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At least 505 records · Page 28Linked to original sources
PubMed2003

[Use of glatiramer acetate (Copaxone) in the treatment of patients with multiple sclerosis. Experience of the Moscow multiple sclerosis center].

146 patients with multiple sclerosis are treated by copaxone in the Moscow MS Centre. The relaps exacerbation rate decreased by 72%, the relapse rate reduced by 25.6% during the copaxone treatment. EDSS score did not increase both in group with and without relapses. The condition of 2/3 patients was stable. To achieve the best effect of treatment the program of patient support was successfully used in the Moscow MS Centre.

Adjuvants, Immunologic↗
PubMed1999

A profile of multiple sclerosis: the New York State Multiple Sclerosis Consortium.

We have obtained a current profile of multiple sclerosis York State through a centralized patient registry and standardized data collection instrument associated with the New York State Multiple Sclerosis Consortium of 12 MS centers located throughout the state. Data from the first 3019 patients with clinically definite MS revealed a clear relationship between MS disease type, duration of disease, and severity of physical disability. Patients with relapsing disease had disease durations approximately half as long as those with progressive forms of the disease (means approximately 6 years versus 11 years). The majority of patients with relapsing disease had Expanded Disability Status Scale (EDSS) scores of 4.0 or less (self-sustained, fully ambulatory), whereas the majority of patients with progressive disease types had EDSS scores of 6.0 or greater (at least unilateral assist for walking). These findings emphasize the importance of early intervention in patients with relapsing disease to slow or prevent the accumulation of physical disability associated with progressive types of disease. Progressive disease was associated with lack of full-time employment and being disabled before the age of 60 years. Patients with relapsing disease were more likely to be employed and have private forms of insurance, whereas patients with progressive types of disease were more likely to have government-supported insurance to cover medical expenses.

Adult↗
PubMed1996

Defining the clinical course of multiple sclerosis: results of an international survey. National Multiple Sclerosis Society (USA) Advisory Committee on Clinical Trials of New Agents in Multiple Sclerosis.

Standardization of terminology used to describe the pattern and course of MS is essential for mutual understanding between clinicians and investigators. It is particularly important in design of, and recruitment for, clinical trials statistically powered for expected outcomes for given patient populations with narrowly defined entry criteria. For agents that prove safe and effective for MS, knowledge of the patient populations in definitive clinical trials assists clinicians in determining who may ultimately benefit from use of the medication. An international survey of clinicians involved with MS revealed areas of consensus about some terms classically used to describe types of the disease and other areas for which there was lack of consensus. In this report, we provide a summary of the survey results and propose standardized definitions for the most common clinical courses of patients with MS.

Disease Progression↗
PubMed2006

The development and validation of the impact of multiple sclerosis scale and the symptoms of multiple sclerosis scale.

OBJECTIVE: To develop and validate the Impact of Multiple Sclerosis Scale (IMSS) and the Symptoms of Multiple Sclerosis Scale (SMSS) using the Extended Disability Status Scale (EDSS) for construct validity. DESIGN: Panel design involving test-retest over 4 months. SETTING: A mailed survey. PARTICIPANTS: Volunteers with a diagnosis of multiple sclerosis (MS) recruited from an MS support service in Australia: 193 people (mean age, 39y) and 150 people participated at time 1 and time 2, respectively. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Principal components analyses, the Cronbach alpha, and descriptive statistics for the 2 scales; correlations for construct validity with the EDSS and retest; and confirmatory factor analysis to test the stability of IMSS and SMSS components over time. RESULTS: The IMSS yielded 5 independent and reliable components; the SMSS yielded 3 components; both component structures were stable over time. These scales showed convergent validity with the EDSS. CONCLUSIONS: The IMSS and SMSS are psychometrically sound scales suitable for clinical and research purposes to assess the symptoms and impact of MS.

Adult↗
PubMed1999

Disease-modifying drugs for relapsing-remitting multiple sclerosis and future directions for multiple sclerosis therapeutics.

With the development of effective therapies for multiple sclerosis (MS), therapeutic nihilism, which was so prevalent just 10 years ago, has given way to exuberance and optimism. The current mood is understandable because MS is such a devastating disease. Within 10 years of symptom onset, 50% of patients with MS are unable to carry out household and employment responsibilities; within 15 to 20 years, 50% are unable to walk unassisted; and within 25 years, 50% are unable to walk at all. The average annual cost of MS in the United States has been estimated at greater than $6.8 billion, or $34 103 per person. This review summarizes evidence that disease-modifying drugs can significantly improve the course of patients with relapsing-remitting MS (RRMS) and frames key issues relating to the use of current drugs. Major issues confronting experimental MS therapeutics are discussed.

Adjuvants, Immunologic↗
PubMed2001

United States open-label glatiramer acetate extension trial for relapsing multiple sclerosis: MRI and clinical correlates. Multiple Sclerosis Study Group and the MRI Analysis Center.

After the placebo-controlled extension of the pivotal US trial of glatiramer acetate for the treatment of relapsing multiple sclerosis ended, 208 participants entered an open-label, long-term treatment protocol Magnetic resonance imaging (MRI) was added to the planned evaluations of these subjects to determine the consequences of long-term treatment on MRI-defined pathology and evaluate its clinical correlates. Of the 147 subjects that remained on long-term follow-up, adequate images were obtained on 135 for quantitative MRI analysis. The initial imaging sessions were performed between June 1998 and January 1999 at 2,447 +/- 61 days (mean +/- standard deviation) after the subject's original randomization. Clinical data from a preplanned clinical visit were matched to MRI within 3 +/- 51 days. At imaging, 66 patients originally randomized to placebo (oPBO) in the pivotal trial had received glatiramer acetate for 1,476 +/- 63 days, and 69 randomized to active treatment with glatiramer acetate (oGA) were on drug for 2,433 +/- 59 days. The number of documented relapses in the 2 years prior to entering the open-label extension was higher in the group originally randomized to placebo (oPBO=1.86 +/- 1.78, oGA=1.03 +/- 1.28; P=0.002). The annualized relapse rate observed during the open-label study was similar for both groups (oPBO=0.2 7, +/- 0.45 oGA=0.28 +/- 0.40), but the reduction in rate from the placebo-controlled phase was greater for those beginning therapy with GA (oPBO reduced by 0.66 +/- 0.71, oGA reduced by 0.23 +/- 0.58; P=0.0002). One or more gadolinium enhancing lesions were found in 27.4% of all patients (number of distinct enhancements=1.16 +/- 2.52, total enhanced tissue volume=97 +/- 26 microl). The risk of having an enhancement was higher in those with relapses during the open-label extension (odds ratio 4.65, 95% confidence interval (CI) 2.0 to 10.7; P=0.001). The odds for finding an enhancement was 2.5 times higher for those patients originally randomized to placebo (CI 1.1 to 5.4; P=0.02) compared to those always on glatiramer acetate. MRI-metrics indicative of chronic pathology, particularly measures of global cerebral tissue loss (atrophy), were uniformly worse for those originally on placebo. These observations enrich our long-term follow up of the clinical consequences of treatment with glatiramer acetate to include its apparent effects on MRI-defined pathology. They show that the effect of glatiramer acetate on enhancements is definite, but modest, consistent with the drug's described mechanisms of action, and that a delay in initiating treatment results in progression of MRI-measured pathology that can be prevented.

Adult↗
PubMed1978

Anamnestic studies in multiple sclerosis: a relationship between familial multiple sclerosis and neoplasia.

A survey of family histories of malignant neoplasia in multiple sclerosis (MS) patients indicates that a positive history of cancer in near relatives is present in 44 percent of patients and 46 percent of controls. However, those MS patients having such a positive history were much more likely than others to also have a family history of MS. Contrariwise, MS patients with a positive family history of MS had a significantly higher rate of cancer in first degree relatives (71 percent) than others. There was a trend indicating less cancer in families of MS patients possessing the HLA-B7 and DW2 histocompatibility antigens.

Female↗
PubMed1996

Guidelines for MRI monitoring of the treatment of multiple sclerosis: recommendations of the US Multiple Sclerosis Society's task force.

In relapsing-remitting and secondary progressive multiple sclerosis (MS), MRI activity on monthly brain scans is a sensitive primary outcome measure in short term exploratory treatment trials. Because conventional MRI findings have a limited correlation with disability, the primary outcome in definitive trials should be clinical, although MRI is useful in providing an index of pathological progression. In trials aimed at preventing evolution from a clinically isolated syndrome to MS, MRI findings should be used in the entry criteria. The likely pathological substrates of irreversible disability are demyelination and axonal loss. Putative MR markers for these pathologies appear to relate more closely to disability than conventional MRI findings. Further technical developments should lead to improved quantitation, pathological specificity and clinical correlations.

Clinical Trials as Topic↗
PubMed1994

Design strategies in multiple sclerosis clinical trials. The Cyclosporine Multiple Sclerosis Study Group.

After analyzing our natural history data on the course of multiple sclerosis (MS) in more than 500 patients followed for 20 years and our experience in several therapeutic trials, we concluded that a phase III (full) trial for efficacy should have certain properties. For a power of 0.8, alpha of 0.05, and attrition rate of 10% per year, we think the trial should have a minimum sample size of 130 (65 in each arm; placebo versus active) if the design is based upon the proportion of subjects worsening by clinical measures. No stratification by entry Extended Disability Status Scale score is needed if worsening is defined as a change of 1.0 units (2 to 0.5 steps) maintained for 90 days for an entry score of 1 to 5.0 units; or 0.5 units (1 to 0.5 steps) if the entry score is 5.5 to 7 units. We need not stratify by course (relapsing-remitting versus relapsing-progressive) but are less certain about progression from the onset. No run-in period is required to define "activity." Minimum time for treatment is 3 years. We review the justification for our conclusions; modifications in sample size that are necessary if survival analysis is used; impact of the interferon-beta trial (future trials will have an "active" control); and alternative strategies possible if magnetic resonance imaging serves as the primary outcome.

Clinical Trials, Phase III as Topic↗