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ID
36513
Beschreibung
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
Stichworte
Versionen (2)
- 19.05.19 19.05.19 -
- 20.09.21 20.09.21 -
Rechteinhaber
See clinicaltrials.gov
Hochgeladen am
19. Mai 2019
DOI
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Lizenz
Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT02499900
Eligibility Multiple Sclerosis NCT02499900
- StudyEvent: Eligibility
Ähnliche Modelle
Eligibility Multiple Sclerosis NCT02499900
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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])
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])
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])
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])
Medical contraindication Copaxone
Item
1. patient had any contraindication to copaxone therapy.
boolean
C1301624 (UMLS CUI [1,1])
C0528175 (UMLS CUI [1,2])
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])
C0178602 (UMLS CUI [1,2])
C0456698 (UMLS CUI [1,3])
Progressive multiple sclerosis
Item
3. patients with progressive forms of ms.
boolean
C1095979 (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])
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])
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])
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])
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])
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])
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])
C1524062 (UMLS CUI [1,2])