Study Comparing Etanercept (ETN) Against a Placebo for Etanercept on a Background Nonsteroidal Anti Inflammatory Drug (NSAIDs) in the Treatment of Early Spondyloarthritis (SpA) Patients Who do Not Have X-ray Structural Changes (EMBARK)

Pfizer

Status and phase: Completed; Phase 3

Conditions: Spondylitis, Ankylosing

Treatments: Other: PLACEBO; Biological: etanercept; Drug: Background NSAID

Study type: Interventional

Funder types: Industry

Identifiers

NCT01258738

B1801031

2010-020077-16 (EudraCT Number)

0881A3-4725 (Other Identifier)

Details and patient eligibility

About

This is a two part study. During period one there will be a comparison of Etanercept (ETN) against a placebo with both arms maintaining the background anti inflammatory drug prescribed by their Physician. The hypothesis is that Etanercept will be superior to the placebo arm as determined by the proportion of subjects achieving Assessments in Ankylosing Spondylitis (ASAS)40 improvement at 12 weeks. This will be followed by 92 weeks extension where everyone in the trial receives Etanercept (ETN) and a background non steroidal anti inflammatory drug(NSAID).

Enrollment: 225 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of axial spondyloarthritis as defined by Assessments in Ankylosing Spondylitis (ASAS)criteria
• Active symptoms defined as Ankylosing Spondylitis Disease Activity Index{BASDAI) > or = 4
• Axial symptoms of back pain with a less than favorable response to on steroidal anti inflammatory drugs at optimal dosage for greater than 4 weeks

Exclusion criteria

• Evidence of current or recent episode of uveitis
• Evidence of IBD flare within 6 months
• Previous treatment with an anti Tumor necrosis factor(TNF)
• Active tuberculosis
• Radiographic sacroiliitis grade 3-4 unilaterally or >= 2 bilaterally

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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225 participants in 2 patient groups, including a placebo group

etanercept

Active Comparator group

Description:

In Period 1 : Subjects will receive via a prefilled syringe an active dose equivalent to 1.0ml of Etanercept solution once weekly SC once weekly. Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician.

Treatment:

Biological: etanercept

Drug: Background NSAID

Drug: Background NSAID

PLACEBO

Placebo Comparator group

Description:

In Period 1: Subjects will receive in a prefilled syringe with a PLACEBO dose equivalent to 1.0 ml of placebo solution once weekly SC Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician.

Treatment:

Other: PLACEBO

Drug: Background NSAID

Drug: Background NSAID