MabionCD20® Compared to MabThera® and Rituxan® in Patients With Rheumatoid Arthritis

Sponsor
Mabion SA
Study ID
NCT04680962
Phase
PHASE3
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • MabionCD20 (candidate biosimilar to rituximab) — BIOLOGICAL
    Intravenous infusion, 10 mg/ml concentrate, 500 ml
  • MabThera® — BIOLOGICAL
    Intravenous infusion, 10 mg/ml concentrate, 500 ml
  • Rituxan® — BIOLOGICAL
    Intravenous infusion, 10 mg/ml concentrate, 500 ml

Study Details

Primary objective of the study is to establish a 3-way PK similarity bridge between MabionCD20 (candidate biosimilar to rituximab), MabThera® (EU-sourced rituximab) and Rituxan® (US-sourced rituximab) following the administration of these drugs to patients with moderate-to-severe rheumatoid arthritis. Main secondary objective is to confirm therapeutic similarity between MabionCD20 and the reference rituximab.

Key Dates

Start date
Aug 3, 2023
Status verified
Aug 2023
Primary completion
Aug 3, 2023
Completion
Aug 3, 2023

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MabionCD20 / MabionCD20
    Patients receive one or two treatment courses of MabionCD20, each consisting of two 1000 mg i.v. infusions at an interval of 14 days. Investigational drug will be administered at Day 1 and Day 15, and, if patient is eligible for re-treatment, also at Week 24 and Week 26.
  • Active Comparator: EU-Rituximab / EU-Rituximab
    Patients receive one or two treatment courses of MabThera®, each consisting of two 1000 mg i.v. infusions at an interval of 14 days. Investigational drug will be administered at Day 1 and Day 15, and, if patient is eligible for re-treatment, also at Week 24 and Week 26.
  • Active Comparator: US-Rituximab / MabionCD20
    Patients receive a single treatment course of Rituxan®, consisting of two 1000 mg i.v. infusions at Day 1 and Day 15. After 24 weeks of follow-up, all patients eligible for re-treatment, are switched to receive a single treatment course of MabionCD20, consisting of two 1000 mg i.v. infusions at Week 24 and Week 26.

Primary Outcome Measure

Area Under the Serum Concentration-time Curve from Day 1 to Week 24, with extrapolation to infinity [AUC 0-inf (D1-W24)] [ Time Frame: Day 1 to Week 24 ]

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