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NCT00770601 · ClinicalTrials.gov registry record · Phase 3
Canakinumab to Treat Neonatal-Onset Multisystem Inflammatory Disease
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 7
- Enrollment target
NCT00770601 is a Phase 3 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 7 participants.
The verdict
NCT00770601, a Phase 3 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 7 participants
- Enrollment target
Study Summary
This study will examine whether a medicine called canakinumab is safe and effective for treating patients with neonatal-onset multisystem inflammatory disease (NOMID), also known as chronic infantile neurologic, cutaneous, articular (CINCA) syndrome. This disease can cause rash, joint deformities, brain inflammation, problems with the eyes and learning difficulties. Canakinumab is an experimental drug that inhibits the action of a protein produced by the body called human IL-1beta, which is responsible for the symptoms in NOMID and also contributes to many other kinds of inflammatory diseases. Patients 2 years of age and older with NOMID / CINCA may be eligible for this study. Participants undergo the following procedures: Screening Phase * Medical history and review of medical records * Blood tests * Daily diary of symptoms and medicines take Washout/Lead-in Phase * Discontinuation of anakinra or other medications, a 6 to 48-hour run-in period (only for patients who discontinued anakinra or other IL-1 blocking therapy). Treatment Phase * Injection of canakinumab under the skin every 8 weeks for 6 months * Monitoring and evaluations during treatment, including: * Quality-of-life questionnaires and daily diary * Vital signs measurements (heartbeat, blood pressure, temperature) * Blood tests * Electrocardiogram * Tuberculosis skin test * Neurological, eye and skin examinations at beginning and end of study * Cognitive evaluation at beginning and end of study * Lumbar puncture (spinal tap) at the beginning of the study, 2 weeks after the second dosing of canakinumab and at the end of the study * X-rays and bone density scan at beginning and end of study * Magnetic resonance imaging (MRI) of the head at beginning and end of study Follow-up Phase * Monthly clinic visits after the last dose of canakinumab for a minimum of 60 days End-of-Study Evaluation * Series of tests 8 weeks after last dose of canakinumab to evaluate treatment response and side effects
Interventions
- DRUG Canakinumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2009-01-26 |
| Est. Completion | 2011-02-17 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00770601
The ClinicalTrials.gov registry entry for NCT00770601 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Canakinumab is the first listed.
NCT00770601 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00770601 about?
NCT00770601 is a clinical study titled "Canakinumab to Treat Neonatal-Onset Multisystem Inflammatory Disease". This study will examine whether a medicine called canakinumab is safe and effective for treating patients with neonatal-onset multisystem inflammatory disease (NOMID), also known as chronic infantile neurologic, cutaneous, articular (CINCA) syndrome. This disease can cause rash, joint deformities, b...
What is the current status of trial NCT00770601?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 7 participants. The study started on 2009-01-26. Estimated completion is 2011-02-17.
What interventions are being tested in trial NCT00770601?
The interventions under investigation include: Canakinumab (DRUG).
Who is sponsoring clinical trial NCT00770601?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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