Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis

Relapsing Remitting Multiple Sclerosis Clinical Trial

— SURPASS  

Official title:

A Multicenter, Randomized, Open-Label, Parallel-Group, Active-Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon Beta-1a) to Natalizumab in Subjects With Relapsing Remitting Multiple Sclerosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01058005
• Other study ID #: 101MS325
• 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

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis

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