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NCT01538719 · ClinicalTrials.gov registry record · Phase 1
IL1-TRAP, Rilonacept, in Systemic Sclerosis
A Phase 1 study, sponsored by Boston University.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01538719 is a Phase 1 study that has completed, run by Boston University. The registered enrollment target is 24 participants.
The verdict
NCT01538719, a Phase 1 study, has completed, sponsored by Boston University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
Scleroderma,also known as systemic sclerosis (SSc), is a multisystem disease affecting skin and other tissues including joints, muscles, lungs, the gastrointestinal tract and kidneys and tissue fibrosis is widespread. SSc presents special problems for developing therapies due to the heterogeneous clinical presentation, the variability of disease progression and the difficulty quantifying the extent of disease. For most disease manifestations, treatment is primarily symptomatic and generally inadequate. This study will utilize a 4-gene biomarker of skin disease as the primary efficacy outcome in a short duration, placebo-controlled clinical trial of rilonacept, designed to provide preliminary data for a larger trial. These gene biomarkers should provide a strong surrogate for such trials in the future and, if IL-1 is indeed the cytokine leading to fibrosis in this disease, provide a highly significant start to finding a therapeutic for SSc that for the first time might dramatically affect fibrosis. A central hypothesis of this study is that IL-1 inhibition will downregulate the 4-gene biomarker over a relatively short period of time, much shorter than is historically thought necessary to see changes in the MRSS, a skin score measurement tool. Entry criteria will include the recent onset of diffuse cutaneous SSc as this is the population most likely to show progressive skin disease and also the population examined in previous studies showing correlations between MRSS and the 4-gene biomarker. Secondary outcomes will include other validated measures of SSc disease activity. MRSS and SSc health assessment questionnaire (SHAQ), will be followed during the trial. This study will also test the effect of rilonacept on global skin gene expression using microarray analyses of skin biopsies. In addition, serum biomarkers of SSc disease activity (COMP, THS-1 and IFI44) and a biomarker of inflammasome activation (CRP) will be tested before and after treatment.
Interventions
- OTHER Placebo
- DRUG Rilonacept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2011-12 |
| Est. Completion | 2017-08-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01538719
The ClinicalTrials.gov registry entry for NCT01538719 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston University, which has 185 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01538719 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01538719 about?
NCT01538719 is a clinical study titled "IL1-TRAP, Rilonacept, in Systemic Sclerosis". Scleroderma,also known as systemic sclerosis (SSc), is a multisystem disease affecting skin and other tissues including joints, muscles, lungs, the gastrointestinal tract and kidneys and tissue fibrosis is widespread. SSc presents special problems for developing therapies due to the heterogeneous cl...
What is the current status of trial NCT01538719?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2011-12. Estimated completion is 2017-08-11.
What interventions are being tested in trial NCT01538719?
The interventions under investigation include: Placebo (OTHER), Rilonacept (DRUG).
Who is sponsoring clinical trial NCT01538719?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
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