A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis

Phase 3

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Biological: CT-P17 SC AI (adalimumab)

• Registration Number: NCT04171414
• Lead Sponsor: Celltrion

Brief Summary

Clinical trial to evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis

Detailed Description

CT-P17, containing the active ingredient adalimumab, is a recombinant humanized monoclonal antibody that is being developed as a similar biological medicinal product to Humira. The purpose of this study is to evaluate usability of subcutaneous auto-injector of CT-P17 in patients with moderate to severe rheumatoid arthritis.

Study Timeline

• Study Start: 2019-09-09
• Study First Submitted: 2019-09-18
• Primary Completion: 2019-11-04
• Study First Submitted QC: 2019-11-19
• Study First Posted: 2019-11-20
• Study Completion: 2020-04-24
• Results First Submitted: 2021-08-16
• Status Verified: 2021-10
• Results First Submitted QC: 2021-10-19
• Last Update Submitted: 2021-10-19
• Results First Posted: 2021-11-17
• Last Update Posted: 2021-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Male or female patient aged 18 to 70 years, inclusive.
• Patient must be able and willing to self-administer subcutaneous (SC) injections via auto injector (AI).

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
"CT-P17 SC AI (adalimumab)"	CT-P17 SC AI (adalimumab)	CT-P17 Subcutaneous(SC) Autoinjector(AI) (adalimumab)

Primary Outcome Measures

Name	Time	Method
The Usability as Assessed by Patients Rating Using PRE- and POST-Self-Injection Assessment Questionnaire (SIAQ) at Week 4	Week 4	The usability of CT-P17 Auto Injector is measured by participant using PRE- and POST-Self-injection Assessment Questionnaire (SIAQ) modules. The PRE-SIAQ module is a 7-item questionnaire and the POST-SIAQ module is a 27-item questionnaire that assesses feelings about injections, self-image, self-confidence (regarding self-administration), pain and skin reactions before after injection. Participants rated each item of the SIAQ on a 5-point (or 6-point) semantic Likert-type scal. (each item graded on a 5-point scale). \[Scores were transformed to Rate between 0 (worst) to 10 (best)\]

Secondary Outcome Measures

Name	Time	Method
Observer's Rating of Successful Self-injection Using Self-injection Assessment Checklist at Weeks 0, 2, 4, and 24	Week 0,2,4,24
Mean for Actual Values and Change From Baseline in DAS28 (CRP and ESR)	Week 8,16,24	DAS28 (CRP) was calculated using the following formula: DAS28 (CRP) = 0.56 X SQRT(TJC28) + 0.28 X SQRT(SJC28) + 0.36 X ln(CRP+1) + 0.014 X GH on VAS + 0.96. DAS28 (CRP) provides a number on a scale from 0 to 10 with higher values indicating greater RA disease activity.; DAS28 (ESR) was calculated using the following formula: DAS28 (CRP) = 0.56 X SQRT(TJC28) + 0.28 X SQRT(SJC28) + 0.36 X ln(ESR) + 0.014 X GH on VAS. DAS28 (ESR) provides a number on a scale from 0 to 10 with higher values indicating greater RA disease activity.; Abbreviation: CRP, C-reactive protein; DAS28, Disease Activity Score using 28 joint counts; ESR, Erythrocyte sedimentation rate
Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24	Week 24

Trial Locations

Locations (1)

Nasz Lekarz Osrodek Badan Klinicznych; 🇵🇱 Bydgoszcz, Poland