ID

34519

Descripción

A Study of Tocilizumab in Combination With an Oral Contraceptive in Patients With Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01044498

Link

https://clinicaltrials.gov/show/NCT01044498

Palabras clave

Versiones (1)
  1. 18/1/19 18/1/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

18 de enero de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT01044498

Inglés

Eligibility Rheumatoid Arthritis NCT01044498

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients with child bearing potential, 18-44 years of age.
Descripción

Adult | Childbearing Potential | Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C3831118
UMLS CUI [3]
C0001779
rheumatoid arthritis (ra) for over 6 months duration.
Descripción

Rheumatoid Arthritis Disease length

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0872146
on oral contraceptive without interruption for at least 3 months with normal cycle control.
Descripción

Contraceptives, Oral | Cycle Control Normal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009905
UMLS CUI [2,1]
C0025329
UMLS CUI [2,2]
C2587213
UMLS CUI [2,3]
C0205307
treatment with disease-modifying anth-rheumatic drugs (dmard) for at least 12 weeks prior to study start.
Descripción

DMARD

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0242708
body weight < 150 kg.
Descripción

Body Weight

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005910
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
functional class iv rheumatoid arthritis (american college of rheumatology [acr] classification).
Descripción

American College of Rheumatology Criteria for Improvement in Rheumatoid Arthritis Functional Status Class

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3273740
UMLS CUI [1,2]
C0598463
UMLS CUI [1,3]
C0456387
history of amenorrhea (unrelated to pregnancy).
Descripción

Amenorrhea | Independent of Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0002453
UMLS CUI [2,1]
C0332291
UMLS CUI [2,2]
C0032961
history or current inflammatory joint disease other than ra.
Descripción

Inflammatory joint disease | Exception Rheumatoid Arthritis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0683381
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003873
rheumatic autoimmune disease other than ra.
Descripción

Autoimmune Disease Rheumatic | Exception Rheumatoid Arthritis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C0035435
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003873
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Similar models

Eligibility Rheumatoid Arthritis NCT01044498

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Childbearing Potential | Age
Item
adult patients with child bearing potential, 18-44 years of age.
boolean
C0001675 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Rheumatoid Arthritis Disease length
Item
rheumatoid arthritis (ra) for over 6 months duration.
boolean
C0003873 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Contraceptives, Oral | Cycle Control Normal
Item
on oral contraceptive without interruption for at least 3 months with normal cycle control.
boolean
C0009905 (UMLS CUI [1])
C0025329 (UMLS CUI [2,1])
C2587213 (UMLS CUI [2,2])
C0205307 (UMLS CUI [2,3])
DMARD
Item
treatment with disease-modifying anth-rheumatic drugs (dmard) for at least 12 weeks prior to study start.
boolean
C0242708 (UMLS CUI [1])
Body Weight
Item
body weight < 150 kg.
boolean
C0005910 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
American College of Rheumatology Criteria for Improvement in Rheumatoid Arthritis Functional Status Class
Item
functional class iv rheumatoid arthritis (american college of rheumatology [acr] classification).
boolean
C3273740 (UMLS CUI [1,1])
C0598463 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
Amenorrhea | Independent of Pregnancy
Item
history of amenorrhea (unrelated to pregnancy).
boolean
C0002453 (UMLS CUI [1])
C0332291 (UMLS CUI [2,1])
C0032961 (UMLS CUI [2,2])
Inflammatory joint disease | Exception Rheumatoid Arthritis
Item
history or current inflammatory joint disease other than ra.
boolean
C0683381 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
Autoimmune Disease Rheumatic | Exception Rheumatoid Arthritis
Item
rheumatic autoimmune disease other than ra.
boolean
C0004364 (UMLS CUI [1,1])
C0035435 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
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