Actively 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
Led by R-Pharm International, LLC · Updated on 2024-12-16
60
Participants Needed
8
Research Sites
377 weeks
Total Duration
On this page
Sponsors
R
R-Pharm International, LLC
Lead Sponsor
A
Atlant Clinical LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. study patient population).
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has Familial Mediterranean Fever (FMF) with resistance or intolerance to colchicine and completed the core study with at least one dose of RPH-104
- Signed and dated informed consent form for participation
- Ability and willingness to follow study procedures, including visiting the study site every 2 weeks for RPH-104 administration, or to self-administer or receive administration at home by medical personnel
You will not qualify if you...
- Any significant medical event or condition during the core study or other conditions that increase risk or affect study results
- Pregnant, breastfeeding, or planning pregnancy during the study or within 2 months after last dose
- Women of childbearing potential and men who are sexually active unwilling to use effective contraception during the study and for 8 weeks after last dose
- Need for certain therapies including systemic glucocorticoids above specified doses, biological products other than RPH-104, immunosuppressants, or experimental drugs other than RPH-104
- Need to use live vaccines during the study or within 3 months after last dose
- Positive tuberculosis screening at core study visit
- Participation in other experimental studies except the core study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Center of Medical Genetics and Primary Health Care LLC
Yerevan, Armenia, 0001
Actively Recruiting
2
FSBEI HE First Moscow State Medical University named after I.M. Sechenov
Moscow, Russia, 119048
Actively Recruiting
3
Moscow Multidisciplinary Scientific and Clinical Center named after S.P. Botkin
Moscow, Russia, 125284
Actively Recruiting
4
Medical Technologies Ltd.
Saint Petersburg, Russia, 191025
Actively Recruiting
5
Terafarm, Llc
Stavropol, Russia, 355000
Actively Recruiting
6
Hacettepe University Faculty of Medicine
Ankara, Turkey (Türkiye), 06230
Actively Recruiting
7
Istanbul University Istanbul Faculty of Medicine
Istanbul, Turkey (Türkiye), 34093
Actively Recruiting
8
Istanbul University Cerrahpasa Faculty of Medicine
Istanbul, Turkey (Türkiye), 34098
Actively Recruiting
Research Team
Y
Yulia Karpova
CONTACT
M
Marina Beloukhova
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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