Avonex liquid | Multiple Sclerosis
Item
must be using liquid avonex® to treat ms. in addition, the subject must be on liquid avonex® for 12 weeks prior to the screening visit.
boolean
C0594372 (UMLS CUI [1,1])
C0302908 (UMLS CUI [1,2])
C0026769 (UMLS CUI [2])
Body mass index | Body Weight Minimum
Item
must have a bmi of 19 to 28 kg/m², inclusive, and a minimum body weight of 50 kg at screening.
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2,1])
C1524031 (UMLS CUI [2,2])
Medical Device Use of Able | Self Administration Injection Able
Item
must be able to physically demonstrate use of the device and be able to self-administer all injections.
boolean
C0025080 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0036589 (UMLS CUI [2,1])
C1533685 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
Able to speak English Language
Item
must be english speaking.
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Protocol Compliance
Item
must be able to understand and comply with the protocol.
boolean
C0525058 (UMLS CUI [1])
Abnormal finding on screening procedure | Blood test abnormal | White Blood Cell Count procedure | Differential white blood cell count procedure | Platelet Count measurement | Hemoglobin measurement | Creatinine measurement, serum | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Prothrombin time
Item
abnormal screening or screening blood tests determined to be clinically significant by the investigator for: white blood count (wbc) or differential, platelet count, hemoglobin, serum creatinine, bilirubin, alanine transaminase (alt) aspartate transaminase (ast), prothrombin time (pt).
boolean
C0421340 (UMLS CUI [1])
C0854146 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0162401 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
C0518015 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
C1278039 (UMLS CUI [8])
C0201836 (UMLS CUI [9])
C0201899 (UMLS CUI [10])
C0033707 (UMLS CUI [11])
Hypersensitivity Rubber Dry
Item
known sensitivity to dry natural rubber.
boolean
C0020517 (UMLS CUI [1,1])
C0035918 (UMLS CUI [1,2])
C0205222 (UMLS CUI [1,3])
Pharmaceutical Preparations | Multiple Sclerosis Symptoms Treating | Comorbidity Treating
Item
treatment with other agents to treat ms symptoms or underlying disease as specified in the protocol.
boolean
C0013227 (UMLS CUI [1])
C0026769 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
Allergic Reaction Severe | Anaphylaxis Severe
Item
history of severe allergic or anaphylactic reactions.
boolean
C1527304 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0002792 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
intolerance to Acetaminophen | intolerance to Ibuprofen | intolerance to Naproxen | intolerance to Aspirin
Item
history of intolerance to acetaminophen (paracetamol), ibuprofen, naproxen, and aspirin that would preclude the use of at least one of these during the study.
boolean
C1744706 (UMLS CUI [1,1])
C0000970 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0020740 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C0027396 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C0004057 (UMLS CUI [4,2])
Local infection Serious
Item
serious local infection
boolean
C1400591 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Clinical Trial Eligibility Criteria Study Protocol
Item
other inclusion and exclusion criteria apply as per biogen idec protocol
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])