Phase
Condition
Heart Disease
Cardiac Disease
Chest Pain
Treatment
RPH-104
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient who fully completed per protocol a 24-week randomized withdrawal period (forthe first 20 randomized patients), or the preparation therapy after the end ofenrolment into the randomized withdrawal period in the main study CL04018068. OR Patient who fully completed per protocol the study CL04018077 (after repeatedscreening).
Voluntarily signed and dated Patient Informed Consent Form for participation in thisstudy.
The patient's ability and willingness, according to the investigator, to follow theschedule of visits, the study procedures and follow the protocol requirements,including the following:
Come to the study site every 2 weeks for the study drug administration byqualified site staff; or
Learn how to perform subcutaneous injections and do it on their own at home asper protocol of this study.
Exclusion
Exclusion Criteria:
Unwillingness or inability of the patient to perform the study procedures inaccordance with the Protocol.
Any medically important event that was reported in a patient during his/herparticipation 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 effectivecontraception methods throughout the study, starting from the moment of signing theinformed consent form and for at least 8 weeks after the last dose of the studydrug. OR Men who are sexually active and do NOT agree to use highly effectivecontraception methods throughout the study, starting from the moment of signing theinformed consent form and for at least 8 weeks after the last dose of the studydrug. Highly effective contraception methods include:
sterilization in women: surgical bilateral removal of the ovaries (with orwithout removal of the uterus) or ligation of the fallopian tubes at least 6weeks before the start of the study therapy. In the case of removal of only theovaries, the reproductive status of a woman should be confirmed by a subsequentassessment of hormone level;
sterilization in men, at least 6 months before the start of the study therapywith proper documentation of the absence of sperm in the ejaculate aftervasectomy. For women participating in the study, a sexual partner after avasectomy should be the only partner;
using a combination of any two of the following methods (a+b or a+c or b+c):
oral, injectable or implanted hormonal contraceptives; in the case of theuse of oral contraceptives, women should continuously use the same drugfor at least 3 months before the start of the study therapy;
an intrauterine device or contraceptive system;
barrier methods of contraception: condom or occlusive cap (diaphragm orcervical cap/contraceptive vaginal ring) with spermicidalfoam/gel/film/cream/vaginal suppository.
The need to use a live (attenuated) vaccine during the study or within 3 monthsafter the last dose of the study drug. Live attenuated vaccines include vaccinesagainst the following viruses: measles, rubella, mumps, chickenpox, rotavirus, flu (as a nasal spray), yellow fever, polio (oral polio vaccine); vaccines againsttuberculosis (BCG), typhoid fever (oral typhoid vaccine) and typhus (typhusvaccine). Immunocompetent family members of the patient should not be vaccinatedwith the oral polio vaccine during the patient's participation in the study.
Other medical conditions or laboratory abnormalities, which may increase thepotential risk associated with participation in the study and treatment with thestudy drug, or may affect the interpretation of the results of the study, and which,in the opinion of the Investigator lead to patient ineligibility for this study.
Parallel participation in other clinical trials (except for the main studyCL04018068) at the time of screening or the use of any unapproved (investigational)drugs (except for RPH-104) less than 4 weeks or 5 half-lives (whichever is greater)before screening. For patients undergoing repeated screening, the following criteria are additionallyapplicable:
Hypersensitivity to the test drug (RPH-104), and/or its components /excipientsand/or drugs of the same chemical class.
Previous use of drugs:
rilonacept - less than 6 weeks before the initial assessment (the day of there-screening visit),
kanakinumab - less than 12 weeks before the initial assessment (the day of there-screening visit),
anakinra - less than 5 days before the initial assessment (the day of there-screening visit),
drugs of the TNF inhibitor class, IL-6 inhibitors, janus kinase inhibitors -less than 12 weeks before the initial assessment (the day of the re-screeningvisit),- - immunosuppressants (azathioprine, cyclosoprine, mycophenolate,mofetil, tacrolimus, sirolimus, mercaptopurine) - less than 24 weeks before theinitial assessment (the day of the re-screening visit),
methotrexate - less than 2 weeks before the initial assessment (the day of there-screening visit),
any other biological drugs in less than 5 periods half-life before the start oftherapy.
- Any conditions or signs in the patient that, according to the investigator'sjudgement, indicate a disorder (suppression) of the patient's immune response and/orsignificantly increase the risk of immunomodulatory therapy, including, but notlimited to, the following:
active bacterial, fungal, viral or protozoal infection revealed at thebeginning of the screening period;
opportunistic infections and/or Kaposi's sarcoma at the beginning of thescreening period;
chronic bacterial, fungal or viral infection requiring systemic therapy at thebeginning of the screening period;
HIV-infection, hepatitis B or C (patients with treated hepatitis C and negativepolymerase chain reaction (PCR) tests after 3 and 6 months are regarded ascured from hepatitis C and can be included in this study);
- A history of active tuberculosis or the presence of risk factors or signs indicatingthe presence of active or latent infection caused by M. Tuberculosis, including butnot limited to the following:
living in specific conditions that increase the risk of contacts withtuberculosis-infected patients, such as prisons, gathering of homeless peopleetc. over the past year until the beginning of the main treatment period;
occupational exposure at a medical institution in the settings of unprotectedcontact with patients with a high risk of tuberculosis or patients withtuberculosis during the last year before the start of the screening period;
close contact, i.e. being in the same room (at home or in another confinedenvironment) for an extended period of time (days or weeks rather than minutesor hours) with a person with active pulmonary tuberculosis within the past yearprior to the beginning of the treatment period;
test results indicating active tuberculosis or latent infection caused by M.Tuberculosis: positive result of QuantiFERON-TB/T-SPOT test.TB during thescreening period; findings of chest X-ray exam in two views confirmingpulmonary tuberculosis during the screening period.
History of alcohol abuse or psychoactive substances abuse as assessed by theInvestigator.
Severe renal impairment: creatinine clearance by Cockcroft-Gault formula <30 mL/minat the screening.
Presence of any of the following at the screening:
absolute neutrophil count <1.5 х 10^9/L,
white blood cells (WBC) count <3.5 х 10^9/L,
platelet count <100 х 10^9/L,
hemoglobin ≤ 80 g/L,
glycated hemoglobin (HbA1c) ≥ 8% (to be evaluated only in patients withdiabetes mellitus),
alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥ 3.0 хupper limit of normal (ULN),
total bilirubin >1.5 х ULN (except for cases of documented Gilbert's syndrome).
Study Design
Study Description
Connect with a study center
National medical research center named after V. A. Almazov
Saint Petersburg, 197341
Russian FederationSite Not Available
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