Eligibility Rheumatoid Arthritis NCT00221000

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Age
Item
18 Years and older
boolean
C0001779 (UMLS CUI-1)
history of RA
Item
Patients must have a history of RA per the ACR criteria for the classification of RA
boolean
C0332119 (UMLS CUI-1)
C0003873 (UMLS CUI-2)
moderately to severely active RA
Item
Patients must have moderately to severely active RA
boolean
C1299393 (UMLS CUI-1)
C0003873 (UMLS CUI-2)
oral corticosteroids max. 15mg/day prednisone equivalent
Item
Patients who are not on oral corticosteroids OR Patients who have been on a stable dose of oral corticosteroids at a prednisone equivalent dosage greater than or equal to 15 mg/day for at least 4 weeks prior to screening.
boolean
platelet count >= 100,000
Item
Patients must have a platelet count greater than or equal to 100,000/cmm.
boolean
C0032181 (UMLS CUI-1)
no pregnancy
Item
Female patients must be one of the following: postmenopausal, surgically incapable of bearing children, practicing an acceptable method of birth control (acceptable methods may include hormonal contraceptives, intrauterine device, and spermicide and barrier). Abstinence or partner/spouse sterility may also qualify at the Investigator's discretion. If a female patient is of childbearing potential, she must have a negative urine pregnancy test at screening.
boolean
C0232973 (UMLS CUI-1)
Compliance
Item
Patients must be able and willing to comply with all study procedures
boolean
C1321605 (UMLS CUI-1)
Informed Consent
Item
Patients must be willing to sign an ICF
boolean
C0021430 (UMLS CUI-1)
weight >= 40kg
Item
Patients must have a body weight greater than or equal to 40 kg (88 lb).
boolean
C0005910 (UMLS CUI-1)
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
other arthritis, arthropathy or inflammatory condition
Item
Patients who have a form of arthritis or arthropathy, other than RA, or any current inflammatory condition that might confound the assessments (e.g., other connective tissue diseases or Lyme disease).
boolean
other study
Item
Patients who have been enrolled in any investigational therapy study for the treatment of RA within 4 weeks prior to the start of the Treatment Period, or patients who are scheduled to receive investigational therapies or a plasma based apheresis procedure (e.g., a protein A column) for the treatment of RA during the course of the study.
boolean
C2348568 (UMLS CUI-1)
ECP not possible
Item
Patients unable to tolerate the extracorporeal volume shifts associated with ECP treatment due to the presence of any of the following conditions: uncompensated congestive heart failure, pulmonary edema, severe chronic obstructive pulmonary disease, severe asthma, renal failure, or hepatic failure.
boolean
Venipuncture difficult
Item
Patients with a poor tolerability of venipuncture or a lack of adequate venous access for required treatments and blood sampling.
boolean
C0190979 (UMLS CUI-1)
C0332218 (UMLS CUI-2)
Allergy to psoralen
Item
Patients who have a known hypersensitivity or allergy to psoralen (methoxsalen)
boolean
Allergy to heparin or citrate products
Item
Patients who have a known hypersensitivity or allergy to both heparin and citrate products
boolean
no stable dose for DMARDs
Item
Patients who are taking any of the following permitted DMARDs and biological agents and have not been on a stable dose for the specific indicated periods of time prior to screening: MTX for at least 8 weeks; leflunomide for at least 8 weeks; infliximab for at least 14 weeks; etanercept for at least 12 weeks; adalimumab for at least 12 weeks
boolean
no stable dose for NSAIDs, anakinra, D-penicillamine, gold salts, azathioprine, oral corticosteroids
Item
Patients who are taking any of the following permitted medications and have not been on a stable dose for at least 4 weeks prior to screening: NSAIDs; anakinra; hydroxychloroquine; chloroquine; sulfasalazine; D-penicillamine; gold salts; azathioprine; oral corticosteroids (greater than or equal to 15 mg/day, prednisone equivalent dose).
boolean
no stable concomitant RA medications
Item
Patients whom the Investigator believes cannot be maintained on stable doses of permitted concomitant RA medications throughout the Treatment Period
boolean
prohibited: cyclophosphamide, chlorambucil, corticosteroid injections
Item
Patients who are taking any of the following prohibited medications: cyclophosphamide; chlorambucil; intramuscular (IM) or intravenous (IV) corticosteroid injection(s), within 4 weeks of screening; intra-articular corticosteroid injection(s) > 60 mg prednisone equivalent total dose, within 4 weeks of screening
boolean
no cancer
Item
Patients who have any known malignant disease (other than basal cell carcinoma) currently or within the last 5 years
boolean
C0445120 (UMLS CUI-1)
blood dyscrasia
Item
Patients who have a pre-existing blood dyscrasia such as bone marrow hypoplasia, leukopenia, thrombocytopenia, significant anemia, or a coagulation disorder
boolean
persistent or severe infection
Item
Patients with a persistent or severe infection within 12 weeks of screening.
boolean
drug or alcohol abuse
Item
Patients with a history of drug or alcohol abuse within 12 weeks of screening.
boolean
C0237123 (UMLS CUI-1)
impaired hepatic function
Item
Patients with impaired hepatic function at screening as shown by abnormal liver function tests (LFT; i.e., aspartate transaminase [AST] or alanine transaminase [ALT] levels > 2 x the upper limit of normal [ULN])
boolean
pregnancy / lactation
Item
Women who are pregnant or lactating
boolean
C0549206 (UMLS CUI-1)
C0006147 (UMLS CUI-2)
Item Group
Medical Concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
RA
Item
Rheumatoid Arthritis
string
C0003873 (UMLS CUI)
69896004 (SNOMED CT 2010_0731)
10039073 (MedDRA 13.1)
M06.9 (ICD-10-CM Version 2010)
714.0 (ICD-9-CM Version 2011)
Moderate
Item
Moderately
string
C1881878 (UMLS CUI)
CRP
Item
C-Reactive Protein Measurement
string
C0201657 (UMLS CUI)
55235003 (SNOMED CT 2010_0731)
10006824 (MedDRA 13.1)
Pharmaceutical Preparations
Item
Medication
text
C0013227 (UMLS CUI-1)
MTX
Item
Methotrexate
string
C0025677 (UMLS CUI)
387381009 (SNOMED CT 2010_0731)
MTHU005020 (LOINC Version 232)
Corticosteroids
Item
Therapeutic Corticosteroid
string
C0001617 (UMLS CUI)
79440004 (SNOMED CT 2010_0731)
Platelet count
Item
Platelet count - finding
string
C1287267 (UMLS CUI)
365632008 (SNOMED CT 2010_0731)
777-3 (LOINC Version 232)
Contraception
Item
Contraception
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
Arthritis
Item
Arthritis
string
C0003864 (UMLS CUI)
3723001 (SNOMED CT 2010_0731)
10003246 (MedDRA 13.1)
MTHU020793 (LOINC Version 232)
M19.90 (ICD-10-CM Version 2010)
716.9 (ICD-9-CM Version 2011)
E12378 (CTCAE Version 4.03)
Inflammation
Item
Inflammation
string
C0021368 (UMLS CUI)
23583003 (SNOMED CT 2010_0731)
10061218 (MedDRA 13.1)
Enrollment
Item
Enrollment
string
C2348568 (UMLS CUI)
Chronic congestive heart failure
Item
Chronic congestive heart failure
string
C0264722 (UMLS CUI)
I50.0 (ICD-10-CM Version 2010)
Pulmonary disease
Item
Lung diseases
string
C0024115 (UMLS CUI)
19829001 (SNOMED CT 2010_0731)
10025082 (MedDRA 13.1)
J98.4 (ICD-10-CM Version 2010)
Kidney Insufficiency
Item
Renal Insufficiency
string
C1565489 (UMLS CUI)
10038474 (MedDRA 13.1)
Liver Insufficiency
Item
Hepatic Insufficiency
string
C1306571 (UMLS CUI)
59927004 (SNOMED CT 2010_0731)
10056542 (MedDRA 13.1)
Allergy
Item
Hypersensitivity
string
C0020517 (UMLS CUI)
257550005 (SNOMED CT 2010_0731)
T78.40 (ICD-10-CM Version 2010)
NSAID
Item
Nonsteroidal Antiinflammatory Drug
string
C0003211 (UMLS CUI)
16403005 (SNOMED CT 2010_0731)
Cancer
Item
Malignant Neoplasms
string
C0006826 (UMLS CUI)
363346000 (SNOMED CT 2010_0731)
10028997 (MedDRA 13.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
Leukocyte Count
Item
White Blood Cell Count procedure (WBC)
string
C0023508 (UMLS CUI)
767002 (SNOMED CT 2010_0731)
10047939 (MedDRA 13.1)
Hb
Item
Hemoglobin
string
C0518015 (UMLS CUI)
38082009 (SNOMED CT 2010_0731)
10019481 (MedDRA 13.1)
LP14449-0 (LOINC Version 232)
Coagulopathy
Item
Blood Coagulation Disorders
string
C0005779 (UMLS CUI)
64779008 (SNOMED CT 2010_0731)
10009802 (MedDRA 13.1)
D68.9 (ICD-10-CM Version 2010)
286 (ICD-9-CM Version 2011)
Infection
Item
Infection
string
C0009450 (UMLS CUI)
257551009 (SNOMED CT 2010_0731)
10021789 (MedDRA 13.1)
Alcohol abuse
Item
Alcohol abuse
string
C0085762 (UMLS CUI)
15167005 (SNOMED CT 2010_0731)
10001584 (MedDRA 13.1)
LP36309-0 (LOINC Version 232)
F10.1 (ICD-10-CM Version 2010)
305.0 (ICD-9-CM Version 2011)
Drug abuse
Item
Drug abuse
string
C0013146 (UMLS CUI)
26416006 (SNOMED CT 2010_0731)
10013654 (MedDRA 13.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
AST
Item
GOT (Serum)
string
C0004002 (UMLS CUI)
26091008 (SNOMED CT 2010_0731)
10003543 (MedDRA 13.1)
ALT
Item
GPT (Serum)
string
C0001899 (UMLS CUI)
56935002 (SNOMED CT 2010_0731)
10001844 (MedDRA 13.1)

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