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Spondylitis clinical trials

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NCT ID: NCT05879419 Recruiting - Clinical trials for Rheumatoid Arthritis

Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseases

RZVRheum
Start date: May 23, 2023
Phase: Phase 4
Study type: Interventional

Introduction: Patients with autoimmune rheumatic diseases (ARDs), rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PAs), ankylosing spondylitis (AS), systemic lupus erythematosus (SLE), primary Sjögren's syndrome (pSS) , systemic sclerosis (SSc), idiopathic inflammatory myopathies (IIM) and primary vasculitides, have a high risk of herpes zoster (HZ) infection. This increased susceptibility is caused by a deficient cell-mediated immune response due to the underlying disease and glucocorticoid and immunosuppressive treatments that impair the T-cell response, including conventional and unconventional synthetic disease-modifying anti-rheumatic drugs (DMARDs) and biological agents. In this context, the recent availability of a recombinant vaccine against HZ (RZV or Shingrix®), composed of recombinant VZV glycoprotein E (gE) and the AS01B adjuvant system (HZ/su), is a major progress regarding safety for immunosuppressed patients. Its effectiveness, however, has been clearly demonstrated for non-immunosuppressed patients and in selected populations of immunocompromised individuals. There are no prospective controlled studies evaluating the immunogenicity of RZV and its impact on the activity of the underlying disease, as well as its safety in patients with ARDs at high-risk for HZ. Hypothesis: RZV has a good safety profile, including with respect to underlying rheumatic disease activity, in patients with ARDs at high risk of HZ. Objectives: Primary: To assess the short-term safety profile in relation to underlying disease activity in patients with ARDs at high risk of HZ immunized with RZV compared to unvaccinated patients. Secondary: To evaluate the general safety of the vaccine in patients with ARDs at high risk of HZ immunized with RZV and non-immunosuppressed control subjects (CG); the humoral and cellular immunogenicity of RZV in patients with ARDs at high risk of HZ compared to CG; the influence of disease treatment on vaccine response; the 12-month persistence of humoral immunogenicity and incident cases of HZ. Specific studies will also be carried out to evaluate the effect of drug withdrawal (methotrexate-MTX and mycophenolate mofetil-MMF) after vaccination in increasing the immune response in patients with ARDs with controlled underlying disease.

NCT ID: NCT05866614 Recruiting - Clinical trials for Rheumatoid Arthritis

A Study to Evaluate the Safety of Remsima® SC in the Treatment of RA, AS, PsA and Ps

Start date: January 13, 2023
Phase:
Study type: Observational [Patient Registry]

This is an observational, prospective cohort study to evaluate the safety of Remsima® SC in the treatment of RA, AS, PsA and Ps.

NCT ID: NCT05862584 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

Impact of Air Pollution on the Course of Inflammatory Rheumatism

Start date: May 26, 2023
Phase: N/A
Study type: Interventional

The objective of this study is to see if there is a link between air pollution and inflammatory rheumatism (rheumatoid arthritis and ankylosing spondylitis) To do this, the investigators are going to follow a cohort of about 200-400 patients for 6 months by means of a self-questionnaire, which the investigators ask the patient to fill in once a week on a fixed day, and opposite the corresponding week to put the letter corresponding to the question concerning the activity of your disease: 3 possible answers: A: no flare-up, B: short flare-up of 1 to 3 days, C: persistent flare-up of more than 3 days Then the investigators will collect the questionnaire at the end of these 6 months and at each visit to the consultation or day hospital (on average every 4 to 6 weeks), and they will look to see if any relapses have occurred. At the same time the investigators will calculate the disease activity score (DAS or BASDAI) to have an objective score. Then in parallel they will look at the level of exposure to air pollution according to the place of residence and work of each patient. The hypothesis is that air pollution has an influence on the activity of inflammatory rheumatism.

NCT ID: NCT05861128 Recruiting - Clinical trials for Ankylosing Spondylitis

Extension Study to Evaluate Safety and Efficacy of Jaktinib in Patients With Active Ankylosing Spondylitis(AS)

Start date: November 10, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if Jaktinib is safe and effective in participants with active ankylosing spondylitis.

NCT ID: NCT05861102 Recruiting - Clinical trials for Ankylosing Spondylitis

Efficacy and Safety Study of Jaktinib in Subjects With Active Ankylosing Spondylitis(AS)

Start date: July 20, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, efficacy and safety study of Jaktinib in subjects with active Ankylosing Spondylitis(AS).

NCT ID: NCT05839925 Completed - Clinical trials for Ankylosing Spondylitis

Prevalence of Temporomandibular Joint Dysfunction in Patients With Ankylosing Spondylitis

Start date: April 1, 2022
Phase:
Study type: Observational

This study included 113 patients diagnosed with ankylosing spondylitis and 110 healthy volunteers. Participants in both groups were evaluated using the 'Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)' diagnostic criteria. In addition, the relationship between temporomandibular joint dysfunction and disease activity was investigated in patients with ankylosing spondylitis.

NCT ID: NCT05835518 Recruiting - Clinical trials for Rheumatoid Arthritis

An Observational, Prospective Study to Assess the Efficacy and Safety of Adalloce in Patients With RA and AS

Start date: January 26, 2023
Phase:
Study type: Observational

This Study is to Assess the Efficacy and Safety of Adalloce in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis, An Observational, Prospective Study

NCT ID: NCT05814939 Recruiting - Clinical trials for Active Ankylosing Spondylitis

Efficacy and Safety Clinical Study of VC005 Tablets in Subjects With Active Ankylosing Spondylitis.

Start date: April 26, 2023
Phase: Phase 2
Study type: Interventional

This clinical trial is a multicenter, randomized, double-blind, controlled phase II clinical study.

NCT ID: NCT05812157 Recruiting - Clinical trials for Axial Spondyloarthritis

Optimizing Anti-IL17 Antibody Therapy by Associating Fiber Supplementation to Correct Treatment-aggravated Gut Dysbiosis in Axial Spondyloarthritis - RESPOND-IL17

RESPOND-IL17
Start date: October 2, 2023
Phase: N/A
Study type: Interventional

Fiber is the main source of energy for colonic bacteria and its consumption favorably modifies the composition of the microbiota in only a few days. Their fermentation in the colon releases short-chain fatty acids (SCFAs). Clostridiales contain many strains producing SCFAs. These SCFAs can restore the intestinal barrier and promote certain anti-inflammatory cells, including regulatory T cells (Tregs), which are essential to the mechanisms in tolerance of the self. Fibers could therefore correct the intestinal abnormalities present in patients with axial spondyloarthritis (AxSpA) and aggravated by anti-IL-17 drugs and thus improve the therapeutic response to these treatments. The hypothesis is that dietary fiber will correct the dysbiosis in AxSpA patients and increase the release of SCFAs, which favorably modulate the immune response and improve AxSpA.

NCT ID: NCT05792358 Enrolling by invitation - Clinical trials for Ankylosing Spondylitis

Wet Cupping Therapy in Ankylosing Spondylitis

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

This study evaluates the efficacy of wet cupping therapy in patients with ankylosing spondylitis.Wet cupping therapy will be applied to half of the patients plus routine pharmaceutical treatment while the other half will receive only pharmaceutics