N/A
Completed N=200
Patient Research Cohort: Rapidly Evolving Multiple Sclerosis
Source: ClinicalTrials.gov NCT01044576 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcomePrimary: Proportion of Research Cohort Subjects Referred Into a Clinical Trial or Offered Treatment With an Appropriate Second-line Therapy. — 178 Participants
Summary
The primary goal of the research cohort is to facilitate patient access to clinical trials testing new therapeutic interventions, or access to second- line treatments.
Secondary objectives of the research cohort study are to obtain detailed clinical phenotyping and immunological analysis of blood samples, aiming to identify and validate biomarkers of disease activity and response to treatment and prognostic markers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Research Cohort Subjects Referred Into a Clinical Trial or Offered Treatment With an Appropriate Second-line Therapy. |
178 | — |
| SECONDARY Access and Utilization of Cohort Data |
179 | — |
| SECONDARY Development of Biomarkers |
179 | — |
| SECONDARY Development of Clinical Prognostic Markers. |
179 | — |
Eligibility Criteria
- Male or Female, aged 18-65
- Able to give informed consent
- Diagnosis of MS according to to the revised McDonald's criteria (Polman et al. Ann Neurol 2005)
- Relapsing-remitting or secondary progressive MS form
- Disease duration ≤15 years from diagnosis
- Expanded disability status scale (EDSS) score 2.0 to 6.0 at screening evaluation
- Highly active and/or treatment-refractory MS activity defined as:
- Two or more clinical exacerbations in the previous 12 months, regardless of treatment; OR:
- One clinical exacerbation and sustained increase in EDSS of at least 1 point in the previous 12 months after receiving immune-modifying treatment, OR:
- Evidence of gadolinium (contrast)-enhancement or increase of T2 lesion load at MRI after receiving immune-modifying treatment. OR
- Not tolerating or not wishing to receive any of the available immune-modifying treatments and meeting one of the stated criteria (b or c) for MS activity in treated subjects (1 relapse and increase in EDSS of at least 1 point in the previous 12 months; or evidence of contrast-enhancement or increase of T2 lesion load at MRI).
Exclusion Criteria
- Contraindication to MRI including but not limited to intracranial aneurism clips (except Sugita), history of intra-orbital metal fragments that have not been removed by an MD (as confirmed by orbital X-Ray), pacemaker and non-MR compatible heart valves, inner ear implants, history of claustrophobia or subject feels unable to lie still on their back for a period of 1.5 hours in the MRI scanner.
- If female, positive urine pregnancy test
- History or presence of renal impairment (e.g. serum creatinine clearance less than 30ml/min)
- Inability to give informed consent/comply with study procedures
Data sourced from ClinicalTrials.gov (NCT01044576). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.