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

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ClinicalTrials.gov Identifier: NCT01044576
Recruitment Status : Completed
First Posted : January 8, 2010
Last Update Posted : August 5, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Relapsing-remitting Multiple Sclerosis Secondary Progressive Multiple Sclerosis

Study Design

Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Research Cohort: Rapidly Evolving Multiple Sclerosis Opening the Window of Therapeutic Opportunity
Study Start Date : January 2010
Primary Completion Date : November 2012
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Multiple Sclerosis
Patients with relapsing-remitting or secondary progressive multiple sclerosis

Outcome Measures

Primary Outcome Measures :
  1. Proportion of research cohort subjects referred into a clinical trial or offered treatment with an appropriate second-line therapy. [ Time Frame: two years ]

Secondary Outcome Measures :
  1. Access and utilization of cohort data. [ Time Frame: two years ]
  2. Development of bio-markers. [ Time Frame: two years ]
  3. Development of clinical prognostic markers. [ Time Frame: two years ]

Biospecimen Retention:   Samples With DNA
whole blood, serum, white cells

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Eligible patients with relapsing-remitting or secondary progressive multiple sclerosis.
  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01044576

United Kingdom
Imperial College NHS Trust
London, United Kingdom
Sponsors and Collaborators
Imperial College London
Medical Research Council
Imperial College Healthcare NHS Trust
University College, London
Queen Mary University of London
University of Cambridge
Principal Investigator: Paolo A Muraro, MD Imperial College London
More Information

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01044576     History of Changes
Other Study ID Numbers: CRO1387
G0800679 ( Other Grant/Funding Number: Medical Research Council of the United Kingdom )
First Posted: January 8, 2010    Key Record Dates
Last Update Posted: August 5, 2015
Last Verified: March 2013

Keywords provided by Imperial College London:
Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis, Chronic Progressive
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases