Ongoing Clinical Trials for Familial Mediterranean Fever
Familial Mediterranean Fever is a genetic disorder that causes recurrent episodes of fever and inflammation. Currently, there is 1 ongoing clinical trial investigating new treatment approaches for patients who do not respond well to standard therapy with Colchicine. This trial is taking place in France and focuses on using Anakinra, an injectable medication, during painful attacks rather than as a daily treatment.
Clinical trial locations
Study on Anakinra and Colchicine for Painful Attacks in Familial Mediterranean Fever Patients Resistant to Colchicine Therapy
This clinical trial is designed for patients with Familial Mediterranean Fever who continue to experience painful attacks despite taking the maximum dose of Colchicine. The study is investigating whether using Anakinra on-demand during attacks can provide better symptom relief compared to standard pain medication.
Who can participate:
- Patients aged 6 years and older with a confirmed diagnosis based on international criteria and two clear genetic mutations related to the condition
- Patients who continue to have one or more attacks per month over a 3-month period despite taking the maximum daily dose of Colchicine
- Patients who experience symptoms such as joint pain, chest pain, stomach pain, muscle pain, or specific skin rashes lasting 1 to 4 days
- Patients who refuse to take daily Anakinra injections but are willing to use them during attacks
- Patients who show no signs of inflammation between attacks
- Patients with full health insurance coverage who can provide written consent
Who cannot participate:
- Patients without a confirmed diagnosis
- Patients who respond well to Colchicine treatment
- Patients who prefer continuous daily therapy instead of on-demand treatment
- Patients unable to understand or follow the study procedures
- Patients without the ability to provide consent or without a legal guardian to do so
Main focus of the trial:
The study aims to evaluate whether using Anakinra as an on-demand treatment during attacks can reduce the number of painful days patients experience each month. Participants will continue taking their regular daily Colchicine dose and will have the option to inject Anakinra when an attack begins or when they anticipate one due to known triggers. The trial will monitor patients over six months, tracking the number of painful days, the severity of attacks, quality of life, and any side effects such as skin reactions at injection sites. The goal is to determine if this approach offers better symptom management than the current standard of care, which involves daily Colchicine combined with pain relief medications taken as needed.
Investigational drugs used:
The trial uses three medications. Colchicine is taken daily at 1 mg to help manage symptoms and reduce inflammation, though participants in this study have shown resistance to its full effects. Anakinra is administered as a 100 mg subcutaneous injection during attacks, starting from the early signs of symptoms and continuing until 24 hours after symptoms resolve, for up to seven days. Anakinra works by blocking interleukin-1, a protein that contributes to inflammation. Pain relievers are also used on-demand to help manage discomfort during attacks as part of standard care.
Summary
Currently, there is one ongoing clinical trial for Familial Mediterranean Fever, taking place in France. This trial focuses specifically on patients who are resistant to standard Colchicine therapy and explores an alternative approach using Anakinra as an on-demand treatment rather than a daily medication. The study reflects an important effort to address the needs of patients who continue to suffer from painful attacks despite maximum doses of conventional treatment. By investigating the use of Anakinra during attacks only, the trial aims to provide a more flexible treatment option for those who prefer not to take daily injections while potentially improving their quality of life and reducing the frequency of painful episodes.