Status:
RECRUITING
Safety and Efficacy of RPH-104 Used to Prevent Recurrent Fever Attacks in Adult Patients With Colchicine Resistant or Colchicine Intolerant Familial Mediterranean Fever
Lead Sponsor:
R-Pharm International, LLC
Collaborating Sponsors:
Atlant Clinical LLC
Unimed Laboratories
Conditions:
Familial Mediterranean Fever
FMF
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess safety and efficacy of the long-term treatment with RPH-104 at doses of 80 or 160 mg once every 2 weeks (q2w) in patients with familial Mediterranean fever (FMF)...
Detailed Description
This study is a long-term open-label extension (OLE) of the core double blind randomized placebo-controlled study CL04018065. This OLE study will have the following periods: 1. Screening period - 2 w...
Eligibility Criteria
Inclusion
- The patient with Familial Mediterranean Fever (FMF) with resistance to or intolerance of colchicine, who completed the core study, during which he/she received at least one dose of RPH-104.
- Voluntarily signed and dated Patient Informed Consent Form (ICF) for participation in this study.
- The patient's ability and desire, according to the Investigator's discretion, to follow the schedule of visits, follow the study procedures and follow the Protocol requirements, including the following:
- to visit the study site every 2 weeks for RPH-104 administration by qualified study site personnel
- or
- • to learn the subcutaneous (SC) injection technique and self-administer RPH-104 at his/her accommodation as per the study Protocol
- or
- • to agree with the qualified medical personnel visits to his/her accommodation for RPH-104 administration.
Exclusion
- Any medically significant event that was observed in a patient during his/her participation in the core study, as well as any other medical conditions (including psychiatric disorders) or laboratory abnormalities, which may increase the potential risk associated with participation in the study and treatment with RPH-104, or may affect the interpretation of the study results, and which, according to the Investigator's opinion, may lead to the patient's non-compliance with the study inclusion criteria.
- Pregnant and/or lactating women or women planning pregnancy during the study or within 2 months after the last RPH-104 dose.
- Women of childbearing potential, i.e. all females with physiological ability to conceive except for those with final cessation of menses, which should be determined retrospectively after 12 months of natural amenorrhea, i.e. amenorrhea with an appropriate clinical status, for example, at respective age, who do not agree to use highly effective contraceptives throughout the study, starting from the moment of signing the ICF and for at least 8 weeks after the last RPH-104 dose or Men who are sexually active and do not agree to use highly effective contraceptives throughout the study, starting from the moment of signing the ICF and for at least 8 weeks after the last RPH-104 dose.
- Highly effective contraception methods include:
- complete abstinence: if it corresponds to the preferred and conventional lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, postovulation method) and interrupted coitus are not considered acceptable contraceptive methods;
- female sterilization: surgical bilateral ovariectomy (with/without hysterectomy) or tubal ligation at least 6 weeks before the start of the core study. In a case of ovariectomy only, the female reproductive status should be verified by further hormonal test;
- male sterilization (with documented absence of sperm in ejaculate post vasectomy) at least 6 months before the start of the core study. Vasectomized male partner should be the only partner of the participating female subject;
- combination of any two of the following methods (a+b or a+c or b+c):
- use of oral, injectable or implanted hormonal contraceptives; in a case of oral contraceptives, the woman should constantly use the same product as was used during the core study;
- installation of an intrauterine device or contraceptive system;
- use of barrier contraceptives: condom or occlusive cap (diaphragm or cervical cap/contraceptive vaginal ring) with spermicidal foam/gel/film/cream/vaginal suppository
- The need for a therapy with any of the following products from the moment of signing the ICF till the study treatment period completion:
- systemic glucocorticoids at a dose exceeding 0,2 mg/kg/day of prednisolone (or 0,16 mg/kg/day of methylprednisolone, or an equivalent dose of another glucocorticoid) orally;
- rilonacept, tocilizumab, rituximab, canakinumab, tumor necrosis factor alpha (TNF-a) inhibitors (TNFi) and other biological products (except for RPH-104);
- immunosuppressants (cyclosporine, methotrexate, leflunomide, thalidomide, azathioprine, 6-mercaptopurine, cyclophosphamide, etc.);
- methylprednisolone (or an equivalent) at a dose of more than 40 mg/day parenterally;
- intramuscular, intra-articular or peri-articular administration of glucocorticoids;
- anakinra;
- tofacitinib, baricitinib;
- any experimental drugs (except for RPH-104)
- The need to use a live (attenuated) vaccine during the study or within 3 months after the last RPH-104 dose. Live attenuated vaccines include vaccines against 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
- Positive results of tuberculosis screening performed at Visit 10 of the core study (QuantiFERON-Tuberculosis(TB)/T-Spot.TB test, chest X-ray).
- Participation in other experimental studies (except for the core study).
Key Trial Info
Start Date :
October 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05190991
Start Date
October 5 2021
End Date
January 1 2029
Last Update
December 16 2024
Active Locations (8)
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1
Center of Medical Genetics and Primary Health Care LLC
Yerevan, Armenia, 0001
2
FSBEI HE First Moscow State Medical University named after I.M. Sechenov
Moscow, Russia, 119048
3
Moscow Multidisciplinary Scientific and Clinical Center named after S.P. Botkin
Moscow, Russia, 125284
4
Medical Technologies Ltd.
Saint Petersburg, Russia, 191025