ID

42947

Beskrivning

Rebif New Formulation (RNF) Quality of Life (QOL) Study; ODM derived from: https://clinicaltrials.gov/show/NCT00472797

Länk

https://clinicaltrials.gov/show/NCT00472797

Nyckelord

Versioner (2)
  1. 2017-08-28 2017-08-28 -
  2. 2021-09-17 2021-09-17 -
Uppladdad den

17 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Relapsing Multiple Sclerosis NCT00472797

Engelsk

Eligibility Relapsing Multiple Sclerosis NCT00472797

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subject with a relapsing form of ms; diagnosis of ms is in accordance with the mcdonald criteria
Beskrivning

Multiple Sclerosis, Relapsing-Remitting

Datatyp

boolean

Alias
UMLS CUI [1]
C0751967
2. subject currently taking rebif 44mcg tiw, and has been on this treatment for at least 6 months (24 weeks) prior to study enrollment
Beskrivning

Rebif

Datatyp

boolean

Alias
UMLS CUI [1]
C0752980
3. subject currently using rebiject ii and 29 gauge needle
Beskrivning

REBIJECT II | Needle Gauge

Datatyp

boolean

Alias
UMLS CUI [1]
C3473277
UMLS CUI [2]
C3640175
4. subject is between 18 and 60 years old inclusive
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
5. subject is able to read and understand english
Beskrivning

Able to read English Language | Comprehension English Language

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0233733
UMLS CUI [2,2]
C0376245
6. subject is willing to follow study procedures
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
7. subject has given written informed consent and signed hipaa
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
8. female subjects must not be either pregnant or breast-feeding and must lack childbearing potential, as defined by either: i) being post-menopausal or surgically sterile, or ii) using a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study. (confirmation required within 30 days prior to start of the study)
Beskrivning

Gender | Pregnancy Absent | Breast Feeding Absent | Childbearing Potential Lacking | Postmenopausal state | Female Sterilization | Hormonal contraception | Intrauterine Devices | Vaginal contraceptive diaphragm | Vaginal Spermicides | Female Condoms

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0006147
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0332268
UMLS CUI [5]
C0232970
UMLS CUI [6]
C0015787
UMLS CUI [7]
C2985296
UMLS CUI [8]
C0021900
UMLS CUI [9]
C0042241
UMLS CUI [10]
C0087145
UMLS CUI [11]
C0221829
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. use of any other injectable medications on a regular basis during the week prior to the screening period or during the screening or treatment periods. receiving a single injection for treatment or prophylaxis of a condition unrelated to the subject's multiple sclerosis or the subject's rebif® therapy (e.g., receiving a influenza or pneumococcus vaccination) is acceptable
Beskrivning

Injectables | Influenza vaccination Acceptable | Pneumococcal immunisation Acceptable

Datatyp

boolean

Alias
UMLS CUI [1]
C0086466
UMLS CUI [2,1]
C0042200
UMLS CUI [2,2]
C1879533
UMLS CUI [3,1]
C2082604
UMLS CUI [3,2]
C1879533
2. subject receiving ms therapy in addition (i.e., combination therapy) to rebif® within 3 months prior to study enrollment or at any time during study protocol.
Beskrivning

Combined Modality Therapy Multiple Sclerosis | Rebif

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009429
UMLS CUI [1,2]
C0026769
UMLS CUI [2]
C0752980
3. subjects who have previously been on rebif new formulation (rnf).
Beskrivning

Rebif Formulation New

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0752980
UMLS CUI [1,2]
C0524527
UMLS CUI [1,3]
C0205314
4. subject with progressive forms of multiple sclerosis (ms).
Beskrivning

Progressive multiple sclerosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0393665
5. subject with history of any chronic pain syndrome.
Beskrivning

Chronic pain syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C1298685
6. subject has any other disease apart from ms that could better explain the subjects signs and symptoms.
Beskrivning

Disease Explanation Signs and Symptoms

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0681841
UMLS CUI [1,3]
C0037088
7. subject has complete transverse myelitis or bilateral optic neuritis.
Beskrivning

Complete Transverse Myelitis | Bilateral optic neuritis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0026976
UMLS CUI [1,2]
C0205197
UMLS CUI [2]
C0861152
8. subjects that use any investigational drug or experimental procedure within 12 weeks of visit 1.
Beskrivning

Investigational New Drugs | Therapy, Investigational

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0949266
9. subject received oral or systemic corticosteroids or acth within 30 days of visit 1 (prior to enrollment).
Beskrivning

Adrenal Cortex Hormones Oral | CORTICOSTEROIDS FOR SYSTEMIC USE | Corticotropin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1527415
UMLS CUI [2]
C3653708
UMLS CUI [3]
C0001655
10. subject has inadequate liver function, defined by a total bilirubin, aspartate aminotransferase (ast) or alanine aminotransferase (alt) or alkaline phosphatase > 2.5 times the upper limit of the normal values.
Beskrivning

Liver Dysfunction | Elevated total bilirubin | Aspartate aminotransferase increased | Alanine aminotransferase increased | Alkaline phosphatase raised

Datatyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0741494
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0151905
UMLS CUI [5]
C0151849
11. subject has inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal.
Beskrivning

Few mature neutrophils in the bone marrow | White blood cell count decreased

Datatyp

boolean

Alias
UMLS CUI [1]
C2748959
UMLS CUI [2]
C0750394
12. subject suffers from other current autoimmune disease.
Beskrivning

Autoimmune Diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0004364
13. subject suffers from major medical or psychiatric illness that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the study protocol
Beskrivning

Illness Major At risk Patient | Mental disorders Major At risk Patient | Illness Major Affecting Protocol Compliance | Mental disorders Major Affecting Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C1444641
UMLS CUI [1,4]
C0030705
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205164
UMLS CUI [2,3]
C1444641
UMLS CUI [2,4]
C0030705
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C0205164
UMLS CUI [3,3]
C0392760
UMLS CUI [3,4]
C0525058
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0205164
UMLS CUI [4,3]
C0392760
UMLS CUI [4,4]
C0525058
14. subject is pregnant or attempting to conceive
Beskrivning

Pregnancy | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
15. visual or physical impairment that precludes completion of diaries and questionnaires.
Beskrivning

Visual Impairment Excludes Subject Diary Completion | Physical impairment Excludes Subject Diary Completion | Visual Impairment Excludes Questionnaires Completion | Physical impairment Excludes Questionnaires Completion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3665347
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C3890583
UMLS CUI [1,4]
C0205197
UMLS CUI [2,1]
C0231171
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C3890583
UMLS CUI [2,4]
C0205197
UMLS CUI [3,1]
C3665347
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0034394
UMLS CUI [3,4]
C0205197
UMLS CUI [4,1]
C0231171
UMLS CUI [4,2]
C0332196
UMLS CUI [4,3]
C0034394
UMLS CUI [4,4]
C0205197
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Similar models

Eligibility Relapsing Multiple Sclerosis NCT00472797

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis, Relapsing-Remitting
Item
1. subject with a relapsing form of ms; diagnosis of ms is in accordance with the mcdonald criteria
boolean
C0751967 (UMLS CUI [1])
Rebif
Item
2. subject currently taking rebif 44mcg tiw, and has been on this treatment for at least 6 months (24 weeks) prior to study enrollment
boolean
C0752980 (UMLS CUI [1])
REBIJECT II | Needle Gauge
Item
3. subject currently using rebiject ii and 29 gauge needle
boolean
C3473277 (UMLS CUI [1])
C3640175 (UMLS CUI [2])
Age
Item
4. subject is between 18 and 60 years old inclusive
boolean
C0001779 (UMLS CUI [1])
Able to read English Language | Comprehension English Language
Item
5. subject is able to read and understand english
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0233733 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
Protocol Compliance
Item
6. subject is willing to follow study procedures
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
7. subject has given written informed consent and signed hipaa
boolean
C0021430 (UMLS CUI [1])
Gender | Pregnancy Absent | Breast Feeding Absent | Childbearing Potential Lacking | Postmenopausal state | Female Sterilization | Hormonal contraception | Intrauterine Devices | Vaginal contraceptive diaphragm | Vaginal Spermicides | Female Condoms
Item
8. female subjects must not be either pregnant or breast-feeding and must lack childbearing potential, as defined by either: i) being post-menopausal or surgically sterile, or ii) using a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study. (confirmation required within 30 days prior to start of the study)
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0332268 (UMLS CUI [4,2])
C0232970 (UMLS CUI [5])
C0015787 (UMLS CUI [6])
C2985296 (UMLS CUI [7])
C0021900 (UMLS CUI [8])
C0042241 (UMLS CUI [9])
C0087145 (UMLS CUI [10])
C0221829 (UMLS CUI [11])
Item Group
C0680251 (UMLS CUI)
Injectables | Influenza vaccination Acceptable | Pneumococcal immunisation Acceptable
Item
1. use of any other injectable medications on a regular basis during the week prior to the screening period or during the screening or treatment periods. receiving a single injection for treatment or prophylaxis of a condition unrelated to the subject's multiple sclerosis or the subject's rebif® therapy (e.g., receiving a influenza or pneumococcus vaccination) is acceptable
boolean
C0086466 (UMLS CUI [1])
C0042200 (UMLS CUI [2,1])
C1879533 (UMLS CUI [2,2])
C2082604 (UMLS CUI [3,1])
C1879533 (UMLS CUI [3,2])
Combined Modality Therapy Multiple Sclerosis | Rebif
Item
2. subject receiving ms therapy in addition (i.e., combination therapy) to rebif® within 3 months prior to study enrollment or at any time during study protocol.
boolean
C0009429 (UMLS CUI [1,1])
C0026769 (UMLS CUI [1,2])
C0752980 (UMLS CUI [2])
Rebif Formulation New
Item
3. subjects who have previously been on rebif new formulation (rnf).
boolean
C0752980 (UMLS CUI [1,1])
C0524527 (UMLS CUI [1,2])
C0205314 (UMLS CUI [1,3])
Progressive multiple sclerosis
Item
4. subject with progressive forms of multiple sclerosis (ms).
boolean
C0393665 (UMLS CUI [1])
Chronic pain syndrome
Item
5. subject with history of any chronic pain syndrome.
boolean
C1298685 (UMLS CUI [1])
Disease Explanation Signs and Symptoms
Item
6. subject has any other disease apart from ms that could better explain the subjects signs and symptoms.
boolean
C0012634 (UMLS CUI [1,1])
C0681841 (UMLS CUI [1,2])
C0037088 (UMLS CUI [1,3])
Complete Transverse Myelitis | Bilateral optic neuritis
Item
7. subject has complete transverse myelitis or bilateral optic neuritis.
boolean
C0026976 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0861152 (UMLS CUI [2])
Investigational New Drugs | Therapy, Investigational
Item
8. subjects that use any investigational drug or experimental procedure within 12 weeks of visit 1.
boolean
C0013230 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
Adrenal Cortex Hormones Oral | CORTICOSTEROIDS FOR SYSTEMIC USE | Corticotropin
Item
9. subject received oral or systemic corticosteroids or acth within 30 days of visit 1 (prior to enrollment).
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C3653708 (UMLS CUI [2])
C0001655 (UMLS CUI [3])
Liver Dysfunction | Elevated total bilirubin | Aspartate aminotransferase increased | Alanine aminotransferase increased | Alkaline phosphatase raised
Item
10. subject has inadequate liver function, defined by a total bilirubin, aspartate aminotransferase (ast) or alanine aminotransferase (alt) or alkaline phosphatase > 2.5 times the upper limit of the normal values.
boolean
C0086565 (UMLS CUI [1])
C0741494 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151905 (UMLS CUI [4])
C0151849 (UMLS CUI [5])
Few mature neutrophils in the bone marrow | White blood cell count decreased
Item
11. subject has inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal.
boolean
C2748959 (UMLS CUI [1])
C0750394 (UMLS CUI [2])
Autoimmune Diseases
Item
12. subject suffers from other current autoimmune disease.
boolean
C0004364 (UMLS CUI [1])
Illness Major At risk Patient | Mental disorders Major At risk Patient | Illness Major Affecting Protocol Compliance | Mental disorders Major Affecting Protocol Compliance
Item
13. subject suffers from major medical or psychiatric illness that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the study protocol
boolean
C0221423 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0030705 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C0030705 (UMLS CUI [2,4])
C0221423 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
C0392760 (UMLS CUI [3,3])
C0525058 (UMLS CUI [3,4])
C0004936 (UMLS CUI [4,1])
C0205164 (UMLS CUI [4,2])
C0392760 (UMLS CUI [4,3])
C0525058 (UMLS CUI [4,4])
Pregnancy | Pregnancy, Planned
Item
14. subject is pregnant or attempting to conceive
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Visual Impairment Excludes Subject Diary Completion | Physical impairment Excludes Subject Diary Completion | Visual Impairment Excludes Questionnaires Completion | Physical impairment Excludes Questionnaires Completion
Item
15. visual or physical impairment that precludes completion of diaries and questionnaires.
boolean
C3665347 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C3890583 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
C0231171 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C3890583 (UMLS CUI [2,3])
C0205197 (UMLS CUI [2,4])
C3665347 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0034394 (UMLS CUI [3,3])
C0205197 (UMLS CUI [3,4])
C0231171 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C0034394 (UMLS CUI [4,3])
C0205197 (UMLS CUI [4,4])
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