Study to Assess the Immunogenicity, Safety, and Efficacy of High Capacity Process Etanercept in Rheumatoid Arthritis Subjects

Pfizer

Status and phase: Completed; Phase 3

Conditions: Arthritis, Rheumatoid

Treatments: Biological: etanercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT02378506

2013-004569-16 (EudraCT Number)

B1801359

Details and patient eligibility

About

Open-label immunogenicity, safety and efficacy study of etanercept manufactured using the high capacity process. Descriptive results will be provided however a formal hypothesis will not be tested in this trial.

Enrollment: 188 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate to severe active disease with presence of at least 4 tender joints and 4 swollen joints.
• Either the patient or a designee must be capable of administering the subcutaneous injection of study drug.

Exclusion criteria

• Prior treatment with etanercept.
• Presence of active infection or active or untreated tuberculosis.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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188 participants in 1 patient group

ETN 50mg QW

Experimental group

Treatment:

Biological: etanercept