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

NCT ID: NCT04171414

Last Updated: 2021-11-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-09

Study Completion Date

2020-04-24

Brief Summary

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

Detailed Description

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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.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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"CT-P17 SC AI (adalimumab)"

CT-P17 Subcutaneous(SC) Autoinjector(AI) (adalimumab)

Group Type EXPERIMENTAL

CT-P17 SC AI (adalimumab)

Intervention Type BIOLOGICAL

Subcutaneous Injection of Adalimumab 40mg once every two weeks

Interventions

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CT-P17 SC AI (adalimumab)

Subcutaneous Injection of Adalimumab 40mg once every two weeks

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PPD Development, LP

INDUSTRY

Sponsor Role collaborator

Celltrion

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MinJi Ma

Role: STUDY_CHAIR

Celltrion, Inc.

Locations

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Nasz Lekarz Osrodek Badan Klinicznych

Bydgoszcz, , Poland

Site Status

Countries

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Poland

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2019-000660-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CT-P17 3.2

Identifier Type: -

Identifier Source: org_study_id