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This is 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-P13 Auto-Injector | Experimental | CT-P13 SC(Subcutaneous) Auto-Injector |
|
| Placebo Auto-Injector | Placebo Comparator | Placebo Auto-Injector |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-P13 SC Auto-Injector | Biological | Subcutaneous(SC) Injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving clinical response according to the ACR20 criteria at Week 12 | To demonstrate superiority of CT P13 SC over Placebo in terms of efficacy as determined by clinical response according to the American College of Rheumatology (ACR) definition of a 20% improvement (ACR20) at Week 12 | Week 0 ~ Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HAQ-DI at Week 12 | Difference in mean change from baseline in HAQ-DI between treatment groups (CT-P13 SC and Placebo) | Week 0 ~ Week 12 |
| Evaluate Pharmacokinetics of CT-P13 SC |
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[Main Inclusion Criteria]
[Main Exclusion Criteria]
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinika Reuma Park Sp. z.o.o | Warsaw | 02-665 | Poland |
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| Placebo Auto-Injector |
| Biological |
Subcutaneous(SC) Injection |
|
Serum concentration of infliximab
| Up to 52 Weeks |
| Evaluate Safety of CT-P13 SC |
| Up to 52 Weeks |