ID

12030

Description

Proof of Concept Study Evaluating RNS60 in the Treatment of Relapsing Remitting Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT01714089 Principal Investigator: Fred Lublin, MD, PhD Mt. Sinai School of Medicine

Link

https://clinicaltrials.gov/show/NCT01714089

Keywords

Versions (1)
  1. 01.09.15 01.09.15 -
Uploaded on

1. September 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Relapsing Remitting Multiple Sclerosis NCT01714089

English

Eligibility Relapsing Remitting Multiple Sclerosis NCT01714089

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. Males or females, aged between 18 and 50 years.
Description

1. Males or females, aged between 18 and 50 years.

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. Diagnosis of RR-MS according to McDonald 2010 diagnostic criteria with a prior brain MRI that demonstrates lesions consistent with RRMS, both within the past year.
Description

2. Diagnosis of RR-MS according to McDonald 2010 diagnostic criteria with a prior brain MRI that demonstrates lesions consistent with RRMS, both within the past year.

Data type

boolean

Alias
UMLS CUI [1]
C0751967
3.No evidence of relapse during the 60 days prior to enrollment.
Description

3.No evidence of relapse during the 60 days prior to enrollment.

Data type

boolean

Alias
UMLS CUI [1]
C0035020
4. EDSS score of 0-5 at screening.
Description

4. EDSS score of 0-5 at screening.

Data type

boolean

Alias
UMLS CUI [1]
C0451246
5. Women of childbearing potential who have a negative pregnancy test (serum HCG) at screening.
Description

5. Women of childbearing potential who have a negative pregnancy test (serum HCG) at screening.

Data type

boolean

Alias
UMLS CUI [1]
C0427780
6. Men or women of reproductive potential who commit to use adequate contraception during the study and for 1 month following the last day of treatment.
Description

6. Men or women of reproductive potential who commit to use adequate contraception during the study and for 1 month following the last day of treatment.

Data type

boolean

Alias
UMLS CUI [1]
C0700589
7. Subjects must be capable of understanding the purpose and risks of the study and provide written, informed consent.
Description

7. Subjects must be capable of understanding the purpose and risks of the study and provide written, informed consent.

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
1. Diagnosis of Secondary Progressive MS, Primary Progressive MS or Progressive Relapsing MS.
Description

1. Diagnosis of Secondary Progressive MS, Primary Progressive MS or Progressive Relapsing MS.

Data type

boolean

Alias
UMLS CUI [1]
C0751965
2.Normal baseline brain MRI.
Description

2.Normal baseline brain MRI.

Data type

boolean

Alias
UMLS CUI [1]
C0412675
3. History of any clinically significant autoimmune disease: inflammatory bowel disease, diabetes, lupus or severe asthma.
Description

3. History of any clinically significant autoimmune disease: inflammatory bowel disease, diabetes, lupus or severe asthma.

Data type

boolean

Alias
UMLS CUI [1]
C0004364
4. Current or prior malignancies (excluding non-melanoma skin carcinoma or in situ carcinoma of the cervix that has been adequately treated.)
Description

4. Current or prior malignancies (excluding non-melanoma skin carcinoma or in situ carcinoma of the cervix that has been adequately treated.)

Data type

boolean

Alias
UMLS CUI [1]
C0006826
5. Significant organ dysfunction, including cardiac, renal (eGFR ≤ 60 ml/min.), liver, central nervous system, pulmonary, vascular, gastrointestinal, endocrine, or metabolic (e.g., creatinine ≥ 1.6 mg/dL; ALT or AST ≥ 1.5x the upper limit of normal), history of myocardial infarction, congestive heart failure, or arrhythmias within 6 months prior to enrollment.the upper limit of normal), history of myocardial infarction, congestive heart failure, or arrhythmias within 6 months prior to enrollment.
Description

5. Significant organ dysfunction, including cardiac, renal (eGFR ≤ 60 ml/min.), liver, central nervous system, pulmonary, vascular, gastrointestinal, endocrine, or metabolic (e.g., creatinine ≥ 1.6 mg/dL; ALT or AST ≥ 1.5x the upper limit of normal), history of myocardial infarction, congestive heart failure, or arrhythmias within 6 months prior to enrollment.the upper limit of normal), history of myocardial infarction, congestive heart failure, or arrhythmias within 6 months prior to enrollment.

Data type

boolean

Alias
UMLS CUI [1]
C0026766
6. Steroid therapy within 60 days prior to enrollment, with the exception of corticosteroids or ACTH for relapse treatment during the course of the study.
Description

6. Steroid therapy within 60 days prior to enrollment, with the exception of corticosteroids or ACTH for relapse treatment during the course of the study.

Data type

boolean

Alias
UMLS CUI [1]
C0149783
7. Known allergy to Gadolinium-DTPA
Description

7. Known allergy to Gadolinium-DTPA

Data type

boolean

Alias
UMLS CUI [1]
C0020517
8. Therapy with any immunomodulatory drugs within 3 months prior to enrollment, including but not limited to interferons, glatiramir acetate, BG-12, teriflunomide, laquinimod and IV immunoglobulin.
Description

8. Therapy with any immunomodulatory drugs within 3 months prior to enrollment, including but not limited to interferons, glatiramir acetate, BG-12, teriflunomide, laquinimod and IV immunoglobulin.

Data type

boolean

Alias
UMLS CUI [1]
C3640099
9. Treatment at any time with immunosuppressive drugs such as cladribine, total lymphoid irradiation, monoclonal antibody treatment, mitoxantrone, Tysabri, fingolimod, cytoxan, methotrexate.
Description

9. Treatment at any time with immunosuppressive drugs such as cladribine, total lymphoid irradiation, monoclonal antibody treatment, mitoxantrone, Tysabri, fingolimod, cytoxan, methotrexate.

Data type

boolean

Alias
UMLS CUI [1]
C0021081
10. Participation in any investigational therapy within one year prior to enrollment, unless given approval by PI.
Description

10. Participation in any investigational therapy within one year prior to enrollment, unless given approval by PI.

Data type

boolean

Alias
UMLS CUI [1]
C0679823
11. Known or suspected current or past alcohol or drug abuse within one year prior to enrollment.
Description

11. Known or suspected current or past alcohol or drug abuse within one year prior to enrollment.

Data type

boolean

Alias
UMLS CUI [1]
C0013146
12. Any medical, psychiatric or other condition that could result in a subject not being able to comply with protocol requirements.
Description

12. Any medical, psychiatric or other condition that could result in a subject not being able to comply with protocol requirements.

Data type

boolean

Alias
UMLS CUI [1]
C0205476
UMLS CUI [2]
C0348080
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Similar models

Eligibility Relapsing Remitting Multiple Sclerosis NCT01714089

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
age
Item
1. Males or females, aged between 18 and 50 years.
boolean
C0001779 (UMLS CUI [1])
Relapsing Remitting Multiple Sclerosis
Item
2. Diagnosis of RR-MS according to McDonald 2010 diagnostic criteria with a prior brain MRI that demonstrates lesions consistent with RRMS, both within the past year.
boolean
C0751967 (UMLS CUI [1])
relapse
Item
3.No evidence of relapse during the 60 days prior to enrollment.
boolean
C0035020 (UMLS CUI [1])
edss score
Item
4. EDSS score of 0-5 at screening.
boolean
C0451246 (UMLS CUI [1])
Pregnancy test negative
Item
5. Women of childbearing potential who have a negative pregnancy test (serum HCG) at screening.
boolean
C0427780 (UMLS CUI [1])
contraception
Item
6. Men or women of reproductive potential who commit to use adequate contraception during the study and for 1 month following the last day of treatment.
boolean
C0700589 (UMLS CUI [1])
informed consent
Item
7. Subjects must be capable of understanding the purpose and risks of the study and provide written, informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Secondary Progressive MS
Item
1. Diagnosis of Secondary Progressive MS, Primary Progressive MS or Progressive Relapsing MS.
boolean
C0751965 (UMLS CUI [1])
brain mri
Item
2.Normal baseline brain MRI.
boolean
C0412675 (UMLS CUI [1])
autoimmune disease
Item
3. History of any clinically significant autoimmune disease: inflammatory bowel disease, diabetes, lupus or severe asthma.
boolean
C0004364 (UMLS CUI [1])
malignancies
Item
4. Current or prior malignancies (excluding non-melanoma skin carcinoma or in situ carcinoma of the cervix that has been adequately treated.)
boolean
C0006826 (UMLS CUI [1])
Multiple Organ Failure
Item
5. Significant organ dysfunction, including cardiac, renal (eGFR ≤ 60 ml/min.), liver, central nervous system, pulmonary, vascular, gastrointestinal, endocrine, or metabolic (e.g., creatinine ≥ 1.6 mg/dL; ALT or AST ≥ 1.5x the upper limit of normal), history of myocardial infarction, congestive heart failure, or arrhythmias within 6 months prior to enrollment.the upper limit of normal), history of myocardial infarction, congestive heart failure, or arrhythmias within 6 months prior to enrollment.
boolean
C0026766 (UMLS CUI [1])
Steroid therapy
Item
6. Steroid therapy within 60 days prior to enrollment, with the exception of corticosteroids or ACTH for relapse treatment during the course of the study.
boolean
C0149783 (UMLS CUI [1])
allergy
Item
7. Known allergy to Gadolinium-DTPA
boolean
C0020517 (UMLS CUI [1])
immunomodulatory drugs
Item
8. Therapy with any immunomodulatory drugs within 3 months prior to enrollment, including but not limited to interferons, glatiramir acetate, BG-12, teriflunomide, laquinimod and IV immunoglobulin.
boolean
C3640099 (UMLS CUI [1])
immunosuppressive agent
Item
9. Treatment at any time with immunosuppressive drugs such as cladribine, total lymphoid irradiation, monoclonal antibody treatment, mitoxantrone, Tysabri, fingolimod, cytoxan, methotrexate.
boolean
C0021081 (UMLS CUI [1])
Participation
Item
10. Participation in any investigational therapy within one year prior to enrollment, unless given approval by PI.
boolean
C0679823 (UMLS CUI [1])
drug abuse
Item
11. Known or suspected current or past alcohol or drug abuse within one year prior to enrollment.
boolean
C0013146 (UMLS CUI [1])
medical; condition
Item
12. Any medical, psychiatric or other condition that could result in a subject not being able to comply with protocol requirements.
boolean
C0205476 (UMLS CUI [1])
C0348080 (UMLS CUI [2])
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