Ustekinumab for the Treatment of Patients With Active Ankylosing Spondylitis

Sponsor
Charite University, Berlin, Germany
Study ID
NCT01330901
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ustekinumab — DRUG
    Ustekinumab 90 mg given subcutaneously at weeks 0, 4, and 16

Study Details

This study is aimed at investigation of efficacy and safety of ustekinumab (monoclonal antibody against interleukin 12 and 23) treatment in patients with active ankylosing spondylitis (AS) fulfilling the modified New York criteria who have had an inadequate response to standard therapy with non-steroidal anti-inflammatory drugs (NSAIDs) or do not tolerate or have a contraindication for NSAIDs.

Key Dates

Start date
Oct 31, 2011
Status verified
Jun 2013
Primary completion
Apr 30, 2013
Completion
May 31, 2013

Study Design

Enrollment
22 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ustekinumab
    Ustekinumab 90 mg subcutaneously at week 0, 4 and 16

Primary Outcome Measure

The Assessment of Spondyloarthritis International Society (ASAS)40 response [ Time Frame: week 24 ]

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