Study, Evaluating Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety Profiles of Rituximab Compared to MabThera® in Patients With Rheumatoid Arthritis

Sponsor
Mabscale, LLC
Study ID
NCT06175338
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab 1000 mg in 150 ml 0,9 % NaCl (total volume of infusion 250 ml)
  • MabThera® — DRUG
    MabThera® 1000 mg in 150 ml 0,9 % NaCl (total volume of infusion 250 ml)

Study Details

A randomised, double blind, parallel group, multicentre study to compare the pharmacokinetics, pharmacodynamics, immunogenicity and safety of Rituximab (Mabscale LLC, Russia) versus MabThera® in patients with rheumatoid arthritis.

Key Dates

Start date
Jun 14, 2023
Status verified
Sep 2024
Primary completion
Nov 30, 2024
Completion
Apr 30, 2025

Study Design

Enrollment
208 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Rituximab (manufactured by Mabscale, LLC)
    Eligible subjects (104 patients) will receive Rituximab 1000 mg in 150 ml 0,9 % NaCl (total volume of infusion 250 ml) twice: on Visit 1 and 5. The following visits are the visits of safety and PK, PD and immunogenicity and also preliminary effectiveness). Patients will also receive background treatment Methotrexate+ Folic acid.
  • Active Comparator: MabThera®
    Eligible subjects (104 patients) will receive MabThera® 1000 mg in 150 ml 0,9 % NaCl (total volume of infusion 250 ml) twice: on Visit 1 and 5. The following visits are the visits of safety and PK, PD and immunogenicity and also preliminary effectiveness). Patients will also receive background treatment Methotrexate+ Folic acid.

Primary Outcome Measure

AUC(w2-24) [ Time Frame: Day 1 to Week 24 ]

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