PK Similarity Prospective Phase 3 Study in Patients With Rheumatoid Arthritis (rituximab)

Celltrion Healthcare

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: MabThera; Drug: Rituxan; Biological: CT-P10

Study type: Interventional

Funder types: Industry

Identifiers

NCT02149121

2013-004555-21 (EudraCT Number)

CT-P10 3.2

Details and patient eligibility

About

This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis.

Enrollment: 384 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient is male or female between 18 and 75 years old, inclusive.
2. Patient has a diagnosis of RA according to the revised 1987 ACR classification criteria (Arnett et al 1988) for at least 6 months prior to randomization.
3. Patient has active disease as defined by the presence of 6 or more swollen joints (of 66 assessed) and 6 or more tender joints (of 68 assessed), and serum CRP ≥1.5 mg/dL (≥15 mg/L) or an ESR ≥28 mm/hour.
4. Patient has experienced an inadequate response to previous or current treatment with the anti-TNF agents infliximab
5. Patient has a proper discontinuation period after treatment with interleukin-1 receptor (IL-1R) antagonist, interleukin-6 receptor (IL-6R) antibody, or abatacept.

Exclusion criteria

1. Patient has taken more than 2 biologic agents.
2. Patient has previously been administered Rituximab or participated in a Rituximab biosimilar study.
3. Patient has allergies or hypersensitivity to murine, chimeric, human, or humanized proteins.
4. Patient has current or past history of chronic infection with hepatitis B, hepatitis C, or infection with human immunodeficiency virus (HIV)-1 or -2 or who has a positive result to the screening test for these infections.
5. Patient has an infection requiring oral antibiotics 2 weeks before randomization, parenteral injection of antibiotics 4 weeks before randomization, other serious infection 6 months before randomization, a history of recurrent herpes zoster or other chronic or recurrent infection 6 weeks before randomization.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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384 participants in 3 patient groups

CT-P10

Experimental group

Description:

rituximab, CT-P10(experimental drug), 1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusion

Treatment:

Biological: CT-P10

Rituxan

Active Comparator group

Description:

US-licensed referece product, 1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusions

Treatment:

Biological: CT-P10

Drug: Rituxan

MabThera

Active Comparator group

Description:

EU-approved reference product, 1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusions

Treatment:

Biological: CT-P10

Drug: MabThera