Clinical Trial to Evaluate Efficacy and Safety of Acellbia® (JSC "BIOCAD") With Methotrexate in First Line Biological Therapy of Patients With Active Rheumatoid Arthritis

NCT02744196 | Completed Phase 3

• 1 other identifier: BCD-020-4
• Study Type: interventional
• Target: 159
• Locations: 0 countries
• Sites: N/A

Brief Summary

The mail goal of this study is to establish superiority in efficacy of Acellbia® applied in a dose of 600 mg (Day 1 and Day 15) in combination with methotrexate in patients with active RA seropositive previously untreated with biological therapy, compared to standard therapy with methotrexate.

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis; rheumatism; Acellbia; methotrexate; biologic therapy; monoclonal antibody; rituximab

Outcome Measures

Primary Outcomes (1)

• Percentage of patients who developed ACR20 response on 24 week of therapy

  The proportion of patients achieving at least a 20% improvement in ACR criteria at 24 weeks of therapy.

  Week 24

Secondary Outcomes (19)

• Percentage of patients who developed ACR50 and ACR70 response on 24 week of therapy

  Week 24

• Percentage of patients who developed ACR20, ACR50 and ACR70 response on 16 week of therapy

  Week 16

• Change in average DAS28-4 (ESR) score after 24 weeks of therapy

  Week 24

• Change in average HAQ-DI score after 24 weeks of therapy

  Week 24

• Change in average score according to modified Sharp method of assessment after 24 weeks of therapy

  Week 24

Study Arms (2)

Acellbia + methotrexate

EXPERIMENTAL

106 patients of this group will receive methotrexate in combination with a drug Acellbia to be used at a dose of 600 mg as a slow intravenous infusion carried out on day 1 and day 15. If a follow-up examination at 24 weeks or later (up to 48 weeks) reveals that the patient still has active arthritis (evaluation index DAS28-4 (ESR)\> 2,6 points), the therapy with Acellbia is repeated by the same scheme - 2 infusion at a dose of 600 mg at intervals of 14 days.

Biological: Acellbia; Drug: Methotrexate

Placebo + methotrexate

PLACEBO COMPARATOR

53 patients of this group will receive methotrexate in combination with a placebo to be used as a slow intravenous infusion carried out on day 1 and day 15. If a follow-up examination at 24 weeks or later (up to 48 weeks) reveals that the patient still has active arthritis (evaluation index DAS28-4 (ESR)\> 2,6 points), the patient receives open therapy with Acellbia is initiated: 2 infusion at a dose of 600 mg at intervals of 14 days.

Biological: Acellbia; Drug: Placebo; Drug: Methotrexate

Interventions

Acellbia BIOLOGICAL

Acellbia is rituximab biosimilar, monoclonal antibody which binds CD20.

Also known as: rituximab

Acellbia + methotrexate; Placebo + methotrexate

Placebo DRUG

Placebo solution will look identical to the Acellbia solution.

Placebo + methotrexate

Methotrexate DRUG

Acellbia + methotrexate; Placebo + methotrexate

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent. Age from 18 to 80 years. Rheumatoid arthritis diagnosed at least 6 months before informed consent signing Presence of more than 8 swollen and more than 8 painful joints at screening. C-reactive protein 7 mg/l or more AND/OR erythrocyte sedimentation rate 28 mm/hour or more.
• Antibodies to citrullinated cyclic peptide 20 U/ml or more AND/OR rheumatoid factor-IgM higher than upper normal limit.
• Documented regular methotrexate intake for 12 weeks, stable dose from 10 to 25 mg/week during last 4 weeks before signing informed consent.

You may not qualify if:

• Methotrexate intolerance. Felty's syndrome. Patient functional status - IV class according to ACR. Previous use of biologic drugs to treat rheumatoid arthritis, biologic drugs that deplete CD20-lymphocytes, azathioprine use in the last 28 days prior to informed consent signing, leflunomide use in the last 8 weeks prior to informed consent signing, sulphasalazine/hydroxyquinoline use in the last 28 days prior to informed consent signing, intraarticular use of corticosteroids in the last 4 weeks prior to informed consent signing, patient requires prednisolone (or analogues) in a dose more than 10 mg/day or dose is unstable during 4 weeks prior to informed consent signing, requirement in non-steroid antiinflammatory drugs if their dose was not stable during last 8 weeks prior to informed consent signing.
• Patient has inflammatory joint disease otherwise than rheumatoid arthritis or systemic autoimmune diseases.

Sponsors & Collaborators

• Biocad: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid; Rheumatic Diseases

Interventions

Rituximab; Methotrexate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Roman Ivanov, PhD

  JCS BIOCAD

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: April 20, 2016
• Study Start: January 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: August 1, 2017
• Last Updated: January 25, 2018

Record last verified: 2018-01