Phase 3
Completed N=391
A Phase I/III Study to Evaluate Efficacy, PK and Safety Between CT-P13 SC and CT-P13 IV in Patients With Active RA
Source: ClinicalTrials.gov NCT03147248 ↗Enrolled (actual)
391
Serious AEs
6.7%
Results posted
Apr 2020
Primary outcomePrimary: Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1) — 12032957.5; 5047724.2; 7333767.0; 9930696.6 hr*ng/mL
◆ Published Evidence
Established
56citations · ~11 / year
Efficacy, pharmacokinetics and safety of subcutaneous versus intravenous CT-P13 in rheumatoid arthritis: a randomized phase I/III trial.
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).
Linked Publications (2)
-
Efficacy, pharmacokinetics and safety of subcutaneous versus intravenous CT-P13 in rheumatoid arthritis: a randomized phase I/III trial.
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Efficacy of subcutaneous vs intravenous infliximab in rheumatoid arthritis: a post-hoc analysis of a randomized phase III trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1) |
12032957.5; 5047724.2; 7333767.0; 9930696.6; 3272936.8; 4835631.9 | — |
| PRIMARY Change From Baseline of Disease Activity Score Using 28 Joint Counts (DAS28) (CRP) at Week 22 (Part 2) |
2.21; 1.94 | — |
| SECONDARY Mean Actual Value of Disease Activity Score Using 28 Joint Counts (DAS28 [CRP]) (Part 2) |
6.0; 5.9; 4.7; 4.6; 4.0; 4.1 | — |
| SECONDARY Number of Patients Achieving Clinical Response According to American College of Rheumatology 20% Response (ACR20) (Part 2) |
63; 57; 107; 103; 124; 130 | — |
| SECONDARY Observed Trough Serum Concentration (Ctrough) of Infliximab (Part 2) |
15.73; 16.00; 8.64; 8.81; 1.89; 12.33 | — |
| SECONDARY Mean Actual Value in Serum CRP Concentration (Pharmacodynamic Parameter) (Part 2) |
1.82; 2.23; 0.47; 0.62; 0.74; 0.98 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03147248) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.