Status:
COMPLETED
Assessment Of The Safety And Efficacy Of BG9924 In Rheumatoid Arthritis (RA) Participants
Lead Sponsor:
Biogen
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Safety and efficacy of BG9924 in RA participants that have had an inadequate response to disease-modifying anti-rheumatic drug (DMARD) therapy.
Eligibility Criteria
Inclusion
- Key
- Diagnosis of RA (functional class I - III)
- Stable dose of MTX
- Inadequate response to at least one conventional DMARD therapy
- Key
Exclusion
- Serious local infection or systemic infection
- 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
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
391 Patients enrolled
Trial Details
Trial ID
NCT00664716
Start Date
July 1 2007
End Date
October 1 2008
Last Update
January 21 2016
Active Locations (8)
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1
Coordinating Research Site
San Miguel de Tucumán, Argentina, T4000AXL
2
Coordinating Research Site
São Paulo, Brazil, 04027-000
3
Coordinating Research Site
Budapest, Hungary, H2143
4
Coordinating Research Site
Cuernavaca, Mexico, 62270