Eligibility Multiple Sclerosis, Relapsing-Remitting NCT00780455

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StudyEvent: Eligibility
1. Eligibility Multiple Sclerosis, Relapsing-Remitting NCT00780455

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Age

Item

female and male patients aged 18 and more;

boolean

C0001779 (UMLS CUI [1])

Multiple Sclerosis, Relapsing-Remitting

Item

confirmed diagnosis of rrms according to the macdonald or poser criteria;

boolean

C0751967 (UMLS CUI [1])

Indication First Betaferon

Item

first indication for betaferon treatment (as described in summary of product characteristics (smpc));

boolean

C3146298 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C0592527 (UMLS CUI [1,3])

Multiple sclerosis relapse Absent

Item

no relapse of multiple sclerosis (ms) in the last two months before the inclusion;

boolean

C0856120 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])

Patients Walking EDSS

Item

walking patients having an expanded disability status scale (edss) score between > 1 and </= 4 at the inclusion visit;

boolean

C0030705 (UMLS CUI [1,1])
C0080331 (UMLS CUI [1,2])
C0451246 (UMLS CUI [1,3])

Childbearing Potential Contraceptive methods

Item

female of child-bearing potential must agree to practice adequate contraception methods over all the duration of the study;

boolean

C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])

Protocol Compliance

Item

patient can follow all the study and comply with all procedures of the trial protocol

boolean

C0525058 (UMLS CUI [1])

Evaluation of laboratory test data | Measurement of liver enzyme Gamma-glutamyltransferase normal | Full blood count normal | Differential white blood cell count normal

Item

laboratory evaluations (i.e. evaluation of hepatic enzymes gammagt, full blood count and differential white blood cell [wbc]) must be available and the results must be normal;

boolean

C0262707 (UMLS CUI [1])
C0428321 (UMLS CUI [2,1])
C0855631 (UMLS CUI [2,2])
C0427692 (UMLS CUI [3])
C0860797 (UMLS CUI [4])

Informed Consent

Item

written informed consent.

boolean

C0021430 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Medical contraindication Betaferon

Item

any contraindication to betaferon as described in the smpc of the product;

boolean

C1301624 (UMLS CUI [1,1])
C0592527 (UMLS CUI [1,2])

Orthopedic Surgical Procedure

Item

patient with a previously orthopaedic surgical intervention within the past year of the inclusion;

boolean

C1136201 (UMLS CUI [1])

Study Subject Participation Status

Item

patient previously included in this study;

boolean

C2348568 (UMLS CUI [1])

Rebif | Avonex | Copaxone

Item

patient previously treated within the past 3 months with rebif, avonex or copaxone;

boolean

C0752980 (UMLS CUI [1])
C0594372 (UMLS CUI [2])
C0528175 (UMLS CUI [3])

Betaferon

Item

patient previously treated within the past 12 months with betaferon;

boolean

C0592527 (UMLS CUI [1])

Study Subject Participation Status | Investigational New Drugs

Item

participation in any clinical trial within the past 30 days involving the investigational drug intake.

boolean

C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])

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Eligibility Multiple Sclerosis, Relapsing-Remitting NCT00780455