Rheumatoid Arthritis Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ABBV-257
This is a Phase 1, randomized, double-blind, placebo-controlled, multiple dose study
designed to assess the safety, tolerability, pharmacokinetics, and immunogenicity of
different dose levels of ABBV-257 given with methotrexate. ABBV-257 or placebo will be
administered once every other week (EOW) for a total of 4 doses. Subjects will continue on
their stable dose of methotrexate weekly throughout participation in the study.
This study will be conducted in approximately 24 subjects in 3 dose groups, with 8 subjects
per group. Within each group, 6 subjects will be randomized to receive ABBV-257 and 2
subjects will receive placebo. Subjects participating in one dose group will be ineligible
to participate in another dose group in the study.
Multiple dose study designed to assess the safety, tolerability, pharmacokinetics, and immunogenicity of different dose levels of ABBV-257 given with methotrexate. ;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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