A Phase 3 Study to Evaluate Efficacy & Safety of Subcutaneous CT-P13 in Patients With Moderate to Severe Active Rheumatoid Arthritis

Phase 3

Active, not recruiting

• Conditions: Moderately to Severely Active Rheumatoid Arthritis
• Interventions: Biological: CT-P13 SC Auto-Injector; Biological: Placebo Auto-Injector

• Registration Number: NCT06738719
• Lead Sponsor: Celltrion

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-13
• Study First Posted: 2024-12-18
• Study Start: 2025-01-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-25
• Primary Completion: 2025-06-25
• Study Completion: 2026-04-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT-P13 Auto-Injector	CT-P13 SC Auto-Injector	CT-P13 SC(Subcutaneous) Auto-Injector
Placebo Auto-Injector	Placebo Auto-Injector	Placebo Auto-Injector

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Klinika Reuma Park Sp. z.o.o; 🇵🇱 Warsawa, Poland