GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera® (ASSIST-RT)

Sandoz

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Biological: Originator rituximab - Rituxan ® or MabThera ®; Biological: GP2013 - A Proposed biosimilar rituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02514772

GP13-302

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of rheumatoid arthritis (RA) according to ACR 2010 criteria
• Completed one full treatment course with either Rituxan® or MabThera®
• Eligible for a further treatment course with Rituxan® or MabThera®- Currently treated with methotrexate

Exclusion criteria

• RA functional status class IV (ACR 1991 revised criteria)
• Systemic manifestation of RA
• Positive serology for hepatitis B or hepatitis C infection
• Active systemic infection
• History of cancer
• Known severely immunocompromised state

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

107 participants in 2 patient groups

GP2013 - proposed biosimilar rituximab

Experimental group

Description:

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).

Treatment:

Biological: GP2013 - A Proposed biosimilar rituximab

Originator rituximab - Rituxan ® or MabThera ®

Active Comparator group

Description:

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).

Treatment:

Biological: Originator rituximab - Rituxan ® or MabThera ®