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])
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])