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NCT01794117 · ClinicalTrials.gov registry record · Phase 2
Anakinra for Inflammatory Pustular Skin Diseases
A Phase 2 study of Palmoplantar Pustulosis and Sneddon-Wilkinson, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT01794117: Completed Phase 2 study of Palmoplantar Pustulosis and Sneddon-Wilkinson, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
NCT01794117 is a Phase 2 study of Palmoplantar Pustulosis and Sneddon-Wilkinson that has completed, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The registered enrollment target is 18 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01794117, a Phase 2 study of Palmoplantar Pustulosis and Sneddon-Wilkinson, has completed, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: * Inflammatory pustular skin diseases are a type of autoinflammatory disease in which the immune system attacks the bodys tissues. These diseases cause painful and itchy skin rashes, eye and mouth irritation, joint pain and fever. Several drugs for treating these diseases suppress the immune system. However, they can cause severe side effects when taken over a long period of time. * Interleukin 1 (IL-1) is a small protein that may be important in causing the inflammation seen in pustular skin disease. Anakinra is a drug that works by blocking IL-1. It has been effective in treating some inflammatory conditions such as rheumatoid arthritis. However, anakinra has not been studied for use in patients with pustular skin disease. Researchers want to see whether anakinra will be effective in treating pustular skin disease. Objectives: \- To see if anakinra can be used to treat inflammatory pustular skin disease. Eligibility: \- Individuals at least 18 years of age who have inflammatory pustular skin disease. Design: * Participants will be screened with a physical exam and medical history. Their disease will be evaluated with blood tests, urine tests and imaging studies. Skin biopsies may also be collected. * Participants will have an initial visit to receive the first dose of anakinra. They will be shown how to give themselves daily injections of anakinra. * Participants will take anakinra for up to 12 weeks as long as there are no severe side effects. During this time, they will keep a study diary to record the severity of any rashes, pustules, itching, fevers, and skin or joint pain. They will bring this diary to their study visits. * Participants will have study visits at weeks 4, 8 and 12. Treatment will be monitored at these visits with blood tests, urine tests and physical exams. Depending on the effects of the treatment, participants may have the dose of anakinra increased or decreased. * Participants will have a final study visit 4 weeks after t
Primary Outcome
Total Body Surface Area Involvement (TBSAI) is defined as the amount of total amount of active disease involvement on a given patient. 50% improvement was the amount of change that we judged at the start of the study would qualify as significant improvement.
Conditions Studied
Interventions
- DRUG Anakinra
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2013-07-22 |
| Est. Completion | 2019-10-07 |
| Phase | Phase 2 |
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)93 total trials
What the finished NCT01794117 record still lists
NCT01794117 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 4 conditions, with Palmoplantar Pustulosis appearing as the primary indexed condition, and to 1 intervention - of which Anakinra is the first listed.
NCT01794117 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01794117 about?
NCT01794117 is a clinical study titled "Anakinra for Inflammatory Pustular Skin Diseases". Background: * Inflammatory pustular skin diseases are a type of autoinflammatory disease in which the immune system attacks the bodys tissues. These diseases cause painful and itchy skin rashes, eye and mouth irritation, joint pain and fever. Several drugs for treating these diseases suppress the i...
What is the current status of trial NCT01794117?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2013-07-22. Estimated completion is 2019-10-07.
What conditions does trial NCT01794117 study?
This clinical trial studies the following conditions: Palmoplantar Pustulosis, Sneddon-Wilkinson, Acrodermatitis Continua of Hallopeau, Pustular Psoriasis.
What interventions are being tested in trial NCT01794117?
The interventions under investigation include: Anakinra (DRUG).
Who is sponsoring clinical trial NCT01794117?
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.
Where is trial NCT01794117 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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