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Ustekinumab for the Treatment of Patients With Active Ankylosing Spondylitis

NCT01330901 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2013-06-04

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Ustekinumab

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

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Joachim Sieper, MD · Charite University, Berlin, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-04-30
Completion
2013-05-31

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01330901 on ClinicalTrials.gov