This is a randomized, vehicle controlled, double-blind, repeat dose comparative study in patients with rheumatoid arthritis (RA) under management with DMARDs and with persistent disease activity. The goal of this study is to evaluate the safety, tolerability and pharmacokinetics of 6 weekly repeat doses of ORTD-1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
17
Once weekly, single subcutaneous injection of ORTD-1 at a volume of 0.45 mL. Six weekly treatments; 28-day follow-up period.
Once weekly subcutaneous injection of vehicle at a volume of 0.45 mL. Six weekly treatments; 28-day follow-up period.
Two subcutaneous injections of ORTD-1 at two injection sites once weekly; 0.90 mL of ORTD-1 per each subcutaneous injection. Six weekly treatments; 28-day follow-up period.
Keck School of Medicine of USC Division of Rheumatology
Los Angeles, California, United States
Orange County Research Center
Tustin, California, United States
Advanced Pharma CR, LLC
Miami, Florida, United States
Safety and Tolerability of ORTD-1 measured by the number of patients with adverse events
Safety will be assessed throughout the duration of the study (weeks 1 through 10) by monitoring of adverse events.
Time frame: 10 weeks
Immunogenicity by measurement of anti-drug antibodies
Immunogenicity is the measurement of anti-drug (ORTD-1) antibodies (ADA) in serum. ADA samples will be analyzed from the change in baseline (Visit 1) using descriptive statistics (mean, median, range and standard deviation).
Time frame: Weeks 1, 3, 5, and 10
Serum concentration of ORTD-1 from baseline
Serum concentration will be measured from the change in baseline (Visit 1) using descriptive statistics (mean, median, range and standard deviation).
Time frame: 10 weeks
Cmax of ORTD-1
Cmax (maximum plasma concentration) will be measured using the arithmetic mean, standard deviation (SD), coefficient of variation (CV) (%), median, minimum, and maximum.
Time frame: Week 1 through week 6
Tmax of ORTD-1
Tmax (time of maximum plasma concentration) will be measured using the arithmetic mean, standard deviation (SD), coefficient of variation (CV) (%), median, minimum, and maximum.
Time frame: Week 1 through week 6
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Two subcutaneous injections of vehicle at two injection sites once weekly; 0.90 mL of vehicle per each subcutaneous injection. Six weekly treatments; 28-day follow-up period.