Corticosteroids for Immune Reconstitution Inflammatory Syndrome (IRIS)
Keywords
Abstract
Dates
Last Verified: | 07/31/2014 |
First Submitted: | 07/28/2010 |
Estimated Enrollment Submitted: | 09/27/2010 |
First Posted: | 09/28/2010 |
Last Update Submitted: | 08/25/2014 |
Last Update Posted: | 09/04/2014 |
Date of first submitted results: | 07/22/2014 |
Date of first submitted QC results: | 07/22/2014 |
Date of first posted results: | 08/12/2014 |
Actual Study Start Date: | 08/31/2010 |
Estimated Primary Completion Date: | 01/31/2012 |
Estimated Study Completion Date: | 01/31/2012 |
Condition or disease
Intervention/treatment
Drug: Methylprednisolone
Drug: IVMP with oral prednisolone taper
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
Experimental: Pulsed IVMP Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator. | |
Experimental: IVMP with oral prednisolone taper Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper of prednisolone over 2 months (suggested dosages starting at 80 mg and tapering to 5 mg). If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time. | Drug: IVMP with oral prednisolone taper Oral prednisolone used as a taper, with suggested dosages starting at 80 mg and tapering to 5 mg. |
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | All |
Accepts Healthy Volunteers | Yes |
Criteria | Key Inclusion Criteria: - Must have been receiving natalizumab for multiple sclerosis (MS) prior to the diagnosis or suspicion of Progressive multifocal leukoencephalopathy (PML). - Subject must be willing to undergo or have completed plasma exchange (PLEX) prior to initiating study treatment. Key Exclusion Criteria: - History of severe allergic or anaphylactic reactions or known hypersensitivity to any drug including hypersensitivity to corticosteroids. NOTE: Other protocol defined inclusion/exclusion criteria may apply. |
Outcome
Primary Outcome Measures
1. Time Course Change in Functional Status Based on Karnofsky Performance Status Index Through 6 Months Following Completion of Plasma Exchange (PLEX) [Baseline up to 6 months]
2. Number of Participants Who Survived at 6 Months Following Completion of Plasma Exchange (PLEX) [6 months]
3. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [from the first dose of study treatment through the end of the treatment period (6 months) + a 4-week post-treatment period]
4. Severity of AEs and SAEs [from the first dose of study treatment through the end of the treatment period (6 months) + a 4-week post-treatment period]
5. Time Course Change in the Global Clinical Impression of Improvement (GCI-I) Scale [Screening to 6 months following completion of PLEX (participants began treatment with intravenous methylprednisolone (IVMP) within 2 weeks after PLEX [or equivalent]).]
6. Time Course Change in Cerebral Dysfunction Using the Symbol Digit Modalities Test (SDMT) [Screening to 6 months following completion of PLEX (participants began treatment with IVMP within 2 weeks after PLEX [or equivalent]).]
7. Time Course Changes in Brain Magnetic Resonance Imaging (MRI) [Screening to 6 months following completion of PLEX (participants began treatment with IVMP within 2 weeks after PLEX [or equivalent]).]
8. Time Course Change in Magnetoencephalography (MEG) Results [Screening to 6 months following completion of PLEX (participants began treatment with IVMP within 2 weeks after PLEX [or equivalent]).]
9. Time Course Change in Clinical Laboratory Values [Screening to 6 months following completion of PLEX (participants began treatment with IVMP within 2 weeks after PLEX [or equivalent]).]
10. Time Course Elimination of Serum Natalizumab Concentration Following Plasma Exchange (PLEX) or Equivalent [Baseline up to 6 months]