GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• GP2013 - A Proposed biosimilar rituximab — BIOLOGICAL
• Originator rituximab - Rituxan ® or MabThera ® — BIOLOGICAL

Study Details

The study objective is to identify potential safety risks of the transition from US-licensed Rituxan® or EU-approved MabThera® to GP2013 (proposed biosimilar product) as compared to continuous treatment with the originator product in terms of general safety and immunogenicity.

Key Dates

Start date

Jul 31, 2015

Status verified

Nov 2017

Primary completion

Jul 31, 2016

Completion

Oct 31, 2016

Study Design

Enrollment

107 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: GP2013 - proposed biosimilar rituximab
  10 mg/mL in 500 mg (50 mL) single-use vials. For i.v. administration, two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v. The treatment course consists of 2 i.v. infusions 2 weeks apart (at Day 1 and Day 14).
• Active Comparator: Originator rituximab - Rituxan ® or MabThera ®
  10 mg/mL in 500 mg (50 mL) single-use vials. For i.v. administration two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v. The treatment course consists of 2 i.v. infusions 2 weeks apart (at Day 1 and Day 14).

Primary Outcome Measure

Number of Patients Experiencing Anaphylactic Reactions [ Time Frame: Within 24 hours of each study drug infusion: on Day 1 and Day 14 ]

Locations (39)

Find similar trials in Huntsville, AL

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