ID

42489

Beskrivning

Abatacept for Patients With Inflammatory Arthritis Associated With Sjögren's Syndrome: an Open-Label Phase II Study; ODM derived from: https://clinicaltrials.gov/show/NCT02027298

Länk

https://clinicaltrials.gov/show/NCT02027298

Nyckelord

Versioner (1)
  1. 2021-07-28 2021-07-28 -
Rättsinnehavare

The Cleveland Clinic Bristol-Myers Squibb

Uppladdad den

28 juli 2021

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Primary Sjogren's Syndrome NCT02027298

Engelsk

Eligibility Primary Sjogren's Syndrome NCT02027298

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of sjogren's syndrome
Beskrivning

Sjogren's syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C1527336
2. patients are at least 18 years or older
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
3. patients should have either pss and/or sss associated with ra, and must have active moderate to severe inflammatory arthritis as defined by painful joint counts (≥5) and swollen joint counts (≥5), or das28 scores>3.2.
Beskrivning

Primary Sjogren's syndrome | Secondary Sjogren's syndrome associated with RA | Active moderate to severe inflammatory arthritis | Arthralgia joint quantity | Swollen joint quantity | DAS28 score

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1527336
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C1299393
UMLS CUI [2,1]
C1527336
UMLS CUI [2,2]
C0175668
UMLS CUI [2,3]
C0003873
UMLS CUI [2,4]
C1299393
UMLS CUI [3,1]
C0003864
UMLS CUI [3,2]
C0205177
UMLS CUI [3,3]
C0679228
UMLS CUI [3,4]
C0152031
UMLS CUI [3,5]
C1265611
UMLS CUI [3,6]
C0003862
UMLS CUI [3,7]
C1265611
UMLS CUI [3,8]
C4481729
4. one non-biologic dmard will be permitted.
Beskrivning

Non-biologic DMARD quantity allowed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4054347
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0683607
5. these patients will be willing and able to comply with treatment and follow-up procedures.
Beskrivning

Ability and willingness to compliance behavior

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0600109
UMLS CUI [1,3]
C0085732
6. these patients will be willing and able to provide written informed consent.
Beskrivning

Ability and willingness to provide an informed consent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0600109
UMLS CUI [1,3]
C0085732
7. both women and men of child bearing age must be willing to use an effective means of birth control while receiving treatment throughout participation in this study. effective contraception methods include abstinence, oral contraceptives (birth control pills), iud, diaphragm, norplant, approved hormone injections, condoms, or medical sterilization.
Beskrivning

Subjects with a childbearing potential must be willing to use an effective means of birth control | Sexual abstinence | Oral contraceptives (birth control pills) | IUD | Diaphragm | Norplant | Approved hormone injections | Condoms | medical sterilization.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0600109
UMLS CUI [1,3]
C3831118
UMLS CUI [2]
C0009905
UMLS CUI [3]
C0036899
UMLS CUI [4]
C0042241
UMLS CUI [5]
C0021900
UMLS CUI [6]
C3842799
UMLS CUI [7]
C0677582
UMLS CUI [8]
C0015787
UMLS CUI [9]
C0024559
UMLS CUI [10,1]
C0199780
UMLS CUI [10,2]
C1272883
UMLS CUI [10,3]
C0205540
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients will be excluded if they have a concomitant disorder requiring systemic glucocorticoid (gc) therapy (prednisone >10 mg daily or gc equivalent), have organ-threatening features, and have any investigational drug including biologics within 28 days of study entry.
Beskrivning

Systemic glucocorticoid | Organ-threatening features | Recent use of investigational drug including biologics

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0744425
UMLS CUI [1,2]
C0205373
UMLS CUI [2,1]
C0678852
UMLS CUI [2,2]
C0749385
UMLS CUI [2,3]
C0009488
UMLS CUI [2,4]
C0231174
UMLS CUI [2,5]
C0035647
UMLS CUI [3,1]
C0304229
UMLS CUI [3,2]
C1531518
UMLS CUI [3,3]
C0332257
UMLS CUI [3,4]
C0332185
2. history of cancer or diabetes mellitus
Beskrivning

History of malignant neoplasms | History of diabetes mellitusa

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0006826
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0011849
3. use of tricyclic antidepressants or anticholinergics
Beskrivning

Tricyclic antidepressants | Anticholinergic agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0003290
UMLS CUI [2]
C0242896
4. evidence of active infection or chronic infection including human immunodeficiency virus (hiv), tuberculosis (tb), hepatitis c, or a positive hepatitis b surface antigen.
Beskrivning

Evidence of Communicable Diseases | HIV | TBC | Hepatitis C | Hepatitis B surface antigen

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0332120
UMLS CUI [2,1]
C0019699
UMLS CUI [2,2]
C0332120
UMLS CUI [3,1]
C0019168
UMLS CUI [3,2]
C1446409
UMLS CUI [3,3]
C0332120
UMLS CUI [4,1]
C2363789
UMLS CUI [4,2]
C1446409
UMLS CUI [4,3]
C0332120
UMLS CUI [5,1]
C0041296
UMLS CUI [5,2]
C0332120
5. patients with latent tb if not treated with isoniazid for at least 4 weeks prior to receiving the study drug
Beskrivning

Latent TBC if not treated with isoniasid recentely

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1609538
UMLS CUI [1,2]
C2827774
UMLS CUI [1,3]
C0022209
UMLS CUI [1,4]
C0332197
6. radiographic evidence of copd, emphysema, and/or interstitial lung disease.
Beskrivning

Evidence of copd | Emphysema | Interstitial lung disease.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024117
UMLS CUI [1,2]
C0332120
UMLS CUI [2,1]
C0034067
UMLS CUI [2,2]
C0332120
UMLS CUI [3,1]
C0206062
UMLS CUI [3,2]
C0332120
7. subjects who are pregnant or who are nursing infants
Beskrivning

Pregnancy | Breastfeeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
8. patients with cytopenia: platelet count <80,000/mm3, absolute neutrophil count<1500/mm3, hematocrit < 20%.
Beskrivning

Platelet count | Absolute neutrophil count | Hematocrit level

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518014
9. patients with renal insufficiency defined by a serum creatinine of greater than or equal to 2.0 mg/dl or creatinine clearance of less than or equal to 35 ml/min.
Beskrivning

Renal insufficiency defined by a serum creatinine or creatinine clearance

Datatyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0373595
10. use of illegal drugs.
Beskrivning

Substance use disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
11. a live vaccination fewer than 4 weeks before enrollment
Beskrivning

Attenuated Bacteria Vaccine recent | Attenuated Live Virus Vaccine recent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1879753
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C1516086
UMLS CUI [2,2]
C0332185
Tillbaka till toppen

Similar models

Eligibility Primary Sjogren's Syndrome NCT02027298

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Sjogren's syndrome
Item
1. diagnosis of sjogren's syndrome
boolean
C1527336 (UMLS CUI [1])
Age
Item
2. patients are at least 18 years or older
boolean
C0001779 (UMLS CUI [1])
Primary Sjogren's syndrome | Secondary Sjogren's syndrome associated with RA | Active moderate to severe inflammatory arthritis | Arthralgia joint quantity | Swollen joint quantity | DAS28 score
Item
3. patients should have either pss and/or sss associated with ra, and must have active moderate to severe inflammatory arthritis as defined by painful joint counts (≥5) and swollen joint counts (≥5), or das28 scores>3.2.
boolean
C1527336 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1299393 (UMLS CUI [1,3])
C1527336 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C0003873 (UMLS CUI [2,3])
C1299393 (UMLS CUI [2,4])
C0003864 (UMLS CUI [3,1])
C0205177 (UMLS CUI [3,2])
C0679228 (UMLS CUI [3,3])
C0152031 (UMLS CUI [3,4])
C1265611 (UMLS CUI [3,5])
C0003862 (UMLS CUI [3,6])
C1265611 (UMLS CUI [3,7])
C4481729 (UMLS CUI [3,8])
Non-biologic DMARD quantity allowed
Item
4. one non-biologic dmard will be permitted.
boolean
C4054347 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0683607 (UMLS CUI [1,3])
Ability and willingness to compliance behavior
Item
5. these patients will be willing and able to comply with treatment and follow-up procedures.
boolean
C1321605 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
Ability and willingness to provide an informed consent
Item
6. these patients will be willing and able to provide written informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
Subjects with a childbearing potential must be willing to use an effective means of birth control | Sexual abstinence | Oral contraceptives (birth control pills) | IUD | Diaphragm | Norplant | Approved hormone injections | Condoms | medical sterilization.
Item
7. both women and men of child bearing age must be willing to use an effective means of birth control while receiving treatment throughout participation in this study. effective contraception methods include abstinence, oral contraceptives (birth control pills), iud, diaphragm, norplant, approved hormone injections, condoms, or medical sterilization.
boolean
C0700589 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C3831118 (UMLS CUI [1,3])
C0009905 (UMLS CUI [2])
C0036899 (UMLS CUI [3])
C0042241 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C3842799 (UMLS CUI [6])
C0677582 (UMLS CUI [7])
C0015787 (UMLS CUI [8])
C0024559 (UMLS CUI [9])
C0199780 (UMLS CUI [10,1])
C1272883 (UMLS CUI [10,2])
C0205540 (UMLS CUI [10,3])
Item Group
C0680251 (UMLS CUI)
Systemic glucocorticoid | Organ-threatening features | Recent use of investigational drug including biologics
Item
1. patients will be excluded if they have a concomitant disorder requiring systemic glucocorticoid (gc) therapy (prednisone >10 mg daily or gc equivalent), have organ-threatening features, and have any investigational drug including biologics within 28 days of study entry.
boolean
C0744425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0678852 (UMLS CUI [2,1])
C0749385 (UMLS CUI [2,2])
C0009488 (UMLS CUI [2,3])
C0231174 (UMLS CUI [2,4])
C0035647 (UMLS CUI [2,5])
C0304229 (UMLS CUI [3,1])
C1531518 (UMLS CUI [3,2])
C0332257 (UMLS CUI [3,3])
C0332185 (UMLS CUI [3,4])
History of malignant neoplasms | History of diabetes mellitusa
Item
2. history of cancer or diabetes mellitus
boolean
C0262926 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0011849 (UMLS CUI [2,2])
Tricyclic antidepressants | Anticholinergic agents
Item
3. use of tricyclic antidepressants or anticholinergics
boolean
C0003290 (UMLS CUI [1])
C0242896 (UMLS CUI [2])
Evidence of Communicable Diseases | HIV | TBC | Hepatitis C | Hepatitis B surface antigen
Item
4. evidence of active infection or chronic infection including human immunodeficiency virus (hiv), tuberculosis (tb), hepatitis c, or a positive hepatitis b surface antigen.
boolean
C0009450 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0019699 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
C0019168 (UMLS CUI [3,1])
C1446409 (UMLS CUI [3,2])
C0332120 (UMLS CUI [3,3])
C2363789 (UMLS CUI [4,1])
C1446409 (UMLS CUI [4,2])
C0332120 (UMLS CUI [4,3])
C0041296 (UMLS CUI [5,1])
C0332120 (UMLS CUI [5,2])
Latent TBC if not treated with isoniasid recentely
Item
5. patients with latent tb if not treated with isoniazid for at least 4 weeks prior to receiving the study drug
boolean
C1609538 (UMLS CUI [1,1])
C2827774 (UMLS CUI [1,2])
C0022209 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
Evidence of copd | Emphysema | Interstitial lung disease.
Item
6. radiographic evidence of copd, emphysema, and/or interstitial lung disease.
boolean
C0024117 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0034067 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
C0206062 (UMLS CUI [3,1])
C0332120 (UMLS CUI [3,2])
Pregnancy | Breastfeeding
Item
7. subjects who are pregnant or who are nursing infants
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Platelet count | Absolute neutrophil count | Hematocrit level
Item
8. patients with cytopenia: platelet count <80,000/mm3, absolute neutrophil count<1500/mm3, hematocrit < 20%.
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518014 (UMLS CUI [3])
Renal insufficiency defined by a serum creatinine or creatinine clearance
Item
9. patients with renal insufficiency defined by a serum creatinine of greater than or equal to 2.0 mg/dl or creatinine clearance of less than or equal to 35 ml/min.
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
Substance use disorders
Item
10. use of illegal drugs.
boolean
C0038586 (UMLS CUI [1])
Attenuated Bacteria Vaccine recent | Attenuated Live Virus Vaccine recent
Item
11. a live vaccination fewer than 4 weeks before enrollment
boolean
C1879753 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C1516086 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial