ID

13614

Descripción

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

Palabras clave

  1. 19/2/16 19/2/16 -
  2. 13/4/21 13/4/21 - Dr. rer. medic Philipp Neuhaus
  3. 28/9/21 28/9/21 - Sarah Riepenhausen
Subido en

19 de febrero de 2016

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Multiple Sclerosis NCT00004816

Eligibility Multiple Sclerosis NCT00004816

Criteria
Descripción

Criteria

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

chronic, advanced, progressive multiple sclerosis

Tipo de datos

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
Descripción

prior biological therapy

Tipo de datos

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
Descripción

prior chemotherapy

Tipo de datos

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
Descripción

prior endocrine therapy

Tipo de datos

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
Descripción

prior radiotherapy

Tipo de datos

boolean

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

investigational drugs

Tipo de datos

boolean

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

age

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

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

Tipo de datos

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

Similar models

Eligibility Multiple Sclerosis NCT00004816

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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