Clinical Trials Logo

Clinical Trial Summary

Primary Sjögren's syndrome (pSS) is a chronic, systemic autoimmune disease characterized by disorders of the lacrimal and salivary glands. The disease can be seen in systemic involvement by affecting any organ. It may result in skin, lung and kidney involvement as well as symptoms such as vasculitis and neuropathy. Patients with PSS often report fatigue as an important symptom to manage. Fatigue, defined as an overwhelming feeling of fatigue, lack of energy, and exhaustion, is associated with poor health and functional impairment. Fatigue is a common symptom of pSS. This symptom is the most important cause of loss of function in patients. It is thought that as a result of fatigue in pSS, decrease in mental health related to physical activity level and quality of life in patients, sleep problems, depression and loss of ability to work. Several mechanisms have been proposed to explain the occurrence of fatigue among sjogren patients, but its underlying physiological basis has not been adequately defined. Therefore, it is a complex, multifaceted and poorly understood symptom. In population-based studies, approximately 20% of healthy adults report experiencing fatigue, and this rate rises to 60%-70% among patients with autoimmune disorders. Fatigue is the most common non-exocrine symptom in pSS, and the prevalence of fatigue disability among patients with pSS has been reported to be approximately 70%.


Clinical Trial Description

In order to evaluate fatigue in primary Sjögren's syndrome patients, questionnaires such as FACIT Fatigue Scale, Sjögren's Syndrome EULAR Patient Reporting Index, Fatigue Severity Scale, Fatigue Multidimensional Assessment Scale and Short Form-36, which are also used in many disease groups, are used. Although the importance of the effect of fatigue on pSS patients has been demonstrated in studies, most of the fatigue assessment questionnaires used are not pSS specific. For this reason, Bowman et al. They developed the Fatigue and Discomfort Profile - Sikka Symptoms Scale (PROFAD-SSI) to assess multidimensional fatigue in patients with pSS, considering disease symptoms. PROFAD-SSI is scored from 0 to 7 on an 8-point Likert scale. The 19-item scale evaluates patients in 8 different dimensions: somatic fatigue, mental fatigue, arthralgia, vascular dysfunction, oral dryness, ocular dryness, cutaneous and vaginal dryness. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04975087
Study type Observational
Source Gazi University
Contact Fulden SARI, doctorate
Phone +90 5069654352
Email fuldensari@hotmail.com
Status Not yet recruiting
Phase
Start date October 15, 2021
Completion date December 30, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT03040583 - The ASSESS National Multi-center Prospective Cohort
Completed NCT01989819 - Primary Sjögren Syndrome
Completed NCT02291029 - Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's Syndrome Phase 2
Terminated NCT02610543 - UCB Proof of Concept Study in Patients With Primary Sjögren's Syndrome Phase 2
Recruiting NCT06203457 - Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome Phase 2
Completed NCT04078386 - A Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Primary Sjögren's Syndrome Phase 2
Recruiting NCT05087589 - Efficacy, Safety and Immunological Evaluation of Tofacitinib in the Treatment of Primary Sjogren's Syndrome Phase 2
Recruiting NCT04212572 - Ultrasound Abnormalities of the Salivary Glands in Primary Sjögren's Syndrome According to the Duration of the Disease
Completed NCT02149420 - PD of VAY736 in Patients With Primary Sjögren's Syndrome Phase 2
Recruiting NCT04858464 - Reliability, Validity of the Turkish Version of the Primary Sjögren Syndrome Quality of Life (PSS-QoL) Questionnaire
Recruiting NCT03003572 - Autoreactive Anti-Ro/SSA IgE To Determine Primary SjögRen's Syndrome's Disease Activity
Completed NCT00632866 - Hydroxychloroquine Versus Placebo in Primary Sjögren's Syndrome Phase 3
Completed NCT02334306 - A Phase 2a, Randomized, Placebo Controlled, Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Primary Sjögren's Syndrome Phase 2
Completed NCT02775916 - Safety, Pharmacokinetics, and Preliminary Efficacy Study of CDZ173 in Patients With Primary Sjögren's Syndrome Phase 2
Completed NCT02464319 - A Phase II Study With Low-dose Recombinant Human IL-2 for the Treatment of Primary Sjögren's Syndrome Phase 2
Terminated NCT01552681 - Baminercept, a Lymphotoxin-Beta Receptor Fusion Protein, for Treatment of Sjögren's Syndrome Phase 2
Completed NCT04186871 - Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis Phase 2
Completed NCT00426543 - Effect of B-cell Depletion in Patients With Primary Sjögren's Syndrome Phase 2
Recruiting NCT04981145 - The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome Phase 4
Completed NCT03627065 - A Study of INCB050465 in Primary Sjögren's Syndrome Phase 2