Active clinical trials for "Spondylarthritis"

PURPOSE: The main purpose is to explore clinical efficacy and safety associated with capsule FMT (cFMT) performed in newly diagnosed, untreated patients with rheumatic and gastrointestinal chronic inflammatory diseases (CIDs). DESIGN AND METHODS: In this 1:1 double-blind, placebo-controlled, randomised, 12-month exploratory trial, 200 patients with at least one of 6 different diagnoses of CIDs fulfilling the study criteria will be enrolled at time of diagnosis. The patient groups are: rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), pulmonary sarcoidosis (PSar), Crohn's disease (CD), and ulcerative colitis (UC). The primary endpoint is change from baseline to eight weeks in the physical component summary (PCS) of the short form health survey (SF-36). Key secondary clinical endpoints will be evaluated at 8 weeks. Other secondary clinical endpoints will be evaluated at 52 weeks and reported in secondary papers. The baseline visit will be performed as quickly as possible after the patient's informed consent has been obtained to ensure no unnecessary treatment delay. Stratified by CID diagnosis, patients will be randomised (1:1) to either placebo or single-donor cFMT processed from stool provided to the hospital from anonymous-to-the-patient healthy donors. The experimental intervention FMT/placebo will be repeated once weekly the first month (i.e., each patient will receive a total of four treatments). In addition, all participants will concomitantly be offered the national guideline first-line anti-inflammatory treatment following the baseline visit. At baseline, 8 weeks, 26 weeks, and 52 weeks a thorough clinical examination will be conducted and all relevant clinical scores for each disease entity will be registered. Patient-reported-outcomes including SF-36 and disease specific questionnaires will be collected at week 1, 2, 3, 4, 8 (primary endpoint evaluation), 26 and 52. Adverse events will be monitored through out the trial.

A few studies have evaluated the effectiveness of yoga therapy in patients with axial spondyloarthritis (axSPA). On the other hand, studies conducted in other chronic rheumatisms such as low back pain, rheumatoid arthritis or other conditions such as cancer have shown that yogatherapy can have a effective action on the physical and psychological level. Yogatherapy is a non-drug "body-mind" approach that would be likely to improve the physical symptoms (pain, stiffness, in particular spinal and pelvic), internal organs (colitis) and psychological symptoms as well as the perception of fatigue of people with axSPA. A 2021 study showed the feasibility and acceptability of regular yogatherapy practice in patients with axSPA. It is therefore necessary to conduct randomized controlled studies to assess the effectiveness of this management strategy.

Tofacitinib (TOFA) is a JAK inhibitor already used in rheumatology for the treatment of moderate-to-severe active rheumatoid arthritis and psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease- modifying antirheumatic drugs. Furthermore, TOFA has been recently approved for the treatment of adult patients with moderate-to-severe active Ulcerative Colitis (UC) who had no response, lose response, or were intolerant to either conventional therapy or a biologic agent. The approval was based on the efficacy demonstrated by TOFA in three phase 3 randomized controlled trials named OCTAVE: two identically designed, 8-week, placebo- controlled, induction studies of oral TOFA 10 mg twice daily followed by the OCTAVE Sustain 52-week maintenance study. About sacroiliitis, 2 out of 8 patients treated with TOFA improved after 8 weeks, compared with 0 out of 3 patients in the placebo group. Obviously, these data should be interpreted with extreme caution since patient numbers were very low, and it should be again emphasized that these trials were not designed to explore the efficacy of TOFA onextraintestinal manifestations. On these premises, we designed a prospective, multicenter, observational, 52-week study with the aim of assess the effectiveness of TOFA on UC-associated spondyloarthropathy.

An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in Patients with Ankylosing Spondylitis

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

The goal of this clinical trial is to evaluate the safety and tolerability of multiple doses of human umbilical cord mesenchymal stem cell injection in patients with Ankylosing Spondylitis, and to further explore the efficacy, pharmacodynamic profile and appropriate dose of administration to provide a basis for the use of safer and more effective treatments for patients with Ankylosing Spondylitis in the future. Participants are required to sign an informed consent form and, after undergoing a series of tests and meeting the protocol's entry and exclusion criteria, are assigned to a dose group for intravenous infusion of human umbilical cord mesenchymal stem cells.

Spondyloarthritis is a chronic inflammatory joint disease that affects the spine and sacroiliac joints. Most untreated patients eventually experience impaired mobility of the spine, pain and reduced physical function. Exercise is a cornerstone in the treatment of patients with spondylarthritis and it has been shown that high intensity exercise is just as effective in reducing disease activity as immunosuppressive medication. Additionally, patients with spondylarthritis have increased risk of cardiovascular disease both due to traditionally risk factors (obesity, high blood pressure etc) but also due to chronic inflammation. A maximal cardiopulmonary exercise test (CPET) is a measure of cardiorespiratory fitness that can be used to show progression of the exercise and which also is correlated to all-cause mortality and life expectancy. The investigators will validate an indirect maximal CPET against the gold standard with direct gas exchange measurements in patients with spondylarthritis. The indirect test is less time consuming, requires less sophisticated equipment, has lesser requirements to test personnel and facilities, and has less expenditures than the direct test. With a validated indirect maximal CPET the test of cardiorespiratory fitness will be more accessible for patients with spondylarthritis both in-hospital but also municipal.

The investigators goal is to provide a mechanism that allows for a better understanding of patient outcomes following rehabilitation. This includes functional outcomes measured by standardized and validated tools from the published literature. It incorporates comorbidities and patient demographic characteristics. It includes measures of general health as well along with activities of daily living and behavioral health aspects. Measures of quality and satisfaction and use of Net Promoter Scores also are included. All of these components come together to form a remarkably comprehensive picture of patients and their associated outcomes. This is a unique milestone in rehabilitative care and will act to inform and direct evidence-based approaches and treatment guidelines. Data are collected via the investigators proprietary electronic medical record system and are synthetic to the clinical process-that is, the data are collected in real-time with patients and the scores are immediately provided to the treating therapist as well as archived for later Registry and scientific use. Subsequent reporting can be risk adjusted to any variable collected which yields robust insights as to idiopathic patient conditions. However, no PHI information will be available.

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

In this study, investigators aimed to observe the examination findings, laboratory findings and drugs used in routine polyclinic controls of the participants using biological and targeted synthetic disease-modifying antirheumatic drug (DMARD) and the doses and side effects of these drugs. The aim of this registry is to evaluate the real-life data of participants receiving these medications. Analysis of treatment follow-up, drug changes, causes of change, treatment-related paradoxic / immune reactions, compliance with adult vaccination programs, nutritional profiles, presence of metabolic syndrome, fertility status, pregnancy outcomes, and vitamin D levels will be recorded in the outpatient clinic. Rheumatoid Arthritis Impact of Disease, Psoriatic Arthritis Impact of Disease (RAID and PSAID indexes), Work Productivity and Activity Impairment Questionnaire (WPAI), drug compliance, central sensitization and fall risk will be evaluated with verbal evaluation forms performed at policlinic controls in patients with spondyloarthritis and rheumatoid arthritis. It is planned to conduct scientific analyzes and publish on various subjects from the recorded information on this registration system. Patients using biological and targeted synthetic DMARD treatments are closely monitored and evaluated in many ways due to the risk profiles and various characteristics of the drugs. With this registry system, it is aimed to evaluate the real-life data of the participants using these drugs. Real-life data are very valuable in monitoring the disease and the drugs. The study is observational and there is no expected risk since no intervention is planned.