NCT06738719
Active, not recruiting
Phase 3
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
Overview
- Phase
- Phase 3
- Intervention
- CT-P13 SC Auto-Injector
- Conditions
- Moderately to Severely Active Rheumatoid Arthritis
- Sponsor
- Celltrion
- Enrollment
- 192
- Locations
- 1
- Primary Endpoint
- Proportion of patients achieving clinical response according to the ACR20 criteria at Week 12
- Status
- Active, not recruiting
- Last Updated
- 10 months ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
CT-P13 Auto-Injector
CT-P13 SC(Subcutaneous) Auto-Injector
Intervention: CT-P13 SC Auto-Injector
Placebo Auto-Injector
Placebo Auto-Injector
Intervention: Placebo Auto-Injector
Outcomes
Primary Outcomes
Proportion of patients achieving clinical response according to the ACR20 criteria at Week 12
Time Frame: 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 Outcomes
- Change from baseline in HAQ-DI at Week 12(Week 0 ~ Week 12)
- Evaluate Pharmacokinetics of CT-P13 SC(Up to 52 Weeks)
- Evaluate Safety of CT-P13 SC(Up to 52 Weeks)
Study Sites (1)
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