Assessment Of The Safety And Efficacy Of BG9924 In Rheumatoid Arthritis (RA) Participants (RESPOND)
Rheumatoid Arthritis
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, RA, DMARD inadequate response, Methotrexate
Eligibility Criteria
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.
Sites / Locations
- Coordinating Research Site
- Coordinating Research Site
- Coordinating Research Site
- Coordinating Research Site
- Coordinating Research Site
- Coordinating Research Site
- Coordinating Research Site
- Coordinating Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo
One Dose
Second Dose
Third Dose
Fourth Dose
Fifth Dose
subcutaneous administration of placebo given for 12 weeks
BG9924 - dosage level administered as per Biogen Idec protocol
BG9924 - dosage level administered as per Biogen Idec protocol
BG9924 - dosage level administered as per Biogen Idec protocol
BG9924 - dosage level administered as per Biogen Idec protocol
BG9924 - dosage level administered as per Biogen Idec protocol