Clinical trial NCT02744196: Clinical Trial to Evaluate Efficacy and Safety of Acellbia® (JSC "BIOCAD") With Methotrexate in First Line Biological Therapy of Patients With Active Rheumatoid Arthritis
Official title: Multicenter Comparative Randomised Double-blind Placebo-controlled Clinical Trial to Evaluate Efficacy and Safety of Acellbia® (JSC "BIOCAD") With Methotrexate in First Line of Biological Therapy of Patients With Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis
rheumatism
Acellbia
methotrexate
biologic therapy
monoclonal antibody
rituximab
Lead sponsor: Biocad
Sponsor class: INDUSTRY
First posted: 2016-04-20
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of patients who developed ACR20 response on 24 week of therapy
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of patients who developed ACR50 and ACR70 response on 24 week of therapy
timeFrame: Week 24
measure: Percentage of patients who developed ACR20, ACR50 and ACR70 response on 16 week of therapy
timeFrame: Week 16
measure: Change in average DAS28-4 (ESR) score after 24 weeks of therapy
timeFrame: Week 24
measure: Change in average HAQ-DI score after 24 weeks of therapy
timeFrame: Week 24
measure: Change in average score according to modified Sharp method of assessment after 24 weeks of therapy
timeFrame: Week 24
measure: Change in average score of erosions according to modified Sharp method of assessment after 24 weeks of therapy
timeFrame: Week 24
measure: Change in average score of joint spase narrowing according to modified Sharp method of assessment after 24 weeks of therapy
timeFrame: Week 24
measure: Percentage of patients with progression of disease according to modified Steinbrocker method of assessment after 24 weeks of treatment
timeFrame: Week 24
measure: Percentage of patients who developed ACR20, ACR50 and ACR70 response on 52 week of therapy
timeFrame: Week 52
measure: Change in average DAS28-4 (ESR) score after 52 weeks of therapy
timeFrame: Week 52
measure: Change in average HAQ-DI score after 52 weeks of therapy
timeFrame: Week 52
measure: Change in average score according to modified Sharp method of assessment after 52 weeks of therapy
timeFrame: Week 52
measure: Change in average score of erosions according to modified Sharp method of assessment after 52 weeks of therapy
timeFrame: Week 52
measure: Change in average score of joint space narrowing according to modified Sharp method of assessment after 52 weeks of therapy
timeFrame: Week 52
measure: Percentage of patients with progression of disease according to modified Steinbrocker method of assessment after 52 weeks of treatment
timeFrame: Week 52
measure: Frequency and severity of AE/SAE
timeFrame: 52 weeks
measure: Frequency of AE 3-4 grade CTCAE 4.03
timeFrame: 52 weeks
measure: Frequency of premature withdrawal due to AE/SAE
timeFrame: 52 weeks
measure: Percentage of patients who have developed binding and neutralizing antibodies to rituximab on week 24 and week 52
timeFrame: Week 24, Week 52
Other outcomes:
Locations:
Study officials:
affiliation: JCS BIOCAD
name: Roman Ivanov, PhD
role: STUDY_CHAIR
References: