atalizumabbehandling af progressiv multipel sklerose - NAPMS

Phase 1

• Conditions: Secondary progressive multiple sclerosis and primary progressive multiple sclerosis; MedDRA version: 12.0Level: LLTClassification code 10063400Term: Secondary progressive multiple sclerosis; MedDRA version: 12.0Level: LLTClassification code 10063401Term: Primary progressive multiple sclerosis

• Registration Number: EUCTR2009-016703-35-DK
• Lead Sponsor: Dansk Multipel Sclerose Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-11-27
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Age between 19 and 55 years
Progressive disease course of multiple sclerosis (primary or secondary)
Duration of progressive phase of at least 1 year
Progression of > 1 EDSS point during the last 2 years (>½ EDSS point if EDSS > 5,5)
EDSS Written and informed consent
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnancy, breast-feeding or lack of anti.conception for fertile women.
Attack during the last month before inclusion.
Treatment with methylprednisolon during 3 months before inclusion.
Treatment with interferon-beta, glatirameracetate, immunoglobulin G or other immune-modulating treatment 3 months prior to inclusion.
Treatment with mitoxantrone, cyclophosphamide, azatriprine or other strong
immunosuppressive drug 6 months prior to inclusion.
Prior experimental treatment with strong immunosuppressive drug which the treating physician means will influence the results of the trial.
Diseases assiociated with immunedeficiency.
Treatment with other anticoagulant than aspirin.
Current malign disease.
Diabetes mellitus or other autoimmune disease.
Renal insuffiency or creatinine > 150 µmol/l.
Travel in tropical areas 3 months prior to inclusion.
Acute or chronic infectious diseases, which the treating physician finds relevant (e.g.

hepatitis B virus, hepatitis C virus, HIV ).
Psychiatric disease or other circumstances that may limit the patients participation in the trial.
Contraindication for MRI scan or gadolinium contrast .

Study & Design

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