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Spondylitis clinical trials

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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.

NCT ID: NCT01061723 Completed - Clinical trials for Ankylosing Spondylitis

Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis

ALIGN
Start date: February 2010
Phase: Phase 2
Study type: Interventional

Primary objective: - to evaluate the efficacy of Sarilumab in patients with Ankylosing Spondylitis [AS] using the Assessment in AS working group criteria [ASAS] 20% response criteria [ASAS20] Secondary objectives: - to demonstrate that Sarilumab is effective on: - assessment of higher level of response (ASAS 40% response criteria [ASAS40]) - partial remission - disease activity - range of motion - Magnetic Resonance Imaging [MRI] of the spine - to assess the safety and tolerability of Sarilumab in patients with AS as well as the pharmacokinetic profile of Sarilumab in patients with AS

NCT ID: NCT01060098 Completed - Clinical trials for Rheumatoid Arthritis

T Cells and TNF (Tumor Necrosis Factor): The Impact of TNF Blockade

Start date: April 2010
Phase:
Study type: Observational

We aim to translate these findings into patients with rheumatoid arthritis and other conditions treated with anti-TNF (anti-tumor necrosis factor) therapy, such as psoriatic arthritis and ankylosing spondylitis. Patients from rheumatology clinics within NHS (National Health Service) trusts will be recruited. We will correlate disease activity assessed by clinical parameters, ultrasonography, and questionnaires with biomarkers in the blood and target tissues, such as synovium and skin.

NCT ID: NCT01038011 Completed - Clinical trials for Ankylosing Spondylitis

Efficacy and Safety of Risedronate (Actonel), a Third Generation Bisphosphonate in Patients With Ankylosing Spondylitis: a Phase 2 Pilot Study

Start date: June 2004
Phase: Phase 2
Study type: Interventional

Randomized, controlled, double-blind, multicenter phase II study comparing risedronate 35mg (ActonelR 35mg weekly tablet) versus placebo in patients with active ankylosing spondylitis (AS) treated with standard first and second-line therapies. Primary efficacy endpoint: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The time schedule for performing the BASDAI was at screening, upon inclusion (T0), then after 3, 6 and 12 months or at the time of premature withdrawal in case of drop-out. secondary endpoints: - Clinical endpoints: The secondary efficacy measures were the following: Bath Ankylosing Spondylitis Functional Index (BASFI) , Bath Ankylosing Spondylitis Metrology Index (BASMI), ASAS (Assessments in Ankylosing Spondylitis) Working Group core set of domains, Spinal pain VAS, ESR, CRP and the percentage of patients achieving 20% or greater decrease in each of these parameters. These parameters were determined at T0, T3, T6, T12 or at the time of premature withdrawal in case of drop-out. The spinal pain assessed by VAS was also done at screening. - DEXA: Dual Energy X-Ray-Absorptiometry (DEXA) measurements were performed in all patients upon inclusion (T0) and at the end of the study (T12). - Biochemical markers: selected biochemical markers of bone metabolism were measured at T0, T3, T6 and T12 or at the time of premature withdrawal in case of drop-out using commercially available kits. Bone formation was assessed by serum bone-specific alkaline phosphatase (BAP) and osteocalcin (OC) levels using commercially available kits. Bone resorption was assessed in serum by the C-terminal telopeptide of type I collagen degradation (Crosslaps R) and urinary N-terminal telopeptide of type I collagen degradation (Osteomark R). - Trial with medicinal product

NCT ID: NCT00953979 Completed - Clinical trials for Ankylosing Spondylitis

Efficacy and Safety of Kunxian Capsule in Treatment Patients With Early Ankylosing Spondylitis

Start date: January 2008
Phase: Phase 4
Study type: Interventional

This is a prospective randomized controlled study to evaluated the efficacy and safety of kunxian capsule in treating of patients with early ankylosing spondylitis (AS). The major outcome index is proportion of patients achieving ASAS20 response at week12, and minor outcome indexes include ASAS50 and ASAS70, BASDAI20,BASDAI50 and BASDAI70. The adverse events at any time were recorded to evaluate the safety.