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Spondylitis, Ankylosing clinical trials

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NCT ID: NCT02962479 Enrolling by invitation - Clinical trials for Ankylosing Spondylitis

Is the Human Microbiome Altered in Patients With Axial Spondyloarthritis?

Start date: October 2016
Phase: N/A
Study type: Observational

This study aims to compare biological communities in stool samples obtained from age, diet and BMI-matched subjects in five study groups: subjects with ankylosing spondylitis (AS) never treated with tumor necrosing factor (TNF) inhibitors, subjects with ankylosing spondylitis previously or currently treated with TNF inhibitors, subjects with non-radiographic axial spondyloarthritis (nrSpA) never treated with tumor necrosing factor (TNF) inhibitors, subjects with non-radiographic axial spondyloarthritis previously or currently treated with TNF inhibitors and healthy participants. The differences in fecal microbiota composition will be explored using shotgun metagenomic sequencing through the University of Washington. The investigators predict that this study will confirm a significant difference between the fecal microbiota composition (FMC) of both AS and nrSpA patients and controls.

NCT ID: NCT02925338 Completed - Clinical trials for Rheumatoid Arthritis

National Observational Study On The Use Of Inflectra™ An Infliximab Biosimilar In Real Life

ReFLECT
Start date: October 19, 2016
Phase:
Study type: Observational

National, prospective, multicentre observational study designed for eligible patients treated with Inflectra. Its objectives are to describe under real conditions of use, the profile of patients treated with Inflectra and the response to treatment.

NCT ID: NCT02922192 Completed - Clinical trials for Rheumatoid Arthritis

Incidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive Analysis

Start date: January 1, 2012
Phase:
Study type: Observational

Purpose: With the existing biologic anti-inflammatory product patents expiring and the FDA approval of new biosimilar and innovator biologics, patients with rheumatologic (RA), psoriatic (PsO-PsA-AS), and gastrointestinal (GI) conditions will have additional therapeutic options. This observational study will describe the patient characteristics of new users of Tumor Necrosis Factor-α (TNF) antagonists, non-TNF- α antagonists, oral DMARD, and non-biologic agents. It will describe in the treatment cohorts outcomes of serious infections that require hospitalization. The BBCIC will use the findings from this descriptive analysis to design a comparative study evaluating the real-world effectiveness and safety of biosimilar and innovator anti-inflammatory biologics.

NCT ID: NCT02915354 Completed - Recurrence Clinical Trials

Relapse of Ankylosing Spondylitis Patients Withdrawal Etanercept After Clinical Remission: a Following-up Study

Start date: July 2007
Phase: Phase 4
Study type: Interventional

The inclusion criteria was patients who aged 18 or older with ankylosing spondylitis, fulfilled the 1984 modified New York criteria for AS. Inclusion criteria enriched the AS patients with clinical remission, including the following definition: 1. Administration of etanercept 50 mg for 6-week period at least; 2. Acquisition of Assessment of SpondyloArthritis International Society criteria 20(ASAS20) response at the end of the treatment. We excluded patients who have developed to complete spinal fusion. We also excluded patients with kidney disease induced by other conditions; pregnancy; suckle; accompany other chronic diseases; various infections in acute stage; and other infectious diseases. At the end of the trial, patients who fulfilled the inclusions would stop etanercept treatment. Cotherapy with disease modifying anti-rheumatic drugs or non-steroidal anti-inflammatory drugs could be continued if maintained at a stable dose;Patients were followed up from the time of etanercept withdrawal per 6 weeks for 3 years by telephone. If symptoms suggestive of relapse or other problems occurred, patients were invited to come back to the center. Relapse after etanercept withdrawal was defined as an increase Bath Spondylitis Disease Activity Index(BASDAI)15 score goes back to 80 percentages of it at the beginning of the trial16. The following data were collected: demographic and disease characteristics, therapeutic modification, clinical values (BASFI, Bath Ankylosing Spondylitis Global Score (BAS-G)), Ankylosing Spondylitis Disease Activity Score (ASDAS)1718) and biologic values at baseline of the trial and the time of relapse. Adverse events and other safety measures were also collected.

NCT ID: NCT02896127 Completed - Clinical trials for Ankylosing Spondyloarthritis

Study of Efficacy and Safety of Secukinumab in Patients With Ankylosing Spondylitis

Start date: October 18, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to demonstrate the clinical efficacy at week 16; and to demonstrate safety and tolerability of secukinumab compared to placebo in patients with ankylosing spondylitis at week 16 and long term safety up to Week 52.

NCT ID: NCT02893254 Completed - AS Clinical Trials

Efficacy and Safety of IBI303 in Adult Patients With Active Ankylosing Spondylitis

Start date: September 22, 2016
Phase: Phase 3
Study type: Interventional

Study of the efficacy and safety of IBI303 compared with adalimumab in adult patients with ankylosing spondylitis (AS) who have had an inadequate response to or who are intolerant to one or more nonsteroidal anti-inflammatory drugs (NSAIDs)

NCT ID: NCT02886689 Completed - Clinical trials for Arthritis, Rheumatoid

C.O.R.P.U.S.: Observational Cohort of Adult and Child Inflammatory Arthritis in France

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

C.O.R.P.U.S. is the first French observatory of care practices in active inflammatory rheumatism of children and adults: rheumatoid arthritis, spondylarthropathy, and idiopathic juvenile arthritis, established under the auspices of national health authorities. Its goal is to document safety, effectiveness in routine practice of various therapy, including biotherapy, of prescription or non-prescription over 5 years. A cohort will be constituted including any new case of active disease (DAS 28 > 3,2, BASDAI > 4, failure of methotrexate), without previous prescription of biotherapy. Therefore, it will be possible to have patients non exposed to biotherapy (non indication, refusal, contraindication) compared to patients exposed to biotherapy, and to monitor adverse events occurrence as well as effectiveness in routine practice over time, according to prescription, maintenance or switch of various therapies.

NCT ID: NCT02840695 Completed - Clinical trials for Ankylosing Spondylitis

Effect of Biological Disease Modifying Anti Rheumatic Drug (bDMARD) Treatment on Spinal Fracture Incidence in Patients With Ankylosing Spondylitis (AS)

Start date: January 2005
Phase: N/A
Study type: Observational [Patient Registry]

Ankylosing spondylitis (AS) is a rheumatoid disease affecting all segments of the axial skeleton, leading to the complete fusion of all spinal segments - the bamboo-spine. During the last decade biological disease modifying anti-rheumatic drugs (bDMARD) have been successfully introduced to reduce the disease activity. It is unclear whether bDMARD treatment had an effect on spinal fracture risk related to AS. This national registry study will investigate the effect of bDMARD treatment on spinal fracture risk in a national cohort of patients with AS.

NCT ID: NCT02809781 Recruiting - Arthritis Clinical Trials

A Pilot Study of MSCs Iufusion and Etanercept to Treat Ankylosing Spondylitis

Start date: June 2016
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and clinical effect of mesenchymal stem cells (MSCs) derived from human bone marrow at a dose of 1.0E+6 MSC/kg in subject for the therapy of Ankylosing spondylitis (AS) and to compare the efficacy of MSCs and Etanercept to treat this disease.

NCT ID: NCT02809300 Recruiting - Clinical trials for Ankylosing Spondylarthritis

Ankylosing Spondylitis and Antiphospholipid Antibodies

ASAA
Start date: November 2015
Phase: N/A
Study type: Interventional

The main objective is to evaluate the prevalence of anti-phospholipid antibodies (APLA) in patients with ankylosing spondylitis (AS). The secondary objectives are: (1) To determine whether the presence of these antibodies is symptomatic (thrombosis or not); (2) Identify a possible relationship between the presence of APLA and a particular form of SA (axial or peripheral); (3) To determine whether the presence of APLA is more frequent in patients receiving anti-tumor necrosis factor (TNF) alpha therapy.