ID

19228

Descrição

Leflunomide + Methotrexate in Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00563849

Link

https://clinicaltrials.gov/show/NCT00563849

Palavras-chave

Versões (1)
  1. 13/12/2016 13/12/2016 -
Transferido a

13 de dezembro de 2016

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00563849

Inglês

Eligibility Rheumatoid Arthritis NCT00563849

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female between ages of 18 and 75 years old.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
female subjects must be of nonchildbearing potential (i.e., surgically sterile or at least 2 years postmenopausal) or their participation is contingent upon the following:
Descrição

Female Sterilization | Postmenopausal state

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0015787
UMLS CUI [2]
C0232970
they are practicing a medically accepted contraceptive regimen (acceptable methods must include one of the following: systemic contraceptive, oral or implanted estrogen/progestin; diaphragm with intravaginal spermicide; cervical cap; intrauterine device; or condom with intravaginal spermicide) and
Descrição

Gender Contraceptive methods | CONTRACEPTIVES,SYSTEMIC | Estrogens Oral | Progestins Oral | Estrogens Contraceptive implant | Progestins Contraceptive implant | Vaginal contraceptive diaphragm | Vaginal Spermicides | CERVICAL CAP FOR CONTRACEPTIVE USE | Intrauterine Devices | Female Condoms

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C1874923
UMLS CUI [3,1]
C0014939
UMLS CUI [3,2]
C1527415
UMLS CUI [4,1]
C0033306
UMLS CUI [4,2]
C1527415
UMLS CUI [5,1]
C0014939
UMLS CUI [5,2]
C1657106
UMLS CUI [6,1]
C0033306
UMLS CUI [6,2]
C1657106
UMLS CUI [7]
C0042241
UMLS CUI [8]
C0087145
UMLS CUI [9]
C0493327
UMLS CUI [10]
C0021900
UMLS CUI [11]
C0221829
they are demonstrated not to be pregnant (by serum pregnancy test) or breast-feeding at the time of study entry and
Descrição

Pregnancy | Breast Feeding | Serum pregnancy test negative

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0430061
they intend to continue the contraceptive regimen and remain not pregnant throughout the study and
Descrição

Contraceptive methods Continue intended | Pregnancy avoidance intended

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C1283828
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0870186
UMLS CUI [2,3]
C1283828
they are willing to undergo pregnancy testing (serum) at screening and (urine) monthly thereafter and
Descrição

Serum pregnancy test Willing | Urine pregnancy test Willing

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0430064
UMLS CUI [1,2]
C0600109
UMLS CUI [2,1]
C0430056
UMLS CUI [2,2]
C0600109
they are fully informed as to the risks of entering the trial and provide written consent to enter the trial; female patients not sexually active should also be adequately informed about appropriate methods of contraception and
Descrição

Informed Consent | Gender Contraceptive methods Informed

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C1522154
they agree to not get pregnant for 24 months after discontinuation of treatment with study medication or they undergo a washout procedure with cholestyramine or charcoal.
Descrição

Pregnancy avoidance Agreement | Washout Cholestyramine | Washout Charcoal

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0870186
UMLS CUI [1,3]
C0680240
UMLS CUI [2,1]
C1710661
UMLS CUI [2,2]
C0008402
UMLS CUI [3,1]
C1710661
UMLS CUI [3,2]
C0007955
male subjects must consent to practice contraception during the study. the subject needs to have clinically diagnosed rheumatoid arthritis including diagnosis of ra by acr criteria greater than or = to 6 months prior to enrollment active disease by acr criteria . men wishing to father a child should consider discontinuing use of study drug and taking cholestyramine 8 gm 3 times daily for 11 days. in addition, males should consider discontinuation of methotrexate treatment and waiting an additional three months.
Descrição

Gender Contraceptive methods | Rheumatoid Arthritis | Investigational New Drug Discontinue | Cholestyramine | Methotrexate Discontinue

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0003873
UMLS CUI [3,1]
C0013230
UMLS CUI [3,2]
C1444662
UMLS CUI [4]
C0008402
UMLS CUI [5,1]
C0025677
UMLS CUI [5,2]
C1444662
active disease by acr criteria despite methotrexate therapy for three of the following four criteria:
Descrição

Active disease | Methotrexate

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2707252
UMLS CUI [2]
C0025677
greater than or = to 9 tender joints
Descrição

Joints tender Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0240094
UMLS CUI [1,2]
C1265611
greater than or = to 6 swollen joints
Descrição

Joints swollen Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0152031
UMLS CUI [1,2]
C1265611
greater than or = to 45 minutes of morning stiffness
Descrição

Morning stiffness Duration

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0457086
UMLS CUI [1,2]
C0449238
esr greater than or = to 28mm/hr
Descrição

Erythrocyte sedimentation rate measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1176468
subject must remain on unchanged doses of nsaids for at least 4 weeks prior to study drug administration and throughout the timecourse of the study.
Descrição

Non-Steroidal Anti-Inflammatory Agents Dose unchanged

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0442739
concomitant therapy will be permitted with corticosteroids at a dose of less than or = to 10 mg prednisone daily (or the steroid equivalent administered orally), provided the dose has been stable for at least 4 weeks prior to the study drug administration; dose must remain constant throughout the timecourse of the study.
Descrição

Adrenal Cortex Hormones | Prednisone | Oral steroid therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2]
C0032952
UMLS CUI [3]
C0574135
subjects must not receive intramuscular, intra-articular or intravenous corticosteroids within 4 weeks prior to initiating study participation or during the study.
Descrição

Adrenal Cortex Hormones Intramuscular | intraarticular injection of corticosteroids | Adrenal Cortex Hormones Intravenous

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1556154
UMLS CUI [2]
C2064783
UMLS CUI [3,1]
C0001617
UMLS CUI [3,2]
C1522726
subjects must be able and willing to comply with the terms of this protocol. informed consent must be obtained for all subjects before enrollment in the study.
Descrição

Protocol Compliance | Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0021430
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Similar models

Eligibility Rheumatoid Arthritis NCT00563849

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female between ages of 18 and 75 years old.
boolean
C0001779 (UMLS CUI [1])
Female Sterilization | Postmenopausal state
Item
female subjects must be of nonchildbearing potential (i.e., surgically sterile or at least 2 years postmenopausal) or their participation is contingent upon the following:
boolean
C0015787 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
Gender Contraceptive methods | CONTRACEPTIVES,SYSTEMIC | Estrogens Oral | Progestins Oral | Estrogens Contraceptive implant | Progestins Contraceptive implant | Vaginal contraceptive diaphragm | Vaginal Spermicides | CERVICAL CAP FOR CONTRACEPTIVE USE | Intrauterine Devices | Female Condoms
Item
they are practicing a medically accepted contraceptive regimen (acceptable methods must include one of the following: systemic contraceptive, oral or implanted estrogen/progestin; diaphragm with intravaginal spermicide; cervical cap; intrauterine device; or condom with intravaginal spermicide) and
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1874923 (UMLS CUI [2])
C0014939 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0033306 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C0014939 (UMLS CUI [5,1])
C1657106 (UMLS CUI [5,2])
C0033306 (UMLS CUI [6,1])
C1657106 (UMLS CUI [6,2])
C0042241 (UMLS CUI [7])
C0087145 (UMLS CUI [8])
C0493327 (UMLS CUI [9])
C0021900 (UMLS CUI [10])
C0221829 (UMLS CUI [11])
Pregnancy | Breast Feeding | Serum pregnancy test negative
Item
they are demonstrated not to be pregnant (by serum pregnancy test) or breast-feeding at the time of study entry and
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0430061 (UMLS CUI [3])
Contraceptive methods Continue intended | Pregnancy avoidance intended
Item
they intend to continue the contraceptive regimen and remain not pregnant throughout the study and
boolean
C0700589 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C1283828 (UMLS CUI [1,3])
C0032961 (UMLS CUI [2,1])
C0870186 (UMLS CUI [2,2])
C1283828 (UMLS CUI [2,3])
Serum pregnancy test Willing | Urine pregnancy test Willing
Item
they are willing to undergo pregnancy testing (serum) at screening and (urine) monthly thereafter and
boolean
C0430064 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0430056 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
Informed Consent | Gender Contraceptive methods Informed
Item
they are fully informed as to the risks of entering the trial and provide written consent to enter the trial; female patients not sexually active should also be adequately informed about appropriate methods of contraception and
boolean
C0021430 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1522154 (UMLS CUI [2,3])
Pregnancy avoidance Agreement | Washout Cholestyramine | Washout Charcoal
Item
they agree to not get pregnant for 24 months after discontinuation of treatment with study medication or they undergo a washout procedure with cholestyramine or charcoal.
boolean
C0032961 (UMLS CUI [1,1])
C0870186 (UMLS CUI [1,2])
C0680240 (UMLS CUI [1,3])
C1710661 (UMLS CUI [2,1])
C0008402 (UMLS CUI [2,2])
C1710661 (UMLS CUI [3,1])
C0007955 (UMLS CUI [3,2])
Gender Contraceptive methods | Rheumatoid Arthritis | Investigational New Drug Discontinue | Cholestyramine | Methotrexate Discontinue
Item
male subjects must consent to practice contraception during the study. the subject needs to have clinically diagnosed rheumatoid arthritis including diagnosis of ra by acr criteria greater than or = to 6 months prior to enrollment active disease by acr criteria . men wishing to father a child should consider discontinuing use of study drug and taking cholestyramine 8 gm 3 times daily for 11 days. in addition, males should consider discontinuation of methotrexate treatment and waiting an additional three months.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0003873 (UMLS CUI [2])
C0013230 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C0008402 (UMLS CUI [4])
C0025677 (UMLS CUI [5,1])
C1444662 (UMLS CUI [5,2])
Active disease | Methotrexate
Item
active disease by acr criteria despite methotrexate therapy for three of the following four criteria:
boolean
C2707252 (UMLS CUI [1])
C0025677 (UMLS CUI [2])
Joints tender Quantity
Item
greater than or = to 9 tender joints
boolean
C0240094 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Joints swollen Quantity
Item
greater than or = to 6 swollen joints
boolean
C0152031 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Morning stiffness Duration
Item
greater than or = to 45 minutes of morning stiffness
boolean
C0457086 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Erythrocyte sedimentation rate measurement
Item
esr greater than or = to 28mm/hr
boolean
C1176468 (UMLS CUI [1])
Non-Steroidal Anti-Inflammatory Agents Dose unchanged
Item
subject must remain on unchanged doses of nsaids for at least 4 weeks prior to study drug administration and throughout the timecourse of the study.
boolean
C0003211 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
Adrenal Cortex Hormones | Prednisone | Oral steroid therapy
Item
concomitant therapy will be permitted with corticosteroids at a dose of less than or = to 10 mg prednisone daily (or the steroid equivalent administered orally), provided the dose has been stable for at least 4 weeks prior to the study drug administration; dose must remain constant throughout the timecourse of the study.
boolean
C0001617 (UMLS CUI [1])
C0032952 (UMLS CUI [2])
C0574135 (UMLS CUI [3])
Adrenal Cortex Hormones Intramuscular | intraarticular injection of corticosteroids | Adrenal Cortex Hormones Intravenous
Item
subjects must not receive intramuscular, intra-articular or intravenous corticosteroids within 4 weeks prior to initiating study participation or during the study.
boolean
C0001617 (UMLS CUI [1,1])
C1556154 (UMLS CUI [1,2])
C2064783 (UMLS CUI [2])
C0001617 (UMLS CUI [3,1])
C1522726 (UMLS CUI [3,2])
Protocol Compliance | Informed Consent
Item
subjects must be able and willing to comply with the terms of this protocol. informed consent must be obtained for all subjects before enrollment in the study.
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
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