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NCT00582907 · ClinicalTrials.gov registry record · Phase 2
Rilonacept for Treatment of Familial Mediterranean Fever (FMF)
A Phase 2 study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT00582907 is a Phase 2 study that has completed, run by The Cleveland Clinic. The registered enrollment target is 14 participants.
The verdict
NCT00582907, a Phase 2 study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
Familial Mediterranean fever (FMF) is a genetic disease resulting in recurrent attacks of fever, abdominal pain, chest pain, arthritis and rash. There are 5-15% of patients who continue to have FMF attacks despite treatment with colchicine or who cannot tolerate colchicine. Currently there are no alternatives to colchicine. Pyrin, the protein that has a defect in FMF has an important role in the regulation of a molecule called interleukin (IL)-1 beta production and activity. This molecule is very important in the process of inflammation in FMF. Therefore we propose to use IL-1 Trap (Rilonacept), a medication that binds and neutralizes IL-1. We will enroll in this study 17 subjects from the age of 4 years, including adults with active FMF despite colchicine therapy. Subjects will receive in random order two 3-month courses of Rilonacept at 2.2 mg/kg (maximum 160 mg) by weekly subcutaneous injection and two 3-month courses of placebo injection. If patients have at least two FMF attacks during a treatment course they will be able to get if they choose the other treatment until the end of that treatment course. Our hypothesis is that Rilonacept will decrease the number of acute FMF attacks and will be safe to use. This study may confirm the importance of IL-1 in the cause of FMF. Funding source - FDA Office of Orphan Products Development
Interventions
- DRUG Placebo
- DRUG Rilonacept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2008-08 |
| Est. Completion | 2011-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00582907
The ClinicalTrials.gov registry entry for NCT00582907 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00582907 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00582907 about?
NCT00582907 is a clinical study titled "Rilonacept for Treatment of Familial Mediterranean Fever (FMF)". Familial Mediterranean fever (FMF) is a genetic disease resulting in recurrent attacks of fever, abdominal pain, chest pain, arthritis and rash. There are 5-15% of patients who continue to have FMF attacks despite treatment with colchicine or who cannot tolerate colchicine. Currently there are no al...
What is the current status of trial NCT00582907?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2008-08. Estimated completion is 2011-09.
What interventions are being tested in trial NCT00582907?
The interventions under investigation include: Placebo (DRUG), Rilonacept (DRUG).
Who is sponsoring clinical trial NCT00582907?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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