Clinical trial NCT01044576: Patient Research Cohort: Rapidly Evolving Multiple Sclerosis
Official title: Patient Research Cohort: Rapidly Evolving Multiple Sclerosis Opening the Window of Therapeutic Opportunity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing-remitting Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
Keywords: Multiple Sclerosis
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Medical Research Council
name: Imperial College Healthcare NHS Trust
name: University College, London
name: Queen Mary University of London
name: GlaxoSmithKline
name: University of Cambridge
First posted: 2010-01-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients with relapsing-remitting or secondary progressive multiple sclerosis.

Brief 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.


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:

  1. Two or more clinical exacerbations in the previous 12 months, regardless of treatment; OR:
  2. One clinical exacerbation and sustained increase in EDSS of at least 1 point in the previous 12 months after receiving immune-modifying treatment, OR:
  3. Evidence of gadolinium (contrast)-enhancement or increase of T2 lesion load at MRI after receiving immune-modifying treatment. OR
  4. 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

Primary outcomes:
measure: Proportion of Research Cohort Subjects Referred Into a Clinical Trial or Offered Treatment With an Appropriate Second-line Therapy.
timeFrame: Two years
Secondary outcomes:
measure: Access and Utilization of Cohort Data
timeFrame: two years
measure: Development of Biomarkers
timeFrame: two years
measure: Development of Clinical Prognostic Markers.
timeFrame: two years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College NHS Trust
Study officials:
affiliation: Imperial College London
name: Paolo A Muraro, MD
role: PRINCIPAL_INVESTIGATOR
References: