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NCT00465985 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Safety, and Tolerability of ACZ885 in Patients With Muckle-Wells Syndrome
A Phase 3 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 3
- Development phase
- 35
- Enrollment target
NCT00465985 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 35 participants.
The verdict
NCT00465985, a Phase 3 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 35 participants
- Enrollment target
Study Summary
This study is designed to provide efficacy and safety data for ACZ885 (a fully human anti-interleukin-1beta (anti-IL-1beta) monoclonal antibody) administered as an injection subcutaneously (s.c.) in patients with Muckle-Wells Syndrome. Part I is an 8-week open-label, active treatment period to identify ACZ885 responders. Part II is a double-blind, placebo-controlled period to assess primarily the efficacy of ACZ885 compared to placebo. Part III is an open-label, active treatment period where patients will receive ACZ885 every 8 weeks after withdrawal or completion of Part II.
Interventions
- DRUG Placebo
- DRUG ACZ885
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2007-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00465985
The ClinicalTrials.gov registry entry for NCT00465985 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis, which has 265 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00465985 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00465985 about?
NCT00465985 is a clinical study titled "Efficacy, Safety, and Tolerability of ACZ885 in Patients With Muckle-Wells Syndrome". This study is designed to provide efficacy and safety data for ACZ885 (a fully human anti-interleukin-1beta (anti-IL-1beta) monoclonal antibody) administered as an injection subcutaneously (s.c.) in patients with Muckle-Wells Syndrome. Part I is an 8-week open-label, active treatment period to iden...
What is the current status of trial NCT00465985?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 35 participants. The study started on 2007-04.
What interventions are being tested in trial NCT00465985?
The interventions under investigation include: Placebo (DRUG), ACZ885 (DRUG).
Who is sponsoring clinical trial NCT00465985?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
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