A Study to Assess the Effect of Tocilizumab Plus Methotrexate on Safety and Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis

Last updated: May 13, 2015
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

3

Condition

Rheumatoid Arthritis

Dermatomyositis (Connective Tissue Disease)

Musculoskeletal Diseases

Treatment

N/A

Clinical Study ID

NCT00754572
ML21530
  • Ages > 18
  • All Genders

Study Summary

This single arm, open-label study will assess the safety and efficacy with regar d to reduction of signs and symptoms of treatment with tocilizumab in combinatio n with methotrexate, in patients with moderate to severe active rheumatoid arthr itis. Patients will receive tocilizumab 8mg/kg iv, every 4 weeks and methotrexat e 10-25mg weekly. The anticipated time on study treatment is 3-12 months, and th e target sample size is <500 individuals.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patients >=18 years with moderate to severe active RA for at least 6 months;

  • swollen joint count >=6 (66 joint count) and tender joint count >=8 (68 joint count)at screening;

  • inadequate response to stable dose of MTX;

  • patients of reproductive potential must be using a reliable means of contraception.

Exclusion

Exclusion Criteria:

  • rheumatic autoimmune disease other than RA;

  • patients with functional class IV RA;

  • diagnosis of juvenile idiopathic or rheumatoid arthritis before age 16 or a history ofcurrent inflammatory joint disease other than RA;

  • prior treatment failure with anti-tumor necrosis factor agent;

  • pregnant or breastfeeding women.

Study Design

Total Participants: 418
Study Start date:
February 01, 2009
Estimated Completion Date:
October 31, 2012

Connect with a study center

  • Buenos Aires, C1280AEB
    Argentina

    Site Not Available

  • empty

    Córdoba, 5000
    Argentina

    Site Not Available

  • Córdoba, X5000FAL
    Argentina

    Site Not Available

  • San Miguel, T4000AXL
    Argentina

    Site Not Available

  • San Miguel De Tucuman, T4000IFP
    Argentina

    Site Not Available

  • empty

    San Miguel de Tucman, T4000IFP
    Argentina

    Site Not Available

  • empty

    Tucuman, 4000
    Argentina

    Site Not Available

  • Salvador, BA 40050-410
    Brazil

    Site Not Available

  • Fortaleza, CE 60170001
    Brazil

    Site Not Available

  • Brasilia, DF 70840-901
    Brazil

    Site Not Available

  • Vitoria, ES 29043-910
    Brazil

    Site Not Available

  • Belo Horizonte, MG 30150-221
    Brazil

    Site Not Available

  • Juiz de Fora, MG 36010-570
    Brazil

    Site Not Available

  • Recife, PE 50000-000
    Brazil

    Site Not Available

  • Curtiba, PR 80030-110
    Brazil

    Site Not Available

  • Rio de Janeiro, RJ 20551-030
    Brazil

    Site Not Available

  • Caxias do Sul, RS 95070-560
    Brazil

    Site Not Available

  • Porto Alegre, RS 90035-003
    Brazil

    Site Not Available

  • Florianopolis, SC 88040-970
    Brazil

    Site Not Available

  • Botucatu, SP 18600-400
    Brazil

    Site Not Available

  • Campinas, SP 13083-888
    Brazil

    Site Not Available

  • Ribeirao Preto, SP 14048-900
    Brazil

    Site Not Available

  • Santo Andre, SP 09060-650
    Brazil

    Site Not Available

  • Sao Jose do Rio Preto, SP 15090-000
    Brazil

    Site Not Available

  • Sao Paulo, SP 04027-000
    Brazil

    Site Not Available

  • empty

    Caixa, 18618-970
    Brazil

    Site Not Available

  • empty

    Curitiba, 80060-240
    Brazil

    Site Not Available

  • empty

    Ribeirão Preto, 3900
    Brazil

    Site Not Available

  • empty

    Ribeirão Preto, 3900
    Brazil

    Site Not Available

  • empty

    São José Do Rio Preto, 15091-000
    Brazil

    Site Not Available

  • empty

    São Paulo, 4029000
    Brazil

    Site Not Available

  • empty

    São José Do Rio Preto, 15091-000
    Brazil

    Site Not Available

  • empty

    São Paulo, 4029000
    Brazil

    Site Not Available

  • empty

    Victoria, 29043910
    Brazil

    Site Not Available

  • Concepcion, 1436
    Chile

    Site Not Available

  • Santiago, 8380000
    Chile

    Site Not Available

  • Temuco, 4780000
    Chile

    Site Not Available

  • Barranquilla,
    Colombia

    Site Not Available

  • Bogota,
    Colombia

    Site Not Available

  • empty

    Bogotá,
    Colombia

    Site Not Available

  • Bogotá,
    Colombia

    Site Not Available

  • Bucaramanga, 0
    Colombia

    Site Not Available

  • Cali,
    Colombia

    Site Not Available

  • Chia-Cundinamarca,
    Colombia

    Site Not Available

  • Medellin,
    Colombia

    Site Not Available

  • empty

    Medellín, 0
    Colombia

    Site Not Available

  • Medellín, 0
    Colombia

    Site Not Available

  • Cartago, 0
    Costa Rica

    Site Not Available

  • Heredia, 00
    Costa Rica

    Site Not Available

  • San Jose, 10103
    Costa Rica

    Site Not Available

  • empty

    San José,
    Costa Rica

    Site Not Available

  • San José,
    Costa Rica

    Site Not Available

  • Cuenca,
    Ecuador

    Site Not Available

  • Guayaquil,
    Ecuador

    Site Not Available

  • Quito, EC170517
    Ecuador

    Site Not Available

  • Chihuahua, 31238
    Mexico

    Site Not Available

  • Guadalajara, 44650
    Mexico

    Site Not Available

  • empty

    Mexico, 06700
    Mexico

    Site Not Available

  • Mexico City, 14140
    Mexico

    Site Not Available

  • Miexico City, 06700
    Mexico

    Site Not Available

  • Queretaro, 76000
    Mexico

    Site Not Available

  • San Luis Potosi, 78240
    Mexico

    Site Not Available

  • Arequipa, 04001
    Peru

    Site Not Available

  • Jesus Maria,
    Peru

    Site Not Available

  • Lima, LIMA 14
    Peru

    Site Not Available

  • San Isidro, Lima 27
    Peru

    Site Not Available

  • Montevideo, 11000
    Uruguay

    Site Not Available

  • Barquisimeto, 3005
    Venezuela

    Site Not Available

  • Caracas, 1010
    Venezuela

    Site Not Available

  • Maracaibo, 4001
    Venezuela

    Site Not Available

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