Etanercept Withdrawal And Retreament Study In Subjects With Nr-ax SpA (RE-EMBARK)

Pfizer

Status and phase: Completed; Phase 4

Conditions: Spondylitis, Ankylosing

Treatments: Biological: Etanercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT02509026

B1801381

2015-000541-24 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to study the benefits and risks of etanercept withdrawal in patients who have achieved a significant clinical response.

Full description

This multcenter, open-label, three period study will evaluate withdrawal and retreatment of etanercept in subjects with nr-ax SpA who achieved adequate response following 24 weeks of treatment.

Enrollment: 210 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of axial SpA duration of symptoms >3 months and <5 years back pain with a less than favorable response to NSAIDs

Exclusion criteria

• radiological sacroiliitis previous treatment with TNF inhibitor, biologic, immunosuppressive

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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210 participants in 1 patient group

Etanercept

Experimental group

Description:

etanercept 50 mg QW

Treatment:

Biological: Etanercept