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ID
13614
Description
A Maintenance Extension of Phase I Pilot Study of Chimeric Anti-CD4 Antibody M-T412 in Patients With Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00004816
Link
https://clinicaltrials.gov/show/NCT00004816
Keywords
Versions (3)
- 2016-02-19 2016-02-19 -
- 2021-04-13 2021-04-13 - Dr. rer. medic Philipp Neuhaus
- 2021-09-28 2021-09-28 - Sarah Riepenhausen
Uploaded on
19 februari 2016
DOI
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License
Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00004816
Eligibility Multiple Sclerosis NCT00004816
- StudyEvent: Eligibility
Similar models
Eligibility Multiple Sclerosis NCT00004816
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
chronic, advanced, progressive multiple sclerosis
Item
diagnosis of chronic, advanced, progressive multiple sclerosis (ms)
boolean
C0393665 (UMLS CUI [1,1])
C0679246 (UMLS CUI [1,2])
C0679246 (UMLS CUI [1,2])
prior biological therapy
Item
biologic therapy: no sensitivity to murine proteins no prior treatment at any time with anti-cd4 antibodies, other murine antibodies, or other anti-t cell antibodies (e.g., xenologous or human) at least 4 weeks since use of other biological agents
boolean
C1514463 (UMLS CUI [1])
C3831519 (UMLS CUI [2])
C2916903 (UMLS CUI [3])
C0312594 (UMLS CUI [4])
C3831519 (UMLS CUI [2])
C2916903 (UMLS CUI [3])
C0312594 (UMLS CUI [4])
prior chemotherapy
Item
chemotherapy: no concomitant chemotherapy at least 3 months since prior chemotherapy
boolean
C1514463 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,2])
prior endocrine therapy
Item
endocrine therapy: no concomitant steroidal therapy at least 3 months since prior steroidal therapy
boolean
C1514463 (UMLS CUI [1,1])
C0038317 (UMLS CUI [1,2])
C0038317 (UMLS CUI [1,2])
prior radiotherapy
Item
radiotherapy: no total lymphoid irradiation prior to study no concomitant radiotherapy at least 3 months since prior radiotherapy
boolean
C1514463 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C1522449 (UMLS CUI [1,2])
investigational drugs
Item
other: no use of investigational drugs within 30 days prior to study
boolean
C0013230 (UMLS CUI [1])
age
Item
age: 21 to 75
boolean
C0001779 (UMLS CUI [1])
hemoglobin, wbc, granulocyte count, platelet count, cd4+ lymphocyte count
Item
hematopoietic: hemoglobin at least 10 g/dl wbc at least 4000/mm3 granulocyte count at least 1500/mm3 platelet count at least 100,000/mm3 cd4+ lymphocyte count at least 300 cells/mm3
boolean
C0019046 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0857490 (UMLS CUI [3])
C0005821 (UMLS CUI [4])
C1277776 (UMLS CUI [5])
C0023508 (UMLS CUI [2])
C0857490 (UMLS CUI [3])
C0005821 (UMLS CUI [4])
C1277776 (UMLS CUI [5])
pregnancy, breast feeding, contraception, substance use disorder, hiv, aids-related complex, comorbidity
Item
other: not pregnant or lactating effective contraception required of fertile patients for 3 months prior to and during study no substance abuse (e.g., drug or alcohol) not hiv positive no aids-related complex (arc) no serum antibodies to hiv negative serum antibody test for hiv within 1 month prior to study no underlying medical or psychiatric condition
boolean
C0549206 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
C0038586 (UMLS CUI [4,1])
C0019682 (UMLS CUI [4,2])
C0009488 (UMLS CUI [5])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
C0038586 (UMLS CUI [4,1])
C0019682 (UMLS CUI [4,2])
C0009488 (UMLS CUI [5])