ID

13614

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT00004816

Keywords

versioni (3)
  1. 19/02/16 19/02/16 -
  2. 13/04/21 13/04/21 - Dr. rer. medic Philipp Neuhaus
  3. 28/09/21 28/09/21 - Sarah Riepenhausen
Caricato su

19 febbraio 2016

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00004816

Inglese

Eligibility Multiple Sclerosis NCT00004816

1 moduli  
Criteria
Descrizione

Criteria

diagnosis of chronic, advanced, progressive multiple sclerosis (ms)
Descrizione

chronic, advanced, progressive multiple sclerosis

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0393665
UMLS CUI [1,2]
C0679246
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
Descrizione

prior biological therapy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C3831519
UMLS CUI [3]
C2916903
UMLS CUI [4]
C0312594
chemotherapy: no concomitant chemotherapy at least 3 months since prior chemotherapy
Descrizione

prior chemotherapy

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0392920
endocrine therapy: no concomitant steroidal therapy at least 3 months since prior steroidal therapy
Descrizione

prior endocrine therapy

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0038317
radiotherapy: no total lymphoid irradiation prior to study no concomitant radiotherapy at least 3 months since prior radiotherapy
Descrizione

prior radiotherapy

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1522449
other: no use of investigational drugs within 30 days prior to study
Descrizione

investigational drugs

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0013230
age: 21 to 75
Descrizione

age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
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
Descrizione

hemoglobin, wbc, granulocyte count, platelet count, cd4+ lymphocyte count

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0019046
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0857490
UMLS CUI [4]
C0005821
UMLS CUI [5]
C1277776
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
Descrizione

pregnancy, breast feeding, contraception, substance use disorder, hiv, aids-related complex, comorbidity

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0700589
UMLS CUI [4,1]
C0038586
UMLS CUI [4,2]
 C0019682
UMLS CUI [5]
C0009488
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Similar models

Eligibility Multiple Sclerosis NCT00004816

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
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])
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])
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])
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])
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])
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])
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])
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