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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: Clinical Trial Phase 4 study, sponsored by Biogen.
NCT01211665 is a Phase 4 study that was terminated before completion, run by Biogen. The registered enrollment target is 3 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Karnofsky Performance Status Index (KPSI) is an assessment tool intended to assist clinicians and caretakers in gauging a patient's functional status and ability to carry out activities of daily living. A KPSI of 100=normal, no complaints, no evidence of disease; 90=able to carry on normal activity, minor signs or symptoms of disease; 80=normal activity with effort, some signs or symptoms of disease; 70=cares for self, unable to carry on normal activity or do active work; 60=requires occasio
Interventions
- DRUG Methylprednisolone
- DRUG Prednisolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2010-09 |
| Est. Completion | 2012-02 |
| Phase | Phase 4 |
Why NCT01211665 stopped before completion
NCT01211665 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Methylprednisolone is the first listed.
NCT01211665 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01211665's enrollment target sits among peer trials
3 1995th of 2000 higher than 3 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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