Study of the Safety and Efficacy of RPH-104 in Preventing Recurrences in Patients With Idiopathic… (NCT05673902) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Study of the Safety and Efficacy of RPH-104 in Preventing Recurrences in Patients With Idiopathic Recurrent Pericarditis
Russia17 participantsStarted 2020-12-11
Plain-language summary
The goal of this clinical trial is to evaluate the safety and efficacy of RPH-104 for long-term use in a population of patients with idiopathic recurrent pericarditis who completed the main study CL04018068.
The primary objective of the study is to evaluate the safety of RPH-104 80 mg once every 2 weeks in patients with idiopathic recurrent pericarditis who completed the main study.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patient who fully completed per protocol a 24-week randomized withdrawal period (for the first 20 randomized patients), or the preparation therapy after the end of enrolment into the randomized withdrawal period in the main study CL04018068.
✓. Voluntarily signed and dated Patient Informed Consent Form for participation in this study.
✓. The patient's ability and willingness, according to the investigator, to follow the schedule of visits, the study procedures and follow the protocol requirements, including the following:
Exclusion criteria
✕. Unwillingness or inability of the patient to perform the study procedures in accordance with the Protocol.
✕. Any medically important event that was reported in a patient during his/her participation in the main study CL04018068, and, in the opinion of the Investigator, is a reason for not including this patient in this open-label study.
✕. Pregnant and lactating women or women planning pregnancy during the study or within 2 months after the last dose of the study drug.
✕. Women of childbearing potential who do NOT agree to use highly effective contraception methods throughout the study, starting from the moment of signing the informed consent form and for at least 8 weeks after the last dose of the study drug.
✕. oral, injectable or implanted hormonal contraceptives; in the case of the use of oral contraceptives, women should continuously use the same drug for at least 3 months before the start of the study therapy;
✕. an intrauterine device or contraceptive system;
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term
Timeframe: Up to week 228
2
Incidence of Treatment-Emergent Serious Adverse Events (SAEs), by System Organ Class and Preferred Term
Timeframe: Up to week 228
3
Incidence of Treatment-Emergent Adverse Events of Special Interest (AESI), by System Organ Class and Preferred Term
Timeframe: Up to week 228
4
Incidence rate for serious adverse events (SAEs)
Timeframe: Up to week 228
5
Incidence rate for adverse events of special Interest (AESI)
✕. barrier methods of contraception: condom or occlusive cap (diaphragm or cervical cap/contraceptive vaginal ring) with spermicidal foam/gel/film/cream/vaginal suppository.
✕. The need to use a live (attenuated) vaccine during the study or within 3 months after the last dose of the study drug. Live attenuated vaccines include vaccines against the following viruses: measles, rubella, mumps, chickenpox, rotavirus, flu (as a nasal spray), yellow fever, polio (oral polio vaccine); vaccines against tuberculosis (BCG), typhoid fever (oral typhoid vaccine) and typhus (typhus vaccine). Immunocompetent family members of the patient should not be vaccinated with the oral polio vaccine during the patient's participation in the study.