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

Celltrion62 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

CT-P17 SC AI (adalimumab)BIOLOGICAL

Subcutaneous Injection of Adalimumab 40mg once every two weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Nasz Lekarz Osrodek Badan Klinicznych

Bydgoszcz, Poland

Outcomes

Primary Outcomes

The Usability as Assessed by Patients Rating Using PRE- and POST-Self-Injection Assessment Questionnaire (SIAQ) at 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). \[Scores were transformed to Rate between 0 (worst) to 10 (best)\]

Time frame: Week 4

Secondary Outcomes

Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24

Time frame: Week 0

Observer's Rating of Successful Self-injection Using Self-injection Assessment Checklist at Weeks 0, 2, 4, and 24

Time frame: Week 0,2,4,24

Mean for Actual Values and Change From Baseline in DAS28 (CRP and ESR)

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

Time frame: Week 8,16,24

Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24

Time frame: Week 2

Data from ClinicalTrials.gov

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