A Study Comparing SB5 to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

NCT02167139 | Completed Phase 3 Results DMC

• 1 other identifier: SB5-G31-RA
• Study Type: interventional
• Target: 544
• Locations: 2 countries
• Sites: 2

Brief Summary

This is a randomised, double-blind, parallel group, multicentre clinical study to evaluate the efficacy, safety, tolerability, pharmacokinetics and immunogenicity of SB5 compared to Humira® in subjects with moderate to severe RA despite MTX therapy.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, Adalimumab

Outcome Measures

Primary Outcomes (1)

• American College of Rheumatology 20% Response Criteria (ACR20)

  Week 24

Secondary Outcomes (3)

• ACR20

  Week 52

• American College of Rheumatology 50% Response Criteria (ACR50)

  Week 24, Week 52

• Disease Activity Score Based on a 28 Joint Count (DAS28)

  Week 24, Week 52

Study Arms (2)

SB5 (proposed biosimilar to adalimumab)

EXPERIMENTAL

SB5 40 mg every other week via subcutaneous injection

Drug: SB5 (proposed biosimilar to adalimumab)

Humira (adalimumab)

ACTIVE COMPARATOR

Humira 40 mg every other week via subcutaneous injection

Drug: Humira (adalimumab); Drug: SB5 (proposed biosimilar to adalimumab)

Interventions

Humira (adalimumab) DRUG

Humira (adalimumab)

SB5 (proposed biosimilar to adalimumab) DRUG

Humira (adalimumab); SB5 (proposed biosimilar to 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:

• Are male or female aged 18-75 years at the time of signing the informed consent form.
• Have been diagnosed as having RA according to the revised 1987 American College of Rheumatology (ACR) criteria for at least 6 months but not exceeding 15 years prior to Screening.
• Have moderate to severe active disease despite MTX therapy defined as:
• More than or equal to six swollen joints and more than or equal to six tender joints (from the 66/68 joint count system) at Screening and Randomisation.
• Either erythrocyte sedimentation rate (Westergren) ≥ 28 mm/h or serum C-reactive protein ≥ 10 mg/dL at Screening.
• Must have been treated with MTX for a total of at least 6 months prior to Randomisation and must have been on both: a stable route of administration (oral or parenteral) and stable dose of MTX (10-25 mg/week) for at least 4 weeks prior to Screening.
• Female subjects who are not pregnant or nursing at Screening and Randomisation and who are not planning to become pregnant from Screening until 5 months after the last dose of IP.

You may not qualify if:

• Have been treated previously with any biological agents including any tumour necrosis factor inhibitor.
• Have a known hypersensitivity to human immunoglobulin proteins or other components of Humira or SB5.
• Have a positive serological test for hepatitis B or hepatitis C or have a known history of infection with human immunodeficiency virus.
• Have a current diagnosis of active tuberculosis (TB), have been recently exposed to a person with active TB, or are considered to have latent TB.
• Have had a serious infection or have been treated with intravenous antibiotics for an infection within 8 weeks or oral antibiotics within 2 weeks prior to Randomisation.
• Have a history of chronic or recurrent infection.
• Have any of the following conditions:
• History of congestive heart failure (New York Heart Association Class III/IV).
• History of acute myocardial infarction or unstable angina within the previous 12 months prior to Screening.
• History of demyelinating disorders.
• History of any malignancy within the previous 5 years prior to Screening.
• History of lymphoproliferative disease including lymphoma.
• Any other disease or disorder which, in the opinion of the Investigator, will put the subject at risk if they are enrolled.
• Have physical incapacitation (ACR functional Class IV or wheelchair-/bed-bound).

Sponsors & Collaborators

• Samsung Bioepis Co., Ltd.: lead

Study Sites (2)

Investigational Site

Kaunas, Lithuania

Location

Investigational site

Katowice, Poland

Location

Related Publications (5)

• Huizinga TWJ, Torii Y, Muniz R. Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity. Rheumatol Ther. 2021 Mar;8(1):41-61. doi: 10.1007/s40744-020-00259-8. Epub 2020 Dec 1.

  PMID: 33263165 DERIVED

• Emery P, Suh CH, Weinblatt ME, Smolen JS, Keystone EC, Genovese M, Vencovsky J, Kay J, Hong E, Baek Y, Ghil J. Impact of immunogenicity on efficacy and tolerability of tumour necrosis factor inhibitors: pooled analysis of biosimilar studies in rheumatoid arthritis. Scand J Rheumatol. 2020 Sep;49(5):361-370. doi: 10.1080/03009742.2020.1732458. Epub 2020 May 29.

  PMID: 32468892 DERIVED

• Smolen JS, Choe JY, Weinblatt ME, Emery P, Keystone E, Genovese MC, Myung G, Hong E, Baek I, Ghil J. Pooled analysis of TNF inhibitor biosimilar studies comparing radiographic progression by disease activity states in rheumatoid arthritis. RMD Open. 2020 Jan;6(1):e001096. doi: 10.1136/rmdopen-2019-001096.

  PMID: 31958281 DERIVED

• Weinblatt ME, Baranauskaite A, Dokoupilova E, Zielinska A, Jaworski J, Racewicz A, Pileckyte M, Jedrychowicz-Rosiak K, Baek I, Ghil J. Switching From Reference Adalimumab to SB5 (Adalimumab Biosimilar) in Patients With Rheumatoid Arthritis: Fifty-Two-Week Phase III Randomized Study Results. Arthritis Rheumatol. 2018 Jun;70(6):832-840. doi: 10.1002/art.40444. Epub 2018 Apr 24.

  PMID: 29439289 DERIVED

• Weinblatt ME, Baranauskaite A, Niebrzydowski J, Dokoupilova E, Zielinska A, Jaworski J, Racewicz A, Pileckyte M, Jedrychowicz-Rosiak K, Cheong SY, Ghil J. Phase III Randomized Study of SB5, an Adalimumab Biosimilar, Versus Reference Adalimumab in Patients With Moderate-to-Severe Rheumatoid Arthritis. Arthritis Rheumatol. 2018 Jan;70(1):40-48. doi: 10.1002/art.40336. Epub 2017 Nov 21.

  PMID: 28950421 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Director, Clinical Development
• Organization: Samsung Bioepis

dh01.shin@samsung.com

+82 31 8061 4534

Study Officials

• Asta Baranauskaite, M.D., Ph.D.

  Hospital of Lithuanian University of Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• 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: June 16, 2014
• First Posted: June 18, 2014
• Study Start: May 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: October 1, 2015
• Last Updated: August 17, 2017
• Results First Posted: January 19, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1); LI (1)