Study of Etanercept in Subjects With Rheumatoid Arthritis Who Have Had an Inadequate Response to Adalimumab or Infliximab Plus Methotrexate
NCT ID: NCT01783015
Last Updated: 2016-01-06
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
16 participants
INTERVENTIONAL
2013-09-30
2014-08-31
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
DOUBLE
Study Groups
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Group A
Subjects who are mAb ADA positive
Etanercept
Etanercept 50 mg once-weekly
Group B
Subjects who are mAb ADA negative
Etanercept
Etanercept 50 mg once-weekly
Group C
Subjects who are mAb ADA positive
Placebo
Etanercept placebo once-weekly
Group D
Subjects who are mAb ADA negative
Placebo
Etanercept placebo once-weekly
Interventions
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Etanercept
Etanercept 50 mg once-weekly
Etanercept
Etanercept 50 mg once-weekly
Placebo
Etanercept placebo once-weekly
Placebo
Etanercept placebo once-weekly
Eligibility Criteria
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Inclusion Criteria
2. A history of inadequate response to infliximab or adalimumab in combination with methotrexate.
3. A stable dose of oral methotrexate for at least 6 weeks before the baseline visit.
Exclusion Criteria
2. Prior treatment with etanercept; both infliximab and adalimumab; or any immunosuppressive biologic agent other than infliximab or adalimumab.
3. Discontinuation of infliximab or adalimumab for a primary reason other than inadequate efficacy response.
18 Years
79 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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RK Will Pty Ltd
Victoria Park, Western Australia, Australia
Cliniques Universitaires Saint-Luc / Service de Rhumatologie
Brussels, , Belgium
Hopital Lapeyronie
Montpellier, , France
Tseung Kwan O Hospital
Tseung Kwan O, New Territories, Hong Kong
Tseung Kwan O Hospital
Tseung Kwan O, NT, , Hong Kong
Bnai Zion Medical Ctr Pharmacy
Haifa, , Israel
Meir Medical Center pharmacy
Kfar Saba, , Israel
LLC "Alliance Biomedical - Russian Group"
Izhevsk, Russian Federation, Russia
LLC Research Medical Complex "Your Health" based on City Clinical Hospital #7
Kazan', , Russia
Scientific Institute of Rheumatology of Russian Academy of Medical Science
Moscow, , Russia
GBOU VPO Moscow State University of Medicine and Dentistry
Moscow, , Russia
Hospital de la Santa Creu i San Pau
Barcelona, Barcelona, Spain
Hospital Regional Universitario Carlos Haya. Hospital Civil
Málaga, Málaga, Spain
Hospital Regional Universitario Carlos Haya.
Málaga, Málaga, Spain
Hospital Infanta Luisa
Seville, , Spain
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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2012-003644-71
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B1801355
Identifier Type: -
Identifier Source: org_study_id
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