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Clinical Trials/EUCTR2005-001026-89-DE
EUCTR2005-001026-89-DE
Active, not recruiting
Not Applicable

Phase IV, multicenter, open label, randomized study of Rebif® 44 mcg administered three times per week by subcutaneous injection compared with no treatment in the therapy of relapsing multiple sclerosis after mitoxantrone - Deescalation to Rebif® after Mitoxantrone therapy (REMAIN study)

Serono GmbH0 sites100 target enrollmentMay 13, 2005
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DrugsRebif

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Serono GmbH
Enrollment
100
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 13, 2005
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Serono GmbH

Eligibility Criteria

Inclusion Criteria

  • •\- Definite RRMS or SPMS with relapses
  • •\- EDSS 1\-6
  • •\- Escalation to mitoxantrone due to relapse activity or MRI activity during last year prior to mitoxantrone or EDSS progression combined with relapse activity or MRI activity during last year prior to mitoxantrone (not due to EDSS progression exclusively)
  • •\- Last mitoxantrone treatment between \>\= 1 and \<\= 6 months
  • •\- Mitoxantrone for min. 9, max. 36 months, total cumulative dose 40\-120 mg/m2 body surface area
  • •\- Subject may not have a confirmed 1point EDSS progression (0\.5 points for EDSS \> 5\.5\) within the last 9 months
  • •\- Subject should be free of relapses over the last 6 months
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

  • •\- Subject received any cytokine or anti\-cytokine therapy within the 3 months prior to Study Day 1 (SD1, week 0\)
  • •\- Subject was escalated to mitoxantrone due to EDSS progression only (without any relapse or MRI activity during the last year prior to mitoxantrone
  • •\- Subject has Primary Progressive MS
  • •\- Subject has Secondary Progressive MS without superimposed relapses
  • •\- Subject received immunmodulatory treatment other than IFN\-beta, glatirameracetat, azatriopine, immunglobulins, or no treatment before mitoxantrone
  • •\- Subject has previously received total lymphoid irradiation
  • •\- Subject received oral or systemic corticosteroids or ACTH within 30 days of SD1
  • •\- Subject received intravenous immunoglobulins or underwent plasmapheresis within the 6 months prior to SD1
  • •\- Subject received immunomodulatory or immunosuppressive therapy (including but not limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide, teriflunomide, laquinimod, Campath) within the 12 months prior to SD1
  • •\- Subject requires chronic or monthly pulse corticosteroids during the study

Outcomes

Primary Outcomes

Not specified

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