The primary objectives are to determine the relationship between blood levels of CDP6038 and suppression of C-reactive Protein (CRP) following single doses given as intravenous (IV) infusion or subcutaneous (SC) injection to Rheumatoid Arthritis (RA) patients. The safety of CDP6038 will also be evaluated.
The secondary objectives of the study include determination of the absolute bioavailability of CDP6038 given via sc administration compared with iv infusion; assessment of the immunogenicity potential of single dose CDP6038 and assessment, on an exploratory basis, of other relevant systemic biomarkers and changes in clinical response.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
40
Unnamed facility
Duncansville, Pennsylvania, United States
Unnamed facility
Dallas, Texas, United States
Unnamed facility
San Antonio, Texas, United States
Unnamed facility
Berlin, Germany
Unnamed facility
PK/PD relationship between systemic CDP6038 exposure and CRP suppression.
Time frame: For 12 weeks following single dose
Evaluate the safety and tolerability of single doses of CDP6038 For 12 weeks following single dose
Time frame: For 12 weeks following single dose
Absolute bioavailability of CDP6038 given by sc injection in comparison with iv infusion
Time frame: For 12 weeks following single dose
Assess the immunogenicity of single dose CDP6038
Time frame: Multiple sampling from 0 to 12 weeks following single dose
Assess, on an exploratory basis, changes in clinical response and other systemic biomarkers associated with RA
Time frame: For 12 weeks following single dose
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Single dose: Placebo IV
Single dose: Placebo SC
Optimized CDP6038 SC doses based on outcome of Cohort 1 with placebo
Individual stable doses of methotrexate.
Cologne, Germany
Unnamed facility
Erlangen, Germany