A Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 With Humira When Co-administered With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03789292
• Other study ID #: CT-P17 3.1
• Secondary ID: 2018-001690-25
• Status: Completed
• Phase: Phase 3
• Start date: November 26, 2018
• Est. completion date: April 24, 2020

Study information

• Verified date: October 2021
• Source: Celltrion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase III Study to Compare Efficacy and Safety of CT-P17 with Humira in Patients With Active Rheumatoid Arthritis

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 demonstrate similar efficacy and safety of CT-P17 and Humira in patients with moderate to severe rheumatoid arthritis when co-administered with methotrexate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 648
• Est. completion date: April 24, 2020
• Est. primary completion date: October 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patient is male or female aged 18 to 75 years old, both inclusive.

• Patient has had a diagnosis of rheumatoid arthritis according to the 2010 American College of Rheumatology(ACR)/EULAR classification criteria for at least 24 weeks prior to the first administration of the study drug .

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) a 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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• CT-P17 SC
Subcutaneous injection of Adalimumab 40mg every two weeks
• Humira SC
Subcutaneous injection of Adalimumab 40mg every two weeks

Locations

Country	Name	City	State
Bulgaria	National Multiprofile Transport Hospital Tsar Boris III	Sofia

Sponsors (1)

Lead Sponsor	Collaborator
Celltrion

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American College of Rheumatology(ACR)20 Response Rate at Week 24.	ACR20 is defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in the three of the following five criteria: 1) patient global assessment of disease activity, 2) physician global assessment of disease activity, 3) functional ability measure using Health Assessment Questionnaire (HAQ), 4) visual analog pain scale, and 5) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)	Week 24
Secondary	ACR50 and ACR70 Response Rate at Week 24	ACR50 and ACR70 are the same instruments with improvement levels defined as 50% and 70% respectively versus 20% for ACR20.	Week 24
Secondary	ACR20, ACR50, and ACR70 Response Rate up to Week 52	ACR20 is defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in the three of the following five criteria: 1) patient global assessment of disease activity, 2) physician global assessment of disease activity, 3) functional ability measure using Health Assessment Questionnaire (HAQ), 4) visual analog pain scale, and 5) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). ACR50 and ACR70 are the same instruments with improvement levels defined as 50% and 70% respectively versus 20% for ACR20.	Up to Week 52
Secondary	Mean Change From Baseline in Disease Activity Measured by DAS28 (CRP)	The Disease activity score (DAS28) (c-reactive protein [CRP]) score was derived using the following formulae: DAS28 (CRP) = 0.56*v(TJC28) + 0.28*v(SJC28) + 0.014*(GH) + 0.36*ln(CRP+1) + 0.96; Where: TJC28 = 28 joint count for tenderness (0-28) SJC28 = 28 joint count for swelling (0-28) Ln (CRP) = natural logarithm of CRP (mg/L : 0.2-236.3 as observed in the study) GH = General Health component of the DAS (patient's global assessment of disease activity) (mm: 0-100).; DAS28 (CRP) values range from 1.03 to 8.77 while higher values mean a higher disease activity.	Week 24
Secondary	Mean Change From Baseline in Disease Activity Measured by DAS28 (CRP)	The Disease activity score (DAS28) (c-reactive protein [CRP]) score was derived using the following formulae: DAS28 (CRP) = 0.56*v(TJC28) + 0.28*v(SJC28) + 0.014*(GH) + 0.36*ln(CRP+1) + 0.96; Where: TJC28 = 28 joint count for tenderness (0-28) SJC28 = 28 joint count for swelling (0-28) Ln (CRP) = natural logarithm of CRP (mg/L : 0.2-236.3 as observed in the study) GH = General Health component of the DAS (patient's global assessment of disease activity) (mm: 0-100).; DAS28 (CRP) values range from 1.03 to 8.77 while higher values mean a higher disease activity.	Up to Week 52