A Study to Evaluate the NSAIDS Sparing Effect of Etanercept in Subjects With Axial Spondyloarthritis (SPARSE)

Pfizer

Status and phase: Completed; Phase 4

Conditions: Axial Spondyloarthritis

Treatments: Drug: placebo; Drug: etanercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT01298531

0881A1-4749

B1801132

Details and patient eligibility

About

This study will compare the Non Steroidal Anti-Inflammatory Drugs (NSAIDs) sparing effect of etanercept with that of placebo in adult subjects with axial Spondyloarthritis.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female subjects aged 18 years and over at the time of consent to the study.
• Diagnosis of SpA, as defined by the ASAS criteria for axial SpA
• Axial involvement refractory to previous or current intake of NSAIDs, defined as at least 2 NSAIDs at maximum tolerated dose determined from past medical history taken for a duration of > 1 month (for both NSAIDs combined) before the Screening visit.
• Active axial involvement defined by mini BASDAI

Exclusion criteria

• Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
• Subjects who have received any previous treatment with etanercept or other TNFα inhibitors or biologic agents.
• Subjects with a known or expected allergy, contraindication, or hypersensitivity to etanercept or its excipients.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

etanercept

Active Comparator group

Description:

Group A: etanercept 50 mg subcutaneous (SC) injections once weekly for 16 weeks.

Treatment:

Drug: etanercept

Drug: etanercept

etanercept-placebo

Placebo Comparator group

Description:

Group B: placebo subcutaneous (SC) injections once weekly for (how many) weeks follwed by etanercept 50 mg SC injections once weekly.

Treatment:

Drug: etanercept

Drug: placebo

Drug: etanercept