Phase 3
Completed N=648
A Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT03789292 ↗Enrolled (actual)
648
Serious AEs
3.6%
Results posted
Nov 2021
Primary outcomePrimary: American College of Rheumatology(ACR)20 Response Rate at Week 24. — 268; 268 Participants
◆ Published Evidence
Established
31citations · ~6 / year
Efficacy and safety of biosimilar CT-P17 versus reference adalimumab in subjects with rheumatoid arthritis: 24-week results from a randomized study.
Summary
This is a Phase III Study to Compare Efficacy and Safety of CT-P17 with Humira in Patients With Active Rheumatoid Arthritis
Linked Publications (2)
-
Efficacy and safety of biosimilar CT-P17 versus reference adalimumab in subjects with rheumatoid arthritis: 24-week results from a randomized study.
-
Efficacy and safety of switching from reference adalimumab to CT-P17 (100 mg/ml): 52-week randomized, double-blind study in rheumatoid arthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY American College of Rheumatology(ACR)20 Response Rate at Week 24. |
268; 268 | — |
| SECONDARY ACR50 and ACR70 Response Rate at Week 24 |
195; 206; 132; 144 | — |
| SECONDARY ACR20, ACR50, and ACR70 Response Rate up to Week 52 |
244; 119; 125; 201; 95; 101 | — |
| SECONDARY Mean Change From Baseline in Disease Activity Measured by DAS28 (CRP) |
-2.945; -3.074; -2.983 | — |
| SECONDARY Mean Change From Baseline in Disease Activity Measured by DAS28 (CRP) |
-2.945; -3.074; -2.983 | — |
Eligibility Criteria
Inclusion Criteria
- Patient is male or female aged 18 to 75 years old, both inclusive.
- Patient has had a diagnosis of rheumatoid arthritis according to the 2010 American College of Rheumatology(ACR)/EULAR classification criteria for at least 24 weeks prior to the first administration of the study drug .
Exclusion Criteria
- Patient who has previously received investigational or licensed product; biologic or targeted synthetic disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis and/or a tumor necrosis factor (TNF) α inhibitor for any purposes.
- 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.
Data sourced from ClinicalTrials.gov (NCT03789292) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.