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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01058005
Other study ID # 101MS325
Secondary ID
Status Terminated
Phase Phase 3
First received January 26, 2010
Last updated August 18, 2014
Start date March 2010
Est. completion date April 2012

Study information

Verified date August 2014
Source Biogen
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products AgencySpain: Spanish Agency of MedicinesItaly: Ministry of HealthCzech Republic: State Institute for Drug ControlPoland: Ministry of HealthHungary: National Institute of PharmacyCanada: Health CanadaLatvia: State Agency of MedicinesUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This was a multicenter, randomized, open-label, parallel-group, active-controlled study. Prior to randomization, participants were to have been treated with glatiramer acetate or interferon β-1a (44 μg). Participants were to be randomized to receive natalizumab, interferon β-1a 44 μg, or glatiramer acetate.


Description:

The protocol was amended in 15 March 2011 to discontinue participants' enrollment and efficacy assessments, and to offer the opportunity for participants already enrolled to continue receiving study treatment for their planned participation in the study. The study had been active in several countries for approximately 1 year, and enrollment had been significantly slower than expected. Thus, the decision was made by the Sponsor to terminate the study since current and projected future enrollment rates would not have provided valuable information in a reasonable timeframe. All clinical efficacy and magnetic resonance imaging (MRI) procedures were removed from the protocol, and safety assessments were to be managed through standard of care activities.


Recruitment information / eligibility

Status Terminated
Enrollment 84
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Key Inclusion Criteria:

1. Have a diagnosis of relapsing remitting multiple sclerosis (MS) as defined by the revised McDonald Committee criteria (Polman 2005).

2. Must have been treated with a stable regimen of either glatiramer acetate (20 mg per day subcutaneous) or interferon beta-1a (44 mcg 3 times per week subcutaneous) as their principal first therapy for MS for 6 to 18 months prior to randomization. (Note: prior treatment with another MS therapy of = 30 days total duration is not exclusionary [e.g. titration to 44 mcg is allowed]).

3. Have had disease activity within 12 months prior to screening while on therapy; disease activity must be observed after a minimum of 6 months on therapy. Qualifying disease activity is defined as:

- One or more clinical relapses OR

- Two or more new MRI lesions (gadolinium [Gd+] and/or T2 hyperintense) For inclusion purposes: (a) a relapse is defined as neurologic signs and/or symptoms documented in the medical record by a neurologist and of sufficient duration to be determined by the Investigator or the Treating Physician as consistent with an MS relapse or (b) MRI activity must be verified by the central reader center.

4. Be naïve to natalizumab.

5. Have a documented Expanded Disability Status Scale (EDSS) score between 0.0 and 5.5, inclusive.

Key Exclusion Criteria:

1. Have a diagnosis of primary progressive, secondary progressive, or progressive relapsing MS (as defined by Lublin and Reingold, 1996). These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Patients with these conditions may also have superimposed relapses, but are distinguished from relapsing-remitting patients by the lack of clinically stable periods or clinical improvement.

2. Have known intolerance, contraindication to, or history of non-compliance with, the use of glatiramer acetate or interferon beta-1a.

3. Have had an MS exacerbation (relapse) within 30 days prior to randomization AND/OR the patient has not stabilized from a previous relapse, in the opinion of the Investigator, prior to randomization.

4. The patient is considered by the Investigator to be immunocompromised based on medical history, physical examination, laboratory testing, or due to prior immunosuppressive or immunomodulating treatment.

5. Subjects for whom MRI is contraindicated, i.e., have pacemakers or other contraindicated implanted metal devices, have suffered or are at risk for side effects from gadolinium (Gd), or have claustrophobia that cannot be medically managed.

6. History of any clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease that would preclude participation in a clinical trial.

7. History of malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).

8. Known history of human immunodeficiency virus (HIV).

9. Positive test result for hepatitis C virus (test for hepatitis C virus antibody [HCVAb]) or hepatitis B virus (test for hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody [HBcAb]).

10. History of transplantation or any anti-rejection therapy.

11. History of progressive multifocal leukoencephalopathy (PML).

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Drug:
BG00002 (natalizumab)
300 mg intravenous injection every 4 weeks
interferon beta-1a
44 mcg subcutaneous injection 3 times per week
glatiramer acetate
20 mg subcutaneous injection once daily

Locations

Country Name City State
Australia Research Site Fitzroy Victoria
Canada Research Site Gatineau Quebec
Czech Republic Research Site Pardubice
Finland Research Site Tampere
France Research Site Strasbourg Bas-Rhin
Hungary Research Site Budapest
Hungary Research Site Esztergom Komárom-Esztergom
Hungary Research Site Nyiregyhaza
Italy Research Site Catania
Italy Research Site Napoli
Italy Research Site Rome
Latvia Research Site Riga
Poland Research Site Bialystok Podlaskie
Poland Research Site Gdansk Pomorskie
Poland Research Site Lódz Lodzkie
Slovenia Research Site Ljubljana
Spain Research Site Alicante
Spain Research Site Barcelona
Spain Research Site Girona
Spain Research Site Madrid
Spain Research Site Santa Cruz de Tenerife
Spain Research Site Sevilla
Sweden Research Site Molndal
United States Research Site Akron Ohio
United States Research Site Atlanta Georgia
United States Research Site Charlotte North Carolina
United States Research Site Cullman Alabama
United States Research Site Detroit Michigan
United States Research Site Fort Collins Colorado
United States Research Site Franklin Tennessee
United States Research Site Kirkland Washington
United States Research Site Knoxville Tennessee
United States Research Site Lexington Kentucky
United States Research Site Maitland Florida
United States Research Site Morgantown West Virginia
United States Research Site New Orleans Louisiana
United States Research Site Norfolk Virginia
United States Research Site Patchogue New York
United States Research Site Phoenix Arizona
United States Research Site Round Rock Texas
United States Research Site Saint Petersburg Florida
United States Research Site Tampa Florida

Sponsors (2)

Lead Sponsor Collaborator
Biogen Elan Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Czech Republic,  Finland,  France,  Hungary,  Italy,  Latvia,  Poland,  Slovenia,  Spain,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Treatment-emergent Serious Adverse Events (SAEs) An SAE was defined as any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event; however, this does not include an event that, had it occurred in a more severe form, might have caused death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also have been any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed in the definition above. See Adverse Events section below for further details. up to 108 Weeks Yes
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