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NCT01842386 · ClinicalTrials.gov registry record · Phase 1
Rituximab for Anti-cytokine Autoantibody-Associated Diseases
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT01842386: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01842386 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01842386, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
Background: * Healthy people have white blood cells that protect them against bacteria, viruses, and fungi. However, some people have diseases which cause the body to make white blood cells that do not work properly. These white blood cells can attack the body s own proteins. These types of diseases are called anti-cytokine autoantibody-associated diseases. They can cause severe illnesses and even death. They are also difficult to treat with standard drugs. * Rituximab is a drug used to treat rheumatoid arthritis. It attacks white blood cells that do not work properly. Currently, it is not approved for treating anti-cytokine autoantibody-associated diseases. However, researchers think that it may be able to help treat people with these immune diseases. Objectives: \- To see if rituximab is a safe and effective treatment for anti-cytokine autoantibody-associated diseases. Eligibility: * Individuals at least 18 years of age who have anti-cytokine autoantibody-associated diseases. * Participants must also be enrolled in a related immune disorder study at the National Institutes of Health. Design: * The study will last 24 months. Participants will take rituximab for 6 months and have follow-up visits for the remaining 18 months. * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Other samples will be collected as needed if participants currently have an infection. * Participants will enter the hospital for 1 week at the start of treatment. They will have four doses of rituximab given 2 days apart. This first treatment will be monitored with frequent blood tests. * Over the next 6 months, participants will have four more doses of rituximab given about 1 month apart. Treatment will be monitored with frequent blood tests and sample collections as needed. * There will be four follow-up study visits at 3, 6, 12, and 18 months after the last dose of rituximab.
Primary Outcome
safe and tolerable administration of rituximab in subjects with anticytokine autoantibody-associated diseases who are refractory to conventional treatment
Interventions
- DRUG Rituximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2014-04-29 |
| Est. Completion | 2021-05-06 |
| Phase | Phase 1 |
What the finished NCT01842386 record still lists
NCT01842386 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which Rituximab is the first listed.
NCT01842386 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01842386 about?
NCT01842386 is a clinical study titled "Rituximab for Anti-cytokine Autoantibody-Associated Diseases". Background: * Healthy people have white blood cells that protect them against bacteria, viruses, and fungi. However, some people have diseases which cause the body to make white blood cells that do not work properly. These white blood cells can attack the body s own proteins. These types of disease...
What is the current status of trial NCT01842386?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2014-04-29. Estimated completion is 2021-05-06.
What interventions are being tested in trial NCT01842386?
The interventions under investigation include: Rituximab (DRUG).
Who is sponsoring clinical trial NCT01842386?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01842386's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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