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NCT01211665 · ClinicalTrials.gov registry record · Phase 4
Corticosteroids for Immune Reconstitution Inflammatory Syndrome (IRIS)
A Phase 4 study, sponsored by Biogen.
- Terminated
- Registry status
- Phase 4
- Development phase
- 3
- Enrollment target
NCT01211665 is a Phase 4 study that was terminated before completion, run by Biogen. The registered enrollment target is 3 participants.
The verdict
NCT01211665, a Phase 4 study, was terminated before completion, sponsored by Biogen.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 3 participants
- Enrollment target
Study Summary
The objectives of this study are to explore the effects of administering high-dose corticosteroids to participants who developed progressive multifocal leukoencephalopathy (PML) while on natalizumab as measured by time-course change in functional status based on Karnofsky Performance Status Index through 6 months following the completion of plasma exchange (PLEX; or equivalent), survival at 6 months following the completion of PLEX (or equivalent), and incidence and severity of adverse events (AEs) and serious adverse events (SAEs); to characterize the evolution of immune reconstitution inflammatory syndrome (IRIS) as measured by time course changes in Global Clinical Impression of Improvement (GCI-I), Symbol Digit Modalities Test (SDMT), brain magnetic resonance imaging (MRI), magnetoencephalography (MEG), chemokines, cytokines, C-reactive protein (CRP), John Cunningham virus (JCV) load and cell count in cerebrospinal fluid (CSF); and to characterize the time course elimination of serum natalizumab concentrations in the study population following the last PLEX (or equivalent) procedure.
Interventions
- DRUG Methylprednisolone
- DRUG Prednisolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2010-09 |
| Est. Completion | 2012-02 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01211665
The ClinicalTrials.gov registry entry for NCT01211665 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Methylprednisolone is the first listed.
NCT01211665 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01211665 about?
NCT01211665 is a clinical study titled "Corticosteroids for Immune Reconstitution Inflammatory Syndrome (IRIS)". The objectives of this study are to explore the effects of administering high-dose corticosteroids to participants who developed progressive multifocal leukoencephalopathy (PML) while on natalizumab as measured by time-course change in functional status based on Karnofsky Performance Status Index th...
What is the current status of trial NCT01211665?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 3 participants. The study started on 2010-09. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01211665?
The interventions under investigation include: Methylprednisolone (DRUG), Prednisolone (DRUG).
Who is sponsoring clinical trial NCT01211665?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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