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 disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-002283-25-FI
• Lead Sponsor: Merck KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-25
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

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

Exclusion Criteria

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