A pilot multi-centre randomised controlled trial of sequential treatment with Mitoxantrone and Glatiramer Acetate vs. Interferon Beta-1a in early active relapsing remitting Multiple Sclerosis. - UNKEMPT

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

Definite MS as determined by the McDonald criteria (Ann Neurol, July 2001) with relapsing remitting disease course, clinical status should be stable or improving for 1 month prior to screening.
Patients 18 to 55 years of age with disease duration less than 5 years from onset, who had 2 relapses in the last 2 years and EDSS 0 – 5.5.

and

At least 3 of the following:
a)Patients with three or more relapses in the first two years of disease
b)Motor involvement in early relapses (weakness/ataxia)
c)Incomplete recovery from early relapses (EDSS >1.5)
d)10 or more lesions on T2-weighted brain MRI

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)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a)Patients ever treated with GA, Mitoxantrone or Interferons.

b)Patients treated with IV immunoglobulins (IVIg) in the 4 weeks prior to screening visits.

c) Patients treated with methotrexate or azathioprine in the previous 6 monthsprior to screening visits.

d) Patients ever treated with cyclophosphamide, Total Lymphoid Irradiation(TLI), or cladribine for injection or anthracenediones or anthracyclines, or prior mediastinal radiotherapy.

e) Patients treated with IV or oral steroids within 30 days of screening visit

f) Pregnant or lactating women at the screening visit.

g) Left ventricular ejection fraction (LVEF) < 50%

h) Patients using catheters or Foley catheters.

i) Patients who have any other known significant systemic medical disease which may confound the evaluation of the study results such as: amyotrophic lateral sclerosis (ALS), cervical spondylitic myelopathy, syphilis, arteritis, cerebellar syndrome, B12/folate deficiency, lyme disease, human lymphotropic virus, type 1 (HTLV 1)-myelopathy.j) Patients with immune deficiency or other medical condition that would preclude treatment with Mitoxantrone, GA or Interferon.k) Abnormal screening blood tests exceeding any of the limits defined below:
· Alanine transaminase (ALT) –twice the upper limit of normal (normal = 5-35 U/L)(may be repeated once)
· Aspartate transaminase (AST)-- twice the upper limit of normal (normal = 0-35 U/L)(may be repeated once)
· Baseline neutrophil counts of less than 1.5 X109/L
· Total white blood cell count less than 2.3 X109/L
· Platelet count less than 80 X109/L
· Creatinine 60 – 110 µmol/L
· Prothrombin time: >150% upper limit of normal (normal = 11.5 – 15.5 secs.)

l) Patients with any medical or psychiatric conditions that would make the patient unsuitable for this research, as determined by the investigator

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Secondary Objective: Annualised Relapse Rate (ARR) - the number of relapses per year over a 36 month period<br> Relapse free patients<br> Time to first relapse<br> Time to withdrawal<br> ;<br> Primary end point(s): Primary Endpoints: Multiple Sclerosis Impact Scale (MSIS)<br> Expanded Disability Status Scale (EDSS)<br> ;<br> Main Objective: Does sequential treatment with Mitoxantrone and Glatiramer Acetate (Copaxone) vs. Interferon Beta in early active relapsing remitting Multiple Sclerosis lead to better patient outcomes (in terms of the reduced relapses, reduced disability and improved quality of life)?<br><br>

Secondary Outcome Measures

Name	Time	Method

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