Moderately to Severely Active Rheumatoid Arthritis
Conditions
Brief summary
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
Interventions
BIOLOGICALCT-P13 SC Auto-Injector
Subcutaneous(SC) Injection
BIOLOGICALPlacebo Auto-Injector
Subcutaneous(SC) Injection
Sponsors
Celltrion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
\[Main Inclusion Criteria\] 1. Patient who is male or female aged 18 to 75 years old (both inclusive). 2. Patient who has a diagnosis of RA at least 24 weeks prior to the first administration of the study drug (Day 1) and fulfill the 2010 ACR/EULAR classification criteria for RA. 3. Patient who has active disease as defined by the presence of 6 or more swollen joints (of 66 assessed), 6 or more tender joints (of 68 assessed), and either a high-sensitivity C-reactive protein (hsCRP) ≥1.0 mg/dL (≥10 mg/L) or an erythrocyte sedimentation rate (ESR) ≥28 mm/hour at Screening. 4. Patient who has been receiving the treatment of oral or parenteral dosing with MTX for at least 12 weeks and has been on stable dosing with MTX between 10 to 25 mg/week for at least 4 weeks prior to the first administration of the study drug (Day 1). 5. Patient who has adequate renal and hepatic function at Screening \[Main
Exclusion criteria
\] 1. Patient who has previously received investigational or licensed product; biological agents or targeted synthetic disease-modifying antirheumatic drugs (DMARDs) (e.g., tofacitinib, baricitinib) for the treatment of RA and/or a tumor necrosis factor (TNF) α inhibitors for the any purpose. 2. Patient who has allergies to any of the excipients of infliximab or any other murine and/or human proteins or patient with a hypersensitivity to immunoglobulin product. 3. Patient who has received or has plan to receive any of prohibited medications or treatments as defined in the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients achieving clinical response according to the ACR20 criteria at Week 12 | Week 0 ~ 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in HAQ-DI at Week 12 | Week 0 ~ Week 12 | Difference in mean change from baseline in HAQ-DI between treatment groups (CT-P13 SC and Placebo) |
| Evaluate Pharmacokinetics of CT-P13 SC | Up to 52 Weeks | Serum concentration of infliximab |
| Evaluate Safety of CT-P13 SC | Up to 52 Weeks | * 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 |
Countries
Poland
Outcome results
None listed