Rheumatoid Arthritis Patients
Item
ra patients:
boolean
C0003873 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
Age
Item
male and female patients aged 18 - 75 years (inclusive).
boolean
C0001779 (UMLS CUI [1])
Body Weight
Item
body weight between 50 and 100 kg (inclusive).
boolean
C0005910 (UMLS CUI [1])
Postmenopausal state | Female Sterilization | Childbearing Potential Methotrexate Dose Stable | Childbearing Potential Contraceptive methods | Gender Contraceptive methods
Item
post menopausal or surgically sterile female patients are allowed. female patients of child-bearing potential may participate if they are already on a stable dose of methotrexate. additional birth control details to be provided at screening. male patients must use an effective contraception method during the study and at least for 2 months following the completion/discontinuation of the study.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0025677 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C0205360 (UMLS CUI [3,4])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0079399 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
Rheumatoid Arthritis disease length
Item
diagnosis of ra, classified by american rheumatism association 1987 revised criteria. disease duration of at least 6 months is essential.
boolean
C0003873 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Rheumatoid Arthritis Functional Status Class
Item
functional status class i, ii or iii classified according to the american college of rheumatology 1991 revised criteria.
boolean
C0003873 (UMLS CUI [1,1])
C0598463 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
Disease Evaluation | Tender joint count | Swollen joint count
Item
active disease evaluation (≥ 6 tender and ≥ 6 swollen joints)
boolean
C0012634 (UMLS CUI [1,1])
C1261322 (UMLS CUI [1,2])
C0451530 (UMLS CUI [2])
C0451521 (UMLS CUI [3])
Disease-Modifying Antirheumatic Drugs Quantity failed | Methotrexate U/week
Item
prior treatment with 1-3 disease-modifying anti-rheumatic drugs (dmards) - patients should have failed at least 1 dmard but should not be deemed "refractory to all therapies". it is expected that patients are on a current treatment with methotrexate
boolean
C0242708 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0025677 (UMLS CUI [2,1])
C0560588 (UMLS CUI [2,2])
Methotrexate Dose Stable | Intolerance to Methotrexate | Folic Acid U/day | Folic Acid U/week | Toxicity Reduction | Non-Steroidal Anti-Inflammatory Agents Dose Stable | Adrenal Cortex Hormones Oral Dose Stable | Prednisone U/day | Prednisone Equivalent U/day | Disease-Modifying Antirheumatic Drugs Any failed
Item
≤ 25 mg/week and with the current dose stable for at least 3 months, however patients who did not tolerate mtx may also be considered. all patients will take folic acid 1 mg daily, or 5 mg weekly post mtx dose, to minimize toxicity, according to local guidelines. in addition to methotrexate, patients may be on either a stable dose of non-steroidal anti-inflammatory drugs (nsaids) and/or a stable dose of oral corticosteroids (prednisone or equivalent ≤ 10 mg daily) for at least 4 weeks prior to randomization. patients who failed any dmards will be allowed.
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C1744706 (UMLS CUI [2,1])
C0025677 (UMLS CUI [2,2])
C0016410 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
C0016410 (UMLS CUI [4,1])
C0560588 (UMLS CUI [4,2])
C0600688 (UMLS CUI [5,1])
C0392756 (UMLS CUI [5,2])
C0003211 (UMLS CUI [6,1])
C0178602 (UMLS CUI [6,2])
C0205360 (UMLS CUI [6,3])
C0001617 (UMLS CUI [7,1])
C1527415 (UMLS CUI [7,2])
C0178602 (UMLS CUI [7,3])
C0205360 (UMLS CUI [7,4])
C0032952 (UMLS CUI [8,1])
C0456683 (UMLS CUI [8,2])
C0032952 (UMLS CUI [9,1])
C0205163 (UMLS CUI [9,2])
C0456683 (UMLS CUI [9,3])
C0242708 (UMLS CUI [10,1])
C1552551 (UMLS CUI [10,2])
C0231175 (UMLS CUI [10,3])
Tuberculin Test Negative | PPD of Tuberculin Units
Item
negative purified protein derivative (ppd) tuberculin skin test reaction (ppd 5 tuberculin units or as according to local standard practice).
boolean
C0041290 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C0034131 (UMLS CUI [2,1])
C1519795 (UMLS CUI [2,2])
Rheumatoid Arthritis Patients
Item
ra patients:
boolean
C0003873 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
Anti-tumor necrosis factor therapy | Interleukin-1 Receptor Antagonist | Biological treatment | Immunosuppressive Agents | Cyclosporine | MYCOPHENOLATE | Tacrolimus
Item
previous treatment with anti-tumor necrosis factor (tnf)-α or anti il-1 therapy (or other biological therapy), immunosuppressive agents such as cyclosporine, mycophenolate or tacrolimus. the following washout period will be required for such patients to be eligible to participate in the trial.
boolean
C0281481 (UMLS CUI [1])
C3536785 (UMLS CUI [2])
C1531518 (UMLS CUI [3])
C0021081 (UMLS CUI [4])
C0010592 (UMLS CUI [5])
C0883242 (UMLS CUI [6])
C0085149 (UMLS CUI [7])
Washout Period | Etanercept | adalimumab
Item
1. 2 months washout prior to screening for etanercept or adalimumab
boolean
C1710661 (UMLS CUI [1])
C0717758 (UMLS CUI [2])
C1122087 (UMLS CUI [3])
Washout Period | infliximab
Item
2. 3 months washout prior to screening for infliximab
boolean
C1710661 (UMLS CUI [1])
C0666743 (UMLS CUI [2])
Washout Period | rituximab
Item
3. 3 months washout prior to screening for rituximab
boolean
C1710661 (UMLS CUI [1])
C0393022 (UMLS CUI [2])
Washout Period | Cyclosporine | MYCOPHENOLATE | Tacrolimus
Item
4. 1 month washout prior to screening for cyclosporine, mycophenolate and tacrolimus.
boolean
C1710661 (UMLS CUI [1])
C0010592 (UMLS CUI [2])
C0883242 (UMLS CUI [3])
C0085149 (UMLS CUI [4])
Disease-Modifying Antirheumatic Drugs Discontinued Due to Lack of Efficacy | Disease-Modifying Antirheumatic Drugs Discontinued Due to Toxicity
Item
if patient has been discontinued from other dmards (disease modifying antirheumatic drugs) for lack of efficacy or toxicity, the patient should be at least 1 month off the agent.
boolean
C0242708 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0235828 (UMLS CUI [1,4])
C0242708 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0600688 (UMLS CUI [2,4])
Congestive heart failure | Long QT Syndrome | Diabetes mellitus poor control | QT corrected interval prolonged
Item
patients with congestive heart failure, qt prolongation syndrome or poorly controlled diabetes mellitus. patients with a history of qtc prolongation will be excluded.
boolean
C0018802 (UMLS CUI [1])
C0023976 (UMLS CUI [2])
C0860161 (UMLS CUI [3])
C0855333 (UMLS CUI [4])
Intraarticular injection of corticosteroids | Corticosteroids injection systemic | Therapeutic procedure Flare of rheumatoid arthritis
Item
patients who have received intra-articular or systemic corticosteroid injections having been required for treatment of acute ra flare (not being part of a regular therapeutic regimen) within 4 weeks prior to randomization.
boolean
C2064783 (UMLS CUI [1])
C2095490 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0581345 (UMLS CUI [3,2])
ID.20
Item
exclusion criteria 2-6 of the health volunteer section also applies here.
boolean
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])