EUCTR2008-008554-23-SE
Active, not recruiting
Not Applicable
eutralizing Antibodies to Interferon beta in patients treated with Rebif New Formulation - NAb development with RNF
The Multiple Sclerosis Research Group, Department of Clinical Neuroscience0 sites100 target enrollmentJune 26, 2009
ConditionsIFNß-naïve patients fulfilling Poser or McDonald criteria for CDMS or MS and in whom a decision has been made to initiate treatment with RNF (Rebif New Formulation).MedDRA version: 9.1Level: LLTClassification code 10028245Term: Multiple sclerosis
DrugsRebif
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- IFNß-naïve patients fulfilling Poser or McDonald criteria for CDMS or MS and in whom a decision has been made to initiate treatment with RNF (Rebif New Formulation).
- Sponsor
- The Multiple Sclerosis Research Group, Department of Clinical Neuroscience
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.IFNß naïve MS patients with RRMS.
- •2\.18\-60 years old.
- •3\.Patients who have agreed to initiate treatment with RNF
- •4\.Patients who have given signed consent to participate in the study.
- •5\.Women shall not be pregnant and shall not have the intention of becoming pregnant during the study.
- •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
Exclusion Criteria
- •1\.Patients with a previous treatment history of IFNß or IFN?.
- •2\.Patients with a positive NAb test before initiation of RNF.
- •3\.Patients treated with glatiramer acetate, IVIG or natalizumab within the previous 3 months.
- •4\.Patients treated with immunosuppressive treatments such as mitoxantrone, alemtuzumab or azathioprine during the previous 6 months.
- •5\.Patients with relevant non\-MS condition potentially complicating IFNß treatment.
- •6\.Contraindication for interferon beta treatment as per SPC.
- •7\.Women that becomes pregnant.
Outcomes
Primary Outcomes
Not specified
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