NCT05489224CompletedPhase 3
A Study to Compare Efficacy and Safety of CT-P47 and RoActemra in Patients With Rheumatoid Arthritis
A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of Two Intravenous Infusion Formulations of Tocilizumab (CT-P47 and RoActemra) When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis
Source: ClinicalTrials.gov · Last updated 8 Oct 2024
Brief summary (registry, in English)
This is a phase 3 study to compare efficacy and safety of CT-P47 and RoActemra in patients with moderate to severe active rheumatoid arthritis.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 471 (actual)
- First submitted
- 24 Jul 2022
- Start date
- 14 Sept 2022
- Primary completion date
- 29 Jun 2023
- Lead sponsor
- Celltrion
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT05489224
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 471
- From 14 Sept 2022 to the primary completion date, 29 Jun 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient who has previously received investigational or licensed product; targeted synthetic DMARD(s) (e.g., tofacitinib, baricitinib) for the treatment of RA and/or an interleukin-6 (IL-6) inhibitor for any purposes.
- Patient who has previously received more than 1 biologic agents approved for the treatment of RA.
Other illness
- Patient who has allergies to any of the excipients of study drug or any other murine and human proteins, or patient with a hypersensitivity to immunoglobulin products.
Who the study is looking for
- Patient is male or female aged 18 to 75 years old, both inclusive.
- Patient has had a diagnosis of RA according to the 2010 ACR/EULAR classification criteria for at least 24 weeks prior to the first administration of the study drug.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| INTER CLINIC Piotr Adrian Klimiuk Coordinator of this site? Confirm its status | Bialystok | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.