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

A Phase III, Open-label, Single-arm, Multiple-dose Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Moderate to Severe Active Rheumatoid Arthritis

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

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Biological: CT-P17 SC AI (adalimumab)

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 3

Contacts and Locations

Study Locations

• Poland
  • Bydgoszcz, Poland
    • Nasz Lekarz Osrodek Badan Klinicznych

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "CT-P17 SC AI (adalimumab)"; CT-P17 Subcutaneous(SC) Autoinjector(AI) (adalimumab)	Biological: CT-P17 SC AI (adalimumab); Subcutaneous Injection of Adalimumab 40mg once every two weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)]	Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24		Week 0
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)	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	Week 8,16,24
Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24		Week 2
Patient's Rating of PRE- and POST-SIAQ at Weeks 0, 2, and 24		Week 24

Collaborators and Investigators

• Sponsor: Celltrion
• Collaborators: PPD
• Investigators: Study Chair: MinJi Ma, Celltrion, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2019
• Primary Completion (Actual): November 4, 2019
• Study Completion (Actual): April 24, 2020

Study Registration Dates

• First Submitted: September 18, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (Actual): November 20, 2019

Study Record Updates

• Last Update Posted (Actual): November 17, 2021
• Last Update Submitted That Met QC Criteria: October 19, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Anti-Inflammatory Agents; Antirheumatic Agents; Adalimumab
• Other Study ID Numbers: CT-P17 3.2; 2019-000660-25 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No