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

Rheumatoid Arthritis Clinical Trial

— ALTERRA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02744196
• Other study ID #: BCD-020-4
• Status: Completed
• Phase: Phase 3
• First received: April 4, 2016
• Last updated: January 24, 2018
• Start date: January 2015
• Est. completion date: August 2017

Study information

• Verified date: January 2018
• Source: Biocad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: August 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• Acellbia
Acellbia is rituximab biosimilar, monoclonal antibody which binds CD20.

Drug:
• Placebo
Placebo solution will look identical to the Acellbia solution.
• Methotrexate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biocad

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Week 24
Secondary	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.	Week 16
Secondary	Change in average DAS28-4 (ESR) score after 24 weeks of therapy	Change in average DAS28-4 (ESR) score after 24 weeks of therapy	Week 24
Secondary	Change in average HAQ-DI score after 24 weeks of therapy		Week 24
Secondary	Change in average score according to modified Sharp method of assessment after 24 weeks of therapy		Week 24
Secondary	Change in average score of erosions according to modified Sharp method of assessment after 24 weeks of therapy		Week 24
Secondary	Change in average score of joint spase narrowing according to modified Sharp method of assessment after 24 weeks of therapy		Week 24
Secondary	Percentage of patients with progression of disease according to modified Steinbrocker method of assessment after 24 weeks of treatment		Week 24
Secondary	Percentage of patients who developed ACR20, ACR50 and ACR70 response on 52 week of therapy	The proportion of patients achieving at least 20%, 50% and 70% improvement in ACR criteria after 52 weeks of therapy.	Week 52
Secondary	Change in average DAS28-4 (ESR) score after 52 weeks of therapy	Change in average DAS28-4 (ESR) score after 52 weeks of therapy	Week 52
Secondary	Change in average HAQ-DI score after 52 weeks of therapy		Week 52
Secondary	Change in average score according to modified Sharp method of assessment after 52 weeks of therapy		Week 52
Secondary	Change in average score of erosions according to modified Sharp method of assessment after 52 weeks of therapy		Week 52
Secondary	Change in average score of joint space narrowing according to modified Sharp method of assessment after 52 weeks of therapy		Week 52
Secondary	Percentage of patients with progression of disease according to modified Steinbrocker method of assessment after 52 weeks of treatment		Week 52
Secondary	Frequency and severity of AE/SAE	Frequency and severity of AE/SAE in patients who received at least one injection of study drug/placebo	52 weeks
Secondary	Frequency of AE 3-4 grade CTCAE 4.03	Frequency of AE 3-4 grade CTCAE 4.03 in patients who received at least one injection of study drug/placebo	52 weeks
Secondary	Frequency of premature withdrawal due to AE/SAE		52 weeks
Secondary	Percentage of patients who have developed binding and neutralizing antibodies to rituximab on week 24 and week 52		Week 24, Week 52