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NCT00288704 · ClinicalTrials.gov registry record · Phase 3
Rilonacept for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)
A Phase 3 study, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 104
- Enrollment target
NCT00288704: Completed Phase 3 study, sponsored by Regeneron Pharmaceuticals.
NCT00288704 is a Phase 3 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 104 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00288704, a Phase 3 study, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 104 participants
- Enrollment target
Study Summary
Inflammatory symptoms of Cryopyrin-Associated Periodic Syndrome (CAPS) are due to mutations in a the NLRP-3 gene (previously known as Cold Induced Autoinflammatory Syndrome-1 or CIAS1). These mutations result in the body's overproduction of interleukin-1 (IL-1), a protein that stimulates the inflammatory process. IL-1 Trap (rilonacept) was designed to bind to the interleukin-1 cytokine and prevent it from binding to its receptors in the body.
Primary Outcome
The mean Key Symptom Score (KSS --from the validated, patient-administered Daily Health Assessment Form(DHAF)) was the average on a 0-10 scale (0=None, 10=Very Severe) of 5 separate scales -- rash, feeling of fever/chills, joint pain, eye redness/pain, and fatigue). KSS was averaged over two 21-day daily reporting periods (the 3 weeks prior to both baseline and week 6). In part A, a negative change in mean values indicated improvement under treatment with rilonacept in symptoms. The DHAF was us
Interventions
- DRUG Placebo
- DRUG rilonacept 160 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2005-12 |
| Est. Completion | 2008-08 |
| Phase | Phase 3 |
What the finished NCT00288704 record still lists
NCT00288704 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00288704 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00288704 about?
NCT00288704 is a clinical study titled "Rilonacept for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)". Inflammatory symptoms of Cryopyrin-Associated Periodic Syndrome (CAPS) are due to mutations in a the NLRP-3 gene (previously known as Cold Induced Autoinflammatory Syndrome-1 or CIAS1). These mutations result in the body's overproduction of interleukin-1 (IL-1), a protein that stimulates the inflamm...
What is the current status of trial NCT00288704?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 104 participants. The study started on 2005-12. Estimated completion is 2008-08.
What interventions are being tested in trial NCT00288704?
The interventions under investigation include: Placebo (DRUG), rilonacept 160 mg (DRUG).
Who is sponsoring clinical trial NCT00288704?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00288704's enrollment target sits among peer trials
104 1671st of 2000 higher than 327 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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