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Spondylitis clinical trials

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NCT ID: NCT01797224 Recruiting - Clinical trials for Rheumatoid Arthritis

OTIS Autoimmune Diseases in Pregnancy Project

Start date: March 2012
Phase:
Study type: Observational

The purpose of the OTIS Autoimmune Diseases in Pregnancy Study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live born infants for five years after birth. With respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be relevant to a medication exposure during pregnancy, and these include both easily recognizable defects which are visible at birth, as well as more subtle or delayed defects that may not be readily identifiable without special expertise and observation beyond the newborn period.

NCT ID: NCT01793285 Completed - Clinical trials for Ankylosing Spondylitis

An Observational, Retrospective, Multicenter, National Study for the Monitoring of Subjects Who Participated in the LoadET Clinical Trial

RELOADET
Start date: December 2010
Phase: N/A
Study type: Observational

Previous studies suggest that an increase in doses of weekly etanercept from 50 mg to 100 mg improves the efficacy of the treatment in patients with cutaneous psoriasis, rheumatoid arthritis, and psoriatic arthritis. In this same line of study, during the 2007 2008 period, we conducted a multicenter, double-blind, 12-week Study (LoadET, 0881A3-102090) comparing the efficacy of etanercept at a standard dose (50 mg/week) versus a double dose (100 mg/week) in subjects with AS refractory to conventional therapy. The interim results of said study do not appear to support the value of doubling the dose of etanercept in the treatment of subjects with AS. Once this study was finalised, the subjects continued to be monitored by their regular physician, who decided on the dose and treatment to follow according to the conditions of standard clinical practice. The objective of this observational study is to evaluate the course of the disease in the long-term (three years) under the conditions of standard clinical practice, in subjects who had participated in the LoadET study. Therefore, we would like to follow-up on those patients by reviewing their clinical histories for the three-year period between the finalisation of their participation in the LoadET Study (0881A3-102090) and now. This will allow us to assess the efficacy and survival of the drug, as well as the possible appearance of side effects in the three years following the finalisation of the study by comparing the results according to if the subjects had received 50 mg/week or 100 mg/week during the LoadET study (0881A3 102090).

NCT ID: NCT01790022 Active, not recruiting - Clinical trials for Ankylosing Spondylitis

Efficacy and Safety of MEthylprednisolone Administered Intravenously for the Treatment of Patients With Active AnkyLosing spondyLitis (METALL)

METALL
Start date: July 2012
Phase: Phase 2
Study type: Interventional

In this study, efficacy of methylprednisolone in reduction of signs and symptoms (back pain, stiffness, joint pain and swelling) of active ankylosing spondylitis (AS) will be investigated. It is expected, that a single dose of methylprednisolone 500 mg given intravenously at baseline will lead to a rapid reduction of symptoms of active AS, which can be seen already 2 weeks after drug administration.

NCT ID: NCT01789151 No longer available - Clinical trials for Rheumatoid Arthritis

99m-Technetium- Glucosamine in Arthritis

Start date: n/a
Phase: N/A
Study type: Expanded Access

Preliminary data following a pilot study from our institution confirms the ability of 99mTc-glucosamine (99mTc-ECDG) to differentiate between active, subclinical and quiescent disease in patients with rheumatoid arthritis, scleroderma lung, and vasculitis. We propose to extend these findings and further evaluate this imaging modality for its clinical utility, limitations, and application. An unacceptably high level of morbidity exists amongst patients suffering from rheumatic disease. This is often the result of mild disease being missed or misdiagnosed, and therapy inordinately delayed or inappropriate. The currently used therapeutic agents themselves have associated side-effects adding to unfavourable clinical outcomes. There is therefore a need for a superior, less expensive and more easily accessible imaging modality to assess the degree of inflammation to guide the clinician. Glucosamine is absorbed and metabolised in a manner not too dissimilar to that of glucose, and it can be readily labelled to form 99mTc-ECDG. Scans can be acquired within 3 hours of intravenous administration of this agent, accurately depicting sites of active inflammation/disease. HYPOTHESIS Glucose is a vital cellular substrate that accumulates at inflamed tissues because of the greater metabolic needs of the cells during active disease. Glucosamine, being an analogue of glucose, is metabolised more quickly in inflamed than non-inflamed tissue and thus 99mTc-ECDG scintigraphy like 18-Fluorodeoxyglucose (18FDG-PET) scintigraphy allows for detection of active inflammation. Unlike current bone scans this agent has the sensitivity to detect subclinical inflammatory disease that would in turn provide essential information to ensure accurate diagnosis and treatment.

NCT ID: NCT01786668 Completed - Clinical trials for Ankylosing Spondylitis

Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis

Start date: April 2013
Phase: Phase 2
Study type: Interventional

This is the first study of oral tofacitinib in adults with active ankylosing spondylitis. It is designed to obtain information on the efficacy and safety of 3 different doses of tofacitinib.

NCT ID: NCT01768858 Completed - Clinical trials for Rheumatoid Arthritis

Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical Practice

Adherence
Start date: February 5, 2013
Phase:
Study type: Observational

The purpose of this non-interventional, multicenter, post-marketing observational study (PMOS) was to assess rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PS), Crohn's disease (CD) and ulcerative colitis (UC) patients' adherence attitudes (beliefs) to maintenance therapy with adalimumab monotherapy or combination therapy with methotrexate (in participants with RA) and to investigate whether there were correlations between such beliefs and adherence to maintenance treatment.

NCT ID: NCT01754727 Completed - Clinical trials for Ankylosing Spondylitis

Impact of Adalimumab (Humira) Therapy on Selected Health Care Resource Utilization and Sick Leave in Patients With Ankylosing Spondylitis in Clinical Practice

IDEA
Start date: December 2012
Phase: N/A
Study type: Observational

Ankylosing Spondylitis (AS) is a disease that represents a considerable economic burden to the health care system as well as the whole society. The introduction of biologic therapy, though allowing for superior clinical and work productivity outcomes, has significantly increased direct medical costs of AS. Therefore it is important to weight the benefits against the costs to gain a basis for decisions on health care resource allocation. Due to differences in the health care systems, health insurance and general country settings, health economic data cannot be generalized across countries. Such data is generally lacking in Central and Eastern European countries, especially in the field of rheumatology. This study will evaluate selected health care resource utilization and productivity losses in patients with AS during and before the treatment with adalimumab in clinical practice. The impact of adalimumab therapy on the extent of outpatient attendance, hospitalizations and sick leave, which could be influenced by relatively short-term adalimumab therapy, will be taken into account, and in relation to treatment response. There is no published data on the impact of adalimumab therapy on hospitalizations and outpatient attendance in patients with AS. Further, data on health care resource utilization and sick leave before and during adalimumab therapy could be translated into financial cost estimates (potential cost savings) by each participating country, based on their own country specific cost per resource.

NCT ID: NCT01750528 Completed - Periodontitis Clinical Trials

Prevalence and Progression of Periodontitis in Ankylosing Spondylitis

Start date: September 2012
Phase: N/A
Study type: Observational

1. Our hypotheses on the relationship between periodontitis and AS are as follows; - The prevalence of periodontitis is higher in AS patients group than that of non-AS control group - Anti-TNF-α therapy would favorably affect the disease course of periodontitis. 2. Based on our hypotheses, the specific objectives of the present proposal are as follows; - The primary objective is to compare the prevalence rate of periodontitis between AS patient group and non-AS group. - The secondary objectives will be: - To observe the carriage rate of P. gingivalis in AS and non-AS groups - To identify clinical parameters associated with the severity of periodontitis in AS group. - To compare the progression of periodontitis at weeks 12 and 24 between AS and non-AS groups or between AS patients with and without anti-TNF-α treatment

NCT ID: NCT01709656 Completed - Clinical trials for Ankylosing Spondylitis

A Molecule Basic Study of Early Warning for New Pathogenic Risk of Ankylosing Spondylitis

Start date: March 2012
Phase: N/A
Study type: Interventional

The investigators will recruit active ankylosing spondylitis patients for injection treatment of Human Mesenchymal Stem Cells (a prospective, open-label, masculine medicine controlled(NSAIDs), clinical trial), and collect their Peripheral Blood Lymphocyte (PBMCs) and sera before and after the treatment of 24 weeks to test the gene expression profiles and study related pathogenesis of AS

NCT ID: NCT01697254 Completed - Clinical trials for Systemic Lupus Erythematosus

The CARRA Registry

CARRA Registry
Start date: August 2009
Phase: N/A
Study type: Observational [Patient Registry]

This CARRA Registry study will create a foundational database for rheumatic diseases of childhood using a novel informatics infrastructure developed as part of the larger clinical project. The creation of a CARRA-wide informatics infrastructure will enable efficient, observational, disease-related data capture across all CARRA sites for pediatric rheumatic diseases. The CARRA Registry study will demonstrate the feasibility of expanding to more data intensive registries for observational studies, comparative effectiveness research, pharmaceutical clinical trials and translational research.