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Spondylitis clinical trials

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NCT ID: NCT01109940 Completed - Clinical trials for Ankylosing Spondylitis

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

Start date: April 2010
Phase: Phase 2
Study type: Interventional

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 with AIN457 for patients in the core trial, to obtain safety and tolerability information. The study will address the evaluation of efficacy following doses of Intravenous infusion (IV) of 3 mg/kg AIN457 given every 4 weeks over a period initially up to 6 months (Part 1) and based on the risk/benefit balance of AIN457 in ankylosing spondylitis a decision was taken to continue dosing for another 6 month period (Part 2).

NCT ID: NCT01104987 Completed - Osteoporosis Clinical Trials

Treatment With Alendronate in Patients With Ankylosing Spondylitis (AS)

Start date: October 2009
Phase: Phase 4
Study type: Observational

This prospective study will assess the effects of treatment with alendronate in osteoporotic patients with ankylosing spondylitis. Primary objectives: - To investigate if alendronate effect bone mineral density (BMD) assessed by dual energy x-ray absorptiometry (DXA) in lumbar spine, hip and distal forearm and assessed by quantitative computed tomography (QCT) in lumbar spine and by Xtreme CT in radius and tibia. Secondary objectives: - To investigate if alendronate effects markers of bone remodeling - To investigate if alendronate influences disease activity (BASDAI), spinal function (BASFI), spinal movement (BASMI) and health related quality of life (SF-36).

NCT ID: NCT01091675 Completed - Clinical trials for Ankylosing Spondylitis

Assessment of the Response to Etoricoxib in Patients With Ankylosing Spondylitis and Inadequate Response to ≥2 NSAIDs

Start date: September 2010
Phase: Phase 3
Study type: Interventional

The goal of this research is to assess the percentage of non-responders to ≥ 2 NSAIDs candidates a biological therapy that could adequately respond to treatment with etoricoxib This study confirm the result of a previous study in a wider similar population. Basing on previous results, the response rate will be assessed by ASASBIO criteria. The efficacy of the treatment with etoricoxib 90 mg will be assessed at week 4 in a population of patients with AS who didn't respond adequately to a previous therapy with ≥ 2 NSAIDs. Those patients that, based on the ASABIO criteria, achieved a sufficient clinical response will be followed until week 24 to asses the maintenance of the study drug effects.

NCT ID: NCT01083693 Completed - Clinical trials for Rheumatoid Arthritis

Quality of Life Outcomes of HUMIRA in Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS) After Unsustainable Response to Biologicals and Disease Modifying Antirheumatic Drugs

Start date: September 2008
Phase: N/A
Study type: Observational

The aim of this post-marketing observational study is to obtain further data on the evaluation of quality of life outcomes of HUMIRA® in routine clinical use in patients with Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) or Ankylosing Spondylitis (AS) after unsustainable clinical response to disease modifying antirheumatic drugs (DMARD) and or biological disease modifying antirheumatic drugs (BDMARD). Treatment strategies in moderate to severe rheumatoid arthritis, psoriatic arthritis and in severe active ankylosing spondylitis commonly consist of introducing biologics after conventional disease modifying antirheumatic drugs or non steroidal antiinflammatory drugs fail. Although biologic disease modifying antirheumatic drugs are generally well-tolerated, intolerances may develop or efficacy may diminish, at which time another biologic disease modifying antirheumatic drug might be considered. This study shall evaluate the quality of life outcomes of HUMIRA®, given after conventional disease modifying antirheumatic drugs and or non antiinflammatory drug failures and or after biological disease modifying antirheumatic drug failures . Failure in this context means primary or secondary loss of efficacy or intolerance to the initial agent.

NCT ID: NCT01083121 Completed - Clinical trials for Rheumatoid Arthritis

Surveillance of Humira Injection in Korean Patients

Start date: April 2007
Phase: N/A
Study type: Observational

Patients who take Humira as prescribed by physicians as per Korean label will be enrolled and observed in normal medical practice setting for not less than 3 months following first dose of Humira. Information on demographics, diagnosis and medical history, results of tuberculosis skin test, results of chest X-ray, Humira treatment information, concomitant medication, physician's global assessment for effectiveness, disease activity assessment for rheumatoid arthritis, disease activity assessment for Crohn's Disease, disease activity assessment for Psoriasis and adverse events will be recorded on case report forms.

NCT ID: NCT01081717 Completed - Clinical trials for Rheumatoid Arthritis

Golimumab Safety and Surveillance Program Using the Ingenix NHI Database

Start date: April 14, 2009
Phase:
Study type: Observational

The participants included in this observational study will be drawn from a research database containing claims and enrollment data for members of a large, geographically diverse US health plan.The objective of this study is to estimate the rate of serious infections, tuberculosis, malignancies, and other outcomes in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis patients treated with golimumab, anti-tumor necrosis factor (TNF) biologics, non-anti-TNF biologics, or systemic non-biological treatments.

NCT ID: NCT01079182 Completed - Clinical trials for Ankylosing Spondylitis

Basic Documentation of Adalimumab (Humira) in Patients With Ankylosing Spondylitis (AS)

Start date: January 2006
Phase: N/A
Study type: Observational

The research question explored in this study was whether the effectiveness and safety of adalimumab in participants with ankylosing spondylitis was maintained during long-term therapy in routine clinical practice in Germany.

NCT ID: NCT01078558 Completed - Clinical trials for Rheumatoid Arthritis

A Belgian Registry of HUMIRA® (Adalimumab) in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis ( ProAct )

ProAct
Start date: May 13, 2004
Phase:
Study type: Observational

This is a five year, post-marketing observational study to follow-up patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis who are treated with HUMIRA (adalimumab).

NCT ID: NCT01078402 Completed - Clinical trials for Ankylosing Spondylitis (AS)

EValuation of HumIRA® in Patients With Active Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis in EASTern European Countries

EviraEAST
Start date: April 2009
Phase: N/A
Study type: Observational

This is a non-interventional, post-marketing, observational study (PMOS) in which Humira (adalimumab) is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. No data currently exists to characterize patient populations being prescribed Humira in Eastern Europe. Further, it is important to establish the clinical outcome and tolerability of Humira in Eastern European patients, as well as their compliance with Humira treatment, in particular the acceptability of self-injection, which may influence all of the above in routine clinical practice.

NCT ID: NCT01077843 Completed - Clinical trials for Ankylosing Spondylitis

Post-authorization Safety Study of Etoricoxib and Other Anti-inflammatory Therapies in European Patients With Ankylosing Spondylitis (MK-0663-163)

Start date: August 17, 2009
Phase:
Study type: Observational

This study is a population-based cohort of patients with ankylosing spondylitis (AS) from general medical practices in the UK, France, and Germany with a nested case control component to assess associations between drug exposures of interest and clinical outcomes relevant to patients using cyclooxygenase-2 (COX-2) inhibitors / nonsteroidal anti-inflammatory drugs (NSAIDS). The main objective of the study is to describe in European participants with AS: 1) the use of etoricoxib 2) characteristics of those who use etoricoxib. 3) the safety profile of etoricoxib and other anti-inflammatory therapies with respect to specific clinical outcomes of interest relative to non-use of these medications and relative to each other.