Study Conducted in Subjects With Rheumatoid Arthritis Who Have Moderate to Severe Disease Activity Despite Methotrexate Therapy With or Without Other Non Biologic Disease Modifying Antirheumatic Drugs (DMARDs)for at Least 12 Weeks Prior to Screening

Last updated: May 25, 2016
Sponsor: Pfizer
Overall Status: Completed

Phase

4

Condition

Arthritis And Arthritic Pain

Rheumatoid Arthritis

Dermatomyositis (Connective Tissue Disease)

Treatment

N/A

Clinical Study ID

NCT01578850
B1801315
B1801315
2011-005448-87
  • Ages 18-70
  • All Genders

Study Summary

To compare the maintenance of efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with or without other disease modifying antirheumatic drugs therapy with that of methotrexate with or without other disease modifying antirheumatic drugs therapy at Week 52 in subjects with moderately to severely active rheumatoid arthritis who have achieved low disease activity after 24 weeks of therapy with open label etanercept 50 mg once weekly plus MTX with or without other disease modifying antirheumatic drugs therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject has a minimum 1 year history/diagnosis of rheumatoid arthritis based on the 1987 American College of Rheumatology (ACR) Revised criteria for RA.

  2. Subject must have active rheumatoid arthritis despite methotrexate (MTX) therapy of ≥10 mg/wk for at least 12 weeks. The MTX dose must be stable for at least 4 weeksimmediately prior to screening.

Exclusion

Exclusion Criteria:

  1. Subjects who used any of the following systemic treatments during the washout periodsgiven below:

  2. Oral corticosteroid dose of prednisone >7.5 mg/day (or equivalent) or a change indose within 28 days of baseline.

  3. Treatment with more than 1 NSAID within 14 days at baseline.

  4. Methotrexate dose greater than 25 mg/week, or change in the dose of methotrexatewithin 28 days of baseline.

  5. Subjects will be allowed to continue the following non biologic DMARDs:sulfasalazine, hydroxychloroquine, and leflumomide. All other non-biologic DMARDs (including but not limited to gold, penicillamine, azathioprine,cyclophospamide), and biologic DMARDs must have been discontinued at least 2months prior to Week 1.

  6. Any biologic B cell depleting agent (eg, rituximab) within 2 years of Week 1.

  7. Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.

  8. Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.

Study Design

Total Participants: 491
Study Start date:
July 01, 2012
Estimated Completion Date:
March 31, 2015

Connect with a study center

  • Hospital Santa Izabel - Santa Casa de Misericórdia da Bahia

    Salvador, Bahia 40050-410
    Brazil

    Site Not Available

  • CIP (Centro Internacional de Pesquisa)

    Goiania, Goiás 74110-120
    Brazil

    Site Not Available

  • CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos LTDA

    Sao Paulo, SP 04209-003
    Brazil

    Site Not Available

  • Research Center

    Juiz de Fora,
    Brazil

    Site Not Available

  • Guangdong General Hospital

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • Chinese Academy of Medical Sciences - Peking Union Medical C

    Beijing, 100050
    China

    Site Not Available

  • Shanghai Changhai Hospital[Rheumatology &Immunology]

    Shanghai, 200433
    China

    Site Not Available

  • Shanghai Changning District Guanghua Hospital of Traditional Chinese and Western Medicine

    Shanghai, 200052
    China

    Site Not Available

  • Centro Integral de reumatolo[Gerencia / Representante Legal]

    Barranquilla, Atlántico 99999
    Colombia

    Site Not Available

  • Fundacion Instituto de Reumatologia Fernando Chalem

    Bogota, Cundinamarca
    Colombia

    Site Not Available

  • Fundacion Instituto de Reumatologia Fernando Chalem

    Bogota DC, Cundinamarca
    Colombia

    Site Not Available

  • Hospital Pablo Tobon Uribe (HPTU)

    Antioquia,
    Colombia

    Site Not Available

  • Revmatologicka poradna III. Interni nefrologicka, revmatologicka a endokrinologicka klinika

    Olomouc, 775 20
    Czech Republic

    Site Not Available

  • Revmatologicky ustav

    Praha 2, 12850
    Czech Republic

    Site Not Available

  • Revmatologicka ambulance

    Praha 5, 150 06
    Czech Republic

    Site Not Available

  • PV-Medical s.r.o.

    Zlin, 760 01
    Czech Republic

    Site Not Available

  • New University Hospital, Alexandria Clinical Research Center

    Alexandria, Al Iskandariyah 21131
    Egypt

    Site Not Available

  • Al Azhar University Hospital [Rheumatology]

    Cairo, Al Qahirah 12111
    Egypt

    Site Not Available

  • Ain Shams University/Al Demerdash Hospital/Diabetology Unit

    Cairo,
    Egypt

    Site Not Available

  • Budai Irgalmasrendi Korhaz

    Budapest, 1023
    Hungary

    Site Not Available

  • Magyar Honvédség Egészségügyi Központ

    Budapest, 1062
    Hungary

    Site Not Available

  • Pharmaceutical Research Center- PRC. Jordan University of Science and Technology

    Irbid, 22110
    Jordan

    Site Not Available

  • American University of Beirut Medical Center

    Beirut, 1107-2020
    Lebanon

    Site Not Available

  • Queen Elizabeth Hospital

    Kota Kinabalu, Sabah 88586
    Malaysia

    Site Not Available

  • Hopsital Putrajaya [Medicine]

    Putrajaya, Wilayah Persekutuan Putrajaya 62250
    Malaysia

    Site Not Available

  • University Malaysia Medical Centre

    Kuala Lumpur, 59100
    Malaysia

    Site Not Available

  • Centro de Investigación y Atención Integral de Durango, SC

    Durango, Durango / Mexico 34080
    Mexico

    Site Not Available

  • Centro de Alta Especialidad en Reumatología e Investigación

    San Luis de Potosi, San Luis Potosí / Mexico 78213
    Mexico

    Site Not Available

  • Centro Medico Las Americas

    Merida, Yucatan
    Mexico

    Site Not Available

  • Hospital Central

    San Luis Potosi, 78290
    Mexico

    Site Not Available

  • Centro de Alta Especialidad en Reumatología e Investigación

    San Luis Potosí, 78213
    Mexico

    Site Not Available

  • De La Salle University Health Sciences Campus- Clinical Epidemiology Unit

    Dasmarinas, Cavite 4114
    Philippines

    Site Not Available

  • St. Luke's Mecical Center

    Quezon, Manila 1102
    Philippines

    Site Not Available

  • Angeles University Foundation Medical Center

    Angeles City, Pampanga
    Philippines

    Site Not Available

  • Chong Hua Hospital, Medical Arts Center

    Cebu City, 6000
    Philippines

    Site Not Available

  • UP-Philippine General Hospital, Medical Research Laboratory, Medicine Department,

    Manila, 1000
    Philippines

    Site Not Available

  • Hamad Medical Corporation

    Doha, 3050
    Qatar

    Site Not Available

  • Spitalul Clinic "Dr.I Cantacuzino" [Sectia Clinica Medicina

    Bucharest, Bucureşti 20475
    Romania

    Site Not Available

  • Spitalul Judetean

    Baia Mare, Maramure 4800
    Romania

    Site Not Available

  • Spitalul Clinic Judetean de Urgenta Brasov

    Brasov, 500365
    Romania

    Site Not Available

  • Spitalul Clinic de Recuperare

    Iasi, 700656
    Romania

    Site Not Available

  • Spitalul Clinic Judetean de Urgenta Targu Mures

    Tg Mures, 540136
    Romania

    Site Not Available

  • LLC Research Medical Complex Your Health based on City Clinical Hospital Number 7 (Actual address)

    Kazan, 420137
    Russian Federation

    Site Not Available

  • LLC Research Medical Complex Your Health based on City Clinical Hospital Number 7(Legal address)

    Kazan, 420097
    Russian Federation

    Site Not Available

  • Krasnoyarsk State Medical University named after Professor V.F. Voyno-Yasenetsky

    Krasnoyarsk, 660014
    Russian Federation

    Site Not Available

  • Krasnoyarsk State Medical University named after Professor V.F. Voyno-Yasenetsky,

    Krasnoyarsk, 660022
    Russian Federation

    Site Not Available

  • FSBSI "Scientific Research Institute of Rheumatology n. a. V.A. Nasonova"

    Moscow, 115522
    Russian Federation

    Site Not Available

  • LLC Institute of Medical Trials (Actual address)

    St. Petersburg, 196084
    Russian Federation

    Site Not Available

  • Al Habib Hospital, Reuhmatology

    Riyadh,
    Saudi Arabia

    Site Not Available

  • Universitas Hospital [Cardiololgy]

    Bloemfontein, Free State 9301
    South Africa

    Site Not Available

  • Vincent Pallotti Hospital

    Cape Town, 7405
    South Africa

    Site Not Available

  • Winelands Medical Research Centre

    Stellenbosch, 7600
    South Africa

    Site Not Available

  • Cathay General Hospital

    Taiwan, Taoyuan 330
    Taiwan

    Site Not Available

  • Buddhist Tzu Chi General Hospital - Dalin Branch

    Chia-Yi, 62247
    Taiwan

    Site Not Available

  • China Medical University Hospital, Division of Rheumatology, Allergy and Immunology

    Taichung, 404
    Taiwan

    Site Not Available

  • Taipei Medical University Hospital

    Taipei, 11042
    Taiwan

    Site Not Available

  • Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine,

    Amphoe Mueang, Chiang Mai 50200
    Thailand

    Site Not Available

  • Siriraj Hospital [Rheumatology]

    Bangkok, 10700
    Thailand

    Site Not Available

  • Khon Kaen University (KKU) - Faculty of Medicine

    Khon Kaen, 40002
    Thailand

    Site Not Available

  • Songklanagarind Hospital

    Songkla, 90110
    Thailand

    Site Not Available

  • Republican Clinical Hospital, Department of Internal Medicine #2 of Crimean State Medical University

    Simferopol, Crimea 95017
    Ukraine

    Site Not Available

  • Komunalnyi zaklad Kyivskoi oblasnoi rady "Kyivska oblasna klinichna likarnia"

    Kyiv, 04107
    Ukraine

    Site Not Available

  • Odessa Regional Clinical Hospital, Outpatient Department

    Odessa, 65025
    Ukraine

    Site Not Available

  • Municipal Institution of Ternopil Regional Council Ternopil University Hospital

    Ternopil, 46000
    Ukraine

    Site Not Available

  • Vinnitsa Regional Clinical Hospital n.a. Pirogov, Department of Faculty Therapy of Vinnitsa NMU

    Vinnitsa, 21018
    Ukraine

    Site Not Available

  • Al Baraha Hospital

    Dubai,
    United Arab Emirates

    Site Not Available

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