Study X052070 will evaluate the safety and pharmacokinetics (PK) of XOMA 052 administered to patients with active, stable, moderate to severe rheumatoid arthritis (RA). It is hypothesized that administration of XOMA 052 is likely to improve inflammatory control in subjects with RA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
18
Unnamed facility
Clearwater, Florida, United States
Unnamed facility
Middleburg Heights, Ohio, United States
Safety assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, and treatment-emergent adverse events.
Time frame: Day 0 pre-dose through Day 56
Pharmacokinetic assessments from serum samples collected at time points specified in the protocol.
Time frame: Day 0 Pre-dose through Day 56
Assessment of inflammatory markers CRP and ESR collected at time points specified in the protocol.
Time frame: Day 0 pre-dose through Day 56
Assessment of Rheumatoid Arthritis disease status by the collection of ACR (American College of Rheumatology) core criteria at time points specified in the protocol.
Time frame: Day 0 pre-dose through Day 56
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