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Brief Title: Evaluation of the Efficacy and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo, in Subjects With Rheumatoid Arthritis (RA) Who Were Taking an Existing Medication Called a Tumour Necrosis Factor Alpha Inhibitor But Had Active Disease
Official Title: A Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-α) Inhibitor Therapy
Study ID: NCT02760433
Brief 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 an existing medication called a tumour necrosis factor alpha inhibitor The primary objective of this study was to evaluate the efficacy of olokizumab (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 rheumatoid arthritis (RA) inadequately controlled by TNF-α inhibitor (TNFi) therapy.
Detailed 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 TNFi therapy. The primary endpoint of the trial was assessed 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 was a randomized, double-blind, parallel-group, placebo-controlled, multicenter study. This study included a 4-week Screening Period, a double-blind Treatment Period from Week 0 to Week 24, and a Safety FollowUp Period from Week 24 to Week 44. A total of 350 subjects were planned to be randomized.Subjects were assessed for eligibility to enter the study during a 4-week Screening Period. Eligible subjects were randomized at Visit 2 in a 2:2:1 ratio in one of 3 treatment groups (planned 140, 140, and 70 subjects per group, respectively) : 1. Olokizumab 64 mg q4w: SC injection of OKZ 64 mg q4w (alternating with SC injection of placebo OKZ q4w to maintain blinding) + MTX for 24 weeks, 2. Olokizumab 64 mg q2w: SC injection of OKZ 64 mg q2w + MTX for 24 weeks or 3. Placebo: SC injection of placebo q2w + MTX for 16 weeks. Subjects who received placebo were re-randomized at Week 16 to receive 64 mg OKZ q4w + Methotrexate or 64 mg OKZ q2w +Methotrexate for 8 weeks. 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 OKZ was administered at Week 20 for subjects receiving OKZ 64 mg q4w and at Week 22 for subjects receiving OKZ 64 mg q2w. 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 did not improve 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 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 123 sites across 11 countries globally (in US,EU, Russian Federation, Asia, Latin America)
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Arizona Arthritis & Rheumatology Associates, P.C., Phoenix, Arizona, United States
CHI St. Vincent Hot Springs, Hot Springs, Arkansas, United States
Medvin Clinical Research, Covina, California, United States
TriWest Research Associates, LLC, El Cajon, California, United States
Saint Jude Heritage Medical Grp, Fullerton, California, United States
С V Mehta MD Med Corp., Hemet, California, United States
Advanced Medical Research, LLC, Lakewood, California, United States
Stanford University School of Medicine, Palo Alto, California, United States
Riverside Medical Clinic, Riverside, California, United States
East Bay Rheumatology Medical Group, Inc., San Leandro, California, United States
Inland Rheumatology Clinical Trials, Inc., Upland, California, United States
Denver Arthritis Clinic, Denver, Colorado, United States
Javed Rheumatology Associates, Newark, Delaware, United States
RASF - Clinical Research Center, Boca Raton, Florida, United States
Suncoast Research Group LLC, Miami, Florida, United States
Omega Research Consultants, Orlando, Florida, United States
Family Clinical Trials, LLC., Pembroke Pines, Florida, United States
AdventHealth Medical Group, PA, Tampa, Florida, United States
Institute of Arthritis Research, Idaho Falls, Idaho, United States
University of Kansas Hospital, Kansas City, Kansas, United States
Graves Gilbert Clinic, Bowling Green, Kentucky, United States
The Arthritis & Diabetes Clinic, Inc., Monroe, Louisiana, United States
Klein and Associates, M.D., P.A., Hagerstown, Maryland, United States
The Center for Rheumatology and Bone Research, Wheaton, Maryland, United States
Clinical Pharmacology Study Group, Worcester, Massachusetts, United States
Glacier View Research Instutute-Rheumatology, Kalispell, Montana, United States
Arthritis & Osteoporosis Associates, PA, Freehold, New Jersey, United States
Lovelace Scientific Resources, Inc., Albuquerque, New Mexico, United States
NYU Langone Ambulatory Care, New York, New York, United States
Medication Management, LLC, Greensboro, North Carolina, United States
Cape Fear Arthritis Care, Leland, North Carolina, United States
Carolina Arthritis Associates, Wilmington, North Carolina, United States
Trinity Medical Group, Minot, North Dakota, United States
Cincinnati Rheumatic Disease Study Group, Cincinnati, Ohio, United States
STAT Research, Inc., Dayton, Ohio, United States
Clinical Research Source, Inc., Perrysburg, Ohio, United States
Arthritis Group, Philadelphia, Pennsylvania, United States
Low Country Research Center, Charleston, South Carolina, United States
Amarillo Center for Clinical Research, Amarillo, Texas, United States
Austin Regional Clinic, P.A., Austin, Texas, United States
Accurate Clinical Research, Inc., Baytown, Texas, United States
Precision Comprehensive Clinical Research Solutions, Grapevine, Texas, United States
Therapeutic Concepts Rheumatology, LLC, Houston, Texas, United States
Rheumatology Clinic of Houston, P.A., Houston, Texas, United States
Accurate Clinical Research, Inc., Houston, Texas, United States
Pioneer Research Solutions, Inc., Houston, Texas, United States
Accurate Clinical Research, Inc., League City, Texas, United States
Endocrinology, Internal Medicine, Lubbock, Texas, United States
Dr. Alex De Jesus Rheumatology, P.A., San Antonio, Texas, United States
Advanced Rheumatology of Houston, Woodville, Texas, United States
Centro de Investigaciones Medicas Mar del Plata, Mar del Plata, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas, Mar del Plata, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Quilmes, Quilmes, Buenos Aires, Argentina
Clinica de Higado y Aparato Digestivo, Rosario, Santa Fe, Argentina
Sanatorio San Martin, Venado Tuerto, Santa Fe, Argentina
Centro Medico Privado de Reumatologia, San Miguel de Tucuman, Tucuman, Argentina
Centro de Investigaciones Reumatológicas, San Miguel de Tucuman, Tucuman, Argentina
Atencion Integral en Reumatologia (AIR), Ciudad Autonoma Buenos Aires, , Argentina
Organizacion Medica de Investigacion (OMI), Ciudad Autonoma Buenos Aires, , Argentina
APRILLUS, Ciudad Autonoma Buenos aires, , Argentina
Instituto Centenario, Ciudad Autonoma Buenos Aires, , Argentina
Hospital Privado Centro Medico de Cordoba S.A, Cordoba, , Argentina
Centro Polivalente de Asistencia e Inv. Clinica CER, San Juan, , Argentina
HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará, Fortaleza, Ceará, Brazil
CEDOES - Diagnóstico e Pesquisa, Vitória, Espírito Santo, Brazil
CIP - Centro Internacional de Pesquisa, Goiânia, Goiás, Brazil
CMiP - Centro Mineiro de Pesquisa, Juiz de Fora, Minas Gerais, Brazil
CETI - Centro de Estudos em Terapias Inovadoras Ltda., Curitiba, Paraná, Brazil
Hospital Bruno Born, Lajeado, Rio Grande Do Sul, Brazil
LMK Serviços Médicos S/S Ltda, Porto Alegre, Rio Grande Do Sul, Brazil
Faculdade de Medicina do ABC, Santo André, Sao Paulo, Brazil
Centro Multidisciplinar de Estudos Clínicos - CEMEC, Sao Bernardo Do Campo, Sao Paulo, Brazil
Clínica de Neoplasias Litoral Ltda., Santa Catarina, , Brazil
Associação de Assistência à Criança Deficiente - AACD, Sao Paulo, , Brazil
CPCLIN - Centro de Pesquisas Clínicas Ltda., São Paulo, , Brazil
Centro de Reumatologia y Ortopedia SAS, Barranquilla, , 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, , Colombia
Revmatologie MUDr. Klara Sirova s.r.o., Ostrava - Moravska Ostrava, , Czechia
CCR Czech, a.s., Pardubice, , Czechia
MEDICAL PLUS s.r.o., Uherske Hradiste, , Czechia
PV - Medical, s.r.o., Zlin, , Czechia
Kerckhoff-Klinik gGmbH, Bad Nauheim, Hessen, Germany
SMO.MD GmbH, Magdeburg, Sachsen Anhalt, Germany
HRF Hamburger Rheuma Forschungszentrum, Hamburg, , Germany
Clinexpert Egeszsegugyi Szolg. es Ker. Kft., Budapest, , Hungary
Obudai Egeszsegugyi Centrum, Budapest, , Hungary
MAV Korhaz és Rendelointezet, Szolnok, , Hungary
Vital Medical Center, Veszprem, , Hungary
Ajou University Hospital, Suwon-si, Gyeonggi-do, Korea, Republic of
Chonnam National University Hospital, Gwangju, , Korea, Republic of
Hallym University Sacred Heart Hospital, Gyeonggi-do, , Korea, Republic of
Severance Hospital, Yonsei University, Seoul, , Korea, Republic of
Centro de Investigacion Clínica GRAMEL S.C, Mexico, Distrito Federal, Mexico
Clinstile, S.A. de C.V., Mexico, Distrito Federal, Mexico
Clinica de Investigacion en Reumatologia y Obesidad S.C., Guadalajara, Jalisco, Mexico
Centro de Estudios de Investigacion Basica y Clinica SC, Guadalajara, Jalisco, 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, San Luis Potos, Mexico
Investigacion y Biomedicina de Chihuahua, S.C., Chihuahua, , Mexico
Szpital Uniwersytecki nr 2 im.dr J. Biziela, Bydgoszcz, , Poland
McBk S.C., Grodzisk Mazowiecki, , Poland
Centrum Medyczne AMED, Lodz, , Poland
Szpital Wojewodzki im. Prymasa Kardynala Stefana Wyszynskiego, Sieradz, , Poland
Samodzielny Publiczny ZOZ Tomaszow Lubelski, Tomaszow Lubelski, , Poland
McM Polimedica, Warszawa, , Poland
State Budgetary Healthcare Institution "City Clinical Hospital # 15 n.a O.M. Filatov" of Moscow Healtheare Department, Moscow, Moscow Region, Russian Federation
City Clinical Hospital #1, Novosibirsk, Novosibirsk Oblast, Russian Federation
Diagnostic Center Ultramed, Omsk, Omsk Oblast, Russian Federation
SBHI of the Republic of Karelia "Republican Hospital named after V.A.Baranov", Petrozavodsk, Republic Of Karelia, Russian Federation
Rostov State Medical Unversity, Rostov-on-Don, Rostov Oblast, Russian Federation
SBHI of Stavropol Region "Stavropol Regional Clinical Hospital", Stavropol', Stavropol Region, Russian Federation
Regional Clinical Hospital, Vladimir, Vladimir Oblast, Russian Federation
FSBSI "Scientific Research Institute of Rheumatology n.a. V.A. Nasonova", Moscow, , Russian Federation
Name: Mikhail Samsonov
Affiliation: R-Pharm
Role: STUDY_DIRECTOR