Trials / Completed
CompletedNCT03789292
A Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active Rheumatoid Arthritis
A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 With Humira When Co-administered With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 648 (actual)
- Sponsor
- Celltrion · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase III Study to Compare Efficacy and Safety of CT-P17 with Humira in Patients With Active Rheumatoid Arthritis
Detailed description
CT-P17, containing the active ingredient adalimumab, is a recombinant humanized monoclonal antibody that is being developed as a similar biological medicinal product to Humira. The purpose of this study is to demonstrate similar efficacy and safety of CT-P17 and Humira in patients with moderate to severe rheumatoid arthritis when co-administered with methotrexate.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CT-P17 SC | Subcutaneous injection of Adalimumab 40mg every two weeks |
| BIOLOGICAL | Humira SC | Subcutaneous injection of Adalimumab 40mg every two weeks |
Timeline
- Start date
- 2018-11-26
- Primary completion
- 2019-10-08
- Completion
- 2020-04-24
- First posted
- 2018-12-28
- Last updated
- 2021-11-17
- Results posted
- 2021-11-17
Locations
1 site across 1 country: Bulgaria
Source: ClinicalTrials.gov record NCT03789292. Inclusion in this directory is not an endorsement.