Ustekinumab for the Treatment of Patients With Active Ankylosing Spondylitis

2014-08-26 23:00:42 | BioPortfolio


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.


This study is a prospective, open-label, proof-of-concept clinical trial that will be conducted in a referral center for patients with AS in Berlin. Eligible patients will be treated with ustekinumab 90 mg given subcutaneously at weeks 0, 4, and 16. The entire study period accounts 28 weeks. Assessment of the primary outcome parameter will be performed at week 24. The patients will be closely monitored throughout the study on a total of 9 visits.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Ankylosing Spondylitis




Department of Rheumatology, Charité - Campus Benjamin Franklin




Charite University, Berlin, Germany

Results (where available)

View Results


Published on BioPortfolio: 2014-08-26T23:00:42-0400

Clinical Trials [114 Associated Clinical Trials listed on BioPortfolio]

Increasing Physical Activity in Ankylosing Spondylitis: a Randomised Controlled Trial

Ankylosing spondylitis is a chronic inflammatory condition that mostly affects the spine. This results in back pain and stiffness, and causes difficulty with daily activities. Physical act...

Pilot Open Label Clinical Trial With Abatacept in Ankylosing Spondylitis

This is an open-label trial investigating the efficacy and safety of abatacept in ankylosing spondylitis. It is planned to treat 30 patients with ankylosing spondylitis from baseline up to...

Clinical Trial of Osteoporosis in Ankylosing Spondylitis

This is an observational study aiming to study the prevalence and risk factors for osteoporosis and vertebral fractures in patients with ankylosing spondylitis attending three Rheumatology...

16.0040 Ankylosing Spondylitis Study

The purpose of this study was to evaluate extended safety and efficacy of etanercept in adults with Ankylosing Spondylitis.

Investigation of 9 Consecutive Remicade Infusions in Ankylosing Spondylitis in Austria (Study P04044)(COMPLETED)

This is a prospective, open-label, 1-arm, multicenter observational study to determine the dose and time span of Remicade between infusions for ankylosing spondylitis (AS).

PubMed Articles [113 Associated PubMed Articles listed on BioPortfolio]

The prevalence of clinically diagnosed ankylosing spondylitis and its clinical manifestations: a nationwide register study.

Prevalence estimates of ankylosing spondylitis vary considerably, and there are few nationwide estimates. The present study aimed to describe the national prevalence of clinically diagnosed ankylosing...

Comparison of patients with ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA) from a single rheumatology clinic in New Delhi.

Comparison of ankylosing spondylitis (AS) with non-radiographic axial spondyloarthritis (nr-axSpA) classified with the recent ASsessment of Ankylosing Spondylitis (ASAS) International Society criteria...

Gene Expression Profiling Analysis of Patients with Ankylosing Spondylitis.

A comprehensive bioinformatics analysis of genes which may have correlations with Ankylosing spondylitis (AS).

Chronic Periodontitis is Associated With Spinal Dysmobility in Patients With Ankylosing Spondylitis.

Although microbes have been suggested to play a role in the pathogenesis of ankylosing spondylitis (AS), several studies present contradictory results regarding the association between AS and chronic ...

Continuous posterior lumbar plexus and continuous parasacral and intubation with lighted stylet for ankylosing spondylitis.

Ankylosing spondylitis is characterized by progressive ossification of the spinal column with resultant stiffness. Ankylosing spondylitis can present significant challenges to the anaesthetist as a co...

Medical and Biotech [MESH] Definitions

A butyl-diphenyl-pyrazolidinedione that has anti-inflammatory, antipyretic, and analgesic activities. It has been used in ANKYLOSING SPONDYLITIS; RHEUMATOID ARTHRITIS; and REACTIVE ARTHRITIS.

A nonsteroidal anti-inflammatory agent with potent analgesic and antiarthritic properties. It has been shown to be effective in the treatment of OSTEOARTHRITIS; RHEUMATOID ARTHRITIS; ankylosing SPONDYLITIS; and in the alleviation of postoperative pain (PAIN, POSTOPERATIVE).

Human histocompatibility (HLA) surface antigen encoded by the B locus on chromosome 6. It is strongly associated with acute anterior uveitis (UVEITIS, ANTERIOR); ANKYLOSING SPONDYLITIS; and REACTIVE ARTHRITIS.

A chronic inflammatory condition affecting the axial joints, such as the SACROILIAC JOINT and other intervertebral or costovertebral joints. It occurs predominantly in young males and is characterized by pain and stiffness of joints (ANKYLOSIS) with inflammation at tendon insertions.

Heterogeneous group of arthritic diseases sharing clinical and radiologic features. They are associated with the HLA-B27 ANTIGEN and some with a triggering infection. Most involve the axial joints in the SPINE, particularly the SACROILIAC JOINT, but can also involve asymmetric peripheral joints. Subsets include ANKYLOSING SPONDYLITIS; REACTIVE ARTHRITIS; PSORIATIC ARTHRITIS; and others.

More From BioPortfolio on "Ustekinumab for the Treatment of Patients With Active Ankylosing Spondylitis"


Relevant Topics

Clincial Trials
Latest News Clinical Trials Research Drugs Reports Corporate
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Latest News Clinical Trials Research Drugs Reports Corporate
Arthritis Fibromyalgia Gout Lupus Rheumatic Rheumatology is the medical specialty concerned with the diagnosis and management of disease involving joints, tendons, muscles, ligaments and associated structures (Oxford Medical Diction...