CompletedPhase 3

A Study to Compare Efficacy and Safety of CT-P47 and RoActemra in Patients With Rheumatoid Arthritis

Poland471 participantsStarted 2022-09-14

Plain-language summary

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.

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.
✕. 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.

Mean Change From Baseline in Disease Activity Score 28 (DAS28) Using Erythrocyte Sedimentation Rate (ESR) at Week 24

Timeframe: Week 24

NCT IDNCT05489224

SponsorCelltrion

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06-29

Results submitted2024-08-05