Safety and Efficacy of Adalimumab in Patients With Active Ankylosing Spondylitis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2009-06-30

Brief Summary

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

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Detailed Description

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Conditions

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Ankylosing Spondylitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Adalimumab

Group Type EXPERIMENTAL

adalimumab (D2E7)

Intervention Type BIOLOGICAL

Adalimumab 40 mg every other week (eow)

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type BIOLOGICAL

Placebo every other week (eow)

Interventions

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adalimumab (D2E7)

Adalimumab 40 mg every other week (eow)

Intervention Type BIOLOGICAL

placebo

Placebo every other week (eow)

Intervention Type BIOLOGICAL

Other Intervention Names

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ABT-D2E7 adalimumab Humira

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No