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

Biocad159 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

159

Conditions

Rheumatoid Arthritis

Interventions

AcellbiaBIOLOGICAL

Acellbia is rituximab biosimilar, monoclonal antibody which binds CD20.

PlaceboDRUG

Placebo solution will look identical to the Acellbia solution.

MethotrexateDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 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. Exclusion Criteria: 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. Full list of inclusion and exclusion criteria can be found in Study Protocol.

Outcomes

Primary Outcomes

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.

Time frame: Week 24

Secondary Outcomes

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

The proportion of patients achieving at least 50% and 70% improvement in ACR criteria at 24 weeks of therapy.

Time frame: Week 24

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

The proportion of patients achieving at least 20%, 50% and 70% improvement in ACR criteria after 16 weeks of therapy.

Time frame: Week 16

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

Time frame: Week 24

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

Time frame: Week 24

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

Time frame: Week 24

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

Time frame: Week 24

Change in average score of joint spase narrowing according to modified Sharp method of assessment after 24 weeks of therapy

Time frame: Week 24

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.