Efficacy and Safety of GTR in Comparison to Copaxone®

Completed · Phase 3 · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

The purpose of this study is demonstrate that efficacy and safety of Synthon's glatiramer acetate (GTR) is equivalent to Copaxone® (Teva) in patients with relapsing remitting multiple sclerosis

Key facts

Study ID

NCT01489254

Run by

Synthon BV

People needed

794

Starts

2011-10-01

Expected to finish

2015-01-01

Last updated by the study team

2016-12-29

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Willing and able to sign written Informed Consent;
• Female and male subjects aged 18-55 years inclusive at the time of Informed Consent signing;
• Diagnosis of RRMS according to the revised McDonald criteria;
• Expanded Disability Status Scale (EDSS) score of 0.0 up to and including 5.5;
• Neurologically stable with no evidence of relapse within 30 days prior to randomization;
• Experienced at least 1 relapse in the year before first screening assessment;
• 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;
• 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 immuno-modulatory treatment, or a screening MRI showing maximally 15 T1-GdE lesions;
• 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;
• Female subjects of childbearing potential must agree to practice appropriate contraceptive methods as assessed by the investigator.

You may not qualify if…

• Any life-threatening, medically unstable or otherwise clinically significant condition or findings other than MS, in particular neoplastic disease, seizure disorders, or psychiatric disease;
• Any clinically significant deviation from reference ranges in laboratory tests;
• Positive laboratory test results for human immunodeficiency virus (HIV), HBsAg or HCV at screening;
• Any significant deviation from reference ranges for hepatic function;
• 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);
• Having been treated with or having received
• 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
• within one year before screening:
• mitoxantrone, but subject cannot be enrolled when mitoxantrone was taken at a cumulative lifetime dosing above 100 mg/m2
• 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)
• within 3 months before screening:
• azathioprine, methotrexate
• plasma exchange
• any other experimental intervention, in particular experimental drugs
• within 1 month before screening:
• Interferon-β 1a or 1b
• short-term oral or injectable corticosteroids for treatment of a relapse
• short-term ACTH
• 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);
• Pregnancy or breastfeeding;
• Known hypersensitivity to gadolinium-containing products, glatiramer acetate or mannitol;

Where it is running

• Synthon investigational site 120 — Port Charlotte, Florida, United States
• Synthon investigational site 130 — Sunrise, Florida, United States
• Synthon investigational site 107 — Elk Grove Village, Illinois, United States
• Synthon investigational site 141 — Raleigh, North Carolina, United States
• Synthon investigational site 106 — Cleveland, Ohio, United States
• Synthon investigational site 135 — Dayton, Ohio, United States
• Synthon investigational site 401 — Bitebsk, Belarus
• Synthon investigational site 403 — Grodno, Belarus
• Synthon investigational site 402 — Homyel, Belarus
• Synthon investigational site 404 — Minsk, Belarus
• Synthon investigational site 407 — Minsk, Belarus
• Synthon investigational site 408 — Minsk, Belarus
• Synthon investigational site 405 — Vitebsk, Belarus
• Synthon investigational site 486 — Banja Luka, Bosnia and Herzegovina
• Synthon investigational site 487 — Sarajevo, Bosnia and Herzegovina
• Synthon investigational site 488 — Tuzla, Bosnia and Herzegovina
• Synthon investigational site 204 — Pleven, Bulgaria
• Synthon investigational site 207 — Pleven, Bulgaria
• Synthon investigational site 206 — Plovdiv, Bulgaria
• Synthon investigational site 202 — Sofia, Bulgaria
• Synthon investigational site 203 — Sofia, Bulgaria
• Synthon investigational site 205 — Sofia, Bulgaria
• Synthon investigational site 208 — Sofia, Bulgaria
• Synthon investigational site 201 — Varna, Bulgaria
• Synthon investigational site 112 — Irvine, California, United States

Full record on ClinicalTrials.gov

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