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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Interventions

Olokizumab
Placebo

Study Description

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)

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Mikhail Samsonov

Affiliation: R-Pharm

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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