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

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Poland

Study Type

Interventional

Intervention

CT-P17 SC AI (adalimumab)

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Nasz Lekarz Osrodek Badan Klinicznych

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

"CT-P17 SC AI (adalimumab)"

Arm Description

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

Outcomes

Primary Outcome Measures

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)]

Secondary Outcome Measures

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

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

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

Full Information

NCT ID

NCT04171414

First Posted

September 18, 2019

Last Updated

October 19, 2021

Sponsor

Celltrion

Collaborators

PPD

1. Study Identification

Unique Protocol Identification Number

NCT04171414

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

September 9, 2019 (Actual)

Primary Completion Date

November 4, 2019 (Actual)

Study Completion Date

April 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Celltrion

Collaborators

PPD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

"CT-P17 SC AI (adalimumab)"

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

CT-P17 SC AI (adalimumab)

Intervention Description

Subcutaneous Injection of Adalimumab 40mg once every two weeks

Primary Outcome Measure Information:

Title

The Usability as Assessed by Patients Rating Using PRE- and POST-Self-Injection Assessment Questionnaire (SIAQ) at Week 4

Description

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 Outcome Measure Information:

Title

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

Time Frame

Week 0

Title

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

Title

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

Description

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

Title

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

Time Frame

Week 2

Title

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

Time Frame

Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

No

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

MinJi Ma

Organizational Affiliation

Celltrion, Inc.

Official's Role

Study Chair

Facility Information:

Facility Name

Nasz Lekarz Osrodek Badan Klinicznych

City

Bydgoszcz

Country

Poland

12. IPD Sharing Statement

Plan to Share IPD

No

Rheumatoid Arthritis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial