Rheumatoid Arthritis Clinical Trial
— RESPONDOfficial title:
Assessment Of Safety, Efficacy, PK&PD Of BG9924 in RA Patients Who Have Had An Inadequate Response To Conventional DMARD Therapy.
Safety and efficacy of BG9924 in RA participants that have had an inadequate response to disease-modifying anti-rheumatic drug (DMARD) therapy.
Status | Completed |
Enrollment | 391 |
Est. completion date | October 2008 |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Key Inclusion Criteria: - Diagnosis of RA (functional class I - III) - Stable dose of MTX - Inadequate response to at least one conventional DMARD therapy Key Exclusion Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Argentina | Coordinating Research Site | Tucuman | |
Brazil | Coordinating Research Site | Sao Paulo | |
Hungary | Coordinating Research Site | Budapest | |
Mexico | Coordinating Research Site | Cuernavaca | |
Poland | Coordinating Research Site | Torun | |
Romania | Coordinating Research Site | Braila | |
Russian Federation | Coordinating Research Site | Moscow | |
United Kingdom | Coordinating Research Site | Leeds | Yorkshire |
Lead Sponsor | Collaborator |
---|---|
Biogen |
Argentina, Brazil, Hungary, Mexico, Poland, Romania, Russian Federation, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate efficacy of BG9924 in combination with methotrexate (MTX) in RA participants who have had an inadequate response to DMARD therapy | 3 months | No | |
Secondary | Assess the safety and tolerability of BG9924 in this participant population | 3 months | No |
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