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Patient Research Cohort: Rapidly Evolving Multiple Sclerosis (PRC-REMS)

This study has been completed.
Sponsor:
Collaborators:
Medical Research Council
Imperial College Healthcare NHS Trust
University College, London
Queen Mary University of London
GlaxoSmithKline
University of Cambridge
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01044576
First received: January 7, 2010
Last updated: August 4, 2015
Last verified: March 2013
January 7, 2010
August 4, 2015
January 2010
November 2012   (Final data collection date for primary outcome measure)
Proportion of research cohort subjects referred into a clinical trial or offered treatment with an appropriate second-line therapy. [ Time Frame: two years ]
Same as current
Complete list of historical versions of study NCT01044576 on ClinicalTrials.gov Archive Site
  • Access and utilization of cohort data. [ Time Frame: two years ]
  • Development of bio-markers. [ Time Frame: two years ]
  • Development of clinical prognostic markers. [ Time Frame: two years ]
Same as current
Not Provided
Not Provided
 
Patient Research Cohort: Rapidly Evolving Multiple Sclerosis
Patient Research Cohort: Rapidly Evolving Multiple Sclerosis Opening the Window of Therapeutic Opportunity

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
whole blood, serum, white cells
Non-Probability Sample
Eligible patients with relapsing-remitting or secondary progressive multiple sclerosis.
  • Relapsing-remitting Multiple Sclerosis
  • Secondary Progressive Multiple Sclerosis
Not Provided
Multiple Sclerosis
Patients with relapsing-remitting or secondary progressive multiple sclerosis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
November 2012
November 2012   (Final data collection date for primary outcome measure)
  • 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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01044576
CRO1387
G0800679 ( Other Grant/Funding Number: Medical Research Council of the United Kingdom )
No
Not Provided
Not Provided
Imperial College London
Imperial College London
  • Medical Research Council
  • Imperial College Healthcare NHS Trust
  • University College, London
  • Queen Mary University of London
  • GlaxoSmithKline
  • University of Cambridge
Principal Investigator: Paolo A Muraro, MD Imperial College London
Imperial College London
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP