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

NCT03789292 | Completed Phase 3 Results DMC

• 2 other identifiers: CT-P17 3.12018-001690-25
• Study Type: interventional
• Target: 648
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• ACR50 and ACR70 Response Rate at Week 24

  Week 24

• ACR20, ACR50, and ACR70 Response Rate up to Week 52

  Up to Week 52

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

  Week 24

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

  Up to Week 52

Study Arms (2)

CT-P17 Subcutaneous(SC) (adalimumab)

EXPERIMENTAL

CT-P17 SC (adalimumab)

Biological: CT-P17 SC

Humira SC (adalimumab)

ACTIVE COMPARATOR

Humira SC (adalimumab)

Biological: CT-P17 SC; Biological: Humira SC

Interventions

CT-P17 SC BIOLOGICAL

Subcutaneous injection of Adalimumab 40mg every two weeks

CT-P17 Subcutaneous(SC) (adalimumab); Humira SC (adalimumab)

Humira SC BIOLOGICAL

Subcutaneous injection of Adalimumab 40mg every two weeks

Humira SC (adalimumab)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celltrion: lead

Study Sites (1)

National Multiprofile Transport Hospital Tsar Boris III

Sofia, Bulgaria

Location

Related Publications (2)

• Furst DE, Jaworski J, Wojciechowski R, Wiland P, Dudek A, Krogulec M, Jeka S, Zielinska A, Trefler J, Bartnicka-Maslowska K, Krajewska-Wlodarczyk M, Klimiuk PA, Lee SJ, Kim SH, Bae YJ, Yang GE, Yoo JK, Kay J, Keystone E. Efficacy and safety of switching from reference adalimumab to CT-P17 (100 mg/ml): 52-week randomized, double-blind study in rheumatoid arthritis. Rheumatology (Oxford). 2022 Apr 11;61(4):1385-1395. doi: 10.1093/rheumatology/keab460.

  PMID: 34142111 DERIVED

• Kay J, Jaworski J, Wojciechowski R, Wiland P, Dudek A, Krogulec M, Jeka S, Zielinska A, Trefler J, Bartnicka-Maslowska K, Krajewska-Wlodarczyk M, Klimiuk PA, Lee SJ, Bae YJ, Yang GE, Yoo JK, Furst DE, Keystone E. Efficacy and safety of biosimilar CT-P17 versus reference adalimumab in subjects with rheumatoid arthritis: 24-week results from a randomized study. Arthritis Res Ther. 2021 Feb 5;23(1):51. doi: 10.1186/s13075-020-02394-7.

  PMID: 33546755 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: JiWoong Lim
• Organization: Celltrion Inc.

jiwoong.lim@celltrion.com

032-850-5806

Study Officials

• MinJi Ma

  Celltrion, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: December 28, 2018
• Study Start: November 26, 2018
• Primary Completion: October 8, 2019
• Study Completion: April 24, 2020
• Last Updated: November 17, 2021
• Results First Posted: November 17, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)