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A Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Subcutaneous CT-P13 in Patients with Moderately to Severely Active Rheumatoid Arthritis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-510945-32-00
Acronym
CT-P13 3.11
Enrollment
189
Registered
2024-12-16
Start date
2024-12-17
Completion date
Unknown
Last updated
2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis

Brief summary

Proportion of patients achieving clinical response according to the ACR20 criteria at Week 12.

Interventions

DRUGHYDROCORTISONE
DRUGHYDROXYCHLOROQUINE
DRUGFOLIC ACID
DRUGPARACETAMOL
DRUGMETHOTREXATE
DRUGIBUPROFEN
DRUGPlacebo (To evaluate the efficacy and safety of CT-P13
DRUGand mainatain blindness during the study
DRUGPlacebo will be administered.)

Sponsors

Celltrion Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Proportion of patients achieving clinical response according to the ACR20 criteria at Week 12.

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026