ID

42489

Descripción

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

Link

https://clinicaltrials.gov/show/NCT02027298

Palabras clave

  1. 28/7/21 28/7/21 -
Titular de derechos de autor

The Cleveland Clinic Bristol-Myers Squibb

Subido en

28 de julio de 2021

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 4.0

Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Primary Sjogren's Syndrome NCT02027298

Eligibility Primary Sjogren's Syndrome NCT02027298

Inclusion Criteria
Descripción

Inclusion Criteria

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

Sjogren's syndrome

Tipo de datos

boolean

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

Age

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

Non-biologic DMARD quantity allowed

Tipo de datos

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.
Descripción

Ability and willingness to compliance behavior

Tipo de datos

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.
Descripción

Ability and willingness to provide an informed consent

Tipo de datos

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.
Descripción

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.

Tipo de datos

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
Descripción

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.
Descripción

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

Tipo de datos

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
Descripción

History of malignant neoplasms | History of diabetes mellitusa

Tipo de datos

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
Descripción

Tricyclic antidepressants | Anticholinergic agents

Tipo de datos

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.
Descripción

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

Tipo de datos

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
Descripción

Latent TBC if not treated with isoniasid recentely

Tipo de datos

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.
Descripción

Evidence of copd | Emphysema | Interstitial lung disease.

Tipo de datos

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
Descripción

Pregnancy | Breastfeeding

Tipo de datos

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%.
Descripción

Platelet count | Absolute neutrophil count | Hematocrit level

Tipo de datos

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.
Descripción

Renal insufficiency defined by a serum creatinine or creatinine clearance

Tipo de datos

boolean

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

Substance use disorders

Tipo de datos

boolean

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

Attenuated Bacteria Vaccine recent | Attenuated Live Virus Vaccine recent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1879753
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C1516086
UMLS CUI [2,2]
C0332185

Similar models

Eligibility Primary Sjogren's Syndrome NCT02027298

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

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

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