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

Celltrion Healthcare

Status and phase: Active, not recruiting; Phase 3

Conditions: Moderately to Severely Active Rheumatoid Arthritis

Treatments: Biological: Placebo Auto-Injector; Biological: CT-P13 SC Auto-Injector

Study type: Interventional

Funder types: Industry

Identifiers

NCT06738719

CT-P13 3.11

Details and patient eligibility

About

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

Enrollment: 192 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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192 participants in 2 patient groups, including a placebo group

CT-P13 Auto-Injector

Experimental group

Description:

CT-P13 SC(Subcutaneous) Auto-Injector

Treatment:

Biological: CT-P13 SC Auto-Injector

Placebo Auto-Injector

Placebo Comparator group

Description:

Placebo Auto-Injector

Treatment:

Biological: Placebo Auto-Injector