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Tests treatment safety and results for Familial Mediterranean Fever
Official title Safety and Efficacy of RPH-104 Used to Prevent Recurrent Fever Attacks in Adult Patients With Colchicine Resistant or Colchicine Intolerant Familial Mediterranean Fever
ClinicalTrials.gov ID: NCT05190991
What this study is testing
What is RPH-104?
RPH-104 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for familial mediterranean fever.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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) with colchicine resistance or intolerance (i.e. colchicine resistant, crFMF), who completed the core study, during which they received at least one dose of RPH-104 (i.e.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- The patient with Familial Mediterranean Fever (FMF) with resistance to or intolerance of colchicine, who completed the core study, during which...
- 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...
- 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
You likely can't join if
- Any medically significant event that was observed in a patient during his/her participation in the core study, as well as any other medical...
- 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...
- complete abstinence: if it corresponds to the preferred and conventional lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation...
- female sterilization: surgical bilateral ovariectomy (with/without hysterectomy) or tubal ligation at least 6 weeks before the start of the core...
- male sterilization (with documented absence of sperm in ejaculate post vasectomy) at least 6 months before the start of the core study. Vasectomized...
See the full eligibility criteria
- 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.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Yerevan, Armenia
- Moscow, Russia
- Saint Petersburg, Russia
- Stavropol, Russia
- Ankara, Turkey (Türkiye)
- Istanbul, Turkey (Türkiye)
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Yerevan, Armenia; Moscow, Russia; Saint Petersburg, Russia; Stavropol, Russia; Ankara, Turkey (Türkiye); Istanbul, Turkey (Türkiye). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.