Long-Term Study of RPH-104 to Prevent Recurring Fever Attacks in Adults with Familial Mediterranean Fever Resistant or Intolerant to Colchicine

What this Trial Is About

Researchers are evaluating the long-term safety and effectiveness of RPH-104 in adults with familial Mediterranean fever FMF who do not respond well to or cannot tolerate colchicine treatment. This study focuses on patients who have already participated in an earlier core trial and received at least one dose of RPH-104. The goal is to understand how well RPH-104 works to prevent recurrent fever attacks in this specific patient group over an extended period. The study includes a screening phase lasting 2 weeks to confirm eligibility and unblind previous treatment assignments. Following this, participants receive open-label RPH-104 injections every two weeks for up to 198 weeks. The doses studied are either 80 mg or 160 mg administered subcutaneously. Patients may receive their injections at the study site or at home if trained to self-administer. Safety and effectiveness are regularly assessed through scheduled visits and phone contacts. If patients experience attacks on the lower dose, an increase to 160 mg may occur. After completing treatment, an 8-week safety follow-up with two visits monitors participants. Participants will visit the study site frequently for drug administration and evaluations, including assessments of side effects and disease activity. Researchers collect data on adverse events, inflammatory markers, symptom severity, and kidney function. Telephone follow-ups also support patient monitoring. The primary outcomes focus on tracking side effects, while secondary outcomes assess disease control and symptom changes. Overall, the study lasts nearly four years, combining treatment and follow-up to provide detailed long-term information on RPH-104 use in colchicine-resistant or intolerant FMF patients.

Safety and Efficacy of RPH-104 Used to Prevent Recurrent Fever Attacks in Adult Patients With Colchicine Resistant or Colchicine Intolerant Familial Mediterranean Fever