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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

NCT ID: NCT03001219

Last Updated: 2020-01-29

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-22

Study Completion Date

2018-11-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part 1: Placebo

Participants will receive placebo (matched to RO7123520) on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate.

Group Type PLACEBO_COMPARATOR

Anti-TNF-alpha

Intervention Type DRUG

Participants will continue their pre-trial anti-TNF-alpha therapy at a stable dose.

Methotrexate

Intervention Type DRUG

Participants will continue their pre-trial methotrexate therapy at a stable dose.

Placebo

Intervention Type DRUG

Participants will receive intravenous infusion of placebo.

Part 1: RO7123520

Participants will receive RO7123520 on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate.

Group Type EXPERIMENTAL

Anti-TNF-alpha

Intervention Type DRUG

Participants will continue their pre-trial anti-TNF-alpha therapy at a stable dose.

Methotrexate

Intervention Type DRUG

Participants will continue their pre-trial methotrexate therapy at a stable dose.

RO7123520

Intervention Type DRUG

Participants will receive intravenous infusion of RO7123520.

Part 2: Placebo

Participants will receive placebo (matched to RO7123520) on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate.

Group Type PLACEBO_COMPARATOR

Anti-TNF-alpha

Intervention Type DRUG

Participants will continue their pre-trial anti-TNF-alpha therapy at a stable dose.

Methotrexate

Intervention Type DRUG

Participants will continue their pre-trial methotrexate therapy at a stable dose.

Placebo

Intervention Type DRUG

Participants will receive intravenous infusion of placebo.

Part 2: RO7123520

Participants will receive RO7123520 on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate.

Group Type EXPERIMENTAL

Anti-TNF-alpha

Intervention Type DRUG

Participants will continue their pre-trial anti-TNF-alpha therapy at a stable dose.

Methotrexate

Intervention Type DRUG

Participants will continue their pre-trial methotrexate therapy at a stable dose.

RO7123520

Intervention Type DRUG

Participants will receive intravenous infusion of RO7123520.

Part 3: Placebo

Participants will receive placebo (matched to RO7123520) on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate.

NOTE: Part 3 was not conducted.

Group Type PLACEBO_COMPARATOR

Anti-TNF-alpha

Intervention Type DRUG

Participants will continue their pre-trial anti-TNF-alpha therapy at a stable dose.

Methotrexate

Intervention Type DRUG

Participants will continue their pre-trial methotrexate therapy at a stable dose.

Placebo

Intervention Type DRUG

Participants will receive intravenous infusion of placebo.

Part 3: RO7123520

Participants will receive RO7123520 on Days 1, 14, 28, and 56 with pre-trial anti-TNF-alpha and methotrexate.

NOTE: Part 3 was not conducted.

Group Type EXPERIMENTAL

Anti-TNF-alpha

Intervention Type DRUG

Participants will continue their pre-trial anti-TNF-alpha therapy at a stable dose.

Methotrexate

Intervention Type DRUG

Participants will continue their pre-trial methotrexate therapy at a stable dose.

RO7123520

Intervention Type DRUG

Participants will receive intravenous infusion of RO7123520.

Interventions

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Anti-TNF-alpha

Participants will continue their pre-trial anti-TNF-alpha therapy at a stable dose.

Intervention Type DRUG

Methotrexate

Participants will continue their pre-trial methotrexate therapy at a stable dose.

Intervention Type DRUG

Placebo

Participants will receive intravenous infusion of placebo.

Intervention Type DRUG

RO7123520

Participants will receive intravenous infusion of RO7123520.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of adult-onset RA as defined by the ACR 2010 criteria, for at least 6 months before screening
* Moderately to severely active RA as defined by at least 4/28 tender joints and at least 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-enhanced magnetic 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 (up to 2-3 times weekly) for short-term relief of pain and participants on regular NSAID use (on stable dose for ≥ 4 weeks)

Exclusion Criteria

* Parenteral glucocorticoids administration (intramuscular, IV) of ≥50 mg within 6 weeks or less than or equal to (≤) 50 milligrams (mg) within 4 weeks prior to planned randomization, or scheduled parenteral administrations during the study
* Joint(s) injected with intra-articular glucocorticoids or hyaluronic acid within 6 weeks 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 activity challenging 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 fungal infections
* History of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Pinnacle Research Group; Llc, Central

Anniston, Alabama, United States

Site Status

Arizona Arthritis & Rheumatology Associates, P.C.

Glendale, Arizona, United States

Site Status

Arizona Arthritis and Rheuma

Mesa, Arizona, United States

Site Status

Arizona Arthritis & Rheumatology Research, PLLC

Phoenix, Arizona, United States

Site Status

Medvin Clinical Research

Covina, California, United States

Site Status

University of California San Diego

La Jolla, California, United States

Site Status

Advanced Medical Research, LLC

Lakewood, California, United States

Site Status

Stanford hospital & Clinics; Investigational Drug Services

Stanford, California, United States

Site Status

Omega Research Consultants LLC

DeBary, Florida, United States

Site Status

San Marcus Research Clinic, Inc.

Hialeah, Florida, United States

Site Status

Millenium Research

Ormond Beach, Florida, United States

Site Status

Clinical Pharmacology Study Group

Worcester, Massachusetts, United States

Site Status

Shores Rheumatology PC

Saint Clair Shores, Michigan, United States

Site Status

Arthritis & Osteoporosis Associates

Freehold, New Jersey, United States

Site Status

Atlantic Coast Rheumatology

Toms River, New Jersey, United States

Site Status

Ocean Rheumatology

Toms River, New Jersey, United States

Site Status

Albuquerque Center For Rheumatology

Albuquerque, New Mexico, United States

Site Status

Albuquerque Clinical Trials

Albuquerque, New Mexico, United States

Site Status

Saint Lawrence Health System; Rheumatology

Canton, New York, United States

Site Status

Paramount Medical Research

Middleburg Heights, Ohio, United States

Site Status

Altoona Center For Clinical Research

Duncansville, Pennsylvania, United States

Site Status

Advanced Rheumatology & Arthritis Research Center

Wexford, Pennsylvania, United States

Site Status

Low Country Rheumatology, PA

Charleston, South Carolina, United States

Site Status

Columbia Arthritis Center (Partnership Practice)

Columbia, South Carolina, United States

Site Status

West Tennessee Research Institute

Jackson, Tennessee, United States

Site Status

Adriana Pop-Moody MD Clinic PA

Corpus Christi, Texas, United States

Site Status

Metroplex Clinical Research

Dallas, Texas, United States

Site Status

Pioneer Research Solutions

Houston, Texas, United States

Site Status

Accurate Clinical Research

Houston, Texas, United States

Site Status

Accurate Clinical Research

Houston, Texas, United States

Site Status

Southwest Rheumatology

Mesquite, Texas, United States

Site Status

Accurate Clinical Research, Inc

Stafford, Texas, United States

Site Status

Centro de Investigaciones Reumatologicas y Osteologicas

Buenos Aires, , Argentina

Site Status

Organización medica de Investi

Cap Fed, , Argentina

Site Status

Cer San Juan

San Juan, , Argentina

Site Status

Centro Medico Privado de Reumatologia; Reumathology

San Miguel, , Argentina

Site Status

Medizinische Universität Wien, Allgemeines Krankenhaus der Stadt Wien

Vienna, , Austria

Site Status

Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS

Barranquilla, , Colombia

Site Status

Centro de Investigacion en Reumatologia y Especialdades Medicas SAS. CIREEM

Bogotá, , Colombia

Site Status

Riesgo de Fractura S.A.

Bogotá, , Colombia

Site Status

Fundación Instituto de Reumatología Fernando Chalem

Bogotá, , Colombia

Site Status

Servimed S.A.S.

Bucaramanga, , Colombia

Site Status

Healthy Medical Center SAS

Zipaquirá, , Colombia

Site Status

Charité Research Organisation GmbH

Berlin, , Germany

Site Status

Centro de Estudio y Tratamiento de Enfermedades Reumaticas

Guatemala City, , Guatemala

Site Status

Clinica Privada de Reumatologia Dr. Henry Briones Alvarado

Guatemala City, , Guatemala

Site Status

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

Torino, Abruzzo, Italy

Site Status

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

Bologna, Emilia-Romagna, Italy

Site Status

Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele

Catania, Sicily, Italy

Site Status

Azienda Ospedaliero Universitaria Careggi - SOD Reumatologia

Florence, Tuscany, Italy

Site Status

Investigacion y Biomedicina de Chihuahua, Sociedad Civil

Chichuahua, Chihuahua, Mexico

Site Status

Centro de Investigacion del Noroeste SC

Tijuana, Estado de Baja California, Mexico

Site Status

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

Guadalajara, Jalisco, Mexico

Site Status

Unidad de Atencion Medica e Investigacion en Salud (UNAMIS)

Mérida, Yucatán, Mexico

Site Status

Centro Médico de las Américas

Mérida, Yucatán, Mexico

Site Status

Javier Orozco Private Practice

Guadalajara, , Mexico

Site Status

Centro de Investigación; Artritis y Osteoporosis S.C.

Mexicali, , Mexico

Site Status

Hospital Angeles Lindavista

México, , Mexico

Site Status

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, , Mexico

Site Status

Policlinica Medica de Queretaro S.C.

Querétaro, , Mexico

Site Status

Hogar Clínica San Juan de Dios

Arequipa, , Peru

Site Status

Clinica Internacional Sede Lima

Lima, , Peru

Site Status

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

Lima, , Peru

Site Status

Instituto de Ginecología y Reproducción

Lima, , Peru

Site Status

Hospital Universitario Marques de Valdecilla; Servicio de Reumatologia

Santander, Cantabria, Spain

Site Status

Complexo Hospitalario Universitario A Coruña; Servicio de Reumatología

A Coruña, LA Coruña, Spain

Site Status

Hospital de Basurto; Servicio de Reumatologia

Bilbao, Vizcaya, Spain

Site Status

Hospital Universitario de la Princesa; Servicio de Reumatologia

Madrid, , Spain

Site Status

Hospital General Universitario Gregorio Marañon; Servicio de Reumatología

Madrid, , Spain

Site Status

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

Hospital Regional Universitario Carlos Haya; Servicio de Psiquiatria

Málaga, , Spain

Site Status

Hospital Universitario Reina Sofía; Servicio de Aparato Digestivo

Murcia, , Spain

Site Status

New Queen Elizabeth Hospital Birmingham

Birmingham, , United Kingdom

Site Status

Cambridge University Hospitals NHS Foundation Trust

Cambridge, , United Kingdom

Site Status

Glasgow Royal Infirmary

Glasgow, , United Kingdom

Site Status

Barts Hospital; Department of Rheumatology

London, , United Kingdom

Site Status

Guys and St Thomas NHS Foundation Trust, Guys Hospital

London, , United Kingdom

Site Status

Newcastle U. Medical School; Institute of Cellular Medicine

Newcastle, , United Kingdom

Site Status

University of Oxford, Botnar Research Centre

Oxford, , United Kingdom

Site Status

Derriford Hospital

Plymouth, , United Kingdom

Site Status

Lister Hospital; Rheumatology Dept

Stevenage, , United Kingdom

Site Status

Countries

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United States Argentina Austria Colombia Germany Guatemala Italy Mexico Peru Spain United Kingdom

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2016-002126-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BP39261

Identifier Type: -

Identifier Source: org_study_id

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