Safety, Tolerability, and Efficacy of GS-9876 in Participants With Active Rheumatoid Arthritis on Background Therapy With Methotrexate

Last updated: August 21, 2018
Sponsor: Gilead Sciences
Overall Status: Completed

Phase

2

Condition

Dermatomyositis (Connective Tissue Disease)

Rheumatoid Arthritis

Musculoskeletal Diseases

Treatment

N/A

Clinical Study ID

NCT02885181
GS-US-379-1582
2016-001496-75
  • Ages 18-75
  • All Genders

Study Summary

The primary objective of this study is to evaluate the effect of GS-9876 versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) in participants with active RA as measured by change from baseline in Disease Activity Score for 28 joint count using C‑reactive protein (CRP) (DAS28 (CRP)) at Week 12.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Active RA disease as defined by: a tender joint count (TJC) of ≥ 6 (out of 68), aswollen joint count (SJC) of ≥ 6 (out of 66) at screening and Day 1

  • Inadequate response to treatment with oral or parenteral methotrexate (MTX) 7.5 to 25mg/week continuously for at least 12 weeks

  • No evidence of active or latent tuberculosis

Exclusion

Key Exclusion Criteria:

  • Prior treatment with B-cell depleting agents (eg, rituximab), unless more than 6months prior to the first dose of study drug and documented return of CD19+ cells atscreening

  • Prior treatment with any commercially available or investigational spleen tyrosinekinase (SYK) inhibitor

  • Concurrent treatment with any other conventional synthetic DMARD (csDMARD) other thanMTX and/or hydroxychloroquine (HCQ) (prior csDMARD treatment allowed if appropriatewash out as defined in the protocol)

  • Concurrent treatment with any biological disease modifying anti-rheumatic drug (bDMARD)(prior bDMARD treatment allowed if appropriate wash out as defined in theprotocol). Prior failure to treatment with bDMARDs is not an exclusion criterion. Note: Other protocol defined Inclusion/ Exclusion criteria may apply.

Study Design

Total Participants: 83
Study Start date:
September 21, 2016
Estimated Completion Date:
September 20, 2017

Connect with a study center

  • MHAT-Plovdiv AD

    Plovdiv, 4000
    Bulgaria

    Site Not Available

  • Umhat Kaspela

    Plovdiv, 4003
    Bulgaria

    Site Not Available

  • NMTH Tsar Boris III

    Sofia, 1233
    Bulgaria

    Site Not Available

  • Revmatologicka ambulance Dr. Zuzana Stejfova

    Praha, 14000
    Czech Republic

    Site Not Available

  • PV-Medical S.R.O

    Zlin, 760001
    Czech Republic

    Site Not Available

  • A-Shine s.r.o.

    Plzen, 31200
    Czechia

    Site Not Available

  • Medical Plus, S.R.O.

    Uherske Hradiste, 68601
    Czechia

    Site Not Available

  • LLC Arensia Exploratory Medicine

    T'bilisi, 0112
    Georgia

    Site Not Available

  • Obudai Egeszsegugyi Centrum

    Budapest, 1036
    Hungary

    Site Not Available

  • Flor Ferenc County Hospital

    Kistarcsa, 2143
    Hungary

    Site Not Available

  • ARENSIA Exploratory Medicine Phase I Unit, Republican Clinical Hospital

    Chisinau, MD-2025
    Moldova, Republic of

    Site Not Available

  • ClinicMed Badurski i wspolnicy Spolka Jawna

    Bialystok, 15-879
    Poland

    Site Not Available

  • Centrum Kliniczno - Badawcze

    Elblag, 82-300
    Poland

    Site Not Available

  • Grazyna Pulka Specjalistyczny Osrodek ALL-MED

    Krakow, 31-023
    Poland

    Site Not Available

  • Kharkiv City Hospital 8

    Kharkiv, 140176
    Ukraine

    Site Not Available

  • Medical Center_Clinic of International Institute of clinical Studies

    Kyiv, 2068
    Ukraine

    Site Not Available

  • Lviv Regional Clinical Hospital Dept of Rheumatology D.Halytskyi Lviv NMU

    L'viv, 79010
    Ukraine

    Site Not Available

  • Global Research Management

    Glendale, California 91204
    United States

    Site Not Available

  • Coalition of Inclusive Medicine

    Los Angeles, California 90020
    United States

    Site Not Available

  • Stanford University

    Palo Alto, California 94305
    United States

    Site Not Available

  • UC Davis Health System

    Sacramento, California 95817
    United States

    Site Not Available

  • Clinical Research of South Florida

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Omega Research Consultants

    DeBary, Florida 32713
    United States

    Site Not Available

  • University Of Florida, Jacksonville

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • Sarasota Arthritis Research Center

    Sarasota, Florida 34239
    United States

    Site Not Available

  • Medical Associates of North Georgia

    Canton, Georgia 30114
    United States

    Site Not Available

  • Indiana University

    Bloomington, Indiana 47405
    United States

    Site Not Available

  • Center For Arthritis and Osteoporosis

    Elizabethtown, Kentucky 42701
    United States

    Site Not Available

  • Tulane University

    New Orleans, Louisiana 70118
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Clinical Research Professionals, LLC

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Albuquerque Center For Rheumatology

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Clinical Research Center of Reading LLC

    Wyomissing, Pennsylvania 19610
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • Accurate Clinical Management - Najam

    Houston, Texas 77084
    United States

    Site Not Available

  • Accurate Clinical Management

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Accurate Clinical Research Inc.

    Stafford, Texas 77477
    United States

    Site Not Available

  • Crossroads Clinical Research, LLC

    Victoria, Texas 77901
    United States

    Site Not Available

  • Medical Center Research LLC

    Webster, Texas 77598
    United States

    Site Not Available

  • McGuire VA Medical Center

    Richmond, Virginia 23249
    United States

    Site Not Available

  • Swedish Medical Center

    Seattle, Washington 98104
    United States

    Site Not Available

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