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Minocycline as add-on to Interferon Beta-1a (Rebif®) in Relapsing Remitting Multiple Sclerosis

2014-08-27 03:13:16 | BioPortfolio

Summary

This is a multicentric, double-blind, placebo-controlled, randomised, parallel group study to estimate the effect of minocycline as add-on to interferon beta 1a (IFN β-1a) in subjects with relapsing remitting multiple sclerosis (RRMS).

Description

Interferon β-1a is the approved standard therapy in RRMS. The beneficial effects of minocycline in the experimental autoimmune encephalomyelitis (EAE) model and its possible effect on the degradation of IFN β-1a suggest that minocycline treatment may have beneficial effects in multiple sclerosis (MS) as add-on therapy in subjects who are on treatment with IFN β-1a. Adjuvant treatment with minocycline is easy to administer, well tolerated and relatively inexpensive. This is a multicentric, double blind, placebo controlled, randomised, parallel group study. Eligible subjects already started with IFN β-1a (Rebif) will be randomised for treatment with either minocycline 200 mg daily as add-on therapy or placebo. The subjects will be examined clinically at baseline and after 12, 24, 48, 72 and 96 weeks. Laboratory tests will be performed at baseline, after 4, 12, 24, 48, 72, and 96 weeks (at 4 weeks only an additional liver enzyme test will be scheduled). The magnetic resonance imaging (MRI) (T1-weighted and T2-weighted) before treatment and after 96 weeks and immunological studies before treatment and after 48 weeks will be performed in a limited number of subjects in selected centers.

OBJECTIVES

Primary objective:

- The effect of minocycline versus placebo in subjects receiving treatment with IFN β-1a on the time to first relapse

Secondary Objectives:

- To estimate the effect of minocycline versus placebo in subjects receiving treatment with IFN β-1a on the mean number of relapses per subject up to year 2

- And in a limited number of 120 subjects, the effect of minocycline versus placebo in subjects receiving treatment with IFN β-1a on the number of new or enlarging lesions on T2 weighted MRI, brain atrophy measured on MRI.

Tertiary Objectives:

- Time to onset of disability progression sustained over at least six months based on change from baseline in Expanded Disability Status Scale (EDSS) in subjects with relapsing-remitting multiple sclerosis who recently started treatment with IFN β-1a . (Disability progression is defined as an increase of: 1.0 point on the EDSS if EDSS was ≥ 1.0 at baseline; and 1.5 point on the EDSS if EDSS was 0.0 at baseline)

- Time to sustained progression by 2 points in 1 Functional System or 1 point in 2 Functional Systems.

- The total number of reported relapses (documented and undocumented). An undocumented relapse is defined as the appearance of new symptoms or worsening of an old symptom, in the absence of fever, over at least 24 hours that could be attributed to multiple sclerosis activity, preceded by stability or improvement for at least 30 days

- The requirement for treatment with glucocorticoids due to relapses

- The time to first documented relapse

- The number of relapse-free (total and documented relapses) patients without progression

- The disease activity measured on the Integrated Disability Status Scale (IDSS)

- The percentage of subjects with a permanent loss of disability of 1.0 score on the EDSS, confirmed at two consecutive visits with an interval of six months

- The total area of MS lesions on T1 and T2 weighted MRI

- Analyse the safety with respect to the combination of Rebif and minocycline

- Rate of dose reduction of IFN β-1a

- Relapse severity based on the EDSS and IDSS

- Immunological analyses in a limited number of patients (MRI subgroup)

- Frequency of increase of liver enzymes according to World Health Organization (WHO) II criteria

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Multiple Sclerosis, Relapsing-Remitting

Intervention

Minocycline, Placebo

Location

Scleroseklinikken afsnit 2082
Copenhagen
Denmark
2100

Status

Recruiting

Source

Merck KGaA

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:16-0400

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Medical and Biotech [MESH] Definitions

A form of multiple sclerosis characterized by a progressive deterioration in neurologic function which is in contrast to the more typical relapsing remitting form. If the clinical course is free of distinct remissions, it is referred to as primary progressive multiple sclerosis. When the progressive decline is punctuated by acute exacerbations, it is referred to as progressive relapsing multiple sclerosis. The term secondary progressive multiple sclerosis is used when relapsing remitting multiple sclerosis evolves into the chronic progressive form. (From Ann Neurol 1994;36 Suppl:S73-S79; Adams et al., Principles of Neurology, 6th ed, pp903-914)

A non-glycosylated form of interferon beta-1 that has a serine at position 17. It is used in the treatment of both RELAPSING-REMITTING MULTIPLE SCLEROSIS and CHRONIC PROGRESSIVE MULTIPLE SCLEROSIS.

A random polymer of L-ALANINE, L-GLUTAMIC ACID, L-LYSINE, and L-TYROSINE that structurally resembles MYELIN BASIC PROTEIN. It is used in the treatment of RELAPSING-REMITTING MULTIPLE SCLEROSIS.

An autoimmune disorder mainly affecting young adults and characterized by destruction of myelin in the central nervous system. Pathologic findings include multiple sharply demarcated areas of demyelination throughout the white matter of the central nervous system. Clinical manifestations include visual loss, extra-ocular movement disorders, paresthesias, loss of sensation, weakness, dysarthria, spasticity, ataxia, and bladder dysfunction. The usual pattern is one of recurrent attacks followed by partial recovery (see MULTIPLE SCLEROSIS, RELAPSING-REMITTING), but acute fulminating and chronic progressive forms (see MULTIPLE SCLEROSIS, CHRONIC PROGRESSIVE) also occur. (Adams et al., Principles of Neurology, 6th ed, p903)

The most common clinical variant of MULTIPLE SCLEROSIS, characterized by recurrent acute exacerbations of neurologic dysfunction followed by partial or complete recovery. Common clinical manifestations include loss of visual (see OPTIC NEURITIS), motor, sensory, or bladder function. Acute episodes of demyelination may occur at any site in the central nervous system, and commonly involve the optic nerves, spinal cord, brain stem, and cerebellum. (Adams et al., Principles of Neurology, 6th ed, pp903-914)

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