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NCT01716312 · ClinicalTrials.gov registry record · Phase 1
Omalizumab for Lupus
A Phase 1 study of Sjogren's Syndrome and Systemic Lupus Erthematosus, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT01716312 is a Phase 1 study of Sjogren's Syndrome and Systemic Lupus Erthematosus that has completed, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The registered enrollment target is 17 participants, below the 287-participant average among 20 other Sjogren's Syndrome trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01716312, a Phase 1 study of Sjogren's Syndrome and Systemic Lupus Erthematosus, has completed, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: * Systemic Lupus Erythematosus (SLE or lupus) is an autoimmune disease, which means the body's immune system mistakenly attacks healthy tissue resulting in inflammation and tissue damage. SLE can involve almost any organ and its symptoms can range in severity from mild to life-threatening; symptoms also vary from person to person. Current treatments for lupus are not effective for some people. Medications used to treat lupus can have serious side effects. * Omalizumab is a drug that has been used to treat severe allergic asthma. It helps to prevent allergic reactions by reducing some antibodies in the blood. These antibodies are also present in some people with Lupus. Researchers want to see if omalizumab is a safe and effective treatment for people with Lupus. Objectives: \- To test the safety of omalizumab for people with lupus. Eligibility: \- Individuals at least 18 years of age who have moderately active Lupus even with standard treatments. Design: * Subject screening will take place at the NIH Clinical Center and will include a medical history, a physical exam, blood and urine laboratory tests, an assessment of Lupus disease activity. Some participants may require some additional testing. All eligible persons who are interested in enrolling will be asked to come back to the NIH within 2 weeks to begin the study. * The study will be conducted in three phases, with a total of 15 study visits over 38 weeks. Two visits will be overnight hospital stays. The rest will be outpatient visits. During each visit the participants will be monitored by doing a physical exam, assessment of their lupus disease activity, review of any treatment related side effects, blood and urine testing. * For the first phase, participants will have infusions (under their skin) of either omalizumab or a placebo. They will have an overnight hospital stay for the first infusion and then an outpatient safety monitor visit 2 weeks after. If subjects safety measures are good t
Conditions Studied
Interventions
- DRUG Omalizumab
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2014-01-08 |
| Est. Completion | 2017-08-24 |
| Phase | Phase 1 |
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 NCT01716312
The ClinicalTrials.gov registry entry for NCT01716312 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 287-participant average among 20 other Sjogren's Syndrome trials with a reported enrollment target (94% lower). 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 2 conditions, with Sjogren's Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Omalizumab is the first listed.
NCT01716312 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT01716312 about?
NCT01716312 is a clinical study titled "Omalizumab for Lupus". Background: * Systemic Lupus Erythematosus (SLE or lupus) is an autoimmune disease, which means the body's immune system mistakenly attacks healthy tissue resulting in inflammation and tissue damage. SLE can involve almost any organ and its symptoms can range in severity from mild to life-threateni...
What is the current status of trial NCT01716312?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2014-01-08. Estimated completion is 2017-08-24.
What conditions does trial NCT01716312 study?
This clinical trial studies the following conditions: Sjogren's Syndrome, Systemic Lupus Erthematosus.
What interventions are being tested in trial NCT01716312?
The interventions under investigation include: Omalizumab (DRUG).
Who is sponsoring clinical trial NCT01716312?
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 NCT01716312 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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