Trials / Completed
CompletedNCT03707535
To Compare the Efficacy, Pharmacokinetics and Safety Between CT-P13 and China Approved Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis
A Randomized, Controlled, Double-Blind, Phase 3 Study to Compare the Efficacy, Pharmacokinetics and Safety Between CT-P13 and China Approved Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 270 (actual)
- Sponsor
- Celltrion · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
To demonstrate that CT-P13 is equivalent to China-approved Remicade at Week 14, in terms of efficacy as determined by clinical response according to the change from baseline in disease activity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CT-P13 | 3 mg/kg, 2-hour infusion per dose co-administered with methotrexate and folic acid |
| BIOLOGICAL | Remicade | 3 mg/kg, 2-hour infusion per dose co-administered with methotrexate and folic acid |
Timeline
- Start date
- 2018-11-12
- Primary completion
- 2020-03-16
- Completion
- 2021-03-05
- First posted
- 2018-10-16
- Last updated
- 2021-09-14
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03707535. Inclusion in this directory is not an endorsement.