NCT03069703 - 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)

doi:10
1016/j.vaccine.2011.04.132
doi:10
1136/ard.2008.088302
doi:10
1136/ard.2010.137778
McGregor JG, Negrete-Lopez R, Poulton CJ, Kidd JM, Katsanos SL, Goetz L, Hu Y, Nachman PH, Falk RJ, Hogan SL
Adverse events and infectious burden, microbes and temporal outline from immunosuppressive therapy in antineutrophil cytoplasmic antibody-associated vasculitis with native renal function. Nephrol Dial Transplant. 2015 Apr;30 Suppl 1:i171-81. doi: 10.1093/ndt/gfv045.
Nazi I, Kelton JG, Larché M, Snider DP, Heddle NM, Crowther MA, Cook RJ, Tinmouth AT, Mangel J, Arnold DM
The effect of rituximab on vaccine responses in patients with immune thrombocytopenia. Blood. 2013 Sep 12;122(11):1946-53. doi: 10.1182/blood-2013-04-494096. Epub 2013 Jul 12.

Multicenter Randomized Controlled Trial Comparing Immunogenicity and Safety of Two Innovative Anti-pneumococcal Vaccine Strategies to Standard Vaccination Regimen in Patients With ANCA-associated Vasculitis Receiving Rituximab Therapy

Details for clinical trial NCT03069703

Clinical trial NCT03069703 - References