Study of the Efficacy and Safety of BCD-089 in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

NCT04227366 | Completed Phase 3

• 1 other identifier: BCD-089-3
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

BCD-089 is the original therapeutic monoclonal antibody binding the alpha subunit of the IL-6 receptor. The aim of the study is to demonstrate the efficacy and safety of BCD-089 in combination with methotrexate in patients with active rheumatoid arthritis resistant to monotherapy with methotrexate.

Conditions

Rheumatoid Arthritis

Keywords

anti-IL-6R; IL-6 receptor inhibitors

Outcome Measures

Primary Outcomes (2)

• ACR 20 response

  The proportion of ACR 20 responders

  Week 12

• Low disease activity

  The proportion of patients with low disease activity according to DAS28-CRP(4) (\< 3,2)

  Week 24

Secondary Outcomes (22)

• Need for rescue therapy

  Week 12.

• RA remission

  Weeks 4, 8, 12, 16, 24.

• RA remission

  Weeks 4, 8, 12, 16, 24.

• RA remission

  Weeks 4, 8, 12, 16, 24.

• Remission according to the ACR/EULAR 2011 criteria

  Weeks 4, 8, 12, 16, 24

Study Arms (2)

Group 1

EXPERIMENTAL

BCD-089

Biological: BCD-089; Drug: Methotrexat

Group 2

PLACEBO COMPARATOR

Placebo

Biological: Placebo; Drug: Methotrexat

Interventions

BCD-089 BIOLOGICAL

BCD-089 162 mg SC

Group 1

Placebo BIOLOGICAL

Placebo

Also known as: Placebo (for BCD-089)

Group 2

Methotrexat DRUG

15 to 25 mg/week

Group 1; Group 2

Eligibility Criteria

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

You may qualify if:

• Signed informed consent form (ICF).
• Men and women aged 18 years or older on the day of signing the ICF.
• Verified rheumatoid arthritis according to the ACR 2010 criteria diagnosed at least 24 weeks before signing the ICF .
• Use of methotrexate for the last 12 weeks before signing the ICF.
• Use of a stable dose of methotrexate for the last 4 weeks before signing the ICF (the dose of methotrexate should be 15 to 25 mg per week). Methotrexate can be used at a dose of 10 mg in the case of intolerability/toxicity of higher doses.
• Inefficacy of methotrexate used for the last 12 weeks before signing the ICF (in the opinion of the Investigator).
• Active rheumatoid arthritis at randomization in the study.
• The ability of the patient (in the Investigator's opinion) to follow the Protocol procedures.
• Patients and their sexual partners of childbearing potential agree to use reliable contraceptive methods starting from signing the ICF, during the study and for 8 weeks from the last injection of the investigational product. This requirement does not apply to patients and their partners who underwent surgical sterilization and to women who are post-menopausal for at least 2 years. Reliable contraceptive methods include one barrier method in combination with one of the following: spermicides, intrauterine device/oral contraceptives.

You may not qualify if:

• Previous exposure to tocilizumab or other anti-IL6 or anti-IL-6R monoclonal antibodies.
• Previous exposure to JAK inhibitors.
• Previous exposure to rituximab or other B-cell depleting/suppressing agents.
• Felty's syndrome (regardless of clinical form).
• Patient's functional status: class IV according to the ACR 1991 classification.
• Known allergy to or intolerance of any ingredients of BCD-089 or placebo.
• Use of any of the following concomitant therapies:
• Oral prednisolone or its equivalent in a dose more than 10 mg/day;
• Need in oral prednisolone (or its equivalent) ≤ 10 mg if its dose was not stable during the last 4 weeks before signing the ICF (patients who used topical glucocorticoids are allowed to participate in the study);
• Need in NSAIDs if the dose was not stable during the last 4 weeks before signing the ICF (patients who have occasionally used NSAIDs for fever or allergy syndrome associated with an intercurrent disease can be included in the study);
• Use of alkylating agents any time within 12 months before signing the ICF.
• Intra-articular use of corticosteroids within 4 weeks before signing the ICF.
• Vaccination with live or attenuated vaccines any time within 8 weeks before signing the ICF.
• Use of leflunomide within 8 weeks before signing the ICF.
• Use of TNFα inhibitors or T-cell costimulation blockers within 8 weeks before signing the ICF.

Sponsors & Collaborators

• Biocad: lead

Study Sites (1)

Research Institute of Rheumotology

Moscow, Russia

Location

Related Publications (1)

• Mazurov V.I., Korolev M.A., Prystrom A.M., Kunder E.V., Soroka N.F., Kastanayan A.A., Povarova T.V., Plaksina T.V., Antipova O.V., Kretchikova D.G., Smakotina S.A., Tciupa O.A., Puntus E.V., Raskina T.A., Shilova L.N., Kropotina T.V., Nesmeyanova O.B., Popova T.A., Vinogradova I.B., Linkova Yu.N., Dokukina E.A., Plotnikova A.V., Pukhtinskaia P.S., Zinkina-Orikhan A.V., Eremeeva A.V., Lutckii A.A. Effectiveness and safety of levilimab in combination with methotrexate in treatment of patients with active rheumatoid arthritis resistant to methotrexate monotherapy (double-blinded randomized placebo controlled phase III clinical study SOLAR). Modern Rheumatology Journal. 2021;15(4):13-23. https://doi.org/10.14412/1996-7012-2021-4-13-23

  BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

levilimab; Methotrexate

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)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yulia Linkova, MD, PhD

  JSC BIOCAD

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: December 25, 2019
• First Posted: January 13, 2020
• Study Start: November 19, 2019
• Primary Completion: March 15, 2021
• Study Completion: March 1, 2022
• Last Updated: May 12, 2022

Record last verified: 2020-11

Locations

RU (1)