NCT05242133 - 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)

Anon, (2017)
[online] Available at: http://www.cinnagen.com/index.php/our-products/human-medicines/cinnovex [Accessed 2 Sep. 2017].
Anon, (2017)
[online] Available at: National Multiple Sclerosis Society. (2017). FDA Approves Plegridy (Pegylated Interferon Beta) For Relapsing MS. [online] Available at: http://www.nationalmssociety.org/About-the-Society/News/FDA-Approves-Plegridy-Pegylated-Interferon-Beta. [Accessed 2 Sep. 2017].
Calabresi PA, Kieseier BC, Arnold DL, Balcer LJ, Boyko A, Pelletier J, Liu S, Zhu Y, Seddighzadeh A, Hung S, Deykin A; ADVANCE Study Investigators
Pegylated interferon ß-1a for relapsing-remitting multiple sclerosis (ADVANCE): a randomised, phase 3, double-blind study. Lancet Neurol. 2014 Jul;13(7):657-65. doi: 10.1016/S1474-4422(14)70068-7. Epub 2014 Apr 30.
National Multiple Sclerosis Society
(2017). FDA Approves Plegridy (Pegylated Interferon Beta) For Relapsing MS. [online] Available at: http://www.nationalmssociety.org/About-the-Society/News/FDA-Approves-Plegridy-Pegylated-Interferon-Beta [Accessed 2 Sep. 2017].

Efficacy and Safety of Peginterferon Beta-1a (CinnaGen) Versus CinnoVex® (CinnaGen) in Reducing the Annualized Relapse Rate in Participants With Relapsing Remitting Multiple Sclerosis: A Phase III, Randomized, Parallel, Noninferiority Study

Details for clinical trial NCT05242133

Clinical trial NCT05242133 - References