Multiple Sclerosis
Item
1. clinically definite multiple sclerosis defined by mcdonald criteria.
boolean
C0026769 (UMLS CUI [1])
Age
Item
2. between 18-65 years of age.
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Protocol Compliance | Self Administration Investigational New Drugs
Item
3. subject must able to understand and sign the irb- approved informed consent form prior to the performance of any study-specific procedures and is willing to comply with the required scheduling and assessments of the protocol, including self-administration of study drug (if assigned to the acth arm).
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
C0036589 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods
Item
4. subjects who are women of childbearing potential, must have a negative serum pregnancy test at the screening visit, and must be willing to practice a reliable birth-control method.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Multiple sclerosis relapse Quantity | Lesion New Quantity MRI | Gadolinium-Enhancing Lesion Quantity MRI | Interferon therapy Stable
Item
5. subjects must have at least one ms relapse within last year and/or at least one new t2 or gadolinium-enhanced lesion on mri while on stable interferon therapy.
boolean
C0856120 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C0205314 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0024485 (UMLS CUI [2,4])
C1333400 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0024485 (UMLS CUI [3,3])
C0279030 (UMLS CUI [4,1])
C0205360 (UMLS CUI [4,2])
EDSS
Item
6. edss (expanded disability status scale) score of 3.0 - 6.5
boolean
C0451246 (UMLS CUI [1])
Interferon-beta Pharmaceutical Preparations | Avonex | Betaseron | Rebif
Item
7. currently on one of the approved beta-interferon drugs (avonex, betaseron, or rebif) for a minimum of 6 months.
boolean
C0015980 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0594372 (UMLS CUI [2])
C0284968 (UMLS CUI [3])
C0752980 (UMLS CUI [4])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent | Female Sterilization Absent | Postmenopausal state Absent | Tubal Ligation | Contraceptive implant | Contraceptives, Oral | Contraceptive patch | Contraceptive injection | Transdermal contraception | Contraception, Barrier | Sexual activity Restricted Partner had vasectomy
Item
1. women who are either pregnant or breastfeeding, and women of child-bearing potential (defined as not surgically sterile or at least two years post menopausal) who are not using one of the following birth control methods: tubal ligation, implantable contraception device, oral, patch, injectable or transdermal contraceptive, barrier method or sexual activity restricted to vasectomized partner.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0015787 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0232970 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0520483 (UMLS CUI [6])
C1657106 (UMLS CUI [7])
C0009905 (UMLS CUI [8])
C2985284 (UMLS CUI [9])
C1656586 (UMLS CUI [10])
C1456475 (UMLS CUI [11])
C0004764 (UMLS CUI [12])
C0036864 (UMLS CUI [13,1])
C0443288 (UMLS CUI [13,2])
C0420842 (UMLS CUI [13,3])
Uncontrolled hypertension | Cardiac Arrhythmia | Gastrointestinal ulcer | Diabetic - poor control | Osteoporosis | Kidney Failure Stage Any | Mental disorders | Health condition Interferes with Study Subject Participation Status
Item
2. uncontrolled hypertension, clinically significant cardiac arrhythmias, gastrointestinal ulcer, uncontrolled diabetes mellitus, osteoporosis, any stage of renal failure, psychiatric disorders or any other clinically significant general health conditions that may interfere with the trial participation.
boolean
C1868885 (UMLS CUI [1])
C0003811 (UMLS CUI [2])
C0237938 (UMLS CUI [3])
C0421258 (UMLS CUI [4])
C0029456 (UMLS CUI [5])
C0035078 (UMLS CUI [6,1])
C1306673 (UMLS CUI [6,2])
C1552551 (UMLS CUI [6,3])
C0004936 (UMLS CUI [7])
C2707304 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C2348568 (UMLS CUI [8,3])
Substance Use Disorders
Item
3. subject has a history of drug or alcohol abuse within the past year.
boolean
C0038586 (UMLS CUI [1])
Steroid therapy
Item
4. subject had corticosteroid treatment within last 90 days.
boolean
C0149783 (UMLS CUI [1])
Pharmaceutical Preparation New Started
Item
5. subject started new medication within last 30 days.
boolean
C0013227 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C1272689 (UMLS CUI [1,3])
Tysabri
Item
6. subject is on tysabri treatment presently or within 6 months of screening.
boolean
C1529600 (UMLS CUI [1])
Novantrone | Cellcept | Rituxan | Chemotherapeutic agent
Item
7. subject is on novantrone, cellcept, rituxan or other chemotherapeutic treatment presently or within 6 months of screening.
boolean
C0282248 (UMLS CUI [1])
C0592558 (UMLS CUI [2])
C0732355 (UMLS CUI [3])
C0729502 (UMLS CUI [4])
Study Subject Participation Status
Item
8. subject is a participant in another research project.
boolean
C2348568 (UMLS CUI [1])
Medical contraindication ACTH | Medical contraindication Methylprednisolone
Item
9. subject has contraindications for either acth or mp administration.
boolean
C1301624 (UMLS CUI [1,1])
C0001655 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0025815 (UMLS CUI [2,2])