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

NCT00219908

Last updated date
Study Location
Hôpital Cote de Nacre
Caen, , 14033, France
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Relapsing-Remitting Multiple Sclerosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-45 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Pfizer Clinical Trials Contact Center

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Advanced Information
Descriptive Information
Brief Title  ICMJE Evaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple Sclerosis
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Relapsing-Remitting Multiple Sclerosis
Intervention  ICMJE Drug: Mitoxantrone
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: September 16, 2005)
124
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE June 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE Not Provided
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00219908
Other Study ID Numbers  ICMJE 981166
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Rennes University Hospital
Collaborators  ICMJE
  • Bayer
  • Wyeth is now a wholly owned subsidiary of Pfizer
  • Farmades, Italy
Investigators  ICMJE
Study Director:Gilles EDAN, ProfessorCHU Rennes
PRS Account Rennes University Hospital
Verification Date September 2005

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