A Phase I/III Study to Evaluate Efficacy, PK and Safety Between CT-P13 SC and CT-P13 IV in Patients With Active RA

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

407 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-12

Study Completion Date

2019-04-15

Brief Summary

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This is a Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between CT-P13 SC and CT-P13 IV in Patients with Active Rheumatoid Arthritis (RA).

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Detailed Description

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A new subcutaneous infliximab formulation is developed by Celltrion, Inc. as an alternative to the intravenous regimen where subcutaneous infliximab injection typically takes less than 2 minutes. The availability of a subcutaneous formulation of infliximab would increase the treatment options available to patients, particularly those wishing to self-administer their therapy. This Phase I/III Study randomized, double-blinded (Part 2 only), multicenter, parallel-group study was designed to evaluate Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active RA.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Part 1 was open label.

Study Groups

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Cohort 1: CT-P13 IV 3 mg/kg

CT-P13 Intravenous (IV) (Infliximab), 3 mg/kg by IV infusion every 8 weeks (Part 1)

Group Type ACTIVE_COMPARATOR

CT-P13

Intervention Type BIOLOGICAL

CT-P13 (3 mg/kg) by IV infusion administered as a 2 hour IV infusion per dose every 8 weeks

Cohort 2: CT-P13 SC 90 mg

CT-P13 Subcutaneous (SC) (Infliximab), 90 mg by SC injection every other week (Part 1)

Group Type EXPERIMENTAL

CT-P13

Intervention Type BIOLOGICAL

CT-P13 (90 mg) by single SC injection every other week

Cohort 3: CT-P13 SC 120 mg

CT-P13 SC (Infliximab), 120 mg by SC injection every other week (Part 1)

Group Type EXPERIMENTAL

CT-P13

Intervention Type BIOLOGICAL

CT-P13 (120 mg) by single SC injection every other week

Cohort 4: CT-P13 SC 180 mg

CT-P13 SC (Infliximab), 180 mg by SC injection every other week (Part 1)

Group Type EXPERIMENTAL

CT-P13

Intervention Type BIOLOGICAL

CT-P13 (180 mg) by double SC 90 mg injections every other week

Arm 1: CT-P13 SC 120 mg

CT-P13 SC (Infliximab), 120 mg by SC injection every other week with placebo intravenous infusion at Weeks 6, 14 and 22 (Part 2)

Group Type EXPERIMENTAL

CT-P13

Intervention Type BIOLOGICAL

CT-P13 (120 mg) by single SC injection every other week with placebo IV at Weeks 6, 14 and 22.

Arm 2: CT-P13 IV 3 mg/kg

CT-P13 IV (Infliximab), 3 mg/kg by IV infusion every 8 weeks with placebo subcutaneous injection at Week 6 and every 2 weeks thereafter up to Week 28 (Part 2)

Group Type ACTIVE_COMPARATOR

CT-P13

Intervention Type BIOLOGICAL

CT-P13 (3 mg/kg) by IV infusion administered as a 2 hour IV infusion per dose every 8 weeks with placebo SC at Week 6 and every other week thereafter up to Week 28

Interventions

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CT-P13

CT-P13 (3 mg/kg) by IV infusion administered as a 2 hour IV infusion per dose every 8 weeks

Intervention Type BIOLOGICAL

CT-P13

CT-P13 (90 mg) by single SC injection every other week

Intervention Type BIOLOGICAL

CT-P13

CT-P13 (120 mg) by single SC injection every other week

Intervention Type BIOLOGICAL

CT-P13

CT-P13 (180 mg) by double SC 90 mg injections every other week

Intervention Type BIOLOGICAL

CT-P13

CT-P13 (120 mg) by single SC injection every other week with placebo IV at Weeks 6, 14 and 22.

Intervention Type BIOLOGICAL

CT-P13

CT-P13 (3 mg/kg) by IV infusion administered as a 2 hour IV infusion per dose every 8 weeks with placebo SC at Week 6 and every other week thereafter up to Week 28

Intervention Type BIOLOGICAL

Other Intervention Names

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Infliximab Infliximab Infliximab Infliximab Infliximab Infliximab

Eligibility Criteria

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Inclusion Criteria

* Patient is male or female between 18 and 75 years old, inclusive.
* Patient has a diagnosis of RA according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for at least 6 months
* Patient has active disease as defined by the presence of 6 or more swollen joints (of 28 assessed), 6 or more tender joints (of 28 assessed) and serum C-reactive protein (CRP) concentration \>0.6 mg/dL
* Patient who completed at least 3 months of treatment of oral or parenteral dosing with Methotrexate between 12.5 to 25 mg/kg (between 10 to 25 mg/week in Korea) and on stable dosing with Methotrexate for at least 4 weeks prior to the first administration of the study drug.

Exclusion Criteria

* Patient who has previously received a biological agent for the treatment of RA and/or a TNFα inhibitor for the treatment of other disease
* 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 had current or past history of chronic infection with hepatitis C or human immunodeficiency virus (HIV)-1 or -2 or current infection with hepatitis B
* Patient who had acute infection requiring oral antibiotics within 2 weeks or parenteral injection of antibiotics within 4 weeks prior to the first administration of the study drug, other serious infection within 6 months prior to the first administration of study drug or recurrent herpes zoster or other chronic or recurrent infection within 6 weeks prior to the first administration of the study drug.
* Patient who had an indeterminate result for interferon-γ release assay (IGRA) or latent tuberculosis (TB) at Screening. For Part 2, if IGRA result was indeterminate at Screening, 1 retest was possible during the screening. If the repeated IGRA result was negative, the patient could be included in the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No