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

NCT06738719 | Completed Phase 3 FDA Drug

• 1 other identifier: CT-P13 3.11
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

  Week 0 ~ Week 12

Secondary Outcomes (3)

• 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 Arms (2)

CT-P13 Auto-Injector

EXPERIMENTAL

CT-P13 SC(Subcutaneous) Auto-Injector

Biological: CT-P13 SC Auto-Injector

Placebo Auto-Injector

PLACEBO COMPARATOR

Placebo Auto-Injector

Biological: Placebo Auto-Injector

Interventions

CT-P13 SC Auto-Injector BIOLOGICAL

Subcutaneous(SC) Injection

CT-P13 Auto-Injector

Placebo Auto-Injector BIOLOGICAL

Subcutaneous(SC) Injection

Placebo Auto-Injector

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient who is male or female aged 18 to 75 years old (both inclusive).
• 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.
• 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.
• 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).
• Patient who has adequate renal and hepatic function at Screening

You may not qualify if:

• 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.
• 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.
• Patient who has received or has plan to receive any of prohibited medications or treatments as defined in the protocol.

Sponsors & Collaborators

• Celltrion: lead

Study Sites (1)

Klinika Reuma Park Sp. z.o.o

Warsaw, 02-665, Poland

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 18, 2024
• Study Start: January 3, 2025
• Primary Completion: June 25, 2025
• Study Completion: April 13, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

PL (1)