Evaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple Sclerosis

This study has been terminated.
Sponsor:
Collaborators:
Bayer
Wyeth is now a wholly owned subsidiary of Pfizer
Farmades, Italy
Information provided by:
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00219908
First received: September 16, 2005
Last updated: December 21, 2005
Last verified: September 2005

September 16, 2005
December 21, 2005
July 1999
Not Provided
Time to confirmed progression of at least one EDSS point during the 3 years of the study.
Same as current
Complete list of historical versions of study NCT00219908 on ClinicalTrials.gov Archive Site
  • - percentage of patients with confirmed progression of at least one point EDSS (confirmed at 3 and 6 months) during the 3 years of the study,
  • - annual rate of relapse;
  • - percentage of relapse-free patients during the study period,
  • - quality of life,
  • - percentage of patients without evidence of disease activity on serial MRIs at months 9, 24 and 36 (number of contrast-enhanced lesions on the annual MRIs, change in lesion burden).
Same as current
Not Provided
Not Provided
 
Evaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple Sclerosis
Evaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple Sclerosis: Induction Treatment With Mitoxantrone Followed by Long-Term Treatment With Interferon-beta1b

The aim of the study is to determine whether a therapeutic strategy combining mitoxantrone and interferon beta1b can delay disease progression of at least one point on EDSS scale in patients with clinically very active relapsing-remitting multiple sclerosis.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Relapsing-Remitting Multiple Sclerosis
Drug: Mitoxantrone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
124
June 2006
Not Provided

Inclusion Criteria:

  • age : 18-45 years,
  • Clinical disease satisfying the Poser criteria (Amdmt n°4)
  • relapsing-remitting disease (Amdmt N°4)
  • at least 2 exacerbations within the preceding 12 months, having left sequelae,
  • MRI activity at inclusion expressed by at least one gadolinium-enhanced lesion (cranial MRI with 0.1mmol/kg gadolinium),
  • a significant disability at inclusion: EDSS score between 2.5 and 5.5 (Amdt N° 4)
  • written informed consent

Exclusion Criteria:

  • pregnancy and breast-feeding
  • use of an insufficiency effective contraceptive method,
  • general immunosuppressive therapy using cyclophosphamide, mitoxantrone,or total lymphoid irradiation
  • treatment with azathioprine during the 3 months preceding the study
  • clinical relapse or intensive corticosteroid treatment within the 30 days preceding inclusion,
  • associated disease (psychiatric disorder, depressive statenot controlled by appropriate drug therapy, history of heart disease at inclusion examination
Not Provided
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
France,   Italy
 
NCT00219908
981166
Not Provided
Not Provided
Rennes University Hospital
  • Bayer
  • Wyeth is now a wholly owned subsidiary of Pfizer
  • Farmades, Italy
Study Director: Gilles EDAN, Professor CHU Rennes
Rennes University Hospital
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP