Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis

Pfizer

Status and phase: Completed; Phase 2

Conditions: Ankylosing Spondylitis

Treatments: Drug: Tofacitinib 10 mg; Drug: Tofacitinib 2 mg; Drug: Tofacitinib 5 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01786668

A3921119

2011-005689-39 (EudraCT Number)

Details and patient eligibility

About

This is the first study of oral tofacitinib in adults with active ankylosing spondylitis. It is designed to obtain information on the efficacy and safety of 3 different doses of tofacitinib.

Enrollment: 208 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented diagnosis of Ankylosing Spondylitis
• Has active disease despite concurrent nonsteroidal anti-inflammatory drugs (NSAIDs) treatment or is intolerant to NSAIDs

Exclusion criteria

• Pregnant or lactating females
• Currently receiving or previous use of a Tumor Necrosis Factor (TNF) inhibitor or any biological agent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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208 participants in 4 patient groups, including a placebo group

Tofacitinib 2 mg

Experimental group

Treatment:

Drug: Tofacitinib 2 mg

Tofacitinib 5 mg

Experimental group

Treatment:

Drug: Tofacitinib 5 mg

Tofacitinib 10 mg

Experimental group

Treatment:

Drug: Tofacitinib 10 mg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo