hypersensitivity to any component of the OKZ drug product, adalimumab, or placebo - Subjects with a known hypersensitivity or contraindication to any component of the rescue medication - History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Olokizumab 64mg q4w
160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial
Olokizumab 64mg q2w
160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial
Adalimumab 40mg q2w
0.4 or 0.8 mL prefilled, single-dose syringe
Placebo q2w
sodium chloride 0.9% solution supplied in either a 10 mL vial or ampoule, depending on market availability. Each placebo will be packed into a cardboard carton to contain 1 vial or ampoule

Locations

Country Name City State
Argentina Institute Investigaciones Clinc Quilme Buenos Aires
Argentina APRILLUS Asistencia e Investigacion Ciudad Autonoma Buenos aires
Argentina Atencion Integral en Reumatologia (AIR) Ciudad Autonoma Buenos Aires
Argentina Instituto Centenario Ciudad Autonoma Buenos Aires
Argentina Organizacion Medica de Investigacion (OMI) Ciudad Autonoma Buenos Aires
Argentina Hospital Privado Centro Medico de Cordoba S.A Cordoba
Argentina Instituto DAMIC Fundacion Rusculleda Cordoba
Argentina Centro de Investigaciones Medicas Mar del Plata Mar del Plata Buenos Aires
Argentina Instituto de Investigaciones Clinicas-Mar del Plata Mar del Plata Buenos Aires
Argentina Instituto Medico CER Quilmes Buenos Aires
Argentina Clinica de Higado y Aparato Digestivo Rosario Santa Fe
Argentina CER San Juan Centro Polivalente de Asistencia e Inv. Clinica San Juan
Argentina Centro de Investigaciones Reumatológicas San Miguel de Tucuman Tucuman
Argentina Centro Medico Privado de Reumatologia San Miguel de Tucuman Tucuman
Argentina Sanatorio San Martin Venado Tuerto Santa Fe
Brazil CETI - Centro de Estudos em Terapias Inovadoras Ltda. Curitiba Paraná
Brazil HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará Fortaleza Ceará
Brazil CIP - Centro Internacional de Pesquisa Goiânia Goiás
Brazil CMiP - Centro Mineiro de Pesquisa Juiz de Fora Minas Gerais
Brazil Hospital Bruno Born Lajeado Rio Grande Do Sul
Brazil Clinilive - Clínica do Idoso e Pesquisa Clínica Maringá Paraná
Brazil LMK Serviços Médicos S/S Ltda Porto Alegre Rio Grande Do Sul
Brazil CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda. Rio de Janeiro
Brazil Clínica de Neoplasias Litoral Santa Catarina
Brazil Faculdade de Medicina do ABC Santo André Sao Paulo
Brazil Centro Multidisciplinar de Estudos Clínicos - CEMEC Sao Bernardo Do Campo Sao Paulo
Brazil CPCLIN - Centro de Pesquisas Clínicas Ltda. São Paulo
Brazil Hospital Abreu Sodré - AACD São Paulo
Brazil CEDOES - Diagnóstico e Pesquisa Vitória Espírito Santo
Bulgaria UMHAT Pulmed OOD Plovdiv
Bulgaria MHAT - Ruse, AD Ruse
Bulgaria Medizinski Zentar-1-Sevlievo EOOD Sevlievo
Bulgaria MHAT - Shumen, AD Shumen
Bulgaria MC Synexus - Sofia EOOD Sofia
Bulgaria Medical Center "Excelsior", OOD Sofia
Bulgaria MHAT "Lyulin", EAD Sofia
Bulgaria NMTH "Tsar Boris III" Sofia
Bulgaria UMHAT Sv. Ivan Rilski EAD Sofia
Bulgaria MDHAT 'Dr. Stefan Cherkezov', AD Veliko Tarnovo
Colombia Centro de Investigacion Medico Barranquilla Atlantico
Colombia Fundacion Instituto de Reumatologia Fernando Chalem Bogota
Colombia Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM Bogotá
Colombia Medicity S.A.S. Bucaramanga
Colombia Clinica de Artritis Temprana S.A. Cali
Czechia CCR Brno s.r.o Brno
Czechia Revmatologie s.r.o. Brno
Czechia Nemocnice Jihlava p.o Jihlava
Czechia MUDr. Gabriela Simkova ordinace lekare specialisty interna revmatologie Kladno
Czechia CTCenter MaVe s.r.o. Olomouc
Czechia Vesalion s.r.o. Ostrava
Czechia Artroscan s.r.o. Ostrava - Trebovice
Czechia ARTHROHELP s.r.o. Pardubice
Czechia CCR Pardubice Pardubice
Czechia Affidea Praha, s.r.o. Praha
Czechia Revmatologicky ustav Praha
Czechia Clintrial, s.r.o. Praha 10
Czechia CCR Prague s.r.o. Praha 3
Czechia MUDR. Zuzana Urbanova Revmatologie Praha 4
Czechia MUDR. Zuzana URBANOVA Revmatologie Praha 4 Nusle
Czechia Fakultni nemocnice v Motole Praha 5
Czechia MEDICAL PLUS s.r.o. Uherske Hradiste
Czechia PV Medical Services s.r.o. Zlin
Estonia East Tallinn Central Hospital Tallinn
Estonia Medita Kliinik OÜ Tartu
Germany Rheumapraxis Dr. med. Reiner Kurthen Aachen Westfalen
Germany Kerckhoff-Klinik gGmbH Bad Nauheim Hessen
Germany Klinische Forschung Berlin-Mitte GmbH Berlin
Germany HRF Hamburger Rheuma Forschungszentrum Hamburg
Germany SMO.MD GmbH Magdeburg Sachsen Anhalt
Germany Studienambulanz Dr. Wassenberg Northeim
Hungary Principal SMO Kft. Baja
Hungary DRC Gyogyszervizsgalo Kozpont Kft. Balatonfured
Hungary Clinexpert Egeszsegugyi Szolg. es Ker. Kft. Budapest
Hungary Obudai Egeszsegugyi Centrum Budapest
Hungary Kiskunhalasi Semmelweis Korhaz Kiskunhalas
Hungary DRC Szekesfehervar Szekesfehervar
Hungary MAV Korhaz és Rendelointezet Szolnok
Hungary Vital Medical Center Veszprem
Korea, Republic of Eulji University Hospital Daejeon
Korea, Republic of Chonnam National University Hospital Gwangju
Korea, Republic of CHA Bundang Medical Center Gyeonggi-do
Korea, Republic of Jeju National University Hospital Jeju
Korea, Republic of Severance Hospital, Yonsei University Seoul
Korea, Republic of The Catholic University of Korea, Seoul St. Mary's Hospital Seoul
Latvia Dr.Saulite-Kandevica Private Practice Liepaja
Lithuania Alyt?us Regional S. Kudirkos Hospital, Public Institution Alytus
Lithuania Republican Kaunas Hospital, Public Institution Kaunas
Lithuania Klaipeda University Hospital, Public Institution Klaipeda
Lithuania Siauliai Republican Hospital, Public Institution Siauliai
Lithuania Center Outpatient Clinic, Public Institution Vilnius
Lithuania Vilnius University Hospital Santariskiu Clinic, Public Institution Vilnius
Mexico Investigacion y Biomedicina de Chihuahua, S.C. Chihuahua
Mexico Centro de Estudios de Investigacion Basica y Clinica SC Guadalajara Jalisco
Mexico Clinica de Investigacion en Reumatologia y Obesidad S.C. Guadalajara Jalisco
Mexico Centro de Investigacion Clínica GRAMEL S.C Mexico DisMexicotrito Federal
Mexico Clinicos Asociados BOCM S.C. Mexico Distrito Federal
Mexico Clinstile, S.A. de C.V. Mexico Distrito Federal
Mexico Cryptex Investigacion Clinica S.C Mexico Distrito Federal
Mexico Clinical Research Institute S.C. Mexico City Estado De Mexico
Mexico Accelerium S. de R.L. de C.V. Monterrey Nuevo León
Mexico Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez Monterrey Nuevo León
Mexico Centro de Alta Especialidad en Reumatología e Investigación del Potosí, S.C. San Luis Potosi
Poland NZOZ ZDROWIE Osteo-Medic Bialystok
Poland Szpital Uniwersytecki nr 2 im.dr J. Biziela Bydgoszcz
Poland MCBK Iwona Czajkowska Anna PodrazkaSzczepaniak S.C. Grodzisk Mazowiecki
Poland Polimedica Centrum Badan, Profilaktyki I Leczenia Kielce
Poland Centrum Medyczne AMED Lodz
Poland ETYKA Osrodek Badan Klinicznych Olsztyn
Poland Szpital Wojewodzki im. Prymasa Kardynala Stefana Wyszynskiego Sieradz
Poland CCBR - Lodz - PL Skierniewice
Poland Clinmed Research Skierniewice
Poland RCMed Sochaczew
Poland KO-MED Centra Kliniczne Staszow Staszow
Poland Samodzielny Publiczny ZOZ Tomaszow Lubelski Tomaszow Lubelski
Poland Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z Torun
Poland McM Polimedica Warszawa
Poland Medycyna Kliniczna Warszawa
Poland Rheuma Medicus Zaklad Opieki Zdrowotnej Warszawa
Poland KO-MED Centra Kliniczne Zamosc Zamosc
Poland Santa Familia Centrum Badan, Profilaktyki i Leczenia Zgierz
Romania Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei" Constanta Constanta
Russian Federation SBEI HPE "Ural State Medical University" of MoH of RF based MBI "Central City Clinical Hospital #6" Ekaterinburg Sverdlovskaya Oblast
Russian Federation State Budgetary Healthcare Institution of Sverdlovsk Region "Sverdlovsk Regional Clinical Hospital #1" Ekaterinburg Sverdlovskaya Oblast
Russian Federation FSBEI HE "FMSMU n.a. I.M. Sechenov of MoH of RF", University Hospital #2, Departament of New Drugs Introduction Moscow Moscovskaya Oblast
Russian Federation Institute n a Nasonova Moscow
Russian Federation State Budgetary Healthcare Institution "City Clinical Hospital # 15 n.a O.M. Filatov" of Moscow Healtheare Department Moscow Moscow Region
Russian Federation SBHI of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a.Semashko" Nizhniy Novgorod Nizhegorodskaya Oblast
Russian Federation SBHI of Republic of Karelia "Republican Hospital named after V.A.Baranov" Petrozavodsk Republic Of Karelia
Russian Federation SPb SBHI "Clinical Rheumatological Hospital #25", Fourth Rheumatology Unit Saint Petersburg Leningradskaya Oblast
Russian Federation Non-govarnmental Healtheare Institution "Regional Clinical Hospital at Smolensk station of OJSC "Russian Railways" Smolensk Smolenskaya Oblast
Russian Federation Hospital n a Kuvatov Ufa Republic Of Bashkortostan
Taiwan Chi Mei Medical Center Tainan
Taiwan Chang Gung Memorial Hospital, Linkou Taoyuan
United Kingdom Basingstoke and North Hampshire Hospital Basingstoke Hampshire
United Kingdom Royal Free Hospital London Greater London
United Kingdom Whipps Cross University Hospital London Greater London
United Kingdom Maidstone Hospital Maidstone Kent
United Kingdom Torbay Hospital Torquay Devon
United Kingdom Arrowe Park Hospital Wirral Merseyside
United States Amarillo Center for Clinical Research Amarillo Texas
United States Austin Regional Clinic, P.A. Austin Texas
United States Accurate Clinical Management LLC Baytown Texas
United States Pioneer Research Solutions, Inc. Beaumont Texas
United States RASF - Clinical Research Center Boca Raton Florida
United States Graves Gilbert Clinic Bowling Green Kentucky
United States New England Research Associates LLC Bridgeport Connecticut
United States NYU Langone ambulatory care Brooklyn New York
United States Medvin Clinical Research Covina California
United States STAT Research, Inc. Dayton Ohio
United States Denver Arthritis Clinic Denver Colorado
United States Altoona Center for Clinical Research, P.C. Duncansville Pennsylvania
United States TriWest Research Associates El Cajon California
United States Arthritis & Osteoporosis Associates, PA Freehold New Jersey
United States Arthritis Center of North Georgia Gainesville Georgia
United States AA MRC LLC Ahmed Arif Medical Research Center Grand Blanc Michigan
United States Precision Comprehensive Clinical Research Solutions Grapevine Texas
United States Medication Management, LLC Greensboro North Carolina
United States Klein and Associates, M.D., P.A. Hagerstown Maryland
United States MD Med Corp. Hemet California
United States Reliable Clinical Research, LLC Hialeah Florida
United States Accurate Clinical Mangemnt LLC Houston Texas
United States Accurate Clinical Research Houston Texas
United States Accurate Clinical Research, Inc. Houston Texas
United States Advanced Rheumatology of Houston Houston Texas
United States Rheumatology Clinic of Houston, P.A. Houston Texas
United States Institute of Arthritis Research Idaho Falls Idaho
United States Glacier View Research Instutute-Rheumatology Kalispell Montana
United States University of Kansas Hospital Kansas City Kansas
United States Accurate Clinical Research, Inc. League City Texas
United States Cape Fear Arthritis Care Leland North Carolina
United States Physician Resrch Collaboration Lincoln Nebraska
United States Valerius Medical Group Los Alamitos California
United States Endocrinology, Internal Medicine Lubbock Texas
United States Marietta Rheumatology Associates, PC Marietta Georgia
United States Arizona Arthritis & Rheumatology Associates, P.C. Mesa Arizona
United States Medical Research Center of Miami Miami Florida
United States Pharmax Research Clinic, Inc. Miami Florida
United States Trinity Medical Group Minot North Dakota
United States The Arthritis & Diabetes Clinic, Inc. Monroe Louisiana
United States Javed Rheumatology Associates Newark Delaware
United States Health Research of Oklahoma, PLLC Oklahoma City Oklahoma
United States Lynn Health Science Institute Oklahoma City Oklahoma
United States Omega Research Consultants Orlando Florida
United States Arthritis Research Palm Harbor Florida
United States Family Clinical Trials, LLC. Pembroke Pines Florida
United States Arizona Arthritis & Rheumatology Associates, P.C. Phoenix Arizona
United States Dr. Alex De Jesus Rheumatology, P.A. San Antonio Texas
United States Rheumatology Center of San Diego San Diego California
United States East Bay Rheumatology Medical Group, Inc. San Leandro California
United States Pacific Arthritis Center Medical Grpoup Santa Maria California
United States Arthritis Northwest, PLLC Spokane Washington
United States Springfield Clinic, LLP Springfield Illinois
United States Low Country Rheumatology, PA Summerville South Carolina
United States Arizona Arthritis & Rheumatology Research, PLLC Sun City Arizona
United States AdventHealth Medical Group, PA Tampa Florida
United States Clinical Research Source, Inc. Toledo Ohio
United States DM Clinical Research Tomball Texas
United States North MS Medical Clinics, Inc. Tupelo Mississippi
United States Inland Rheumatology Clinical Trials Upland California
United States Lovelace Scientific Resources, Inc. Venice Florida
United States Center for Rheumatology Research West Hills California
United States The Center for Rheumatology and Bone Research Wheaton Maryland
United States Medvin Clinical Research Whittier California

Sponsors (3)

Lead Sponsor Collaborator
R-Pharm International, LLC OCT Clinical Trials, Quintiles, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Bulgaria,  Colombia,  Czechia,  Estonia,  Germany,  Hungary,  Korea, Republic of,  Latvia,  Lithuania,  Mexico,  Poland,  Romania,  Russian Federation,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Subjects Achieving American College of Rheumatology 20% (ACR20) Response The difference between OKZ and placebo in the percentage of subjects achieving an ACR20 response and remaining on randomized treatment and in the study at Week 12. (where a responder was defined as any subject satisfying ACR20 criteria and remaining on randomized treatment and in the study at Week 12) This endpoint served to demonstrate that the efficacy of OKZ was superior to placebo. American College of Rheumatology 20 % response is a composite defined as a = 20% improvement from baseline in the swollen joint counts assessed in 66 joints and in the tender joint count assessed in 68 joints; and a =20% improvement from baseline in at least 3 of the 5 remaining core set measures:
Patient Global Assessment of Disease Activity (VAS)
Patient Assessment of Pain (VAS)
HAQ-DI
Physician Global Assessment (VAS)
Level of acute phase reactant (CRP)
at Week 12
Secondary Percentage of Subjects Achieving ACR20 Response: Olokizumab Comparison With Adalimumab A responder was defined as any subject satisfying ACR20 criteria and remaining on randomized treatment and in the study at Week 12.This endpoint served to demonstrate that the efficacy of OKZ was non-inferior to adalimumab, provided that superiority of adalimumab to placebo (assay sensitivity) was demonstrated concurrently based on the same endpoint.
American College of Rheumatology 20 % response is a composite defined as a = 20% improvement from baseline in the swollen joint counts assessed in 66 joints and in the tender joint count assessed in 68 joints; and a =20% improvement from baseline in at least 3 of the 5 remaining core set measures:
Patient Global Assessment of Disease Activity (VAS)
Patient Assessment of Pain (VAS)
HAQ-DI
Physician Global Assessment (VAS)
Level of acute phase reactant (CRP)
at Week 12
Secondary Percentage of Subjects Achieving Low Disease Activity Defined as Disease Activity Score 28-joint count (DAS28) C-reactive protein (CRP) <3.2, and remaining on randomized treatment and in the study at Week 12 at Week 12
Secondary Percentage of Subjects Achieving Low Disease Activity: Olokizumab Comparison With Adalimumab Percentage of subjects achieving low disease activity, defined as DAS28 (CRP) <3.2, and remaining on randomized treatment and in the study at Week 12; served to demonstrate that the efficacy of OKZ was noninferior to adalimumab, provided that superiority of adalimumab to placebo (assay sensitivity) was demonstrated concurrently based on the same endpoint at Week 12
Secondary Improvement of Physical Ability From Baseline to Week 12, as Measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) Change of physical ability from baseline (the last available assessment prior to the first dose of the study treatment) to week 12, as measured by HAQ-DI. The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions.The domains are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities, and each domain consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3 where 0 = without any difficulty (the best outcome), 1 = with some difficulty, 2 = much difficulty, and 3 = unable to do (the worst outcome). Each category is given a score by taking the maximum score of each question. A decrease from baseline indicates improvement for HAQ-DI.The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered. The HAQ-DI total score ranges from 0 (the best outcome) to 3 (the worst outcome). Baseline to Week 12
Secondary Percentage of Subjects Achieving American College of Rheumatology 50% (ACR50) Response Difference between OKZ and placebo in the percentage of subjects achieving an ACR50 response and remaining on randomized treatment and in the study at Week 24
American College of Rheumatology 50% Response is a composite defined as =50%, improvement from baseline in the swollen joint counts assessed in 66 joints and in the tender joint count assessed in 68 joints; and a =50%, improvement from baseline in at least 3 of the 5 remaining core set measures:
Patient Global Assessment of Disease Activity (VAS)
Patient Assessment of Pain (VAS)
HAQ-DI
Physician Global Assessment (VAS)
Level of acute phase reactant (CRP)
at Week 24
Secondary Percentage of Subjects With Clinical Disease Activity Index (CDAI) = 2.8 (Remission) Difference between OKZ and placebo in the percentage of subjects with Clinical Disease Activity Index (CDAI) =2.8 (remission) and remaining on randomized treatment and in the study at Week 24 at Week 24
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