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NCT00094900 · ClinicalTrials.gov registry record · Phase 2
Interleukin-1 Trap to Treat Autoinflammatory Diseases
A Phase 2 study, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- Completed
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT00094900 is a Phase 2 study that has completed, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The registered enrollment target is 11 participants.
The verdict
NCT00094900, a Phase 2 study, has completed, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
Autoinflammatory diseases are illnesses characterized by episodes of inflammation that, unlike autoimmune disorders, lack the production of high titer autoantibodies or antigen-specific T cells. There is growing genetic and clinical evidence that Interleukin-1 (IL-1) plays a pathogenic role in several of these diseases. This exploratory study aims to examine the utility of the experimental drug candidate, IL 1 Trap (Regeneron Pharmaceuticals, Inc.) in the treatment of adult subjects with the autoinflammatory disorders Neonatal Onset Multisystem Inflammatory Disease (NOMID), Muckle-Wells Syndrome (MWS), and Familial Cold Autoinflammatory Syndrome (FCAS), Familial Mediterranean Fever (FMF), and adult Still's disease. FMF is associated with mutations in pyrin encoding MEFV. NOMID, MWS and FCAS are associated with mutations in cryopyrin-encoding CIAS1. This pilot study is designed to address: 1) the utility of IL 1 Trap in the treatment of subjects with diseases known to respond to IL-1 blockade (NOMID/MWS/FCAS) as shown by response to treatment with anakinra \[Kineret\]; 2) the response to IL-1 blockade of subjects with Adult Still's disease and colchicine-resistant FMF once the efficacy of IL-1 Trap has been established in NOMID/MWS/FCAS subjects; and 3) the biochemistry and genetics of autoinflammatory diseases and IL-1 related inflammation. IL-1 Trap is a recombinant fusion protein with picomolar affinity for IL-1 and a half-life of approximately 7.5 days in humans. This agent is currently in Phase 2 clinical studies for the treatment of rheumatoid arthritis and initial studies have shown activity against clinical and biochemical indicators of inflammation. Compared with anakinra, this agent may exhibit improved dosing convenience, potential for fewer injection site reactions, and improved efficacy due to the extremely high affinity of IL-1Trap for its target. In this study, biochemical, genetic, and clinical correlates of autoinflammatory disease will initially
Interventions
- DRUG IL-1 Trap
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2004-10 |
| Est. Completion | 2010-12 |
| Phase | Phase 2 |
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)93 total trials
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00094900
The ClinicalTrials.gov registry entry for NCT00094900 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which IL-1 Trap is the first listed.
NCT00094900 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00094900 about?
NCT00094900 is a clinical study titled "Interleukin-1 Trap to Treat Autoinflammatory Diseases". Autoinflammatory diseases are illnesses characterized by episodes of inflammation that, unlike autoimmune disorders, lack the production of high titer autoantibodies or antigen-specific T cells. There is growing genetic and clinical evidence that Interleukin-1 (IL-1) plays a pathogenic role in sever...
What is the current status of trial NCT00094900?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2004-10. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00094900?
The interventions under investigation include: IL-1 Trap (DRUG).
Who is sponsoring clinical trial NCT00094900?
This trial is sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total clinical trials registered on ClinicalTrials.gov.
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