Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00130637 · ClinicalTrials.gov registry record · Phase 2
Human Anti-Tac (Daclizumab) to Treat Juvenile Idiopathic Arthritis (JIA)-Associated Uveitis
A Phase 2 study of Immunosuppression and Anterior Uveitis, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT00130637 is a Phase 2 study of Immunosuppression and Anterior Uveitis that has completed, run by National Eye Institute (NEI). The registered enrollment target is 6 participants, below the 647-participant average among 12 other Immunosuppression trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00130637, a Phase 2 study of Immunosuppression and Anterior Uveitis, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will examine the safety and effectiveness of a monoclonal antibody called humanized anti-Tac (HAT, also called daclizumab) to treat children and adolescents with uveitis (chronic inflammatory eye disease) associated with juvenile idiopathic arthritis (JIA). Monoclonal antibodies are genetically engineered proteins made in large quantities and directed against a specific target in the body. The HAT antibody is designed to prevent a specific chemical interaction needed for immune cells to produce inflammation. Current treatments for uveitis include steroids and immune-suppressing drugs. These treatments do not always work or they may cause significant side effects. This study will determine whether daclizumab can improve uveitis in children and reduce the need for other medicines. Patients between 6 and 18 years of age with active non-infectious JIA-associated uveitis requiring treatment with anti-inflammatory medications as often as three times a day or more may be eligible for this study. Each candidate is screened with a medical history, physical examination, blood tests, eye examination, and the following specialized tests: * Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina are taken using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating the presence of inflammation. * Optical coherence tomography to measure retinal thickness. The eyes are examined through a machine that produces cross-sectional pictures of the retina. These measures are repeated during the study to determine changes, if any, in retinal thickening. * Stereoscopic color fundus photography to examine the back of the eye. The pupils are dilated with eye drops to examine and photograph the back of the eye. Upon entering the study, participants receive a 90-minute infusion of daclizu
Conditions Studied
Interventions
- DRUG Daclizumab
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2005-08 |
| Est. Completion | 2008-05 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00130637
The ClinicalTrials.gov registry entry for NCT00130637 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, below the 647-participant average among 12 other Immunosuppression trials with a reported enrollment target (99% lower). The listed sponsor is National Eye Institute (NEI), which has 221 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Immunosuppression appearing as the primary indexed condition, and to 1 intervention - of which Daclizumab is the first listed.
NCT00130637 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00130637 about?
NCT00130637 is a clinical study titled "Human Anti-Tac (Daclizumab) to Treat Juvenile Idiopathic Arthritis (JIA)-Associated Uveitis". This study will examine the safety and effectiveness of a monoclonal antibody called humanized anti-Tac (HAT, also called daclizumab) to treat children and adolescents with uveitis (chronic inflammatory eye disease) associated with juvenile idiopathic arthritis (JIA). Monoclonal antibodies are genet...
What is the current status of trial NCT00130637?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2005-08. Estimated completion is 2008-05.
What conditions does trial NCT00130637 study?
This clinical trial studies the following conditions: Immunosuppression, Anterior Uveitis, Arthritis, Juvenile Idiopathic, Iritis.
What interventions are being tested in trial NCT00130637?
The interventions under investigation include: Daclizumab (DRUG).
Who is sponsoring clinical trial NCT00130637?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00130637 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Immunosuppression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy
RECRUITING · Phase 2
-
Immunosuppression Withdrawal for Stable Pediatric Liver Transplant Recipients
COMPLETED · Phase 2
-
Pathological Myeloid Activation After Sepsis and Trauma
RECRUITING
-
Impact of Immunosuppression Adjustment on COVID-19 Vaccination Response in Kidney Transplant Recipients
RECRUITING · Phase 4
-
Vascularized Composite Bladder Allograft Transplantation
RECRUITING · NA
-
Oral Bacteria and Immune System Problems Involved in Gum Disease (Periodontitis)
RECRUITING
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.