Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)

Pfizer

Status and phase: Completed; Phase 3

Conditions: Ankylosing Spondylitis

Treatments: Drug: Tofacitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03502616

2018-000226-58 (EudraCT Number)

A3921120

AS (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine if tofacitinib is safe and effective in subjects with active ankylosing spondylitis.

Enrollment: 270 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has a diagnosis of Ankylosing Spondylitis (AS) based on the Modified New York Criteria for AS (1984).
• Must have a radiograph of SI joints (AP Pelvis) documenting diagnosis of AS.
• Has active disease despite nonsteroidal anti-inflammatory drug (NSAID) therapy or intolerant to NSAIDs.

Exclusion criteria

• History of known or suspected complete ankylosis of the spine.
• History of allergies, intolerance or hypersensitivity to lactose or tofacitinib.
• History of any other rheumatic disease.
• Any subject with condition affecting oral drug absorption.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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270 participants in 2 patient groups, including a placebo group

Tofacitinib

Experimental group

Treatment:

Drug: Tofacitinib

Placebo

Placebo Comparator group

Treatment:

Drug: Tofacitinib