A clinical trial comparing the efficacy, and safety and tolerability of two disease modifying MS drugs (GTR and Copaxone®) in patients with relapsing remitting multiple sclerosis for 9 months followed by a 15 month GTR treatment part to evaluate efficacy and safety of long-term GTR treatment.
- Conditions
- Relapsing remitting multiple sclerosisTherapeutic area: Diseases [C] - Nervous System Diseases [C10]MedDRA version: 15.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
- Registration Number
- EUCTR2011-000888-27-EE
- Lead Sponsor
- Synthon BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 750
1.Willing and able to sign written Informed Consent;
2.Female and male subjects aged 18-55 years inclusive at the time of Informed Consent signing;
3.Diagnosis of RRMS according to the revised McDonald criteria
4.Screening Expanded Disability Status Scale (EDSS) score of 0.0 up to and including 5.5;
5.Neurologically stable with no evidence of relapse within 30 days prior to bazeline assessments;
6.Experienced at least 1 relapse in the year before first screening assessment;
7.At least 1 T1-weighted Gadolinium enhancing (T1-GdE) lesion on routine brain MRI taken within 3 months of starting screening or on screening brain MRI (as confirmed by central imaging laboratory);
8.Having a routine brain MRI showing maximally 15 T1-GdE lesions if scan is taken without subject receiving immuno-modulatory treatment, or a routine brain MRI showing maximally 5 T1-GdE lesions when taken while on immune-modulatory treatment, or a screening MRI showing maximally 15 T1-GdE lesions;
9.Must decline initiation or continuation of treatment with other available disease-modifying drugs for MS, for whatever reason, after having been informed about their respective benefits and possible adverse events by the investigator;
10.Female subjects of childbearing potential must agree to practice appropriate contraceptive methods as assessed by the investigator.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 750
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
1.Any life-threatening, medically unstable or otherwise clinically significant condition or findings other than MS, in particular neoplastic disease, seizure disorders, or psychiatric disease;
2.Any clinically significant deviation from reference ranges in laboratory tests;
3.Positive laboratory test results for human immunodeficiency virus (HIV), HBsAg or HCV at screening;
4.Any significant deviation from reference ranges for hepatic function as defined by either AST (SGOT), ALT (SGPT), GGT, or AP elevated 3-fold or higher beyond the upper limit of the reference range or total bilirubin elevated 2-fold or higher beyond the upper limit of the reference range (in case of Gilbert’s Syndrome, a joint documented decision will be made between the investigator and the Medical Officer);
5.Positive urine drug screen or history of substance abuse within the year before screening (any use of illicit or prescription drugs or alcohol constituting an abuse pattern in the opinion of the investigator);
6.Having been treated with or having received
a.at any time:
•glatiramer acetate, cladribine, rituximab, cyclophosphamide, alemtuzumab, or other immunosuppressive treatments with effects potentially lasting for more than 6 months;
•total lymphoid irradiation or bone marrow transplantation;
b.within one year before screening:
•mitoxantrone, but subject cannot be enrolled when mitoxantrone was taken at a cumulative lifetime dosing above 100 mg/m2;
c.within 6 months before screening:
•fingolimod, immunoglobulins and/or monoclonal antibodies (including natalizumab), leflunomide, or putative MS treatments;
•chronic oral or injected corticosteroids or injected ACTH (more than 30 consecutive days);
d.within 3 months before screening:
•azathioprine, methotrexate;
•plasma exchange;
•any other experimental intervention, in particular experimental drugs;
e.within 1 month before screening:
•Interferon-ß 1a or 1b;
•short-term oral or injectable corticosteroids for treatment of a relapse;
•short-term ACTH;
7.Having, in the opinion of the investigator, consecutively failed on efficacy grounds two full and adequate courses of accepted treatment modalities (normally at least one year of treatment for each);
8.Pregnancy or breastfeeding;
9.Known hypersensitivity to gadolinium-containing products, glatiramer acetate or mannitol;
10.Having an estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2;
11.Inability to undergo (repeat) MRI investigations as judged by the investigator, e.g., due to claustrophobia, metal implants or fragments, tattoos or permanent make-up;
12.Any reason why, in the investigator's opinion, the subject should not participate.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method