A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
- Sponsor
- Celltrion
- Study ID
- NCT04171414
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- CT-P17 SC AI (adalimumab) — BIOLOGICALSubcutaneous Injection of Adalimumab 40mg once every two weeks
Study Details
Clinical trial to evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
Key Dates
- Start date
- Sep 9, 2019
- Status verified
- Oct 2021
- Primary completion
- Nov 4, 2019
- Completion
- Apr 24, 2020
Study Design
- Enrollment
- 62 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: "CT-P17 SC AI (adalimumab)"CT-P17 Subcutaneous(SC) Autoinjector(AI) (adalimumab)
Primary Outcome Measure
The Usability as Assessed by Patients Rating Using PRE- and POST-Self-Injection Assessment Questionnaire (SIAQ) at Week 4 [ Time Frame: Week 4 ]
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