A Study of RO7123520 to Evaluate the Safety and Efficacy in Participants With Moderately To Severely Active Rheumatoid Arthritis (RA) Who Are Inadequately Responding to Anti-Tumor Necrosis Factor (TNF)-Alpha Therapy

Last updated: January 17, 2020
Sponsor: Hoffmann-La Roche
Overall Status: Terminated

Phase

2

Condition

Dermatomyositis (Connective Tissue Disease)

Rheumatoid Arthritis

Arthritis And Arthritic Pain

Treatment

N/A

Clinical Study ID

NCT03001219
BP39261
2016-002126-36
  • Ages > 18
  • All Genders

Study Summary

This is a Phase IIa/b double-blind, placebo-controlled, randomized, parallel group, multicenter study to evaluate the safety and efficacy of RO7123520 as adjunctive therapy in participants with RA who are inadequately responding to standard-of-care (methotrexate and anti-TNF-alpha therapy). Part 1 of the study will evaluate safety. Part 2 will evaluate efficacy and safety. Part 3 will evaluate dose-ranging efficacy. Participants will have the option of continuing to the extension period of the study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of adult-onset RA as defined by the ACR 2010 criteria, for at least 6 monthsbefore screening

  • Moderately to severely active RA as defined by at least 4/28 tender joints and atleast 4/28 swollen joints, and a DAS28 greater than or equal to (≥) 3.2

  • For Part 2 only: Active synovitis and/or osteitis as determined by contrast-enhancedmagnetic resonance imaging

  • Participants must be taking stable dose of anti-TNF-alpha therapies

  • Participants on stable oral glucocorticoids within 6 weeks of planned randomization

  • Participants taking non-steroidal anti-inflammatory drugs (NSAIDs) intermittently (upto 2-3 times weekly) for short-term relief of pain and participants on regular NSAIDuse (on stable dose for ≥ 4 weeks)

Exclusion

Exclusion Criteria:

  • Parenteral glucocorticoids administration (intramuscular, IV) of ≥50 mg within 6 weeksor less than or equal to (≤) 50 milligrams (mg) within 4 weeks prior to plannedrandomization, or scheduled parenteral administrations during the study

  • Joint(s) injected with intra-articular glucocorticoids or hyaluronic acid within 6weeks prior to planned randomization

  • Active inflammatory diseases of the joints not related to RA

  • Systemic autoimmune disease other than RA

  • Juvenile idiopathic arthritis or juvenile RA and/or RA developed before the age of 16

  • Active fibromyalgia that makes appropriate assessment of RA disease activitychallenging in the opinion of the Investigator

  • RA participants functional status class IV according to the ACR 1991 criteria

  • Participants with severe chronic or recurrent viral, bacterial, parasitic, or fungalinfections

  • History of active hepatitis B virus (HBV), hepatitis C virus (HCV), or humanimmunodeficiency virus (HIV) infection

  • Any identified confirmed congenital or acquired immunodeficiency

  • Abnormal laboratory values and liver function test

  • Myocardial infarction within less than 6 months prior to participation in the study

  • Severe central or peripheral nervous system diseases

Study Design

Total Participants: 109
Study Start date:
December 22, 2016
Estimated Completion Date:
November 06, 2018

Connect with a study center

  • Organización medica de Investi

    Cap fed, 1015
    Argentina

    Site Not Available

  • Centro de Investigaciones Reumatologicas y Osteologicas

    Ciudad Autonoma de Buenos Aires, 1111
    Argentina

    Site Not Available

  • Instituto de Asistencia Reumatologica Integral

    San Fernando, 1646
    Argentina

    Site Not Available

  • Cer San Juan

    San Juan, 5400
    Argentina

    Site Not Available

  • Centro Medico Privado de Reumatologia; Reumathology

    San Miguel, T4000AXL
    Argentina

    Site Not Available

  • Medizinische Universität Wien, Allgemeines Krankenhaus der Stadt Wien

    Wien, 1090
    Austria

    Site Not Available

  • Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS

    Barranquilla, 00000
    Colombia

    Site Not Available

  • Centro de Investigacion en Reumatologia y Especialdades Medicas SAS. CIREEM

    Bogota, 110221
    Colombia

    Site Not Available

  • Fundación Instituto de Reumatología Fernando Chalem

    Bogota, 111211
    Colombia

    Site Not Available

  • Riesgo de Fractura S.A.

    Bogota, 110221
    Colombia

    Site Not Available

  • Riesgo de Fractura S.A.

    Bogota D.C.,
    Colombia

    Site Not Available

  • Servimed S.A.S.

    Bucaramanga, 680003
    Colombia

    Site Not Available

  • Clinica de Artritis Temprana S.A.

    Cali, 00000
    Colombia

    Site Not Available

  • Healthy Medical Center SAS

    Zipaquirá,
    Colombia

    Site Not Available

  • Revmatologicky Ustav

    Praha, 128 50
    Czech Republic

    Site Not Available

  • MEDICAL PLUS, s.r.o.

    Uherske Hradiste,
    Czech Republic

    Site Not Available

  • Charité Research Organisation GmbH

    Berlin, 10117
    Germany

    Site Not Available

  • Praxis Dres. Jung

    Deggingen,
    Germany

    Site Not Available

  • Centro Clinico de Especialidades Medicas

    Ciudad De Guatemala, 01011
    Guatemala

    Site Not Available

  • Centro de Estudio y Tratamiento de Enfermedades Reumaticas

    Guatemala,
    Guatemala

    Site Not Available

  • Clinica Privada de Reumatologia Dr. Henry Briones Alvarado

    Guatemala,
    Guatemala

    Site Not Available

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino; Radiology

    Torino, Abruzzo 10126
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi; U.O. Malattie Infettive

    Bologna, Emilia-Romagna 40138
    Italy

    Site Not Available

  • Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele

    Catania, Sicilia 95123
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Careggi - SOD Reumatologia

    Firenze, Toscana 50134
    Italy

    Site Not Available

  • Centro de Investigacion del Noroeste SC

    Tijuana, BAJA California 22010
    Mexico

    Site Not Available

  • Investigacion y Biomedicina de Chihuahua, Sociedad Civil

    Chichuahua, Chihuahua 31000
    Mexico

    Site Not Available

  • Centro Integral en Reumatología S.A. de C.V. (CIRSA)

    Guadalajara, Jalisco 44160
    Mexico

    Site Not Available

  • Centro Médico de las Américas

    Merida, Yucatan
    Mexico

    Site Not Available

  • Unidad de Atencion Medica e Investigacion en Salud (UNAMIS)

    Mérida, Yucatan 97070
    Mexico

    Site Not Available

  • Javier Orozco Private Practice

    Guadalajara, 44650
    Mexico

    Site Not Available

  • Centro de Investigación; Artritis y Osteoporosis S.C.

    Mexicali, 21200
    Mexico

    Site Not Available

  • Hospital Angeles Lindavista

    Mexico, 07760
    Mexico

    Site Not Available

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, 64460
    Mexico

    Site Not Available

  • Policlinica Medica de Queretaro S.C.

    Queretaro, 76000
    Mexico

    Site Not Available

  • Hogar Clínica San Juan de Dios

    Arequipa,
    Peru

    Site Not Available

  • Hospital Nacional Almanzor Aguinaga Asenjo; Unidad De Investigacion Del Servicio De Oncologia Medica

    Chiclayo, CIX
    Peru

    Site Not Available

  • Clinica Internacional Sede Lima

    LIma, Lima 01
    Peru

    Site Not Available

  • Hospital Guillermo Almenara Irigoyen Hospital Guillermo Almenara Irigoyen Hospital Guillermo Almen

    La Victoria, Lima 13
    Peru

    Site Not Available

  • Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

    Lima, Lima 41
    Peru

    Site Not Available

  • Instituto de Ginecología y Reproducción

    Lima,
    Peru

    Site Not Available

  • Niepubliczny Zakład Opieki Zdrowotnej "Vesalius" Sp. z o.o.

    Krakw, 31-216
    Poland

    Site Not Available

  • Medyczne Centrum Hetmanska

    Poznan, 60-218
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny nr 1 im. prof.Tadeusza Sokolowskiego

    Szczecin, 71-242
    Poland

    Site Not Available

  • Reumatika - Centrum Reumatologii Niepubliczny Zakład Opieki Zdrowotnej

    Warszawa, 02-653
    Poland

    Site Not Available

  • Hospital Universitario Marques de Valdecilla; Servicio de Reumatologia

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Complexo Hospitalario Universitario A Coruña; Servicio de Reumatología

    A Coruña, LA Coruña 15006
    Spain

    Site Not Available

  • Hospital de Basurto; Servicio de Reumatologia

    Bilbao, Vizcaya 48013
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañon; Servicio de Reumatología

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario de la Princesa; Servicio de Reumatologia

    Madrid, 28006
    Spain

    Site Not Available

  • Hospital Regional Universitario Carlos Haya; Servicio de Psiquiatria

    Malaga, 29010
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofía; Servicio de Aparato Digestivo

    Murcia, 30003
    Spain

    Site Not Available

  • New Queen Elizabeth Hospital Birmingham

    Birmingham, B15 2WB
    United Kingdom

    Site Not Available

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

  • Glasgow Royal Infirmary

    Glasgow, G4 0SF
    United Kingdom

    Site Not Available

  • Barts Hospital; Department of Rheumatology

    London, E1 4DG
    United Kingdom

    Site Not Available

  • Guys and St Thomas NHS Foundation Trust, Guys Hospital

    London, SE1 9RT
    United Kingdom

    Site Not Available

  • Manchester Royal Infirmary; Kellgren Centre for Rheumatology

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

  • Newcastle U. Medical School; Institute of Cellular Medicine

    Newcastle,
    United Kingdom

    Site Not Available

  • University of Oxford, Botnar Research Centre

    Oxford,
    United Kingdom

    Site Not Available

  • Derriford Hospital

    Plymouth, PL6 8DH
    United Kingdom

    Site Not Available

  • Lister Hospital; Rheumatology Dept

    Stevenage, SG1 4AB
    United Kingdom

    Site Not Available

  • Pinnacle Research Group; Llc, Central

    Anniston, Alabama 36207
    United States

    Site Not Available

  • Arizona Arthritis & Rheumatology Associates, P.C.

    Glendale, Arizona 85306
    United States

    Site Not Available

  • Arizona Arthritis and Rheuma

    Mesa, Arizona 85202
    United States

    Site Not Available

  • Arizona Arthritis & Rheumatology Research, PLLC

    Phoenix, Arizona 85037
    United States

    Site Not Available

  • Medvin Clinical Research

    Covina, California 91723
    United States

    Site Not Available

  • University of California San Diego

    La Jolla, California 92093
    United States

    Site Not Available

  • Advanced Medical Research, LLC

    Lakewood, California 90712
    United States

    Site Not Available

  • Stanford hospital & Clinics; Investigational Drug Services

    Stanford, California 94304
    United States

    Site Not Available

  • Omega Research Consultants LLC

    DeBary, Florida 32713-1817
    United States

    Site Not Available

  • San Marcus Research Clinic, Inc.

    Hialeah, Florida 33015-5110
    United States

    Site Not Available

  • Millenium Research

    Ormond Beach, Florida 32174
    United States

    Site Not Available

  • Alastair C. Kennedy, M.D., P.A.

    Vero Beach, Florida 32960-4891
    United States

    Site Not Available

  • Ochsner Clin Foundatn; Clin Res

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Clinical Pharmacology Study Group

    Worcester, Massachusetts 01610
    United States

    Site Not Available

  • Shores Rheumatology PC

    Saint Clair Shores, Michigan 48080
    United States

    Site Not Available

  • Jackson Arthritis Clinic

    Flowood, Mississippi 39232
    United States

    Site Not Available

  • Arthritis & Osteoporosis Associates

    Freehold, New Jersey
    United States

    Site Not Available

  • Atlantic Coast Rheumatology

    Toms River, New Jersey 08755
    United States

    Site Not Available

  • Ocean Rheumatology

    Toms River, New Jersey 08775
    United States

    Site Not Available

  • Albuquerque Center For Rheumatology

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Albuquerque Clinical Trials

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Saint Lawrence Health System; Rheumatology

    Canton, New York 13617
    United States

    Site Not Available

  • Paramount Medical Research

    Middleburg Heights, Ohio 44130
    United States

    Site Not Available

  • Oklahoma Center For Arthritis Therapy & Research

    Tulsa, Oklahoma 74104
    United States

    Site Not Available

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Advanced Rheumatology & Arthritis Research Center

    Wexford, Pennsylvania 15090
    United States

    Site Not Available

  • Low Country Rheumatology, PA

    Charleston, South Carolina 29406
    United States

    Site Not Available

  • Columbia Arthritis Center (Partnership Practice)

    Columbia, South Carolina 29204
    United States

    Site Not Available

  • West Tennessee Research Institute

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • Adriana Pop-Moody MD Clinic PA

    Corpus Christi, Texas 78404
    United States

    Site Not Available

  • Metroplex Clinical Research

    Dallas, Texas 75231
    United States

    Site Not Available

  • Accurate Clinical Research

    Houston, Texas 77089
    United States

    Site Not Available

  • Pioneer Research Solutions

    Houston, Texas 077099
    United States

    Site Not Available

  • Southwest Rheumatology

    Mesquite, Texas 75150
    United States

    Site Not Available

  • Accurate Clinical Research, Inc

    Stafford, Texas 77477
    United States

    Site Not Available

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