Assessment Of The Safety And Efficacy Of BG9924 In Rheumatoid Arthritis (RA) Participants
NCT ID: NCT00664716
Last Updated: 2016-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
391 participants
INTERVENTIONAL
2007-07-31
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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Placebo
subcutaneous administration of placebo given for 12 weeks
Placebo
Placebo comparator
One Dose
BG9924 - dosage level administered as per Biogen Idec protocol
Baminercept alfa 1
experimental - one dose level
Second Dose
BG9924 - dosage level administered as per Biogen Idec protocol
Baminercept alfa 2
experimental - second dose level
Third Dose
BG9924 - dosage level administered as per Biogen Idec protocol
Baminercept alfa 3
experimental - third dose level
Fourth Dose
BG9924 - dosage level administered as per Biogen Idec protocol
Baminercept alfa 4
experimental - fourth dose level
Fifth Dose
BG9924 - dosage level administered as per Biogen Idec protocol
Baminercept alfa 5
experimental - fifth dose level
Interventions
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Baminercept alfa 1
experimental - one dose level
Placebo
Placebo comparator
Baminercept alfa 2
experimental - second dose level
Baminercept alfa 3
experimental - third dose level
Baminercept alfa 4
experimental - fourth dose level
Baminercept alfa 5
experimental - fifth dose level
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stable dose of MTX
* Inadequate response to at least one conventional DMARD therapy
Exclusion Criteria
* History (Hx) of recurrent infections requiring oral or parenteral anti-infective treatment
* Hx of tuberculosis (TB) or positive purified protein derivative (PPD) test during the screening period
* Clinical significant lab tests at screening
* Positive for Hep C or Hep B at screening
18 Years
75 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Coordinating Research Site
San Miguel de Tucumán, , Argentina
Coordinating Research Site
São Paulo, , Brazil
Coordinating Research Site
Budapest, , Hungary
Coordinating Research Site
Cuernavaca, , Mexico
Coordinating Research Site
Torun, , Poland
Coordinating Research Site
Brăila, , Romania
Coordinating Research Site
Moscow, , Russia
Coordinating Research Site
Leeds, Yorkshire, United Kingdom
Countries
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References
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Bienkowska J, Allaire N, Thai A, Goyal J, Plavina T, Nirula A, Weaver M, Newman C, Petri M, Beckman E, Browning JL. Lymphotoxin-LIGHT pathway regulates the interferon signature in rheumatoid arthritis. PLoS One. 2014 Nov 18;9(11):e112545. doi: 10.1371/journal.pone.0112545. eCollection 2014.
Other Identifiers
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104RA202
Identifier Type: -
Identifier Source: org_study_id
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