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| ID | Type | Description | Link |
|---|---|---|---|
| G0800679 | Other Grant/Funding Number | Medical Research Council of the United Kingdom |
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| Name | Class |
|---|---|
| Medical Research Council | OTHER_GOV |
| Imperial College Healthcare NHS Trust | OTHER |
| University College, London | OTHER |
| Queen Mary University of London |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multiple Sclerosis | Patients with relapsing-remitting or secondary progressive multiple sclerosis |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Research Cohort Subjects Referred Into a Clinical Trial or Offered Treatment With an Appropriate Second-line Therapy. | The primary goal of the observational research cohort is to facilitate patient access to clinical trials testing new therapeutic interventions or appropriate management for rapidly evolving multiple sclerosis (MS). This was devised as a single, combined primary outcome measure. The primary outcome is the proportion of research cohort subjects either referred into a clinical trial or offered treatment with an appropriate second-line therapy. (approved Protocol Version 4.1 - September 13th, 2011). The statistical assumption based on data from similar research cohorts stipulated that 50% of recruited patients will consent to proceed to further clinical trials or access new therapies. | Two years |
| Measure | Description | Time Frame |
|---|---|---|
| Access and Utilization of Cohort Data | The outcome reports the Number of participants whose data was used in any approved research. Examples of utilisation of data include imaging data analysis for MS-related research performed on the study participants' dataset and analysis of correlation of clinical phenotype with imaging data. Given the exploratory nature, no specific quantitative assumptions are made on the secondary outcome. Examples of studies utilising the anonymised cohort data: (1) Rapidly evolving multiple sclerosis: MRI findings predict clinical progression and disease phenotype (Dr Jean Lee, Dr A Waldmann, Dr R Newbould, ICL). (2) A study to characterize the novel TSPO PET radioligand [18F]PBR111 as an in vivo marker of microglial activation in Multiple Sclerosis (Dr A Colasanti, Imanova Ltd and GlaxoSmithKline). Conditions for participants to meet this outcome measure are: (A) completion of study visits (B) maintained (non-revoked) consent and (C) utilisation of the anonymised data in any further study. |
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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:
Exclusion Criteria:
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Eligible patients with relapsing-remitting or secondary progressive multiple sclerosis.
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| Name | Affiliation | Role |
|---|---|---|
| Paolo A Muraro, MD | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College NHS Trust | London | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Multiple Sclerosis | Patients with relapsing-remitting or secondary progressive multiple sclerosis |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Multiple Sclerosis | Patients with relapsing-remitting or secondary progressive multiple sclerosis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Research Cohort Subjects Referred Into a Clinical Trial or Offered Treatment With an Appropriate Second-line Therapy. | The primary goal of the observational research cohort is to facilitate patient access to clinical trials testing new therapeutic interventions or appropriate management for rapidly evolving multiple sclerosis (MS). This was devised as a single, combined primary outcome measure. The primary outcome is the proportion of research cohort subjects either referred into a clinical trial or offered treatment with an appropriate second-line therapy. (approved Protocol Version 4.1 - September 13th, 2011). The statistical assumption based on data from similar research cohorts stipulated that 50% of recruited patients will consent to proceed to further clinical trials or access new therapies. | Inclusion criteria were aimed to selecting a patient population who is at increased risk of continued progression and loss of function but has not accumulated irreversible neuronal injury or degeneration. All subjects who consented, met the study inclusion criteria and completed the study were included in this outcome analysis. There was no pre-planned subgroup analysis. | Posted | Count of Participants | Participants | Two years |
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Multiple Sclerosis | Patients with relapsing-remitting or secondary progressive multiple sclerosis |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Paolo Muraro | Imperial College London | 02075946670 | p.muraro@imperial.ac.uk |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D020528 | Multiple Sclerosis, Chronic Progressive |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| OTHER |
| GlaxoSmithKline | INDUSTRY |
| University of Cambridge | OTHER |
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whole blood, serum, white cells
| two years |
| Development of Biomarkers | The outcome consists of the Number of participants whose data was used in biomarkers development studies. Biomarkers studies include analysis of blood immunological studies performed on the study participants' dataset and analysis of correlation of clinical phenotype with immunological data, examples given below. Conditions for participants to meet this outcome measure are: (A) completion of study visits (B) maintained (non-revoked) consent and (C) utilisation of the anonymised immunological and clinical data in any biomarkers study. Given the exploratory nature, no quantitative assumptions are made on the outcome. Examples of studies of biomarkers: 1) Functional relevance of haematopoietic stem cell mobilisation following therapeutic alpha 4-integrin blockade in multiple sclerosis (Dr MMattoscio, ICL). 2)The relationship between T cell responses and disease progression in demyelinating disorders of the central nervous system (Prof D Altmann, ICL). | two years |
| Development of Clinical Prognostic Markers. | The outcome consists of the Number of participants whose data was used in studies aimed at the development of markers of clinical prognosis. Those are studies involving statistical analysis and models that may enable prognostic predictions from clinical phenotype, imaging and immunological data in any combination, with examples indicated below. Conditions for participants to meet this outcome measure are: (A) completion of study visits (B) maintained (non-revoked) consent and (C) utilisation of the anonymised imaging immunological and clinical data in any prognostic development research. Given their exploratory nature, no specific quantitative assumptions are made on the secondary outcome. Example of studies of prognostic markers: 1) Worse Physical Disability is associated with High Blood frequency of CD8+CD57+(ILT2+PD-1+) T-cells in MS Patients with Older Appearing Brains (Dr S Jacobs, Prof R Nicholas and Prof J Cole, Imperial College London and KCL). | two years |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Multiple Sclerosis | Patients with relapsing-remitting or secondary progressive multiple sclerosis |
|
|
| Secondary | Access and Utilization of Cohort Data | The outcome reports the Number of participants whose data was used in any approved research. Examples of utilisation of data include imaging data analysis for MS-related research performed on the study participants' dataset and analysis of correlation of clinical phenotype with imaging data. Given the exploratory nature, no specific quantitative assumptions are made on the secondary outcome. Examples of studies utilising the anonymised cohort data: (1) Rapidly evolving multiple sclerosis: MRI findings predict clinical progression and disease phenotype (Dr Jean Lee, Dr A Waldmann, Dr R Newbould, ICL). (2) A study to characterize the novel TSPO PET radioligand [18F]PBR111 as an in vivo marker of microglial activation in Multiple Sclerosis (Dr A Colasanti, Imanova Ltd and GlaxoSmithKline). Conditions for participants to meet this outcome measure are: (A) completion of study visits (B) maintained (non-revoked) consent and (C) utilisation of the anonymised data in any further study. | Inclusion criteria were aimed to selecting a patient population who is at increased risk of continued progression and loss of function but has not accumulated irreversible neuronal injury or degeneration. All subjects who consented, met the study inclusion criteria and completed the study were included in this outcome analysis. There was no pre-planned subgroup analysis. | Posted | Count of Participants | Participants | two years |
|
|
|
| Secondary | Development of Biomarkers | The outcome consists of the Number of participants whose data was used in biomarkers development studies. Biomarkers studies include analysis of blood immunological studies performed on the study participants' dataset and analysis of correlation of clinical phenotype with immunological data, examples given below. Conditions for participants to meet this outcome measure are: (A) completion of study visits (B) maintained (non-revoked) consent and (C) utilisation of the anonymised immunological and clinical data in any biomarkers study. Given the exploratory nature, no quantitative assumptions are made on the outcome. Examples of studies of biomarkers: 1) Functional relevance of haematopoietic stem cell mobilisation following therapeutic alpha 4-integrin blockade in multiple sclerosis (Dr MMattoscio, ICL). 2)The relationship between T cell responses and disease progression in demyelinating disorders of the central nervous system (Prof D Altmann, ICL). | Inclusion criteria were aimed to selecting a patient population who is at increased risk of continued progression and loss of function but has not accumulated irreversible neuronal injury or degeneration. All subjects who consented, met the study inclusion criteria and completed the study were included in this outcome analysis. There was no pre-planned subgroup analysis. | Posted | Count of Participants | Participants | two years |
|
|
|
| Secondary | Development of Clinical Prognostic Markers. | The outcome consists of the Number of participants whose data was used in studies aimed at the development of markers of clinical prognosis. Those are studies involving statistical analysis and models that may enable prognostic predictions from clinical phenotype, imaging and immunological data in any combination, with examples indicated below. Conditions for participants to meet this outcome measure are: (A) completion of study visits (B) maintained (non-revoked) consent and (C) utilisation of the anonymised imaging immunological and clinical data in any prognostic development research. Given their exploratory nature, no specific quantitative assumptions are made on the secondary outcome. Example of studies of prognostic markers: 1) Worse Physical Disability is associated with High Blood frequency of CD8+CD57+(ILT2+PD-1+) T-cells in MS Patients with Older Appearing Brains (Dr S Jacobs, Prof R Nicholas and Prof J Cole, Imperial College London and KCL). | Inclusion criteria were aimed to selecting a patient population who is at increased risk of continued progression and loss of function but has not accumulated irreversible neuronal injury or degeneration. All subjects who consented, met the study inclusion criteria and completed the study were included in this outcome analysis. There was no pre-planned subgroup analysis. | Posted | Count of Participants | Participants | two years |
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| 0 |
| 200 |
| 0 |
| 200 |
| 0 |
| 200 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |