Study of Safety and Efficacy of BCD-020 Comparing to MabThera in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to prove that efficacy, safety and immunogenicity of BCD-020 is
      equivalent to MabThera when used in combination with methotrexate for the treatment of
      patient with rheumatoid arthritis
    

Detailed description: 
      This is an international multicenter double-blind randomized clinical study of the efficacy
      and safety (Phase III) with an active comparator; the study provides the additional
      evaluation of the interchangeability of rituximab biosimilar and original product MabThera.

      The study will include 308 subjects with active seropositive rheumatoid arthritis who had
      intolerance or inadequate response to current therapy regimens including one or more TNF
      inhibitors, or who had contraindications to TNF inhibitors.

      The first 24-week stage includes one course of rituximab therapy. The first study stage
      proposes central randomization into 2 large groups (1:1): patients from the first group will
      recieve BCD-020 (rituximab manufactured by CJSC BIOCAD) at a dose 1000 mg in a drop-wise
      manner on day 1 and day 15; patients from the second group will recieve MabThera at a same
      regimen.

      On the final visit of Stage 1 (visit 11 at week 24) all efficacy parameters must be
      evaluated. If the disease activity remains (DAS28 score ≥2.6 or increased by 0.6 points or
      more compared to the last measurement) the patient will recieve another course of rituximab
      treatment. In this case a partial crossover (Stage 2) will take place (by means of the second
      randomization): one half of patients with active RA, previously treated with BCD-020, will
      receive MabThera at a dose 1000 mg on day 1 and day 15; and one half of patients with active
      RA, previously treated with MabThera, will receive BCD-020 at a dose 1000 mg ion day 1 and
      day 15. After the first rituximab infusion performed for retreatment, the patient will
      undergo 24-week follow-up (counted starting from the date of retreatment initiation). Thus,
      effects of the switch from BCD-020 to MabThera and vice versa will be assessed in 24 weeks
      after the crossover (Stage 2 of the study).

      Patients in whom remission of RA (DAS28 < 2.6) is reported on week 24 counting from the
      initial randomization will undergo the follow up for the next 24 weeks. During this period
      they will attend 3 visits (weeks 32, 40 and 48) in order to monitor the disease. If the
      exacerbation occurs within the time period not corresponding to week 32 or week 40, the
      patient will be invited to the study site for an out-of-schedule visit. If disease
      exacerbation is confirmed, he/she undergoes the second randomization, second rituximab
      treatment course and further follow up for 6 months (as described above).
    

Intervention name(s): Rituximab
Intervention type(s): Drug
Intervention description(s): Patients will will receive rituximab a dose of 1000 mg , intravenously, slowly, once in 2 weeks, with 2 infusions per course (on day 1 and day 15).
Other intervention name(s): MabThera, Rituxan, BCD-020
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: rheumatoid arthritis, DMARDs; rituximab; biosimilar; interchangeability