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Efficacy of AIN457 in Adults (18-65 Years) With Moderate to Severe Ankylosing Spondylitis

2014-07-24 14:14:58 | BioPortfolio

Summary

This study is designed as a proof of concept of AIN457 in patients with ankylosing spondylitis. The study will address the evaluation of the efficacy at 6 and up to 28 weeks after two doses of AIN457 administered three weeks apart In Part 1 patients will be administered either AIN457 10 mg/kg or placebo. In Part 2, patients will be administered either 10 mg/kg, 1.0 mg/kg or 0.1 mg/kg AIN457. Thirty patients will be enrolled in Part 1 and an additional 30 patients into Part 2 (i.e. no patients will be enrolled into both Parts 1 and 2).

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Ankylosing Spondylitis

Intervention

AIN457, AIN457, AIN457, ARIN457, AIN457

Location

Arizona Arthritis & Rheumatology Associates, PC, 10599 N. Tatum Blvd Suite F-150,
Paradise Valley
Arizona
United States
85253

Status

Recruiting

Source

Novartis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:14:58-0400

Clinical Trials [174 Associated Clinical Trials listed on BioPortfolio]

Safety and Tolerability of AIN457 in Adults (18-65 Years) With Moderate to Severe Ankylosing Spondylitis

This study is designed as an extension study to the proof-of-concept trial CAIN457A2209 in patients with moderate to severe ankylosing spondylitis and aims to provide continuous treatment ...

Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)

This study will assess at Week 16 the efficacy and safety of AIN457 at different doses in patients with active RA despite stable MTX therapy. Treatment will continue up to Week 48 with a s...

Safety and Efficacy of AIN457 in Patients With Active Non-infectious Uveitis

This study will assess the safety and efficacy of AIN457 as adjunctive therapy for the treatment of intermediate uveitis, posterior uveitis, or panuveitis requiring systemic immunosuppress...

Extension Study to Assess Safety and Efficacy of AIN457 in Patients With Active Non-infectious Uveitis

The purpose of the extension study is to provide patients completing the 28-week core study with an opportunity to receive an additional 22 weeks of continuous treatment.

A Randomized, Double-blind, Placebo-controlled Multicenter Study of Secukinumab (AIN457) to Examine the Clinical Efficacy and the Nonsteroidal Anti-inflammatory Drug (NSAID)-Sparing Effect of Secukinumab Over 16 Weeks in Patients With Ankylosing Spondylit

The current study will assess the clinical Assessment of SpondyloArthritis international Society (ASAS) 20 response to Secukinumab and evaluate to which extent concomitant nonsteroidal ant...

PubMed Articles [94 Associated PubMed Articles listed on BioPortfolio]

Biomechanical properties of low back myofascial tissue in younger adult ankylosing spondylitis patients and matched healthy control subjects.

Ankylosing spondylitis is a degenerative and inflammatory rheumatologic disorder that primarily affects the spine. Delayed diagnosis leads to debilitating spinal damage. This study examines biomechani...

Influence of HLA-B27 on the Ankylosing Spondylitis phenotype: results from the REGISPONSER database.

To assess HLA-B27 influence on the clinical phenotype of Ankylosing Spondylitis (AS) patients.

Radiologic and Pathological Investigation of Pseudarthrosis in Ankylosing Spondylitis: Distinguishing Between Inflammatory and Traumatic Etiology.

To investigate the pathogenesis of pseudarthrosis in ankylosing spondylitis (AS) based on the pathological analysis of specimens harvested during surgery.

Audiologic profile in patients with ankylosing spondylitis: A controlled study of 30 patients.

Recent studies have identified sensorineural hearing loss as a possible manifestation of ankylosing spondylitis. We conducted a study of 30 patients with ankylosing spondylitis to characterize their a...

Complications of total hip arthroplasty in patients with ankylosing spondylitis.

To compare the risks of complications of primary total hip arthroplasty (THA) between patients with ankylosing spondylitis (AS) and those without AS.

Medical and Biotech [MESH] Definitions

A chimeric monoclonal antibody to TNF ALPHA that is used in the treatment of RHEUMATOID ARTHRITIS; ANKYLOSING SPONDYLITIS; PSORIATIC ARTHRITIS and CROHN'S DISEASE.

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).

A recombinant version of soluble human TNF receptor that binds specifically to TUMOR NECROSIS FACTOR and inhibits its binding with endogenous TNF receptors. It prevents the inflammatory effect of TNF and is used to treat RHEUMATOID ARTHRITIS; PSORIATIC ARTHRITIS and ANKYLOSING SPONDYLITIS.

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.

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