A multicenter, randomized, rater-blind study to compare the efficacy and safety of natalizumab (300 mg IV every four weeks) with Interferon beta-1a (44 mcg SC three times a week) in subjects with relapsing multiple sclerosis previously treated with Interferon beta-1a (22 or 44 mcg SC three times a week).

• Register: EUCTR
• Last refreshed on: 22 April 2013
• Main ID: EUCTR2004-004130-14-AT
• Date of registration: 13/01/2005
• Prospective Registration: Yes
• Primary sponsor: Biogen Idec GmbH
• Public title: A multicenter, randomized, rater-blind study to compare the efficacy and safety of natalizumab (300 mg IV every four weeks) with Interferon beta-1a (44 mcg SC three times a week) in subjects with relapsing multiple sclerosis previously treated with Interferon beta-1a (22 or 44 mcg SC three times a week).
• Scientific title: A multicenter, randomized, rater-blind study to compare the efficacy and safety of natalizumab (300 mg IV every four weeks) with Interferon beta-1a (44 mcg SC three times a week) in subjects with relapsing multiple sclerosis previously treated with Interferon beta-1a (22 or 44 mcg SC three times a week).
• Date of first enrolment: 17/02/2005
• Target sample size: 1050
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-004130-14
• 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

Key inclusion & exclusion criteria

Inclusion criteria:
Male and female subjects between 18 and 55 years of age who have a diagnosis of multiple sclerosis (MS) as defined by McDonald et al., criteria #1-4 (McDonald et al., 2001, Section 22), and a baseline EDSS score between 0.0 and 5.5, inclusive.

Randomized patients must have been treated with IFN beta-1a at either 22 or 44 mcg SC three times a week (TIW) for at least 9 months prior to randomization and must have experienced at least one medically documented clinical relapse on IFN beta-1a therapy within the 24 months prior to randomisation.
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:
Primary progressive, secondary progressive, or progressive relapsing MS.

MS relapse has occurred, in the opinion of the investigator, within 30 days prior to randomization AND/OR the subject has not stabilized from a previous relapse, in the opinion of the investigator, prior to randomization.

A clinically significant infectious illness.

History of malignancy.

History of, or abnormal laboratory results indicative of, any significant cardiac, endocrinologic, hematological, hepatic, immunological, metabolic, agrological, pulmonary, gastrointestinal, dermatological, psychiatric, renal, and/or other major disease, that, in the opinion of the investigator, would preclude the administration of a recombinant humanized antibody immunomodulating agent.

History of severe allergic or anaphylactic reactions or known drug hypersensitivity.

Abnormal blood tests, performed at the screening visit.

Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception (as defined by the investigator) during the study. The rhythm method is not to be used as the sole method of contraception.

Nursing mothers, pregnant women, and women planning to become pregnant while on study.

Previous participation in this study.

Participation in any other investigational study within 6 months prior to randomization.


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

Health Condition(s) or Problem(s) studied

Male and female subjects with relapsing multiple sclerosis previously treated with interferon beta-1a (22 mcg or 44 mcg, SC three times a week).

Intervention(s)

Product Name: Natalizumab
Product Code: Not Applicable
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: natalizumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-

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

Primary Outcome(s)

Secondary Objective: Secondary objectives include evaluation of the relative efficacy of natalizumab with IFN beta-1a on other relapse and MRI outcomes.

The safety, tolerability and relative effects of natalizumab and IFN beta-1a on quality of life will alsobe assessed.

Main Objective: The primary objective of this study is to compare the effect of natalizumab with IFN beta-1a on the annualized rate of clinical relapses at 1 year.

Primary end point(s): The primary endpoint of this study is to compare the effect of natalizumab with IFN beta-1a on:
· Annualized clinical relapse rate

The secondary objectives of this study are to compare the effect of natalizumab with IFN beta-1a on:

· Probability of remaining relapse free
· Time to first relapse
· T2 activity on brain MRI scans
· Safety and tolerability
· Quality of Life

Secondary ID(s)

IMA 04001