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

NCT ID: NCT06738719

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-03
• Study Completion Date: 2026-04-15

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

Conditions

Moderately to Severely Active Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CT-P13 Auto-Injector

CT-P13 SC(Subcutaneous) Auto-Injector

Group Type: EXPERIMENTAL

CT-P13 SC Auto-Injector

Intervention Type: BIOLOGICAL

Subcutaneous(SC) Injection

Placebo Auto-Injector

Placebo Auto-Injector

Group Type: PLACEBO_COMPARATOR

Placebo Auto-Injector

Intervention Type: BIOLOGICAL

Subcutaneous(SC) Injection

Interventions

CT-P13 SC Auto-Injector

Subcutaneous(SC) Injection

Intervention Type: BIOLOGICAL

Placebo Auto-Injector

Subcutaneous(SC) Injection

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celltrion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Klinika Reuma Park Sp. z.o.o

Warsaw, , Poland

Countries

Poland

Other Identifiers

CT-P13 3.11

Identifier Type: -

Identifier Source: org_study_id