Trials / Completed
CompletedNCT03147248
A Phase I/III Study to Evaluate Efficacy, PK and Safety Between CT-P13 SC and CT-P13 IV in Patients With Active RA
A Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety Between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients With Active Rheumatoid Arthritis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 407 (actual)
- Sponsor
- Celltrion · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CT-P13 | CT-P13 (3 mg/kg) by IV infusion administered as a 2 hour IV infusion per dose every 8 weeks |
| BIOLOGICAL | CT-P13 | CT-P13 (90 mg) by single SC injection every other week |
| BIOLOGICAL | CT-P13 | CT-P13 (120 mg) by single SC injection every other week |
| BIOLOGICAL | CT-P13 | CT-P13 (180 mg) by double SC 90 mg injections every other week |
| BIOLOGICAL | CT-P13 | CT-P13 (120 mg) by single SC injection every other week with placebo IV at Weeks 6, 14 and 22. |
| 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 |
Timeline
- Start date
- 2016-09-12
- Primary completion
- 2018-05-21
- Completion
- 2019-04-15
- First posted
- 2017-05-10
- Last updated
- 2020-04-08
- Results posted
- 2020-04-08
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03147248. Inclusion in this directory is not an endorsement.