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NCT Number: NCT03789292

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

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Multiprofile Transport Hospital Tsar Boris III

Sofia, Bulgaria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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) 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.

Treatment and study plan

CT-P17 SC

Biological

Subcutaneous injection of Adalimumab 40mg every two weeks

Humira SC

Biological

Subcutaneous injection of Adalimumab 40mg every two weeks

Primary outcomes

  1. American College of Rheumatology(ACR)20 Response Rate at Week 24.

    Time frame: 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)

Secondary outcomes

  1. ACR50 and ACR70 Response Rate at Week 24

    Time frame: Week 24

    ACR50 and ACR70 are the same instruments with improvement levels defined as 50% and 70% respectively versus 20% for ACR20.

  2. ACR20, ACR50, and ACR70 Response Rate up to Week 52

    Time frame: 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.

  3. Mean Change From Baseline in Disease Activity Measured by DAS28 (CRP)

    Time frame: Week 24

    The Disease activity score (DAS28) (c-reactive protein [CRP]) score was derived using the following formulae:

    DAS28 (CRP) = 0.56*√(TJC28) + 0.28*√(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.

  4. Mean Change From Baseline in Disease Activity Measured by DAS28 (CRP)

    Time frame: Up to Week 52

    The Disease activity score (DAS28) (c-reactive protein [CRP]) score was derived using the following formulae:

    DAS28 (CRP) = 0.56*√(TJC28) + 0.28*√(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.

Sponsors and collaborators

Lead sponsor

Celltrion

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Dec 28, 2018
Registry last updated
Nov 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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