ID

43709

Beskrivning

RNF and Betaseron® Tolerability Study; ODM derived from: https://clinicaltrials.gov/show/NCT00428584

Länk

https://clinicaltrials.gov/show/NCT00428584

Nyckelord

Versioner (2)
  1. 2017-06-16 2017-06-16 -
  2. 2021-09-20 2021-09-20 -
Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Relapsing Remitting Multiple Sclerosis (RRMS) NCT00428584

Engelsk

Eligibility Relapsing Remitting Multiple Sclerosis (RRMS) NCT00428584

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subject with diagnosis of rrms according to mcdonald criteria or poser
Beskrivning

Multiple Sclerosis, Relapsing-Remitting

Datatyp

boolean

Alias
UMLS CUI [1]
C0751967
2. subject is between 18 and 60 years old inclusive
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
3. subject is willing to follow study procedures
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
4. subject has given written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
5. female subjects must be neither pregnant nor breast-feeding and must lack childbearing potential, as defined by either:
Beskrivning

Pregnancy Absent | Breast Feeding Absent | Childbearing Potential Lacking

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0332268
being post-menopausal or surgically sterile, or
Beskrivning

Postmenopausal state | Female Sterilization

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
using a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study.
Beskrivning

Hormonal contraception | Intrauterine Device | Vaginal contraceptive diaphragm | Vaginal Spermicides | Female Condom

Datatyp

boolean

Alias
UMLS CUI [1]
C2985296
UMLS CUI [2]
C0021900
UMLS CUI [3]
C0042241
UMLS CUI [4]
C0087145
UMLS CUI [5]
C0221829
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subject has clinically isolated syndrome (cis), primary progressive ms, or secondary progressive ms without superimposed relapses.
Beskrivning

Clinically isolated syndrome | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Secondary Progressive | Relapse Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C2921627
UMLS CUI [2]
C0751964
UMLS CUI [3]
C0751965
UMLS CUI [4,1]
C0035020
UMLS CUI [4,2]
C0332197
2. subject has had any prior interferon beta therapy (either beta-1b or beta-1a) prior to study day 1.
Beskrivning

Interferon-beta | interferon beta-1b | Interferon beta-1a

Datatyp

boolean

Alias
UMLS CUI [1]
C0015980
UMLS CUI [2]
C0244713
UMLS CUI [3]
C0254119
3. subject received any other approved disease modifying therapy for ms (glatiramer acetate) or any cytokine or anti-cytokine therapy within the 3 months prior to study day 1.
Beskrivning

Disease Modification Therapeutic procedure Multiple Sclerosis | glatiramer acetate | Cytokine therapy | anti-cytokine therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3840684
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C0026769
UMLS CUI [2]
C0289884
UMLS CUI [3]
C0199974
UMLS CUI [4]
C0281178
4. subject received immunomodulatory or immunosuppressive therapy (including but not limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide, mitoxantrone, teriflunomide, natalizumab, laquinimod, campath and cladribine) within the 12 months prior to study day 1.
Beskrivning

Immunomodulation | Therapeutic immunosuppression | Cyclophosphamide | Cyclosporine | Methotrexate | Azathioprine | Linomide | Mitoxantrone | teriflunomide | natalizumab | laquinimod | Campath | Cladribine

Datatyp

boolean

Alias
UMLS CUI [1]
C1963758
UMLS CUI [2]
C0021079
UMLS CUI [3]
C0010583
UMLS CUI [4]
C0010592
UMLS CUI [5]
C0025677
UMLS CUI [6]
C0004482
UMLS CUI [7]
C0950651
UMLS CUI [8]
C0026259
UMLS CUI [9]
C1718383
UMLS CUI [10]
C1172734
UMLS CUI [11]
C1260208
UMLS CUI [12]
C0939276
UMLS CUI [13]
C0092801
5. subject had prior use of cladribine or has previously received total lymphoid irradiation.
Beskrivning

Cladribine | Lymphatic Irradiation Total

Datatyp

boolean

Alias
UMLS CUI [1]
C0092801
UMLS CUI [2,1]
C0024230
UMLS CUI [2,2]
C0439810
6. subject has known allergy to natural or recombinant interferon or any other component of formulation excipient(s) of rebif® or betaseron®: mannitol, poloxamer 188, methionine, benzyl alcohol or albumin (human).
Beskrivning

Hypersensitivity interferon alfa natural | Hypersensitivity Recombinant Interferon | Hypersensitivity Rebif Excipient | Hypersensitivity Betaseron Excipient | Mannitol allergy | Hypersensitivity Poloxamer 188 | Hypersensitivity Methionine | Hypersensitivity Benzyl Alcohol | Hypersensitivity Albumin Human

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0002199
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1522537
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0752980
UMLS CUI [3,3]
C0015237
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0284968
UMLS CUI [4,3]
C0015237
UMLS CUI [5]
C0571922
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0600611
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0025646
UMLS CUI [8,1]
C0020517
UMLS CUI [8,2]
C0005100
UMLS CUI [9,1]
C0020517
UMLS CUI [9,2]
C0304925
7. 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® or betaseron® therapy (e.g. receiving a influenza or pneumococcus vaccination) is acceptable.
Beskrivning

Injectables Regular | Multiple Sclerosis | Rebif | Betaseron | Influenza vaccination | Pneumococcal vaccination

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0086466
UMLS CUI [1,2]
C0205272
UMLS CUI [2]
C0026769
UMLS CUI [3]
C0752980
UMLS CUI [4]
C0284968
UMLS CUI [5]
C0042200
UMLS CUI [6]
C0588097
8. history of any chronic pain syndrome.
Beskrivning

Chronic pain syndrome

Datatyp

boolean

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

Disease Has explanation Signs and Symptoms | Multiple Sclerosis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1562009
UMLS CUI [1,3]
C0037088
UMLS CUI [2]
C0026769
10. subject has complete transverse myelitis or bilateral optic neuritis.
Beskrivning

Transverse Myelitis Complete | Bilateral optic neuritis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0026976
UMLS CUI [1,2]
C0205197
UMLS CUI [2]
C0861152
11. subjects who used any investigational drug or experimental procedure within 12 weeks prior to visit 1.
Beskrivning

Investigational New Drugs | Therapy, Investigational

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0949266
12. 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

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

Datatyp

boolean

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

White blood cell count decreased

Datatyp

boolean

Alias
UMLS CUI [1]
C0750394
14. subject suffers from current autoimmune disease (other than rrms).
Beskrivning

Autoimmune Diseases | Multiple Sclerosis, Relapsing-Remitting

Datatyp

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0751967
15. 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 Study Subject | Mental disorder Major At risk Study Subject | Illness Major Affecting Protocol Compliance | Mental disorder 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]
C0681850
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205164
UMLS CUI [2,3]
C1444641
UMLS CUI [2,4]
C0681850
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
16. subject is pregnant or attempting to conceive
Beskrivning

Pregnancy | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
17. 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
18. subject received oral or systemic corticosteroids or acth within 30 days of visit 1.
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
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Similar models

Eligibility Relapsing Remitting Multiple Sclerosis (RRMS) NCT00428584

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis, Relapsing-Remitting
Item
1. subject with diagnosis of rrms according to mcdonald criteria or poser
boolean
C0751967 (UMLS CUI [1])
Age
Item
2. subject is between 18 and 60 years old inclusive
boolean
C0001779 (UMLS CUI [1])
Protocol Compliance
Item
3. subject is willing to follow study procedures
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
4. subject has given written informed consent
boolean
C0021430 (UMLS CUI [1])
Pregnancy Absent | Breast Feeding Absent | Childbearing Potential Lacking
Item
5. female subjects must be neither pregnant nor breast-feeding and must lack childbearing potential, as defined by either:
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
Postmenopausal state | Female Sterilization
Item
being post-menopausal or surgically sterile, or
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
Hormonal contraception | Intrauterine Device | Vaginal contraceptive diaphragm | Vaginal Spermicides | Female Condom
Item
using a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study.
boolean
C2985296 (UMLS CUI [1])
C0021900 (UMLS CUI [2])
C0042241 (UMLS CUI [3])
C0087145 (UMLS CUI [4])
C0221829 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Clinically isolated syndrome | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Secondary Progressive | Relapse Absent
Item
1. subject has clinically isolated syndrome (cis), primary progressive ms, or secondary progressive ms without superimposed relapses.
boolean
C2921627 (UMLS CUI [1])
C0751964 (UMLS CUI [2])
C0751965 (UMLS CUI [3])
C0035020 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Interferon-beta | interferon beta-1b | Interferon beta-1a
Item
2. subject has had any prior interferon beta therapy (either beta-1b or beta-1a) prior to study day 1.
boolean
C0015980 (UMLS CUI [1])
C0244713 (UMLS CUI [2])
C0254119 (UMLS CUI [3])
Disease Modification Therapeutic procedure Multiple Sclerosis | glatiramer acetate | Cytokine therapy | anti-cytokine therapy
Item
3. subject received any other approved disease modifying therapy for ms (glatiramer acetate) or any cytokine or anti-cytokine therapy within the 3 months prior to study day 1.
boolean
C0012634 (UMLS CUI [1,1])
C3840684 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0026769 (UMLS CUI [1,4])
C0289884 (UMLS CUI [2])
C0199974 (UMLS CUI [3])
C0281178 (UMLS CUI [4])
Immunomodulation | Therapeutic immunosuppression | Cyclophosphamide | Cyclosporine | Methotrexate | Azathioprine | Linomide | Mitoxantrone | teriflunomide | natalizumab | laquinimod | Campath | Cladribine
Item
4. subject received immunomodulatory or immunosuppressive therapy (including but not limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide, mitoxantrone, teriflunomide, natalizumab, laquinimod, campath and cladribine) within the 12 months prior to study day 1.
boolean
C1963758 (UMLS CUI [1])
C0021079 (UMLS CUI [2])
C0010583 (UMLS CUI [3])
C0010592 (UMLS CUI [4])
C0025677 (UMLS CUI [5])
C0004482 (UMLS CUI [6])
C0950651 (UMLS CUI [7])
C0026259 (UMLS CUI [8])
C1718383 (UMLS CUI [9])
C1172734 (UMLS CUI [10])
C1260208 (UMLS CUI [11])
C0939276 (UMLS CUI [12])
C0092801 (UMLS CUI [13])
Cladribine | Lymphatic Irradiation Total
Item
5. subject had prior use of cladribine or has previously received total lymphoid irradiation.
boolean
C0092801 (UMLS CUI [1])
C0024230 (UMLS CUI [2,1])
C0439810 (UMLS CUI [2,2])
Hypersensitivity interferon alfa natural | Hypersensitivity Recombinant Interferon | Hypersensitivity Rebif Excipient | Hypersensitivity Betaseron Excipient | Mannitol allergy | Hypersensitivity Poloxamer 188 | Hypersensitivity Methionine | Hypersensitivity Benzyl Alcohol | Hypersensitivity Albumin Human
Item
6. subject has known allergy to natural or recombinant interferon or any other component of formulation excipient(s) of rebif® or betaseron®: mannitol, poloxamer 188, methionine, benzyl alcohol or albumin (human).
boolean
C0020517 (UMLS CUI [1,1])
C0002199 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1522537 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0752980 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0284968 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
C0571922 (UMLS CUI [5])
C0020517 (UMLS CUI [6,1])
C0600611 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C0025646 (UMLS CUI [7,2])
C0020517 (UMLS CUI [8,1])
C0005100 (UMLS CUI [8,2])
C0020517 (UMLS CUI [9,1])
C0304925 (UMLS CUI [9,2])
Injectables Regular | Multiple Sclerosis | Rebif | Betaseron | Influenza vaccination | Pneumococcal vaccination
Item
7. 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® or betaseron® therapy (e.g. receiving a influenza or pneumococcus vaccination) is acceptable.
boolean
C0086466 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0026769 (UMLS CUI [2])
C0752980 (UMLS CUI [3])
C0284968 (UMLS CUI [4])
C0042200 (UMLS CUI [5])
C0588097 (UMLS CUI [6])
Chronic pain syndrome
Item
8. history of any chronic pain syndrome.
boolean
C1298685 (UMLS CUI [1])
Disease Has explanation Signs and Symptoms | Multiple Sclerosis
Item
9. subject has any other disease apart from ms that could better explain the subjects signs and symptoms.
boolean
C0012634 (UMLS CUI [1,1])
C1562009 (UMLS CUI [1,2])
C0037088 (UMLS CUI [1,3])
C0026769 (UMLS CUI [2])
Transverse Myelitis Complete | Bilateral optic neuritis
Item
10. 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
11. subjects who used any investigational drug or experimental procedure within 12 weeks prior to visit 1.
boolean
C0013230 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
Elevated total bilirubin | Aspartate aminotransferase increased | Alanine aminotransferase increased | Alkaline phosphatase raised
Item
12. 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
C0741494 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0151849 (UMLS CUI [4])
White blood cell count decreased
Item
13. subject has inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal.
boolean
C0750394 (UMLS CUI [1])
Autoimmune Diseases | Multiple Sclerosis, Relapsing-Remitting
Item
14. subject suffers from current autoimmune disease (other than rrms).
boolean
C0004364 (UMLS CUI [1])
C0751967 (UMLS CUI [2])
Illness Major At risk Study Subject | Mental disorder Major At risk Study Subject | Illness Major Affecting Protocol Compliance | Mental disorder Major Affecting Protocol Compliance
Item
15. 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])
C0681850 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C0681850 (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
16. 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
17. 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])
Adrenal Cortex Hormones Oral | CORTICOSTEROIDS FOR SYSTEMIC USE | Corticotropin
Item
18. subject received oral or systemic corticosteroids or acth within 30 days of visit 1.
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C3653708 (UMLS CUI [2])
C0001655 (UMLS CUI [3])
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