Efficacy and Safety of RPH-104 Treatment in Patients With Recurrent Pericarditis

Inclusion criteria

• ✓. complete abstinence (if it agrees with the preferable and usual lifestyle of the patient). \[Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\];
• ✓. sterilization: bilateral removal of the ovaries (with or without removal of the uterus) or tubal ligation at least 6 weeks before the start of the study therapy. If only the ovaries have been removed, the reproductive status of the woman should be confirmed by subsequent hormone tests;
• ✓. sterilization of the male partner at least 6 weeks before the start of the study therapy (with proper documentation of the absence of sperm cells in the ejaculate after vasectomy) \[in female subjects, the sexual partner after vasectomy should be the only partner\];
• ✓. use of a combination of any two of the following (a+b or a+c, or b+c):
• ✓. the use of oral, injectable or implanted hormonal contraceptives; in the case of oral contraceptives, women should consistently use the same drug for a minimum of 3 months prior to the initiation of the study treatment;
• ✓. placement of an intrauterine device (IUD) or intrauterine system (IUS);
• ✓. barrier methods of contraception: a condom or occlusive cap (diaphragm or cervical/vault caps) and spermicidal foam/gel/film/cream/vaginal suppository.