Ustekinumab for the Treatment of Patients With Active Ankylosing Spondylitis

23:33 EDT 22nd August 2014 | BioPortfolio

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.

Description

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

Conditions

Ankylosing Spondylitis

Intervention

Ustekinumab

Location

Department of Rheumatology, Charité - Campus Benjamin Franklin
Berlin
Germany
12203

Status

Completed

Source

Charite University, Berlin, Germany

Results (where available)

View Results

Links

Clinical Trials [80 Associated Clinical Trials listed on BioPortfolio]

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)

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

An Open-Label Multicentre Long-Term Extension Study of Etanercept for Ankylosing Spondylitis

This study is an extension trial of 0881A3-312-EU and is designed to provide information on the safety and efficacy of etanercept in patients with ankylosing spondylitis for up to 3 additi...

PubMed Articles [122 Associated PubMed Articles listed on BioPortfolio]

Ustekinumab for the treatment of patients with active ankylosing spondylitis: results of a 28-week, prospective, open-label, proof-of-concept study (TOPAS).

To evaluate efficacy and safety of ustekinumab in patients with ankylosing spondylitis (AS).

Usage of Conventional PCR Technology for the Detection of HLA-B27 Allele: A Significant Molecular Marker of Ankylosing Spondylitis.

Ankylosing spondylitis is a chronic inflammatory disease that has been linked to the human leukocyte antigen class I allele HLA-B27. More than 90 % of patients with ankylosing spondylitis possess the...

An epidemiological study on ankylosing spondylitis in southern Albania.

To evaluate the incidence and prevalence of ankylosing spondylitis (AS) in southern Albania and to assess the association of various demographic risk factors with the severity of disease.

Ankylosing spondylitis functional and activity indices in clinical practice.

Clinicians have at hand several indices to evaluate disease activity and functionality in ankylosing spondylitis (AS), in order to evaluate the prognostic and the treatment of AS patients.

The re-evaluation of 140 patients diagnosed as ankylosing spondylitis and nonradiographic axial spondyloarthritis.

To re-evaluate the diagnoses of ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis (nr-axSpA) and analyze the incidence and reason of misdiagnosis.

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.

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