A Phase I/III Study to Evaluate Efficacy, PK and Safety Between CT-P13 SC and CT-P13 IV in Patients With Active RA
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: CT-P13; CT-P13; CT-P13; CT-P13; CT-P13; CT-P13
Intervention description: CT-P13 (3 mg/kg) by IV infusion administered as a 2 hour IV infusion per dose every 8 weeks; CT-P13 (90 mg) by single SC injection every other week; CT-P13 (120 mg) by single SC injection every other week; CT-P13 (180 mg) by double SC 90 mg injections every other week; CT-P13 (120 mg) by single SC injection every other week with placebo IV at Weeks 6, 14 and 22.; 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 MeSH terms: Infliximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Part 1 was open label.
Enrollment: 407.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      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).
    

Eligibility criteria:

        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.