Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01801449 · ClinicalTrials.gov registry record · Phase 2
Rilonacept for Deficiency of the Interleukin-1 Receptor Antagonist (DIRA)
A Phase 2 study, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- Completed
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT01801449 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 6 participants.
The verdict
NCT01801449, 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
- 6 participants
- Enrollment target
Study Summary
Background: \- Deficiency of the IL-1 receptor antagonist (DIRA) is a condition that causes repeated episodes of inflammation. People with DIRA can have rashes, fever, and joint pain. Most treatments for DIRA are intended to control the immune system to stop these inflammations. There are drugs that can treat DIRA, but they have to be given daily as injections. Researchers want to try another drug, rilonacept, as a treatment for DIRA. It needs to be given only once a week. Rilonacept will be given to individuals who are at least 3 months old and who have DIRA. Objectives: \- To test the safety and effectiveness of rilonacept for children and adults with DIRA. Eligibility: \- Individuals at least 3 months old who have DIRA. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Other tests to study pain and movement will be given. Imaging studies such as bone density scans and x-rays may also be taken. * Participants will have a minimum of four to five study visits over 12 months. Those who are on different anti-inflammatory drugs (such as anakinra) will stop taking them before beginning the study visits. * Participants will have rilonacept injections weekly while on this study. The dose will be adjusted as needed to help treat the DIRA symptoms. Participants will keep a diary to monitor their symptoms and any side effects. * Treatment with rilonacept will be given for 1 year. Participants will have study visits to monitor the treatment. They will provide blood samples and have other tests at these study visits.
Interventions
- DRUG Rilonacept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2013-02-12 |
| Est. Completion | 2016-04-28 |
| Phase | Phase 2 |
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)93 total trials
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01801449
The ClinicalTrials.gov registry entry for NCT01801449 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 6 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 Rilonacept is the first listed.
NCT01801449 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01801449 about?
NCT01801449 is a clinical study titled "Rilonacept for Deficiency of the Interleukin-1 Receptor Antagonist (DIRA)". Background: \- Deficiency of the IL-1 receptor antagonist (DIRA) is a condition that causes repeated episodes of inflammation. People with DIRA can have rashes, fever, and joint pain. Most treatments for DIRA are intended to control the immune system to stop these inflammations. There are drugs tha...
What is the current status of trial NCT01801449?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2013-02-12. Estimated completion is 2016-04-28.
What interventions are being tested in trial NCT01801449?
The interventions under investigation include: Rilonacept (DRUG).
Who is sponsoring clinical trial NCT01801449?
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.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.