Safety, Pharmacodynamics and Pharmacokinetics of GSK2136525 Repeat Dose in Rheumatoid Arthritis
Status:
Terminated
Trial end date:
2013-03-19
Target enrollment:
Participant gender:
Summary
The assessment of otelixizumab in rheumatoid arthritis subjects will provide safety,
tolerability, pharmacodynamic and pharmacokinetic information which will enable the
identification of appropriate safe and well-tolerated dosage regimens to be used in clinical
efficacy studies. This study will consist of a screening phase, followed by a treatment
period where four cohorts of subjects will receive 5 daily intravenous infusions of
otelixizumab. The cumulative dose will increase in each successive cohort and infusion rates
can be adjusted based on signs and symptoms of cytokine release syndrome and to ensure the
specified maximum infusion rate is not exceeded. Serial blood samples will be obtained for
clinical laboratory testing, determination of pharmacodynamic markers, serum otelixizumab PK
parameters, exploratory biomarkers and immunogenicity. Safety and pharmacodynamic data from
the previous cohort(s) will be evaluated prior to dosing subsequent cohorts to ensure safety.
Adverse events, laboratory values, vital signs and ECG's will be monitored closely during
this study. All subjects in the study will undergo long-term follow-up out to 48 months to
monitor patient safety.