A study To Evaluate the Efficacy, Safety and Tolerability of Plovamer Acetate Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis
- Conditions
- Relapsing Remitting Multiple Sclerosis (RRMS)MedDRA version: 17.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2013-002283-25-GB
- Lead Sponsor
- Merck KGaA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 550
1. Male or female, between the ages of 18 and 60 years.
2. Patient is able to learn and self-administer SC injections (a care-giver may be trained to inject the patient).
3. Patients must have a current diagnosis of RRMS (according to the 2010 McDonald MS diagnostic criteria).
Other protocol defined inclusion criteria could apply
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 550
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Patients are not eligible for this trial if they fulfill any of the following exclusion criteria:
1. Any MS categorized as primary progressive, secondary progressive and progressive relapsing.
2. Any relapse of MS within 30 days of the Baseline Visit 2.
3. Allergy to mannitol, plovamer acetate, Copaxone (glatiramer acetate), Gd contrast for MRI.
4. Systemic glucocorticoid therapy within 30 days of Baseline Visit 2. Any requirement for continuous systemic glucocorticoid administration during the trial period. (Note: Treatment with interferons such as Avonex®, Rebif®, or Betaseron® will be allowed until the baseline visit, as no wash-out period is needed.)
5. Contraindication to Copaxone use.
Other protocol defined exclusion criteria could apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this trial is to evaluate the efficacy of plovamer acetate (0.5 mg, 3 mg, 10 mg and 20 mg) administered as weekly SC injection vs. Copaxone 20 mg administered as daily SC injection after 40 weeks of treatment on the mean number of T1 gadolinium (Gd)-enhancing lesions per patient and scan on brain MRI scans at Weeks 24, 28, 32, 36, and 40 in patients with RRMS. ;Secondary Objective: To evaluate the efficacy of plovamer acetate (0.5 mg, 3 mg, 10 mg and 20 mg), administered as weekly SC injection vs. Copaxone 20 mg administered as daily SC injection after 40 weeks of treatment;Primary end point(s): The primary endpoint is the mean number of T1 Gd-enhancing lesions per patient per scan measured over 5 monthly visits (Weeks 24, 28, 32, 36 and 40).<br>;Timepoint(s) of evaluation of this end point: 40 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Mean Annualized Relapse Rate.<br>· Percentage of patients remaining relapse-free at<br>Week 40.<br>· Mean number of new T1 Gd-enhancing lesions per<br>patient and scan from 5 serial MRI scans performed on<br>Weeks 24, 28, 32, 36, and 40.<br>· Mean number of new or enlarging T2 lesions per patient and scan from 5 serial MRIs performed on Weeks 24, 28, 32, 36, and 40.<br>· Mean number of new, unenhancing T1 lesions (black holes) per patient and scan on MRI scans from 5 serial MRIs performed on Weeks 24, 28, 32, 36, and 40.<br>· Mean change in volume of T1 Gd-enhancing lesions per patient baseline vs. mean of 5 serial MRI scans performed on Weeks 24, 28, 32, 36, and 40.<br>· Mean change per patient in volume of T2 Gd-enhancing lesions baseline vs. last MRI scan performed between Weeks 24 and 40.<br>· Time to first relapse.<br>· Mean change in brain volume per patient baseline vs. last MRI performed between Weeks 24 and 40.;Timepoint(s) of evaluation of this end point: 40 weeks