ID

44373

Descrição

Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis Treated With Copaxone®; ODM derived from: https://clinicaltrials.gov/show/NCT02499900

Link

https://clinicaltrials.gov/show/NCT02499900

Palavras-chave

Versões (2)
  1. 19/05/2019 19/05/2019 -
  2. 20/09/2021 20/09/2021 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

20 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT02499900

Inglês

Eligibility Multiple Sclerosis NCT02499900

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. men or women at least 18 years of age or older.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
2. patients must have a confirmed and documented rrms diagnosis
Descrição

Multiple Sclerosis, Relapsing-Remitting

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0751967
3. patients must be ambulatory with a kurtzke edss score of 0 to 5.5 at screening visit.
Descrição

Ambulatory | EDSS

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0439841
UMLS CUI [2]
C0451246
4. patients must be in a stable neurological condition, relapse-free and free of any corticosteroid treatment 30 days prior to randomization.
Descrição

Condition Neurological Stable | Relapse Free of | Steroid therapy Free of

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0205494
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0035020
UMLS CUI [2,2]
C0332296
UMLS CUI [3,1]
C0149783
UMLS CUI [3,2]
C0332296
5. women of child-bearing potential must have a negative urine pregnancy test at screening visit and must practice an acceptable method of birth
Descrição

Childbearing Potential Urine pregnancy test negative | Childbearing Potential Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430057
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
6. patients must be able to sign and date a written informed consent prior to entering the study.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
7. patients must be willing and able to comply with the protocol requirements for the duration of the study.
Descrição

Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patient had any contraindication to copaxone therapy.
Descrição

Medical contraindication Copaxone

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0528175
2. previous use of copaxone 40 mg/ml three times per week.
Descrição

Copaxone Dose times/week

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0528175
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0456698
3. patients with progressive forms of ms.
Descrição

Progressive multiple sclerosis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0393665
4. patients with neuromyelitis optica.
Descrição

Neuromyelitis Optica

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027873
5. use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening.
Descrição

Investigational New Drugs | Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2348568
6. patients who have been treated with; immunosuppressive medications, immunoglobulins and/or monoclonal antibodies, alemtuzumab, cladribine, cyclophosphamide or mitoxantrone at any time
Descrição

Immunosuppressive Agents | Immunoglobulins | Monoclonal Antibodies | alemtuzumab | Cladribine | Cyclophosphamide | Mitoxantrone

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C0021027
UMLS CUI [3]
C0003250
UMLS CUI [4]
C0383429
UMLS CUI [5]
C0092801
UMLS CUI [6]
C0010583
UMLS CUI [7]
C0026259
7. chronic (more than 30 consecutive days) systemic (iv, po or im) corticosteroid treatment within 6 months prior to screening visit.
Descrição

Systemic Corticosteroid Therapy Intravenous chronic | Systemic Corticosteroid Therapy Oral chronic | Systemic Corticosteroid Therapy Intramuscular chronic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C4053960
UMLS CUI [1,2]
C1522726
UMLS CUI [1,3]
C0205191
UMLS CUI [2,1]
C4053960
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C0205191
UMLS CUI [3,1]
C4053960
UMLS CUI [3,2]
C1556154
UMLS CUI [3,3]
C0205191
8. pregnancy or breastfeeding.
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
9. clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation
Descrição

Medical condition Study Subject Participation Status Excluded | Operative Surgical Procedures Study Subject Participation Status Excluded

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0332196
10. employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals
Descrição

Employee Clinical Study Site | Individuals Involvement with Clinical Trial | Family member Involvement with Clinical Trial

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0599987
UMLS CUI [1,2]
C2347790
UMLS CUI [2,1]
C0027361
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0008976
UMLS CUI [3,1]
C0086282
UMLS CUI [3,2]
C1314939
UMLS CUI [3,3]
C0008976
other criteria may apply, please contact the investigator for more information
Descrição

Eligibility Criteria Additional

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1524062
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Similar models

Eligibility Multiple Sclerosis NCT02499900

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. men or women at least 18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Multiple Sclerosis, Relapsing-Remitting
Item
2. patients must have a confirmed and documented rrms diagnosis
boolean
C0751967 (UMLS CUI [1])
Ambulatory | EDSS
Item
3. patients must be ambulatory with a kurtzke edss score of 0 to 5.5 at screening visit.
boolean
C0439841 (UMLS CUI [1])
C0451246 (UMLS CUI [2])
Condition Neurological Stable | Relapse Free of | Steroid therapy Free of
Item
4. patients must be in a stable neurological condition, relapse-free and free of any corticosteroid treatment 30 days prior to randomization.
boolean
C0348080 (UMLS CUI [1,1])
C0205494 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0035020 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C0149783 (UMLS CUI [3,1])
C0332296 (UMLS CUI [3,2])
Childbearing Potential Urine pregnancy test negative | Childbearing Potential Contraceptive methods
Item
5. women of child-bearing potential must have a negative urine pregnancy test at screening visit and must practice an acceptable method of birth
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Informed Consent
Item
6. patients must be able to sign and date a written informed consent prior to entering the study.
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
7. patients must be willing and able to comply with the protocol requirements for the duration of the study.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Copaxone
Item
1. patient had any contraindication to copaxone therapy.
boolean
C1301624 (UMLS CUI [1,1])
C0528175 (UMLS CUI [1,2])
Copaxone Dose times/week
Item
2. previous use of copaxone 40 mg/ml three times per week.
boolean
C0528175 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0456698 (UMLS CUI [1,3])
Progressive multiple sclerosis
Item
3. patients with progressive forms of ms.
boolean
C0393665 (UMLS CUI [1])
Neuromyelitis Optica
Item
4. patients with neuromyelitis optica.
boolean
C0027873 (UMLS CUI [1])
Investigational New Drugs | Study Subject Participation Status
Item
5. use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening.
boolean
C0013230 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
Immunosuppressive Agents | Immunoglobulins | Monoclonal Antibodies | alemtuzumab | Cladribine | Cyclophosphamide | Mitoxantrone
Item
6. patients who have been treated with; immunosuppressive medications, immunoglobulins and/or monoclonal antibodies, alemtuzumab, cladribine, cyclophosphamide or mitoxantrone at any time
boolean
C0021081 (UMLS CUI [1])
C0021027 (UMLS CUI [2])
C0003250 (UMLS CUI [3])
C0383429 (UMLS CUI [4])
C0092801 (UMLS CUI [5])
C0010583 (UMLS CUI [6])
C0026259 (UMLS CUI [7])
Systemic Corticosteroid Therapy Intravenous chronic | Systemic Corticosteroid Therapy Oral chronic | Systemic Corticosteroid Therapy Intramuscular chronic
Item
7. chronic (more than 30 consecutive days) systemic (iv, po or im) corticosteroid treatment within 6 months prior to screening visit.
boolean
C4053960 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C4053960 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
C4053960 (UMLS CUI [3,1])
C1556154 (UMLS CUI [3,2])
C0205191 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
8. pregnancy or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medical condition Study Subject Participation Status Excluded | Operative Surgical Procedures Study Subject Participation Status Excluded
Item
9. clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
Employee Clinical Study Site | Individuals Involvement with Clinical Trial | Family member Involvement with Clinical Trial
Item
10. employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals
boolean
C0599987 (UMLS CUI [1,1])
C2347790 (UMLS CUI [1,2])
C0027361 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C0086282 (UMLS CUI [3,1])
C1314939 (UMLS CUI [3,2])
C0008976 (UMLS CUI [3,3])
Eligibility Criteria Additional
Item
other criteria may apply, please contact the investigator for more information
boolean
C1516637 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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