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Corticosteroids for Immune Reconstitution Inflammatory Syndrome (IRIS) (IRIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01211665
Recruitment Status : Terminated (This study was stopped prematurely due to lack of enrollment within a 1-5-year period.)
First Posted : September 29, 2010
Results First Posted : August 13, 2014
Last Update Posted : September 5, 2014
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by (Responsible Party):
Biogen

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Immune Reconstitution Inflammatory Syndrome
Leukoencephalopathy, Progressive Multifocal
Interventions Drug: Methylprednisolone
Drug: Prednisolone
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pulsed IVMP IVMP With Oral Prednisolone Taper
Hide Arm/Group Description 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. Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
Period Title: Overall Study
Started 2 1
Completed 0 1 [1]
Not Completed 2 0
Reason Not Completed
Withdrawal by Subject             1             0
Death             1             0
[1]
completed treatment with study drug
Arm/Group Title Pulsed IVMP IVMP With Oral Prednisolone Taper Total
Hide Arm/Group Description 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. Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time. Total of all reporting groups
Overall Number of Baseline Participants 2 1 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
1
 100.0%
3
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
Female
2
 100.0%
1
 100.0%
3
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Time Course Change in Functional Status Based on Karnofsky Performance Status Index Through 6 Months Following Completion of Plasma Exchange (PLEX)
Hide Description 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 occasional assistance but is able to care for most personal needs; 50=requires considerable assistance and frequent medical care; 40=disabled, requires special care and assistance; 30=severely disabled, hospitalization is indicated, although death is not imminent; 20=very sick, hospitalization is necessary, active support treatment is necessary; 10=moribund, fatal processes progressing rapidly; 0=dead.
Time Frame Baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
This study was stopped prematurely due to lack of enrollment; this analysis was not performed.
Arm/Group Title Pulsed IVMP IVMP With Oral Prednisolone Taper
Hide Arm/Group Description:
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.
Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Number of Participants Who Survived at 6 Months Following Completion of Plasma Exchange (PLEX)
Hide Description Following the completion of rapid removal of natalizumab using PLEX or equivalent.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed IVMP IVMP With Oral Prednisolone Taper
Hide Arm/Group Description:
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.
Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
Overall Number of Participants Analyzed 2 1
Measure Type: Number
Unit of Measure: participants
1 1
3.Primary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description AE=any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.
Time Frame from the first dose of study treatment through the end of the treatment period (6 months) + a 4-week post-treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed IVMP IVMP With Oral Prednisolone Taper
Hide Arm/Group Description:
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.
Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
Overall Number of Participants Analyzed 2 1
Measure Type: Number
Unit of Measure: participants
AEs 2 1
SAEs 2 1
4.Primary Outcome
Title Severity of AEs and SAEs
Hide Description AEs and SAEs were categorized as mild, moderate or severe according to the following criteria: Mild=barely noticeable to participant or does not make participant uncomfortable; does not influence performance or functioning; prescription drug not ordinarily needed for relief of symptom(s) but may be given because of personality of participant. Moderate=of a sufficient severity to make participant uncomfortable; performance of daily activity is influenced; participant is able to continue in study; treatment for symptom(s) may be needed. Severe=symptoms cause severe discomfort; symptoms cause incapacity or significant impact on participant's daily life; severity may cause cessation of treatment with study treatment; treatment for symptom(s) may be given and/or participant hospitalized. Please see Outcome Measure 3 for AE and SAE definitions.
Time Frame from the first dose of study treatment through the end of the treatment period (6 months) + a 4-week post-treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pulsed IVMP IVMP With Oral Prednisolone Taper
Hide Arm/Group Description:
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.
Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
Overall Number of Participants Analyzed 2 1
Measure Type: Number
Unit of Measure: events
Mild SAE 1 1
Moderate SAE 1 1
Severe SAE 2 0
Mild AE 3 5
Moderate AE 3 1
Severe AE 0 0
5.Primary Outcome
Title Time Course Change in the Global Clinical Impression of Improvement (GCI-I) Scale
Hide Description The GCI-I scale is a 7-point scale that assesses how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention, and rates it as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
Time Frame Screening to 6 months following completion of PLEX (participants began treatment with intravenous methylprednisolone (IVMP) within 2 weeks after PLEX [or equivalent]).
Hide Outcome Measure Data
Hide Analysis Population Description
This study was stopped prematurely due to lack of enrollment; this analysis was not performed.
Arm/Group Title Pulsed IVMP IVMP With Oral Prednisolone Taper
Hide Arm/Group Description:
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.
Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Primary Outcome
Title Time Course Change in Cerebral Dysfunction Using the Symbol Digit Modalities Test (SDMT)
Hide Description The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution.
Time Frame Screening to 6 months following completion of PLEX (participants began treatment with IVMP within 2 weeks after PLEX [or equivalent]).
Hide Outcome Measure Data
Hide Analysis Population Description
This study was stopped prematurely due to lack of enrollment; this analysis was not performed.
Arm/Group Title Pulsed IVMP IVMP With Oral Prednisolone Taper
Hide Arm/Group Description:
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.
Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Primary Outcome
Title Time Course Changes in Brain Magnetic Resonance Imaging (MRI)
Hide Description The brain MRI data collected included: progressive multifocal leukoencephalopathy (PML) lesion localization, T2 hyperintense lesion volume, and signs of cerebral edema.
Time Frame Screening to 6 months following completion of PLEX (participants began treatment with IVMP within 2 weeks after PLEX [or equivalent]).
Hide Outcome Measure Data
Hide Analysis Population Description
This study was stopped prematurely due to lack of enrollment; this analysis was not performed.
Arm/Group Title Pulsed IVMP IVMP With Oral Prednisolone Taper
Hide Arm/Group Description:
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.
Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Primary Outcome
Title Time Course Change in Magnetoencephalography (MEG) Results
Hide Description MEG was used to map brain activity.
Time Frame Screening to 6 months following completion of PLEX (participants began treatment with IVMP within 2 weeks after PLEX [or equivalent]).
Hide Outcome Measure Data
Hide Analysis Population Description
This study was stopped prematurely due to lack of enrollment; no data on this endpoint was collected.
Arm/Group Title Pulsed IVMP IVMP With Oral Prednisolone Taper
Hide Arm/Group Description:
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.
Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Primary Outcome
Title Time Course Change in Clinical Laboratory Values
Hide Description Clinical laboratory values included chemokines, cytokines, C-reactive protein (CRP), John Cunningham (JC) virus load, and cell count in cerebrospinal fluid.
Time Frame Screening to 6 months following completion of PLEX (participants began treatment with IVMP within 2 weeks after PLEX [or equivalent]).
Hide Outcome Measure Data
Hide Analysis Population Description
This study was stopped prematurely due to lack of enrollment; this analysis was not performed.
Arm/Group Title Pulsed IVMP IVMP With Oral Prednisolone Taper
Hide Arm/Group Description:
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.
Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Primary Outcome
Title Time Course Elimination of Serum Natalizumab Concentration Following Plasma Exchange (PLEX) or Equivalent
Hide Description [Not Specified]
Time Frame Baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
This study was stopped prematurely due to lack of enrollment; this analysis was not performed.
Arm/Group Title Pulsed IVMP IVMP With Oral Prednisolone Taper
Hide Arm/Group Description:
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.
Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame AEs and SAEs were collected from the first dose of study treatment through the end of the treatment period (6 months) + a 4-week post-treatment period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pulsed IVMP IVMP With Oral Prednisolone Taper
Hide Arm/Group Description 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. Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
All-Cause Mortality
Pulsed IVMP IVMP With Oral Prednisolone Taper
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Pulsed IVMP IVMP With Oral Prednisolone Taper
Affected / at Risk (%) Affected / at Risk (%)
Total   2/2 (100.00%)   1/1 (100.00%) 
Immune system disorders     
Immune Reconstitution Syndrome  1  0/2 (0.00%)  1/1 (100.00%) 
Infections and infestations     
Progressive Multifocal Leukoencephalopathy  1  1/2 (50.00%)  1/1 (100.00%) 
Urinary Tract Infection  1  1/2 (50.00%)  0/1 (0.00%) 
Nervous system disorders     
Grand Mal Convulsion  1  1/2 (50.00%)  0/1 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonia Aspiration  1  1/2 (50.00%)  0/1 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pulsed IVMP IVMP With Oral Prednisolone Taper
Affected / at Risk (%) Affected / at Risk (%)
Total   2/2 (100.00%)   1/1 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  1/2 (50.00%)  0/1 (0.00%) 
Gastrointestinal disorders     
Anal Fissure  1  1/2 (50.00%)  0/1 (0.00%) 
Diarrhoea  1  1/2 (50.00%)  0/1 (0.00%) 
Vomiting  1  1/2 (50.00%)  0/1 (0.00%) 
Infections and infestations     
Pneumonia  1  1/2 (50.00%)  0/1 (0.00%) 
Progressive Multifocal Leukoencephalopathy  1  0/2 (0.00%)  1/1 (100.00%) 
Metabolism and nutrition disorders     
Hypokalaemia  1  0/2 (0.00%)  1/1 (100.00%) 
Psychiatric disorders     
Insomnia  1  0/2 (0.00%)  1/1 (100.00%) 
Skin and subcutaneous tissue disorders     
Skin Haemorrhage  1  1/2 (50.00%)  0/1 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Biogen Idec Study Medical Director
Organization: Biogen Idec
EMail: clinicaltrials@biogenidec.com
Layout table for additonal information
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01211665    
Other Study ID Numbers: 101JC404
2010-020369-26 ( EudraCT Number )
First Submitted: July 29, 2010
First Posted: September 29, 2010
Results First Submitted: July 23, 2014
Results First Posted: August 13, 2014
Last Update Posted: September 5, 2014