Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis (CREDO 4)

September 28, 2023 updated by: R-Pharm International, LLC

A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis

The primary objective of this study was to evaluate the long-term safety and tolerability of olokizumab (OKZ) 64 mg administered subcutaneously (SC) once every 2 weeks (q2w) or once every 4 weeks (q4w) in subjects with moderately to severely active rheumatoid arthritis (RA) who previously had completed 24 weeks of double-blind treatment in Study CREDO 1, 2 or 3 (core studies). The long-term efficacy, immunogenicity, the physical function and quality of life of subjects received long-term treatment with OKZ were assessed as well.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This OLE study (CL04041024) included an 82-week open-label Treatment Period that followed completion of one of the core studies (Study CREDO 1, 2 or 3). The OLE open-label Treatment Period lasted from Visit 1 (OLE Baseline/Week 24) to Visit 10 (End of Treatment (EoT)/Week 106), followed by a 20-week Safety Follow-Up Period from Week 106 to Week 126. The first visit of the OLE study was the same visit as the Week 24 visit in the core studies.

Subjects were randomized to 1 of the 2 OKZ treatment groups in the OLE study based on the treatment received in the core studies. Subjects who had received OKZ (q2w or q4w) in the core study in which they had participated (including subjects who received placebo in Study CREDO 3 and were re-randomized to OKZ at Week 16) received the same OKZ treatment regimen in the OLE study. Subjects who had received placebo (Study CREDO 1 and CREDO 2) or adalimumab (Study CREDO 2) in the core study in which they had participated were randomized in a 1:1 ratio to OKZ 64 mg q2w or OKZ 64 mg q4w regimens in the OLE study.

For the first 12 weeks of the OLE, all subjects were required to remain on a stable dose of background methotrexate (MTX) at 15 to 25 mg/week (or≥10 mg/week if there was documented intolerance to higher doses) with a stable route of administration (oral, SC, or intramuscular (IM)). After 12 weeks (Visit 4 [Week 36] of the OLE study), the Investigator might adjust the MTX dosage and route, per local guidelines. Methotrexate might be adjusted only for safety reasons according to Investigator discretion before Visit 4 (Week 36) of the OLE study.

Subjects who had been on rescue disease-modifying anti-rheumatic drugs (DMARDs) during the core studies were asked to continue these medications for the first 12 weeks of the OLE study. The Investigator could adjust these background medications if deemed appropriate after Visit 4 (Week 36) of the OLE study. Background rescue therapy might be adjusted only for safety reasons according to Investigator discretion before Visit 4 (Week 36) of the OLE study.

Throughout the study, concomitant treatment with folic acid ≥ 5 mg per week or equivalent was required for all subjects.

Subjects returned to the study site periodically for safety and response assessments as per the Schedule of Events.

The last dose of open-label study treatment in the OLE study was administered at Week 104 for all subjects. After completion of the 82-week open-label Treatment Period, subjects entered the 20-week Safety Follow-Up Period. During the Safety Follow-Up Period, subjects returned for 3 visits at +4, +8, and +22 weeks after the last dose of study treatment.

Subjects who discontinued the open-label treatment prematurely required to come for the EoT Visit 2 weeks after the last study treatment administration and then return for the 3 Safety Follow-Up Visits +4, +8, and +22 weeks after the last study treatment administration.

Adverse events were assessed throughout the study period and evaluated using the Common Technology Criteria version 4.0 (CTCAE v 4.0).

There were ongoing monitoring of safety events, including laboratory findings by the Sponsor or its designee. In addition, safety parameters were assessed throughout the study by an independent Data Safety Monitoring Board (DSMB).

Study Type

Interventional

Enrollment (Actual)

2106

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, B7600FZN
        • Instituto de Investigaciones Clinicas-Mar del Plata
      • Ciudad Autonoma Buenos Aires, Argentina, C1015ABO
        • Organizacion Medica de Investigacion (OMI)
      • Ciudad Autonoma Buenos Aires, Argentina, C1204AAD
        • Instituto Centenario
      • Ciudad Autonoma Buenos aires, Argentina, C1046AAQ
        • APRILLUS Asistencia E Investigacion
      • Cordoba, Argentina, 5016
        • Hospital Privado Centro Médico de Córdoba
      • Córdoba, Argentina, X5003DCE
        • Instituto DAMIC Fundacion Rusculleda
      • San Juan, Argentina, 5400
        • CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
      • Santa Fe, Argentina, S2000CFJ
        • Clinica de Higado y Aparato Digestivo
      • Tucuman, Argentina, T4000BRD
        • Centro de Investigaciones Reumatológicas
    • Buenos Aires
      • Mar del Plata, Buenos Aires, Argentina, B7600FYK
        • Centro de Investigaciones Medicas Mar del Plata
      • Quilmes, Buenos Aires, Argentina, B1878DVB
        • Instituto Médico Cer
      • Quilmes, Buenos Aires, Argentina, B1878GEG
        • Instituto de Investigaciones Clinicas Quilmes
    • Santa Fe
      • Venado Tuerto, Santa Fe, Argentina, S2600KUE
        • Sanatorio San Martin
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina, T4000AXL
        • Centro Medico Privado de Reumatologia
  • Belarus
    • Minsk Oblast
      • Minsk, Minsk Oblast, Belarus, 220013
        • Minsk City Clinical Hospital #1
    • Vitebsk Oblast
      • Vitebsk, Vitebsk Oblast, Belarus, 210037
        • Vitebsk Clinical Hospital
  • Brazil
      • Rio de Janeiro, Brazil, 20241-180
        • CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda.
      • São Paulo, Brazil, 01228-200
        • CPCLIN - Centro de Pesquisas Clínicas Ltda.
      • São Paulo, Brazil, 04032-060
        • Associação de Assistência à Criança Deficiente - AACD
    • Ceará
      • Fortaleza, Ceará, Brazil, 60430-370
        • HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
    • Espírito Santo
      • Vitória, Espírito Santo, Brazil, 29055-450
        • CEDOES - Diagnóstico e Pesquisa
    • Goiás
      • Goiânia, Goiás, Brazil, 74110-120
        • CIP - Centro Internacional de Pesquisa
    • Minas Gerais
      • Juiz de Fora, Minas Gerais, Brazil, 36010-570
        • CMiP - Centro Mineiro de Pesquisa
    • Paraná
      • Curitiba, Paraná, Brazil, 80030-110
        • CETI - Centro de Estudos em Terapias Inovadoras Ltda.
      • Maringá, Paraná, Brazil, 87013-250
        • Clinilive - Clínica do Idoso e Pesquisa Clínica
    • Rio Grande Do Sul
      • Lajeado, Rio Grande Do Sul, Brazil, 95900-010
        • Hospital Bruno Born
      • Pôrto Alegre, Rio Grande Do Sul, Brazil, 90480-000
        • LMK Serviços Médicos S/S Ltda
    • Santa Catarina
      • Itajaí, Santa Catarina, Brazil, 88301-215
        • Clínica de Neoplasias Litoral Ltda.
    • Sao Paulo
      • Santo André, Sao Paulo, Brazil, 09060-650
        • Faculdade de Medicina do ABC
      • Sao Bernardo Do Campo, Sao Paulo, Brazil, 09715-090
        • Centro Multidisciplinar de Estudos Clínicos - CEMEC
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • DCC 'Sv. Pantaleymon' OOD
      • Plovdiv, Bulgaria, 4000
        • UMHAT Pulmed OOD
      • Plovdiv, Bulgaria, 4001
        • UMHAT "Kaspela", EOOD
      • Ruse, Bulgaria, 7002
        • MHAT - Ruse, AD
      • Sevlievo, Bulgaria, 5400
        • Medizinski Zentar-1-Sevlievo EOOD
      • Shumen, Bulgaria, 9700
        • MHAT - Shumen, AD
      • Sofia, Bulgaria, 1233
        • NMTH "Tsar Boris III"
      • Sofia, Bulgaria, 1336
        • MHAT "Lyulin", EAD
      • Sofia, Bulgaria, 1431
        • UMHAT "Sv. Ivan Rilski", EAD
      • Sofia, Bulgaria, 1784
        • MC "Synexus - Sofia", EOOD
      • Sofia, Bulgaria, 1407
        • Medical Center "Excelsior", OOD
      • Veliko Tarnovo, Bulgaria, 5000
        • MDHAT 'Dr. Stefan Cherkezov', AD
  • Colombia
      • Barranquilla, Colombia, 80020
        • Centro de Reumatologia y Ortopedia SAS
      • Bogotá, Colombia, 110221
        • Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM
      • Bogotá, Colombia, 111211
        • Fundacion Instituto de Reumatologia Fernando Chalem
      • Bucaramanga, Colombia, 680003
        • Medicity S.A.S.
      • Cali, Colombia, 76001
        • Clinica de Artritis Temprana S.A.S
  • Czechia
      • Brno, Czechia, 602 00
        • CCR Brno s.r.o
      • Brno, Czechia, 602 00
        • iMedica s.r.o.
      • Brno, Czechia, 638 00
        • Revmatologie s.r.o.
      • Jihlava, Czechia, 586 01
        • Nemocnice Jihlava p.o.
      • Kladno, Czechia, 272 01
        • MUDr Gabriela Simkova Ordinace Lekare Specialisty Interna Revmatologie
      • Olomouc, Czechia, 77900
        • CTCenter MaVe s.r.o.
      • Ostrava, Czechia, 70200
        • Vesalion s.r.o.
      • Ostrava - Trebovice, Czechia, 722 00
        • Artroscan s.r.o.
      • Pardubice, Czechia, 530 02
        • Arthrohelp S.R.O.
      • Pardubice, Czechia, 530 02
        • CCR Czech, a.s.
      • Praha, Czechia, 110 00
        • Clintrial s.r.o.
      • Praha, Czechia, 148 00
        • Affidea Praha s.r.o.
      • Praha 2, Czechia, 128 00
        • Revmatologicky ustav
      • Praha 3, Czechia, 130 00
        • CCR Prague s.r.o.
      • Praha 4, Czechia, 140 00
        • MUDR Zuzana URBANOVA Revmatologie
      • Praha 4 Nusle, Czechia, 140 00
        • MUDR Zuzana URBANOVA Revmatologie
      • Praha 5, Czechia, 150 06
        • Fakultni nemocnice v Motole
      • Uherske Hradiste, Czechia, 686 01
        • MEDICAL Plus s.r.o.
      • Zlin, Czechia, 760 01
        • PV - MEDICAL, s.r.o.
  • Estonia
      • Tallinn, Estonia, 11312
        • East Tallinn Central Hospital
      • Tartu, Estonia, 50708
        • MediTrials OÜ
  • Germany
      • Berlin, Germany, 10117
        • Klinische Forschung Berlin-Mitte GmbH
      • Hamburg, Germany, 20095
        • HRF Hamburger Rheuma Forschungszentrum
    • Hessen
      • Bad Nauheim, Hessen, Germany, 61231
        • Kerckhoff-Klinik gGmbH
    • Nordrhein Westfalen
      • Aachen, Nordrhein Westfalen, Germany, 52064
        • Rheumapraxis Dr. med. Reiner Kurthen
      • Ratingen, Nordrhein Westfalen, Germany, 40878
        • Studienambulanz Dr. Wassenberg
    • Sachsen Anhalt
      • Magdeburg, Sachsen Anhalt, Germany, 39120
        • SMO.MD GmbH
  • Hungary
      • Baja, Hungary, 6500
        • Principal SMO Kft.
      • Balatonfüred, Hungary, 8230
        • DRC Gyogyszervizsgalo Kozpont Kft.
      • Budapest, Hungary, 1033
        • Clinexpert Kft.
      • Budapest, Hungary, 1036
        • Obudai Egeszsegugyi Centrum Kft.
      • Kiskunhalas, Hungary, 6400
        • Kiskunhalasi Semmelweis Korhaz
      • Szolnok, Hungary, 5000
        • MAV Korhaz es Rendelointezet
      • Székesfehérvár, Hungary, 8000
        • DRC Szekesfehervar
      • Veszprem, Hungary, 8200
        • Vital-Medicina Kft.
  • Korea, Republic of
      • Daejeon, Korea, Republic of, 35233
        • Eulji University Hospital
      • Gwangju, Korea, Republic of, 501-757
        • Chonnam National University Hospital
      • Jeju, Korea, Republic of, 63241
        • Jeju National University Hospital
      • Seoul, Korea, Republic of, 6591
        • The Catholic University of Korea, Seoul St. Mary's Hospital
      • Seoul, Korea, Republic of, 120-752
        • Severance Hospital, Yonsei University No. 31 Office, Pediatric Oncology Clinic
    • Gyeonggi-do
      • Anyang-si, Gyeonggi-do, Korea, Republic of, 431-796
        • Hallym University Sacred Heart Hospital
      • Suwon-si, Gyeonggi-do, Korea, Republic of, 443-380
        • Ajou University Hospital
  • Latvia
      • Liepaja, Latvia, LV-3401
        • Dr.Saulite-Kandevica Private Practice
  • Lithuania
      • Alytus, Lithuania, 62114
        • Alytus Regional S. Kudirkos Hospital, Public Institution
      • Kaunas, Lithuania, 45130
        • Republican Kaunas Hospital, Public Institution
      • Klaipeda, Lithuania, 92288
        • Klaipeda University Hospital, Public Institution
      • Siauliai, Lithuania, 76231
        • Siauliai Republican Hospital, Public Institution
      • Vilnius, Lithuania, LT-01117
        • Center Outpatient Clinic, Public Institution
      • Vilnius, Lithuania, LT-08661
        • Vilnius University Hospital Santariskiu Clinics, Public Institution
  • Mexico
      • Chihuahua, Mexico, 31000
        • Investigacion y Biomedicina de Chihuahua, S.C.
      • Mexico City, Mexico, 54055
        • Clinical Research Institute S.C.
      • San Luis Potosí, Mexico, 78213
        • Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 3300
        • Clinicos Asociados BOCM S.C.
      • Mexico, Distrito Federal, Mexico, 3720
        • Centro de Investigacion Clínica GRAMEL S.C
      • Mexico, Distrito Federal, Mexico, 6100
        • Comite Mexicano Para la Prevencion de Osteoporosis AC
      • Mexico, Distrito Federal, Mexico, 6700
        • Clinstile, S.A. de C.V.
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44650
        • Clinica de Investigacion en Reumatologia y Obesidad S.C.
      • Guadalajara, Jalisco, Mexico, 44690
        • Centro de Estudios de Investigacion Basica Y Clinica SC
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64000
        • Accelerium S. de R.L. de C.V.
      • Monterrey, Nuevo León, Mexico, 64460
        • Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
  • Poland
      • Bialystok, Poland, 15-270
        • CERMED
      • Bialystok, Poland, 15-351
        • Zdrowie Osteo-Medic
      • Bydgoszcz, Poland, 85-168
        • Szpital Uniwersytecki nr 2 im.dr J. Biziela
      • Grodzisk Mazowiecki, Poland, 05-825
        • MCBK Iwona Czajkowska Anna Podrażka- Szczepaniak S.C.
      • Kielce, Poland, 25-355
        • Polimedica Centrum Badań, Profilaktyki I Leczenia
      • Lodz, Poland, 90-368
        • CCBR - Lodz - PL
      • Lodz, Poland, 91-363
        • Centrum Medyczne AMED
      • Olsztyn, Poland, 10-117
        • ETYKA Osrodek Badan Klinicznych
      • Sieradz, Poland, 98-200
        • Szpital Wojewodzki im. Prymasa Kardynala Stefana Wyszynskiego
      • Skierniewice, Poland, 96-100
        • Clinmed Research
      • Sochaczew, Poland, 96-500
        • RCMed
      • Staszow, Poland, 28-200
        • KO-MED Centra Kliniczne Staszow
      • Tomaszow Lubelski, Poland, 22-600
        • Samodzielny Publiczny ZOZ Tomaszow Lubelski
      • Torun, Poland, 87-100
        • Nasz Lekarz Przychodnie Medyczne
      • Warszawa, Poland, 00-874
        • Medycyna Kliniczna
      • Warszawa, Poland, 02-118
        • Rheuma Medicus Zaklad Opieki Zdrowotnej
      • Warszawa, Poland, 02-777
        • McM Polimedica
      • Zamosc, Poland, 22-400
        • KO-MED Centra Kliniczne Zamosc
      • Zgierz, Poland, 95-100
        • SANTA FAMILIA Centrum Badan, Profilaktyki i Leczenia
  • Russian Federation
      • Moscow, Russian Federation, 115522
        • FSBSI "Scientific Research Institute of Rheumatology n.a. V.A. Nasonova"
      • Moscow, Russian Federation, 119991
        • FSAEI HE "First MSMU n.a. I.M. Sechenov of the Ministry of Health of the Russian Federation"
      • Saint Petersburg, Russian Federation, 197341
        • FSBI "National Medical Research Center n.a. V.A.Almazov" of the Ministry of Healthcare of the Russian Federation
    • Altai Region
      • Barnaul, Altai Region, Russian Federation, 656038
        • FSBEI HE "Altai State Medical University of the Ministry of Healthcare of Russian Federation"
    • Kemerovo Oblast
      • Kemerovo, Kemerovo Oblast, Russian Federation, 650066
        • Medical Center LLC "Maksimum Zdoroviya"
    • Kemerovskaya Oblast
      • Kemerovo, Kemerovskaya Oblast, Russian Federation, 650000
        • SAHI of Kemerovo region "Regional Clinical Hospital for War Veterans"
    • Kurskaya Oblast
      • Kursk, Kurskaya Oblast, Russian Federation, 305007
        • Budgetary Healthcare Institution "Kursk Regional Clinical Hospital" of Healthcare Committee of Kursk region
    • Leningradskaya Oblast
      • Saint Petersburg, Leningradskaya Oblast, Russian Federation, 190068
        • SPb SBHI "Clinical Rheumatological Hospital #25", Fourth Rheumatology Unit
    • Moscovskaya Oblast
      • Moscow, Moscovskaya Oblast, Russian Federation, 119049
        • SBHI of Moscow "City Clinical Hospital No.1 n.a. Pirogov" Healthcare Department of Moscow
      • Moscow, Moscovskaya Oblast, Russian Federation, 119435
        • FSAEI HE "First MSMU n.a. I.M. Sechenov of the Ministry of Health of the Russian Federation" University Clinical Hospital No.1
      • Moscow, Moscovskaya Oblast, Russian Federation, 119991
        • FSAEI HE "First MSMU n.a. I.M. Sechenov of the Ministry of Health of the Russian Federation"
    • Moscow Region
      • Moscow, Moscow Region, Russian Federation, 111539
        • State Budgetary Healthcare Institution "City Clinical Hospital # 15 n.a O.M. Filatov" of Moscow Healtheare Department
    • Moskovskaya Oblast
      • Moscow, Moskovskaya Oblast, Russian Federation, 115093
        • SBHI of Moscow "City Clinical Hospital #4 of Moscow Healthcare Departament"
    • Nizhegorodskaya Oblast
      • Nizhniy Novgorod, Nizhegorodskaya Oblast, Russian Federation, 603126
        • SBHI of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a.Semashko"
    • Nizhny Novgorod Oblast
      • Nizhny Novgorod, Nizhny Novgorod Oblast, Russian Federation, 603005
        • SBHI of Nizhegorodsky Region "State Clinical Hospital #5 of Nizhegorodsky District of Nizhny Novgorod"
    • Novosibirsk Oblast
      • Novosibirsk, Novosibirsk Oblast, Russian Federation, 630005
        • State Autonomous Healthcare Institution of Novosibirsk region "City Polyclinic #1"
    • Omskaya Oblast
      • Omsk, Omskaya Oblast, Russian Federation, 644024
        • LLC "Clinical Diagnostic Center "Ultramed"
      • Omsk, Omskaya Oblast, Russian Federation, 644111
        • Budgetary Healthcare Institution of Omsk Region "Regional Clinical Hospital"
    • Republic Of Karelia
      • Petrozavodsk, Republic Of Karelia, Russian Federation, 185019
        • SBHI of the Republic of Karelia "Republican Hospital named after V.A. Baranov"
    • Respublic Of Bashkortostan
      • Ufa, Respublic Of Bashkortostan, Russian Federation, 450005
        • State Budgetary Healthcare Institution "Republican Clinical Hospital n.a. G.G. Kuvatov"
    • Rostovskaya Oblast
      • Rostov, Rostovskaya Oblast, Russian Federation, 344022
        • FSBEI HE "Rostov State Medical Unversity" of Ministry of Health of the Russian Federation
    • Ryazan Oblast
      • Ryazan, Ryazan Oblast, Russian Federation, 390026
        • FSBEI HE 'Ryazan State Medical University n.a. I.P.Pavlov" of the Ministry of Health of Russian Federation
    • Saratovskaya Oblast
      • Saratov, Saratovskaya Oblast, Russian Federation, 410012
        • FSBEI HE "Saratov SMU n.a. V.I.Razumovsky of Ministry of Health of Russian Federation"
      • Saratov, Saratovskaya Oblast, Russian Federation, 410053
        • State Healthcare Institution "Regional Clinical Hospital"
    • Smolenskaya Oblast
      • Smolensk, Smolenskaya Oblast, Russian Federation, 214025
        • Private Healthcare Institution "Clinical Hospital Russian Railways-Medicine of City Smolensk"
    • Stavropol Region
      • Stavropol', Stavropol Region, Russian Federation, 355030
        • FSBEI HE StSMU MOH Russia based on SBHI of Stavropol Region "Stavropol Regional Clinical Hospital"
    • Sverdlovskaya Oblast
      • Ekaterinburg, Sverdlovskaya Oblast, Russian Federation, 620102
        • State Autonomous Healthcare Institution of Sverdlovsk Region "Sverdlovsk Regional Clinical Hospital No.1"
      • Ekaterinburg, Sverdlovskaya Oblast, Russian Federation, 620149
        • FSBEI HE "Ural State Medical University" of Ministry of Health of Russian Federation based on MBI "Central City Clinical Hospital No.6"
    • The Republic Of Tatarstan
      • Kazan', The Republic Of Tatarstan, Russian Federation, 420012
        • FSBEI HE "Kazan State Medical University of the Ministry of Health of the Russian Federation" on the base of SAHI "Republican Clinical Hospital of the Ministry of Health of Tatarstan Republic"
    • Tulskaya Oblast
      • Tula, Tulskaya Oblast, Russian Federation, 300053
        • State Healthcare Institution of Tula Region "Tula Regional Clinical Hospital"
    • Ulyanovskaya Oblast
      • Ulyanovsk, Ulyanovskaya Oblast, Russian Federation, 432063
        • State Healthcare Institution "Ulyanovsk Regional Clinical Hospital"
    • Vladimirskaya Oblast
      • Vladimir, Vladimirskaya Oblast, Russian Federation, 600023
        • SBHI of Vladimir Region "Regional Clinical Hospital", Rheumatology Departament
    • Yaroslavsakaya Oblast
      • Yaroslavl, Yaroslavsakaya Oblast, Russian Federation, 150003
        • State Autonomous Helthcare Institution of Yaroslavl region "Clinical Hospital of Emergency Care n.a. Solovyev"
    • Yaroslavskaya Oblast
      • Yaroslavl', Yaroslavskaya Oblast, Russian Federation, 150062
        • SBHI "Yaroslavl Regional Clinical Hospital", Rheumatology department
  • Taiwan
      • Tainan, Taiwan, 710
        • Chi Mei Medical Center, Yung Kang Branch
      • Taoyuan, Taiwan, 333
        • Chang Gung Memorial Hospital, Linkou
  • United Kingdom
    • Devon
      • Torquay, Devon, United Kingdom, TQ2 7AA
        • Torbay Hospital
    • Greater London
      • London, Greater London, United Kingdom, NW3 2QG
        • Royal Free Hospital
      • London, Greater London, United Kingdom, E11 1NR
        • Whipps Cross University Hospital
    • Hampshire
      • Basingstoke, Hampshire, United Kingdom, RG24 9NA
        • Basingstoke and North Hampshire Hospital
    • Kent
      • Maidstone, Kent, United Kingdom, ME16 9QQ
        • Maidstone Hospital
    • Merseyside
      • Wirral, Merseyside, United Kingdom, L49 5PE
        • Arrowe Park Hospital
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85210
        • AZ Arthritis & Rheum' Research
      • Phoenix, Arizona, United States, 85032
        • Arizona Arthritis & Rheumatology Associates, P.C.
      • Sun City, Arizona, United States, 85351
        • Arizona Arthritis & Rheumatology Research, PLLC
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • CHI St. Vincent Hot Springs
    • California
      • Covina, California, United States, 91722
        • Medvin Clinical Research
      • Hemet, California, United States, 92543
        • C.V Mehta MD Med Corp..
      • La Palma, California, United States, 90623
        • Advanced Medical Research, LLC
      • Los Alamitos, California, United States, 90720-5403
        • Valerius Medical Group
      • Palo Alto, California, United States, 94304
        • Stanford University School of Medicine
      • San Diego, California, United States, 92128
        • Rheumatology Center of San Diego
      • San Leandro, California, United States, 94578
        • East Bay Rheumatology Medical Group, Inc.
      • Upland, California, United States, 91786
        • Inland Rheumatology Clinical Trials, Inc.
      • West Hills, California, United States, 91307
        • Center for Rheumatology Research, Comprehensive Rheumatology Center
      • Whittier, California, United States, 90602
        • Medvin Clinical Research
    • Colorado
      • Denver, Colorado, United States, 80230
        • Denver Arthritis Clinic
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • New England Research Associates LLC
    • Delaware
      • Newark, Delaware, United States, 19713
        • Javed Rheumatology Associates
    • Florida
      • Boca Raton, Florida, United States, 33486
        • RASF - Clinical Research Center
      • Hialeah, Florida, United States, 33012
        • Reliable Clinical Research, LLC
      • Miami, Florida, United States, 33126
        • Pharmax Research Clinic
      • Miami, Florida, United States, 33135
        • Suncoast Research Group, LLC
      • Miami, Florida, United States, 33134
        • Medical Research Center of Miami
      • Orlando, Florida, United States, 32810
        • Omega Research Consultants
      • Palm Harbor, Florida, United States, 34684
        • Arthritis Research of Florida, INC
      • Pembroke Pines, Florida, United States, 33026
        • Family Clinical Trials, LLC.
      • Tampa, Florida, United States, 33614
        • AdventHealth Medical Group, PA
      • Venice, Florida, United States, 34292
        • Lovelace Scientific Resources, Inc.
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Arthritis Center of North Georgia
      • Marietta, Georgia, United States, 30060
        • Marietta Rheumatology Associates, PC
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Institute of Arthritis Research
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Hospital
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Graves Gilbert Clinic
    • Louisiana
      • Monroe, Louisiana, United States, 71203
        • The Arthritis & Diabetes Clinic, Inc.
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Klein and Associates, M.D., P.A.
      • Wheaton, Maryland, United States, 20902
        • The Center for Rheumatology and Bone Research
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • Clinical Pharmacology Study Group
    • Michigan
      • Grand Blanc, Michigan, United States, 48439
        • AA MRC LLC Ahmed Arif Medical Research Center
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • North MS Medical Clinics, Inc.
    • Montana
      • Kalispell, Montana, United States, 59901
        • Glacier View Research Institute-Rheumatology
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Physician Research Collaboration
    • New Jersey
      • Freehold, New Jersey, United States, 07728
        • Arthritis & Osteoporosis Associates, PA
    • New Mexico
      • Albuquerque, New Mexico, United States, 87114
        • Lovelace Scientific Resources, Inc.
    • New York
      • Brooklyn, New York, United States, 11201
        • NYU Langone Ambulatory Care
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • Medication Management, LLC
      • Leland, North Carolina, United States, 28451
        • Cape Fear Arthritis Care
      • Wilmington, North Carolina, United States, 28401
        • Carolina Arthritis Associates
    • North Dakota
      • Minot, North Dakota, United States, 58701
        • Trinity Medical Group
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Cincinnati Rheumatic Disease Study Group
      • Dayton, Ohio, United States, 45417
        • STAT Research, Inc.
      • Toledo, Ohio, United States, 43606
        • Clinical Research Source, Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science Institute
      • Oklahoma City, Oklahoma, United States, 73103
        • Health Research of Oklahoma, PLLC
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research, P.C.
      • Philadelphia, Pennsylvania, United States, 19152
        • Arthritis Group
    • South Carolina
      • Summerville, South Carolina, United States, 29486
        • Low Country Rheumatology, PA
    • Texas
      • Amarillo, Texas, United States, 79124
        • Amarillo Center for Clinical Research
      • Austin, Texas, United States, 78731
        • Austin Regional Clinic, P.A.
      • Baytown, Texas, United States, 77521
        • Accurate Clinical Management., LLC
      • Colleyville, Texas, United States, 76034
        • Precision Comprehensive Clinical Research Solutions
      • Cypress, Texas, United States, 77429
        • Pioneer Research Solutions, Inc.
      • Houston, Texas, United States, 77074
        • Houston Institute for Clinical Research
      • Houston, Texas, United States, 77004
        • Therapeutic Concepts Rheumatology,LLC
      • Houston, Texas, United States, 77065
        • Rheumatology Clinic of Houston, P.A.
      • Houston, Texas, United States, 77089
        • Accurate Clinical Mangemnt - Partner
      • Houston, Texas, United States, 77089
        • Accurate Clinical Research, Inc.
      • League City, Texas, United States, 77573
        • Accurate Clinical Research, Inc.
      • Lubbock, Texas, United States, 79410
        • West Texas Clinical Research
      • San Antonio, Texas, United States, 78229
        • Dr Alex De Jesus Rheumatology, P.A.
      • The Woodlands, Texas, United States, 77382
        • Advanced Rheumatology of Houston
      • Tomball, Texas, United States, 77375
        • DM Clinical Research
    • Washington
      • Spokane, Washington, United States, 99204
        • Arthritis Northwest, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Subjects may be enrolled in the study only if they meet all of the following criteria:

  1. Subject must be willing and able to sign informed consent
  2. Subject must have completed the 24-week double-blind Treatment Period in 1 of the 3 core studies (CL04041022, CL04041023, or CL04041025).
  3. Subject must have maintained their stable dose (and route) of MTX 15 to 25 mg/week (or ≥ 10 mg/week if there is documented intolerance to higher doses) during the core study and plan to maintain the same dose and route of administration for ≥ 12 additional weeks
  4. Subjects must be willing to take folic acid or equivalent throughout the study.

Exclusion Criteria:

  1. Subject with any medically important condition in the core study (e.g., clinically significant laboratory values, frequent Adverse events (AEs) or serious adverse events (SAEs), infection SAEs, and/or other concurrent severe and/or uncontrolled medical condition) which would make this subject unsuitable for inclusion in the open-label extension (OLE) study in the Investigator's judgement.
  2. Subject has evidence of active tuberculosis (TB)

  3. Subject with a positive or repeated indeterminate interferon-gamma release assay (IGRA) result at Week 22 of the core study

    - Subjects may be enrolled in the OLE study if they fulfill all 3 of the following criteria prior to the first dose of study treatment:

    1. Active TB is ruled out by a certified TB specialist or pulmonologist who is familiar with diagnosing and treating TB (as acceptable per local practice);
    2. The subject starts prophylaxis for latent TB infection (LTBI) according to country-specific/Centers for Disease Control and Prevention (CDC) guidelines (treatment with isoniazid for 6 months is not an appropriate prophylactic regime for this study and it should not be used); and
    3. The subject is willing to complete the entire course of recommended LTBI therapy.
  4. Subject has planned surgery during the first 12 weeks of the OLE study
  5. Female subjects who are pregnant or who are planning to become pregnant during the study or within 6 months of the last dose of study drug

  6. 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.

    Highly effective contraception is defined as:

    • Female sterilization surgery: hysterectomy, surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least 6 weeks prior to the first dose of study treatment in the core study

      • In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by documented follow-up hormone level assessment
    • Total abstinence if it is the preferred and constant lifestyle of the subject. Thus, periodic abstinence such as ovulation, symptothermal, postovulation, calendar methods, and withdrawal are not acceptable methods of contraception.
    • Male sterilization surgery: at least 6 months prior to the first dose of study treatment in the core study (with the appropriate postvasectomy documentation of the absence of sperm in the ejaculate). For female subjects, the vasectomized male should be the only partner.
    • Placement of established intrauterine device (IUD): IUD copper or IUD with progesterone
    • Barrier method (condom and intravaginal spermicide, cervical caps with spermicide, or diaphragm with spermicide) in combination with the following: established oral, injected, or implanted hormone methods of contraception or contraceptive patch.
  7. Subject is unwilling or unable to follow the procedures outlined in the protocol.
  8. Other medical or psychiatric conditions, or laboratory abnormalities that may increase the potential risk associated with study participation and administration of the study treatment, or that may affect study results interpretation and, as per Investigator's judgement, make the subject ineligible.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm 1: OKZ 64 mg q4w + MTX
Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Drug: Olokizumab 64 mg SC q4w
160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS).PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.
Drug: Concomitant treatment

Methotrexate 15 to 25 mg/week (or ≥ 10 mg/week if there was documented intolerance to higher doses). (Subject maintained their stable dose and route (oral, SC, or IM) during the core study and for ≥ 12 additional weeks of OLE.)

Folic acid ≥ 5 mg per week or equivalent
Experimental: Treatment Arm 2: OKZ 64 mg q2w + MTX
Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Drug: Concomitant treatment

Methotrexate 15 to 25 mg/week (or ≥ 10 mg/week if there was documented intolerance to higher doses). (Subject maintained their stable dose and route (oral, SC, or IM) during the core study and for ≥ 12 additional weeks of OLE.)

Folic acid ≥ 5 mg per week or equivalent

Drug: Olokizumab 64 mg SC q2w
160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population)
Time Frame: up to Week 126
Incidence of Treatment-Emergent Adverse Events Reported for ≥5% of Subjects in Any Treatment Group by System Organ Class or Preferred Term
up to Week 126
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term (Safety Population)
Time Frame: up to Week 126

Incidence of Serious Treatment-Emergent Adverse Events by System Organ Class or Preferred Term.

Deaths are included.
up to Week 126
Incidence of Treatment-Emergent Adverse Events of Special Interest (AESI)
Time Frame: up to Week 126
up to Week 126
Incidence of Treatment-Emergent AEs Leading to Withdrawal of the Study Treatment
Time Frame: up to Week 126
up to Week 126
Incidence Rate of Treatment Emergent AEs Per Patient-years of Exposure
Time Frame: up to Week 126
Incidence Rate of all Subjects with at Least One Treatment Emergent AE. Subject Incidence Rate (IR) is summarized per 100 subject years (SY) of follow-up (/100 SY) based on the OLE safety population and presented by study treatments.
up to Week 126
Incidence Rate of Treatment Emergent SAEs Per Patient-years of Exposure
Time Frame: up to Week 126
Incidence Rate of all Subjects with at Least One Treatment Emergent SAE. Subject Incidence Rate (IR) is summarized per 100 subject years (SY) of follow-up (/100 SY) based on the OLE safety population and presented by study treatments.
up to Week 126
Incidence Rate of Treatment Emergent AESIs (Safety Population)
Time Frame: up to Week 126
Incidence Rate of all Subjects with at Least One Treatment Emergent AESI. Subject Incidence Rate (IR) is summarized per 100 subject years (SY) of follow-up (/100 SY) based on the OLE safety population and presented by study treatments.
up to Week 126

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American College of Rheumatology 20% (ACR20) Response Rates Compare Against Core Baseline Through Week 82
Time Frame: up to Week 82

Number and Proportion of subjects achieving an ACR20 response who remain on randomized open-label treatment and in the study, assessed at several timepoints up to Week 82.

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)
up to Week 82
American College of Rheumatology 50% (ACR50) Response Rates Compare Against Core Baseline Through Week 82
Time Frame: up to Week 82

Number and Proportion of subjects achieving an ACR50 response who remain on randomized open-label treatment and in the study, assessed at several timepoints up to Week 82

American College of Rheumatology 50 % response is a composite defined as a ≥ 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)
up to Week 82
American College of Rheumatology 70% (ACR70) Response Rates Compare Against Core Baseline Through Week 82
Time Frame: up to Week 82

Number and Proportion of subjects achieving an ACR70 response who remain on randomized open-label treatment and in the study, assessed at several timepoints up to Week 82

American College of Rheumatology 70 % response is a composite defined as a ≥ 70% improvement from baseline in the swollen joint counts assessed in 66 joints and in the tender joint count assessed in 68 joints; and a ≥ 70% 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)
up to Week 82
Proportion of Subjects With Simplified Disease Activity Index (SDAI) Remission Through Week 82
Time Frame: up to week 82

The number and proportion of subjects with SDAI score ≤ 3.3 (considered to be in remission).

The SDAI was calculated in the statistical database for analysis purposes using the SJC (28 joints), TJC (28 joints), CRP (mg/dL), the Patient Global Assessment of Disease Activity (VAS) (in cm), and the Physician Global Assessment (VAS) (in cm) according to the following formula: SJC + TJC + Patient Global Assessment of Disease Activity (VAS) + Physician Global Assessment (VAS) + CRP (mg/dL)
up to week 82
Disease Activity Score 28-joint Count (DAS28) Response Rates Through Week 82
Time Frame: up to Week 82

Number and Proportion of subjects with DAS28 low disease activity (based on DAS28 C-reactive protein (CRP) < 3.2), who remain on randomized open-label treatment and in the study, assessed at several timepoints up to Week 82.

The DAS28 (CRP) was calculated in the statistical database for analysis purposes using the Swollen joint count (SJC) (28 joints), Tender joint count (TJC) (28 joints), CRP level, and the Patient Global Assessment of Disease Activity Visual Analog Scale (VAS) (100 mm VAS, where 0 is "no disease activity" and 100 was "maximal disease activity") according to the following formula: [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.36 × natural log (CRP+1)] + [0.014 × VAS] + 0.96.
up to Week 82
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 12
Time Frame: Core baseline, Week 12

HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement.

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 (activity) 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 (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.
Core baseline, Week 12
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 20
Time Frame: Core baseline, Week 20

HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement.

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 (activity) 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 (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.
Core baseline, Week 20
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 28
Time Frame: Core baseline, Week 28

HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement.

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 (activity) 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 (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.
Core baseline, Week 28
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 40
Time Frame: Core baseline, Week 40

HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement.

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 (activity) 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 (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.
Core baseline, Week 40
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 52
Time Frame: Core baseline, Week 52

HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement.

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 (activity) 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 (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.
Core baseline, Week 52
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 64
Time Frame: Core baseline, Week 64

HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement.

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 (activity) 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 (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.
Core baseline, Week 64
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Core Baseline at Week 82
Time Frame: Core baseline, Week 82

HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement.

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 (activity) 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 (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.
Core baseline, Week 82
Proportion of Subjects With Health Assessment Questionnaire - Disability Index (HAQ-DI) Improvement Through Week 82
Time Frame: up to week 82

The number and proportion of subjects with HAQ-DI improvement ≥ 0.22 Against OLE Baseline.

HAQ-DI Range: 0 (the best outcome) - 3 (the worst outcome), with a decrease from baseline indicating improvement.

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 (activity) 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 (i.e., question in each category with the highest score for that category). The HAQ-DI was calculated by dividing the sum of the category scores by the number of categories with at least 1 question answered.
up to week 82
Changes From Core Baseline Over Time in Clinical Disease Activity Index (CDAI)
Time Frame: up to week 82

CDAI Range: 0 (the best outcome) - 76 (the worst outcome), with a decrease from baseline indicating improvement.

The CDAI was calculated in the statistical database for analysis purposes using the SJC (28 joints), TJC (28 joints), the Patient Global Assessment of Disease Activity (VAS) (in cm), and the Physician Global Assessment (VAS) (in cm) according to the following formula: CDAI = SJC + TJC + Patient Global Assessment of Disease Activity (VAS) + Physician Global Assessment (VAS)
up to week 82

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

R-Pharm International, LLC

Collaborators

IQVIA Pvt. Ltd
OCT Clinical Trials

Investigators

  • Study Director: Mikhail Samsonov, Chief Medical Officer, R-Pharm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2017

Primary Completion (Actual)

September 1, 2021

Study Completion (Actual)

September 1, 2021

Study Registration Dates

First Submitted

February 7, 2017

First Submitted That Met QC Criteria

April 14, 2017

First Posted (Actual)

April 19, 2017

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

September 28, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL04041024
  • 2015-005309-35 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on Olokizumab 64 mg SC q4w

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe