Safety and Efficacy of Adalimumab in Patients With Active Ankylosing Spondylitis

Abbott

Status and phase: Completed; Phase 3

Conditions: Ankylosing Spondylitis

Treatments: Biological: adalimumab (D2E7); Biological: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00195819

M03-606

Details and patient eligibility

About

The purpose of the study is to assess the safety and clinical efficacy of adalimumab in subjects with active ankylosing spondylitis

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject was age 18 or older and in relatively good health (Investigator discretion) with a recent stable medical history.
• Subject met the definition of AS based on the Modified New York Criteria.
• Subject had an inadequate response to or intolerance to one or more NSAIDs as defined by the Investigator

Exclusion criteria

• Subject had previously received anti-TNF therapy.
• Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
• Female subject who is pregnant or breast-feeding or considering becoming pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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82 participants in 2 patient groups, including a placebo group

Adalimumab

Experimental group

Treatment:

Biological: adalimumab (D2E7)

Placebo

Placebo Comparator group

Treatment:

Biological: placebo