This is a Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of Subcutaneous CT-P13 in Patients with Moderately to Severely Active Rheumatoid Arthritis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
192
Subcutaneous(SC) Injection
Subcutaneous(SC) Injection
Klinika Reuma Park Sp. z.o.o
Warsaw, Poland
Proportion of patients achieving clinical response according to the ACR20 criteria at Week 12
To demonstrate superiority of CT P13 SC over Placebo in terms of efficacy as determined by clinical response according to the American College of Rheumatology (ACR) definition of a 20% improvement (ACR20) at Week 12
Time frame: Week 0 ~ Week 12
Change from baseline in HAQ-DI at Week 12
Difference in mean change from baseline in HAQ-DI between treatment groups (CT-P13 SC and Placebo)
Time frame: Week 0 ~ Week 12
Evaluate Pharmacokinetics of CT-P13 SC
Serum concentration of infliximab
Time frame: Up to 52 Weeks
Evaluate Safety of CT-P13 SC
* Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 * All reported terms of AEs will be coded to system organ class (SOC) and preferred term (PT) according to the Medical Dictionary for Regulatory Activities (MedDRA) and severity grading of AEs will be recorded according to the CTCAE Version 5.0
Time frame: Up to 52 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.