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NCT00886795 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of Abatacept in Subjects With Chronic Urticaria Who Have Had an Inadequate Response to Anti-histamine Therapy
A Phase 1 study of Urticaria, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
- 1
- Study location
NCT00886795: Completed Phase 1 study of Urticaria, sponsored by Johns Hopkins University.
NCT00886795 is a Phase 1 study of Urticaria that has completed, run by Johns Hopkins University. The registered enrollment target is 4 participants, below the 59-participant average among 3 other Urticaria trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00886795, a Phase 1 study of Urticaria, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is being done to find out if a drug called Abatacept (Orencia ®) is safe and effective in treating people with chronic urticaria (persistent hives).
Primary Outcome
Participants were monitored for adverse events (AEs) at each visit. Cumulative AEs were tracked including specific AE, severity, and relationship on source documentation. Special attention was given to infusion-related events and hypersensitivity reactions. Assessment of Complete Blood Count (CBC) and Metabolic profile were also tracked.
Conditions Studied
Interventions
- DRUG abatacept (Orencia ®)
Study Locations (1)
Maryland
- Johns Hopkins Arthritis Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2009-05 |
| Est. Completion | 2013-03 |
| Phase | Phase 1 |
What the finished NCT00886795 record still lists
NCT00886795 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 59-participant average among 3 other Urticaria trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Urticaria appearing as the primary indexed condition, and to 1 intervention - of which abatacept (Orencia ®) is the first listed.
NCT00886795 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00886795 about?
NCT00886795 is a clinical study titled "Safety and Efficacy of Abatacept in Subjects With Chronic Urticaria Who Have Had an Inadequate Response to Anti-histamine Therapy". This study is being done to find out if a drug called Abatacept (Orencia ®) is safe and effective in treating people with chronic urticaria (persistent hives).
What is the current status of trial NCT00886795?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2009-05. Estimated completion is 2013-03.
What conditions does trial NCT00886795 study?
This clinical trial studies the following conditions: Urticaria.
What interventions are being tested in trial NCT00886795?
The interventions under investigation include: abatacept (Orencia ®) (DRUG).
Who is sponsoring clinical trial NCT00886795?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00886795 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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