Study To Evaluate The Safety And Efficacy Of ILV-094 In Subjects With Rheumatoid Arthritis
NCT ID: NCT00883896
Last Updated: 2022-10-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
195 participants
INTERVENTIONAL
2009-06-18
2011-02-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1
Part 1: Placebo
Placebo
Part 1: Placebo SC administration every 2 weeks X 10 weeks.
Arm 2
Part 1: 100 mg ILV-094 SC Q4W
ILV-094
Part 1: ILV-094 100 mg SC every 4 weeks (alternating ILV-094 100 mg and placebo every 2 weeks) X 10 weeks.
Arm 3
Part 1: 100 mg ILV-094 SC Q2W
ILV-094
Part 1: ILV-094 100 mg SC every 2 weeks X 10 weeks.
Arm 4
Placebo
Part 2: Placebo SC administration every 2 weeks X 10 weeks
Arm 5
Part 2: 200 mg ILV-094 SC Q2W
ILV-094
Part 2: ILV-094 200 mg SC every 2 weeks X 10 weeks
Interventions
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Placebo
Part 1: Placebo SC administration every 2 weeks X 10 weeks.
ILV-094
Part 1: ILV-094 100 mg SC every 4 weeks (alternating ILV-094 100 mg and placebo every 2 weeks) X 10 weeks.
ILV-094
Part 1: ILV-094 100 mg SC every 2 weeks X 10 weeks.
Placebo
Part 2: Placebo SC administration every 2 weeks X 10 weeks
ILV-094
Part 2: ILV-094 200 mg SC every 2 weeks X 10 weeks
Eligibility Criteria
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Inclusion Criteria
* Active RA at the time of screening and baseline consisting of \>= 5 swollen and \>= 5 tender 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 (up to 25 mg weekly) for at least 8 weeks prior to the baseline visit.
Exclusion Criteria
* Cancer or history of cancer (other than cutaneous basal cell carcinoma and squamous cell carcinoma or in situ cervical cancer)
* Any prior use of B cell-depleting therapy
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Arizona Arthritis & Rheumatology Research, PLLC
Glendale, Arizona, United States
Desert Medical Advances
Palm Desert, California, United States
Arthritis Center
Palm Harbor, Florida, United States
Clinical Research Advantage, Inc.
Sarasota, Florida, United States
The Arthritis Specialty Centre
Sarasota, Florida, United States
Diagnostic Rheumatology and Research PC
Indianapolis, Indiana, United States
Clayton Medical Research
St Louis, Missouri, United States
Deaconess Hospital
Cincinnati, Ohio, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Clinical Research Center of Reading
West Reading, Pennsylvania, United States
Clinical Research Center of Reading, LLC
Wyomissing, Pennsylvania, United States
Arthritis Care and Diagnostic Center
Dallas, Texas, United States
Arthritis & Osteoporosis Center of South Texas
San Antonio, Texas, United States
AZ Jan Palfijn
Antwerp, , Belgium
Cliniques Universitaires St Luc Avenue Hippocrate 10 UCL
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Reuma Instituut
Hasselt, , Belgium
Chu Liege Sart Tilman B 35
Liège, , Belgium
Centro de Reumatologia y Ortopedia
Barranquilla, Atlántico, Colombia
Fundacion Instituto de Reumatologia Fernando Chalem
Bogota, Cundinamarca, Colombia
Medicity S.A.S
Bucaramanga, Santander Department, Colombia
Servimed EU
Bucaramanga, Santander Department, Colombia
University Hospital Centre Rijeka
Rijeka, , Croatia
University Hospital Center Zagreb
Zagreb, , Croatia
Klinikum Innenstadt der Ludwig-Maximillians-Universität
München, , Germany
Budai Irgalmasrendi Hospital
Budapest, , Hungary
Obudai Egeszsegugyi Centrum Kft
Budapest, , Hungary
Josa Andras Oktatokorhaz Egeszsegugyi Szolgaltato Nonprofit Kft.
Nyíregyháza, , Hungary
Markusovszky Hospital
Szombathely, , Hungary
National Hospital Organization Shimoshizu National Hospital
Yotsukaidou, Chiba, Japan
Gunma University Hospital
Maebashi, Gunma, Japan
National Hospital Organization Sagamihara National Hospital
Sagamihara, Kanagawa, Japan
Medical Corporation Wakoukai Kurashiki Kousai Hospital
Kurashiki, Okayama-ken, Japan
Institute of Rheumatology, Tokyo Women's Medical University Hospital
Shinjyuku-ku, Tokyo, Japan
Inoue Hospital
Gunma, , Japan
Matsubara Clinic
Hyōgo, , Japan
Matsubara Mayflower Hospital
Hyōgo, , Japan
Centro de Estudio de Investigacion Basica y Clinica S.C
Jalisco, Guadalajara, Mexico
AMC
Amsterdam, North Holland, Netherlands
Centrul Medical Terra Med
Cluj-Napoca, Cluj, Romania
SC Duo Medical SRL
Bucharest, , Romania
Spitalul Clinic Sf. Maria
Bucharest, , Romania
Spitalul Clinic Colentina
Bucharest, , Romania
Centrul de Boli Reumatismale Dr. I. Stoia
Bucharest, , Romania
Spitalul Clinic Judetean de Urgenta Tg Mures
Târgu Mureş, , Romania
Institute of Rheumatology of Russian academy of Medical Scie
Moscow, , Russia
City Clinical Hospital # 1 n.a. Pirogov
Moscow, , Russia
State Educational Institution of Additional Professional Education
Saint Petersburg, , Russia
State Health care institution of Leningrad Regional Clinical Hospital
Saint Petersburg, , Russia
State education institution of higher vocational education Smolensk State Medical Academy Roszdrav
Smolensk, , Russia
State Healthcare Institution Yaroslavl Regional Clinical Hospital
Yaroslavl, , Russia
Municipal Institution City Clinical Hospital #40
Yekaterinburg, , Russia
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B1981001
Identifier Type: OTHER
Identifier Source: secondary_id
2008-006936-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3199K1-2001
Identifier Type: -
Identifier Source: org_study_id
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