NCT04656015 - 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)

Bernstein CN, Benchimol EI, Bitton A, Murthy SK, Nguyen GC, Lee K, Cooke-Lauder J, Kaplan GG
The Impact of Inflammatory Bowel Disease in Canada 2018: Extra-intestinal Diseases in IBD. J Can Assoc Gastroenterol. 2019 Feb;2(Suppl 1):S73-S80. doi: 10.1093/jcag/gwy053. Epub 2018 Nov 2.
Fung G, Luo H, Qiu Y, Yang D, McManus B
Myocarditis. Circ Res. 2016 Feb 5;118(3):496-514. doi: 10.1161/CIRCRESAHA.115.306573. Review.
Matsuura E, Atzeni F, Sarzi-Puttini P, Turiel M, Lopez LR, Nurmohamed MT
Is atherosclerosis an autoimmune disease? BMC Med. 2014 Mar 18;12:47. doi: 10.1186/1741-7015-12-47. Review.

Cardiovascular Manifestation of Inflamatory Bowel Disease Patient ( Tissue Doppler Echocardiography and Cardiac MRI )

Clinical trial NCT04656015 - References