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Axial Spondyloarthritis clinical trials

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NCT ID: NCT02744014 Completed - Clinical trials for Axial Spondyloarthritis

Add-on Therapy for Axial Spondyloarthritis

Start date: April 21, 2016
Phase: N/A
Study type: Interventional

Rationale: Recent investigations suggest that, through certain concentration/meditation techniques, it is possible to modulate autonomic activity. The results of a recent randomized controlled trial investigating the "Wim Hof Method" have shown a direct biological effect on in-vivo cytokine production and are strongly encouraging the clinical evaluation of the technique's efficacy in immune-mediated inflammatory diseases. Objective: To investigate whether an add-on mindset & physical therapy program based on the "Wim Hof Method" can safely and efficaciously be applied in patients with active axial spondyloarthritis. Study design: Prospective open-label randomized controlled trial, safety and efficacy. Study population: Twenty-four patients with active axial spondyloarthritis between 18 and 45 years of age. Intervention: A 30-day training program of add-on mindset and physical therapy for axial spondyloarthritis, using the methodology as designed and instructed by Wim Hof. It involves breathing techniques, training of mindset and concentration, and gradual cold exposure. Main study parameters/endpoints: Safety evaluation of the program is the primary aim of the study. Secondary endpoint is the modulation of serum CRP levels. Exploratory objectives include modulation of clinical disease activity (ASDAS), quality of life (SF-36, EQ-5D), depressive symptoms (HADS), and predictive role of generalized and specific outcome expectancies (EPQ-N, LOT-R, VAS scales).

NCT ID: NCT02687620 Active, not recruiting - Clinical trials for Ankylosing Spondylitis

Does Immunogenicity Have an Influence on the Efficacy of Anti-TNF Therapy in Patients With AS: An Inception Cohort Study

Start date: September 2014
Phase:
Study type: Observational

The purpose of this prospective cohort study is to evaluate the influence of serum drug levels and development of anti-drug antibodies on clinical response to anti-TNF agents in ankylosing spondylitis(AS) treatment. Secondary aims are to assess the demographic, clinical and laboratory variables associated with the development of anti-TNF drug antibodies at baseline or disease course and to reveal the impact of anti-drug antibodies on long-term efficacy or safety in particular drug survival in AS patients treated in daily clinical practice.

NCT ID: NCT02552212 Completed - Clinical trials for Axial Spondyloarthritis

Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS

C-AXSPAND
Start date: September 2015
Phase: Phase 3
Study type: Interventional

Patients with active Axial Spondyloarthritis without x-ray evidence of Ankylosing Spondylitis and with signs of inflammation will be randomly assigned to receive certolizumab pegol (CZP) 200 mg every two weeks or placebo. The primary objective is to demonstrate the efficacy of CZP in these patients.

NCT ID: NCT02486302 Completed - Clinical trials for Rheumatoid Arthritis

A Study To Evaluate The Efficacy Of Enbrel (REGISTERED) Etanercept Over A Period Of 12 Months In The Routine Treatment Of Patients With Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriatic Arthritis, Or Plaque Psoriasis.

ADEQUATE
Start date: March 24, 2015
Phase:
Study type: Observational

The purpose of this non-interventional study is to evaluate the efficacy of etanercept during routine clinical use over a maximum of 12 months in patients with rheumatoid arthritis (RA), psoriatic arthritis(PsA), axial spondyloarthritis(axSpA) or plaque psoriasis (PsO). In so doing, particular attention will be paid to the proportion of those patients who only attain the desired treatment goal after 12 weeks of treatment. The primary efficacy end point for the study is the proportion of patients who attain the desired treatment goal after 12 and 24 weeks,

NCT ID: NCT02438787 Terminated - Clinical trials for Axial Spondyloarthritis

A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF(Alpha) Refractory Participants With Active Radiographic Axial Spondyloarthritis

Start date: July 31, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy of ustekinumab, in adult anti-TNF(alpha) refractory participants with active radiographic axial spondyloarthritis (AxSpA), as measured by the reduction in signs and symptoms of radiographic AxSpA.

NCT ID: NCT02437162 Terminated - Clinical trials for Axial Spondyloarthritis

A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNFα Naive Participants With Active Radiographic Axial Spondyloarthritis

Start date: September 3, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy of ustekinumab, in adult participants with active radiographic axial spondyloarthritis (AxSpA), who are naive to anti-TNF alpha agents, as measured by the reduction in signs and symptoms of radiographic AxSpA.

NCT ID: NCT02429882 Withdrawn - Clinical trials for Axial Spondyloarthritis

Study of Efficacy and Safety of Brodalumab Compared With Placebo in Subjects With Axial Spondyloarthritis

Start date: May 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of brodalumab compared with placebo in participants with axial spondyloarthritis. Subjects will be randomized in a 1:1 ratio to brodalumab or placebo for the first part of the study. Subjects will then receive open label brodalumab for the remainder of the study. The entire study will be 312 weeks in duration for each subject.

NCT ID: NCT02374749 Completed - Clinical trials for Axial Spondyloarthritis

COMorbidities and EDucation in SPondyloArthritis Study

COMEDSPA
Start date: March 23, 2015
Phase: N/A
Study type: Interventional

Giving both the gap existing between the current recommendations to prevent/detect comorbidities and the clinical practice in patients suffering from spondyloarthritis and also the specificity of some recommendations to rheumatic diseases, it seems logical to check these recommendations in a rheumatologic "environment". This study with its two parts should be able to demonstrate: - The importance of a systematic evaluation of comorbidities in Spondyloarthritis, - The utility of a nurse-led program of self-assessment and self-management of the disease

NCT ID: NCT02356874 Completed - Clinical trials for Axial Spondyloarthritis

The Effect of Exercise on Disease Activity and Cardiovascular Risk for Patients With Axial SpondyloArthritis

ESpA
Start date: August 2015
Phase: N/A
Study type: Interventional

The overall aim of this multicenter randomised controlled trial (RCT) is to investigate if exercise can modify the disease course and prevent comorbidity in patient with spondyloarthritis (SpA).

NCT ID: NCT02354105 Completed - Clinical trials for Axial Spondyloarthritis

A Study to Assess the Effectiveness of Certolizumab Pegol in Patients With Axial Spondyloarthritis in Daily Life

CIMAX
Start date: January 12, 2015
Phase:
Study type: Observational

The primary purpose is to assess the effectiveness of certolizumab pegol in patients with axial spondyloarthritis under routine clinical practice.