NCT04858464 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Lackner A, Ficjan A, Stradner MH, Hermann J, Unger J, Stamm T, Stummvoll G, Dür M, Graninger WB, Dejaco C
It's more than dryness and fatigue: The patient perspective on health-related quality of life in Primary Sjögren's Syndrome - A qualitative study. PLoS One. 2017 Feb 9;12(2):e0172056. doi: 10.1371/journal.pone.0172056. eCollection 2017.
Lackner A, Stradner MH, Hermann J, Unger J, Stamm T, Graninger WB, Dejaco C
Assessing health-related quality of life in primary Sjögren's syndrome-The PSS-QoL. Semin Arthritis Rheum. 2018 Aug;48(1):105-110. doi: 10.1016/j.semarthrit.2017.11.007. Epub 2017 Nov 27.
Ng WF, Bowman SJ
Primary Sjogren's syndrome: too dry and too tired. Rheumatology (Oxford). 2010 May;49(5):844-53. doi: 10.1093/rheumatology/keq009. Epub 2010 Feb 10. Review.

Reliability, Validity, and Cross-Cultural Adaptation of the Turkish Version of the Primary Sjögren Syndrome Quality of Life (PSS-QoL) Questionnaire

Clinical trial NCT04858464 - References