A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon β 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - ND

• Register: EUCTR
• Last refreshed on: 3 April 2012
• Main ID: EUCTR2009-015556-15-IT
• Date of registration: 07/06/2010
• Prospective Registration: Yes
• Primary sponsor: BIOGEN IDEC LTD
• Public title: A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon β 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - ND
• Scientific title: A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon β 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - ND
• Date of first enrolment: 07/06/2010
• Target sample size: 1800
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-015556-15
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Austria, Denmark, Finland, Germany, Greece, Hungary, Italy, Netherlands, Portugal, Slovenia, Spain, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Have signed written informed consent 2. Have a diagnosis of relapsing remitting multiple sclerosis as defined by the revised McDonald Committee criteria (Polman 2005). 3. Must have been treated with a stable regimen of either glatiramer acetate (20 mg per day SC) or interferon β-1a (44 mcg 3 times per week) as their principal first therapy for MS for 6 to 18 months prior to randomization. 4. Have had disease activity within 12 months prior to screening while on therapy; 5. Be na?ve to natalizumab. 6. Be between the ages of 18 and 60, inclusive at the time of informed consent. 7. Have a documented EDSS score between 0.0 and 5.5, inclusive.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Have a diagnosis of primary progressive, secondary progressive, or progressive relapsing MS (as defined by Lublin and Reingold, 1996). 2. Have known intolerance, contraindication to, or history of non-compliance with, the use of glatiramer acetate or interferon β-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 5. Subjects for whom MRI is contraindicated, 6. History of any clinically significant (as determined by the Investigator) 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 or hepatitis B virus and/or hepatitis B core antibody 10. History of transplantation or any anti-rejection therapy. 11. History of severe allergic or anaphylactic reactions or known drug hypersensitivity. 12. A clinically significant infectious illness (within 30 days prior to screening. 13. History of PML.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10063399

Intervention(s)

Trade Name: TYSABRI
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Natalizumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-

Trade Name: COPAXONE
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Glatiramer acetate
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-

Trade Name: REBIF
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon beta-1a
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 44-

Trade Name: REBIF*SC 12SIR 6000000UI 22MCG
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon beta-1a
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 22-

Primary Outcome(s)

Main Objective: The primary study objective is to evaluate the efficacy (clinical and MRI) of switching to natalizumab compared to receiving interferon β1-a or glatiramer acetate.

Secondary Objective: The secondary study objective is to evaluate the effect on quality of life of switching to natalizumab compared to receiving interferon β1-a or glatiramer acetate.

Primary end point(s): The primary endpoint in this study is the annualized relapse rate in subjects with relapsing remitting multiple sclerosis (RRMS).

Secondary ID(s)

2009-015556-15-FI

101MS325