ASSERT
What it found
The trial was stopped early for safety reasons.
Reason given: Slow enrollment decreased sample size; No unexpected safety issues.
What was tested
Treatment tested
- Glatiramer acetate
Unknown
- Prednisone
Glucocorticoid receptor agonist
Placebo or sham
- Placebo
Results by group
Percent Change From Baseline to Termination in Normalized Brain Volume Measured According to the SIENA (Structural Imaging Evaluation Using Normalization of Atrophy) Method
Day 0, latest scan at month 24, 36 or early termination visit
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| GA + Placebo | -0.46 percent change of baseline brain volume | 0.088 (Standard Error) | 105 |
| GA + Prednisone | -0.43 percent change of baseline brain volume | 0.106 (Standard Error) | 84 |
GA + Placebo
GA + Prednisone
p = 0.8023; Mean Difference (Final Values) -0.03 (95% CI -0.26–0.20)
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| GA + Placebo | 199 | 16 (8.0%) | |
| GA + Prednisone | 209 | 13 (6.2%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Percent Change From Baseline to Termination in Normalized Brain Volume Measured According to the SIENA (Structural Imaging Evaluation Using Normalization of Atrophy) Method
Day 0, latest scan at month 24, 36 or early termination visit
MRI lesionsBrain volume loss
Other measures (3)
Cumulative Number of Enhancing Lesions at Months 12, 24 and 36
Months 12, 24, and 36
MRI lesionsChange From Baseline to Month 36 or Early Termination Visit in Volume of T2-Lesions
Day 0, Month 36 or the early termination visit
MRI lesionsChange From Baseline to Month 36 or Early Termination Visit in Volume of Hypointense Lesions
Day 0, Month 36 or early termination visit
MRI lesions
Who could take part
Relapsing MS · 18 to 55
Inclusion Criteria: 1. Clinically definite multiple sclerosis (CDMS) according to Poser (Ann. Neurol. 1983) or McDonald (Ann. Neurol. 2001) 2. Subjects eligible for GA treatment based on the investigator's clinical assessment and according to the current indication. 3. Subjects must have a relapsing remitting disease course. 4. Subjects must have had at least 1 documented relapse within the last year prior to study entry. 5. Subjects may be male or female. Women of childbearing potential must practice an acceptable method of birth control. Acceptable methods include oral contraceptive, contraceptive patch, long-acting injectable contraceptive, double-barrier method (condom or intrauterine device [IUD] with spermicide), or partner's vasectomy. 6. Subjects must be between the ages of 18 and 55 years inclusive. 7. Subjects must be ambulatory, with a Kurtzke Expanded Disability Status Scale (EDSS) score between 0 and 5.0 inclusive. 8. Subjects must be willing and able to give written informed consent prior to entering the study. Exclusion Criteria: 1. Long-term glatiramer acetate users who have been on therapy within 6 months of the baseline magnetic resonance imaging (MRI). New glatiramer acetate users who have initiated therapy for more than 6 weeks prior to the baseline MRI. 2. Previous use of cladribine. 3. Previous use of mitoxantrone. 4. Use of digitalis at study entry. 5. Previous use of immunosuppressive agents (such as azathioprine, cyclophosphamide or mycophenolate mofetil) in the last 6 months prior to screening. 6. Use of experimental or investigational drugs, including intravenous (IV) immunoglobulin within 6 months prior to screening. 7. Use of interferon agents within 1 month prior to the baseline MRI. 8. Use of corticosteroids (IV, intramuscular [IM] and/or by mouth [PO]) within 30 days prior to the baseline MRI. 9. Chronic corticosteroid (IV, IM and/or PO) treatment (more than 30 consecutive days) in the 6 months prior to the screening visit. 10. Subjects with diabetes. 11. Previous total body irradiation or total lymphoid irradiation. 12. Pregnancy or breast feeding. 13. Significant medical or psychiatric condition that affects the subject's ability to give informed consent, or to complete the study, or any condition which the investigator feels may interfere with participation in the study (e.g. alcohol or drug abuse). 14. Other diseases that can cause brain atrophy (ex. neurodegenerative disorder, cerebrovascular disease, history of alcohol abuse). 15. Bone density less than -2.5 standard deviations (SD) (osteoporosis). 16. A known history of sensitivity to mannitol. 17. Contraindication to, or known history of, sensitivity or severe reaction to steroids. 18. A known history of sensitivity to gadolinium. 19. Inability to successfully undergo MRI scanning. 20. Previous use of natalizumab.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This is a study evaluating the effect on brain volume of daily glatiramer acetate (GA) and add-on pulse steroids.
Papers
Results
Jacobian integration method increases the statistical power to measure gray matter atrophy in multiple sclerosis.Neuroimage Clin · 2014
Results
Milo R, Panitch H. Combination therapy in multiple sclerosis. J Neuroimmunol. 2011 Feb;231(1-2):23-31. doi: 10.1016/j.jneuroim.2010.10.021. Epub 2010 Dec 15.
Loading reviews and guidelines…
Related trials
- TWINS
Phase 3 · Not yet recruiting
Still running
- IN-DXM-EMRR
Phase 2 · Enrolling by invitation
Still running
- AIOLOS
Recruiting
Still running
- Full Responders
Phase 4 · Stopped early
Stopped early
- A Study to Learn More About The Safety of Diroximel Fumar…
Running, not recruiting
Still running
- A Open-label Study to Assess Response to COVID-19 Vaccine…
Phase 4 · Stopped early
Stopped: safety
History
Started
Jan 2005
Main results due
May 2009
Finished
May 2009
Results posted
Jan 2014
Assembled by software from public sources and not checked by people. Each record links to its source. Report an error