Monitoring natural killer cells in multiple sclerosis patients treated with fingolimod

Phase 1

• Conditions: relapsing-remitting multiple sclerosis; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-000411-91-DE
• Lead Sponsor: Charité - Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-04
• Last Update Posted: 4 December 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

•Definite diagnosis of RRMS according to the 2010 revised McDonald criteria (Polman et al., 2011)
•18 to 65 years old
•Indication for on-label treatment with fingolimod (Gilenya®) ac-cording to the current approval
•EDSS score = 6,0
•Neurological stable with no evidence of relapse or corticosteroid treatment within 30 days prior to screening
•Ability to provide written informed consent
•Highly effective contraception (Pearl Index < 1), reliable absti-nence from any heterosexual relationships, or sterilization of the only partner in women of childbearing potential
•Negative pregnancy test (HCG rapid test in the urine) at screen-ing and baseline in women of childbearing potential

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Patients with MS manifestations other than RRMS
•Patients with known contraindications to Gilenya® according to the current Fachinformation”, in particular
•Immunodeficiency syndrome
•Increased risk of opportunistic infections
•Severe active or chronic active infections (hepatitis, tubercu-losis)
•History or presence of malignancy (other than localized basal or squamous cell carcinoma of the skin).Severe liver dysfunction (Child Pugh C)
•Hypersensitivity against active or any other compound of study medication
•2nd degree Mobitz Type II or higher degree AV block, Sick-sinus syndrome, or Sinu-atrial heart block, Significant QT pro-longation (QTc>470 msec (female) or >450 msec (males))
•History of symptomatic bradycardia or recurrent syncope, known ischaemic heart disease, cerebrovascular disease, history of my-ocardial infarction, hypokalaemia, congestive heart failure, history of cardiac arrest, uncontrolled hypertension, or severe sleep ap-neaPatients with clinically significant liver, kidney or bone marrow dysfunction, defined by the following laboratory values at the time of screening:
•HB <8.5 g / dl
•WBC <2.5 / nl
•platelets <100/nl
•creatinine clearance by Cockroft-Gault formula: Cl <110ml/min (men) and Cl <95ml/min (women), from age of 30 limit drops 10ml/min per decade
•AST / ALT> 3.5 times higher than the upper reference value
•bilirubine> 2.0 mg / dl
•Patients without a history of varicella or without vaccination against varicella zoster virus (VZV) and VZV negative antibody serology
•Pregnancy or lactation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified