Status:
ACTIVE_NOT_RECRUITING
Study, Evaluating Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety Profiles of Rituximab Compared to MabThera® in Patients With Rheumatoid Arthritis
Lead Sponsor:
Mabscale, LLC
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
A randomised, double blind, parallel group, multicentre study to compare the pharmacokinetics, pharmacodynamics, immunogenicity and safety of Rituximab (Mabscale LLC, Russia) versus MabThera® in patie...
Detailed Description
RIT-1/01092021 is a double-blind randomized, parallel group, multicenter clinical trial comparing pharmacokinetics, pharmacodynamics, immunogenicity and safety of Rituximab (Mabscale LLC, Russia) and ...
Eligibility Criteria
Inclusion
- Male and Female 18-65 y.o. with body weight 50-120 kg
- Patients with active rheumatoid arthritis with disease duration minimum 6 months prior to screening visit per ACR/EULAR 2019 criteria classification.
- Moderate or severe active course of rheumatoid arthritis, which is defined as the fulfillment of all of the following conditions:
- ≥6 tender joints (based on a score of 68 joints) at screening and baseline; And
- ≥6 swollen joints (based on a score of 66 joints) at screening and at baseline; And
- level of C-reactive protein is not less than 10 mg/l or ESR is not less than 28 mm/hour at screening.
- Positive result of the analysis for antibodies to cyclic citrullinated peptide (≥10 units/ml) and / or the presence of rheumatoid factor (≥ 20 units/ml) at screening (see section).
- Received treatment for RA and experienced an inadequate response or intolerance to treatment with at least 1 anti-TNF alpha therapy;
- Must have received MTX for a minimum of 12 weeks, with the last 4 weeks, prior to screening at a stable dose 10-25 mg/week;
Exclusion
- Contraindications according to the MabThera SmPC and every serious coexisting diseases which, in the Investigator's opinion, would preclude subject participation
- History of current rheumatic autoimmune disease other than RA and current inflammatory joint disease other than RA
- Positive tests for HIV, hepatitis B surface antigen (HBsAg) Anti-HBc antibody, hepatitis C antibody
- Prior treatment with rituximab, other anti-CD20 mAb
- Pregnancy or lactation or women planning to get pregnant during the course of the study and/or within 12 months post last study drug infusion
- COVID prior 8 weeks prior to Screening visit or other acute systemic infection within 4 weeks prior to Day 1
- Allergic reaction or intolerance to rituximab, MabionCD20 or any of their components
- Severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or previous treatment of any lymphocyte-depleting therapies
- Confirmed current active tuberculosis (TB).
- Any significant cardiac disease
- History of a severe allergic reaction or anaphylactic reaction to a biological agent or history of hypersensitivity to any component of the study drug including known hypersensitivity or allergy to a murine product.
Key Trial Info
Start Date :
June 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2025
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT06175338
Start Date
June 14 2023
End Date
April 1 2025
Last Update
September 19 2024
Active Locations (12)
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1
Immanuel Kant Baltic Federal University
Kaliningrad, Russia
2
Scientific-Research Medical Complex Your Health
Kazan', Russia
3
LLC "Medical Center Revma-Med"
Kemerovo, Russia
4
LLC "Korolev Family Clinic №4"
Korolyov, Russia