NCT05839925 - 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)

Bilgin E, Bilgin E, Ozdemir O, Kalyoncu U
Temporomandibular disorders in ankylosing spondylitis: a cross-sectional, monocentric study. Rheumatol Int. 2020 Jun;40(6):933-940. doi: 10.1007/s00296-020-04563-y. Epub 2020 Apr 1.
Braun J, Sieper J
Ankylosing spondylitis. Lancet. 2007 Apr 21;369(9570):1379-1390. doi: 10.1016/S0140-6736(07)60635-7.
Huang YF, Chang CT, Muo CH, Chiu KM, Tsai CH, Liu SP
Bidirectional relationship between temporomandibular disorder and ankylosing spondylitis: a population-based cohort study. Clin Oral Investig. 2021 Nov;25(11):6377-6384. doi: 10.1007/s00784-021-03938-0. Epub 2021 Apr 14.
Rudwaleit M, van der Heijde D, Landewe R, Listing J, Akkoc N, Brandt J, Braun J, Chou CT, Collantes-Estevez E, Dougados M, Huang F, Gu J, Khan MA, Kirazli Y, Maksymowych WP, Mielants H, Sorensen IJ, Ozgocmen S, Roussou E, Valle-Onate R, Weber U, Wei J, Sieper J
The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection. Ann Rheum Dis. 2009 Jun;68(6):777-83. doi: 10.1136/ard.2009.108233. Epub 2009 Mar 17. Erratum In: Ann Rheum Dis. 2019 Jun;78(6):e59.
Souza RC, de Sousa ET, Sousa D, Sales M, Dos Santos Oliveira R, Mariano MH, Rushansky E, Amorim Gomes AC, Silva E
Prevalence of Temporomandibular Joint Disorders in Patients with Ankylosing Spondylitis: A Cross-Sectional Study. Clin Cosmet Investig Dent. 2021 Nov 11;13:469-478. doi: 10.2147/CCIDE.S320537. eCollection 2021.

Prevalence of Temporomandibular Joint Dysfunction in Patients With Ankylosing Spondylitis and Comparison of the Findings With Healthy Controls

Details for clinical trial NCT05839925

Clinical trial NCT05839925 - References