Status:
COMPLETED
Natalizumab De-escalation With Interferon Beta-1b
Lead Sponsor:
Claudio Gobbi
Collaborating Sponsors:
Ospedale Civico, Lugano
Conditions:
Relapsing-remitting Multiple Sclerosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
Multiple Sclerosis (MS) is the most common neurological disorder causing disability in young adults. The management of MS-patients requires treatment with disease-modifying agents, monoclonal antibodi...
Detailed Description
At present, there is no cure for multiple sclerosis and the management of MS-patients requires treatment with disease-modifying agents such as interferon-beta or glatiramer acetate, monoclonal antibod...
Eligibility Criteria
Inclusion
- Female or male patients with relapsing-remitting forms of multiple sclerosis (according to McDonald's criteria)
- Age between 18 and 60 years
- Natalizumab-treatment for at least 12 month following the current Swiss guidelines for treatment initiation
- Eligible patients are clinically stable (free from relapses and 6-month confirmed disability progression for at least 6 months) while on natalizumab-treatment
- Women of potential childbearing with active contraceptive methods
- Patients who are willing to undergo study procedures
- Patients who are willing and able to sign informed consent
Exclusion
- Patients who have previously entered this study
- Natalizumab-treatment for less than 12 month following the current Swiss guidelines for treatment initiation
- Sign of clinical disease activity within the 6 month
- One or more relapses and/or 6-month confirmed disability progression during the 6 months prior to the study
- Any disease other than multiple sclerosis that would better explain the patient's signs and symptoms
- Secondary progressive MS
- Primary progressive MS
- Pregnancy - Urine pregnancy test at baseline visit - or breast feeding
- Uncontrolled, clinically significant heart diseases, such as arrhythmias, angina, or uncompensated congestive heart failure
- History of severe depression or attempted suicide or current suicidal ideation
- Medical or psychiatric conditions that compromise the ability to give informed consent, to comply with the protocol, or to complete the study
- Uncontrolled seizure disorder
- Myopathy or clinically significant liver disease
- Inability, in the opinion of the principal investigator or staff, to comply with protocol requirements for the duration of the study
- Known hypersensitivity to interferon-beta or other human proteins including albumin
- Any contraindication for MRI or contrast administration
- A history of drug abuse in the 6 months prior to screening
- Treatment with any of the following in the 30 days before day 1: systemic corticosteroids, ACTH, or other investigational drugs.
- Participation in any other study involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study
- Current participation on other clinical trials
- Treatment with drugs which might interfere with the evaluation of study drugs during the study protocol
- Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01144052
Start Date
June 1 2010
End Date
November 1 2011
Last Update
April 17 2014
Active Locations (1)
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1
Neurocenter of Southern Switzerland, Ospedale Civico Lugano
Lugano, Canton Ticino, Switzerland, 6900