Study To Evaluate The Safety And Efficacy Of ILV-094 In Subjects With Rheumatoid Arthritis

Last updated: September 23, 2022
Sponsor: Pfizer
Overall Status: Completed

Phase

2

Condition

Rheumatoid Arthritis

Dermatomyositis (Connective Tissue Disease)

Arthritis And Arthritic Pain

Treatment

N/A

Clinical Study ID

NCT00883896
3199K1-2001
2008-006936-37
B1981001
  • Ages > 18
  • All Genders

Study Summary

The primary objective of this study is to assess the safety and efficacy of different dose regimens of ILV-094 compared with placebo, administered subcutaneously to subjects with active rheumatoid arthritis who are taking methotrexate.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Meets the American College of Rheumatology (ACR) 1987 revised criteria forclassification of Rheumatoid Arthritis (RA) for at least 6 months prior to screening
  • Active RA at the time of screening and baseline consisting of >= 5 swollen and >= 5tender joints (28-joint count) and at least 1 of the following at screening:C-reactive protein >= 10 mg/L or Erythrocyte Sedimentation Rate >= 28 mm/h
  • Must be receiving methotrexate for at least 12 weeks, with a stable route and dose (upto 25 mg weekly) for at least 8 weeks prior to the baseline visit.

Exclusion

Exclusion Criteria:

  • Subjects with other rheumatic diseases
  • Cancer or history of cancer (other than cutaneous basal cell carcinoma and squamouscell carcinoma or in situ cervical cancer)
  • Any prior use of B cell-depleting therapy

Study Design

Total Participants: 195
Study Start date:
June 18, 2009
Estimated Completion Date:
February 18, 2011

Connect with a study center

  • AZ Jan Palfijn

    Antwerpen, 2170
    Belgium

    Site Not Available

  • Cliniques Universitaires St Luc Avenue Hippocrate 10 UCL

    Brussels, 1200
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Gent

    Gent, 9000
    Belgium

    Site Not Available

  • Reuma Instituut

    Hasselt, 3500
    Belgium

    Site Not Available

  • Chu Liege Sart Tilman B 35

    Liege, 4000
    Belgium

    Site Not Available

  • Centro de Reumatologia y Ortopedia

    Barranquilla, Atlantico
    Colombia

    Site Not Available

  • Fundacion Instituto de Reumatologia Fernando Chalem

    Bogota, Cundinamarca
    Colombia

    Site Not Available

  • Medicity S.A.S

    Bucaramanga, Santander
    Colombia

    Site Not Available

  • Servimed EU

    Bucaramanga, Santander
    Colombia

    Site Not Available

  • University Hospital Centre Rijeka

    Rijeka, 51000
    Croatia

    Site Not Available

  • University Hospital Center Zagreb

    Zagreb, 10000
    Croatia

    Site Not Available

  • Pfizer Investigational Site

    München, 80336
    Germany

    Site Not Available

  • Klinikum Innenstadt der Ludwig-Maximillians-Universität

    München, 80336
    Germany

    Site Not Available

  • Budai Irgalmasrendi Hospital

    Budapest, 1023
    Hungary

    Site Not Available

  • Obudai Egeszsegugyi Centrum Kft

    Budapest, 1036
    Hungary

    Site Not Available

  • Josa Andras Oktatokorhaz Egeszsegugyi Szolgaltato Nonprofit Kft.

    Nyiregyhaza, 4400
    Hungary

    Site Not Available

  • Markusovszky Hospital

    Szombathely, 9700
    Hungary

    Site Not Available

  • National Hospital Organization Shimoshizu National Hospital

    Yotsukaidou, Chiba 284-0003
    Japan

    Site Not Available

  • Gunma University Hospital

    Maebashi, Gunma 371-8511
    Japan

    Site Not Available

  • National Hospital Organization Sagamihara National Hospital

    Sagamihara, Kanagawa 228-8522
    Japan

    Site Not Available

  • Medical Corporation Wakoukai Kurashiki Kousai Hospital

    Kurashiki, Okayama 712-8044
    Japan

    Site Not Available

  • Institute of Rheumatology, Tokyo Women's Medical University Hospital

    Shinjyuku-ku, Tokyo 162-0054
    Japan

    Site Not Available

  • Inoue Hospital

    Gunma, 370-0053
    Japan

    Site Not Available

  • Matsubara Clinic

    Hyogo, 650-0001
    Japan

    Site Not Available

  • Matsubara Mayflower Hospital

    Hyogo, 673-1462
    Japan

    Site Not Available

  • Centro de Estudio de Investigacion Basica y Clinica S.C

    Jalisco, Guadalajara 44690
    Mexico

    Site Not Available

  • AMC

    Amsterdam, Noord-Holland 1105AZ
    Netherlands

    Site Not Available

  • Centrul Medical Terra Med

    Cluj-Napoca, Cluj 400275
    Romania

    Site Not Available

  • Centrul de Boli Reumatismale Dr. I. Stoia

    Bucuresti, 020983
    Romania

    Site Not Available

  • SC Duo Medical SRL

    Bucuresti, 010584
    Romania

    Site Not Available

  • Spitalul Clinic Colentina

    Bucuresti, 020125
    Romania

    Site Not Available

  • Spitalul Clinic Sf. Maria

    Bucuresti, 011172
    Romania

    Site Not Available

  • Spitalul Clinic Judetean de Urgenta Tg Mures

    Targu Mures, 540136
    Romania

    Site Not Available

  • Municipal Institution City Clinical Hospital #40

    Ekaterinburg, 620102
    Russian Federation

    Site Not Available

  • City Clinical Hospital # 1 n.a. Pirogov

    Moscow, 119049
    Russian Federation

    Site Not Available

  • Institute of Rheumatology of Russian academy of Medical Scie

    Moscow, 115522
    Russian Federation

    Site Not Available

  • State Educational Institution of Additional Professional Education

    Saint Petersburg, 191015
    Russian Federation

    Site Not Available

  • State Health care institution of Leningrad Regional Clinical Hospital

    Saint Petersburg, 194291
    Russian Federation

    Site Not Available

  • State education institution of higher vocational education Smolensk State Medical Academy Roszdrav

    Smolensk, 214019
    Russian Federation

    Site Not Available

  • Pfizer Investigational Site

    St. Petersburg, 194291
    Russian Federation

    Site Not Available

  • Pfizer Investigational Site

    St.Petersburg, 194291
    Russian Federation

    Site Not Available

  • State Healthcare Institution Yaroslavl Regional Clinical Hospital

    Yaroslavl, 150062
    Russian Federation

    Site Not Available

  • Arizona Arthritis & Rheumatology Research, PLLC

    Glendale, Arizona 85304
    United States

    Site Not Available

  • Desert Medical Advances

    Palm Desert, California 92260
    United States

    Site Not Available

  • Arthritis Center

    Palm Harbor, Florida 34684
    United States

    Site Not Available

  • Clinical Research Advantage, Inc.

    Sarasota, Florida 34233
    United States

    Site Not Available

  • The Arthritis Specialty Centre

    Sarasota, Florida 34233
    United States

    Site Not Available

  • Diagnostic Rheumatology and Research PC

    Indianapolis, Indiana 46227
    United States

    Site Not Available

  • Clayton Medical Research

    Saint Louis, Missouri 63117
    United States

    Site Not Available

  • Pfizer Investigational Site

    St Louis, Missouri 63117
    United States

    Site Not Available

  • Deaconess Hospital

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Clinical Research Center of Reading

    West Reading, Pennsylvania 19611
    United States

    Site Not Available

  • Clinical Research Center of Reading, LLC

    Wyomissing, Pennsylvania 19610
    United States

    Site Not Available

  • Arthritis Care and Diagnostic Center

    Dallas, Texas 75231
    United States

    Site Not Available

  • Arthritis & Osteoporosis Center of South Texas

    San Antonio, Texas 78232
    United States

    Site Not Available

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