Comparative Pharmacokinetic Trial of RGB-03 and MabThera

Gedeon Richter

Status and phase: Unknown; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: MabThera (rituximab); Drug: RGB-03

Study type: Interventional

Funder types: Industry

Identifiers

NCT02371096

RGB-03-104

Details and patient eligibility

About

Pharmacokinetic properties, efficacy, safety and tolerability of RGB-03 and MabThera will be compared in patients suffering from Rheumatoid Arthritis.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Active Rheumatoid Arthritis
• Inadequate response or intolerance to other DMARDs and anti-TNFs
• Treatment with Methotrexate

Exclusion criteria

• Previous treatment with rituximab
• Patients with systemic manifestations of rheumatoid arthritis
• Patients seropositive for HIV, HCV, HBV
• Female patients nursing

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

0 participants in 2 patient groups

RGB-03

Experimental group

Treatment:

Drug: RGB-03

MabThera (rituximab)

Active Comparator group

Treatment:

Drug: MabThera (rituximab)