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

Sponsors

Lead Sponsor: Celltrion

Collaborator: PPD

Source Celltrion
Brief Summary

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

Overall Status Recruiting
Start Date September 9, 2019
Completion Date May 2020
Primary Completion Date November 2019
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Usability of the Auto-injector (AI) at Week 4 Week 4
Secondary Outcome
Measure Time Frame
Number of successful self-injection Upto Week 24
Percentage of successful self-injection Upto Week 24
Usability of the Auto-injector (AI) Upto Week 24
Efficacy of the CT-P17 Auto Injector with the mean change from baseline in Disease Activity Score in 28 Joints (DAS28-C-reactive protein [CRP]) [The larger the score decreases, the better the patient's status goes] Upto Week 24
Efficacy of the CT-P17 Auto Injector with the mean change from baseline in Disease Activity Score in 28 Joints (DAS28- erythrocyte sedimentation rate [ESR]) [The larger the score decreases, the better the patient's status goes] Upto Week 24
Incidence of Adverse Events (AEs) Upto Week 24
Enrollment 50
Condition
Intervention

Intervention Type: Biological

Intervention Name: CT-P17 SC AI (adalimumab)

Description: Subcutaneous Injection of Adalimumab 40mg once every two weeks

Arm Group Label: "CT-P17 SC AI (adalimumab)"

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Healthy Volunteers: No

Overall Contact

Last Name: Changwoo Park

Phone: +82 32 850 5701

Email: [email protected]

Location
Facility: Status: Contact: Nasz Lekarz Osrodek Badan Klinicznych Jeka Slawomir
Location Countries

Poland

Verification Date

November 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: "CT-P17 SC AI (adalimumab)"

Type: Experimental

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov