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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT01489254
Date of registration: 08/12/2011
Prospective Registration: Yes
Primary sponsor: Synthon BV
Public title: Efficacy and Safety of GTR in Comparison to Copaxone® GATE
Scientific title: Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, 9 Month, Equivalence Trial Comparing the Efficacy and Safety and Tolerability of GTR (Synthon BV) to Copaxone® (Teva) in Subjects With Relapsing Remitting Multiple Sclerosis Followed by an Open-label 15 Month GTR Treatment Part Evaluating the Long-term GTR Treatment Effects
Date of first enrolment: October 2011
Target sample size: 794
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01489254
Study type:  Interventional
Study design:   
Phase:  Phase 3
Countries of recruitment
Belarus Bosnia and Herzegovina Bulgaria Croatia Czech Republic Estonia Georgia Germany
Greece Italy Kazakhstan Mexico Moldova, Republic of Poland Romania Russian Federation
Serbia South Africa Ukraine United Kingdom United States
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

1. 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

2. within one year before screening:

- mitoxantrone, but subject cannot be enrolled when mitoxantrone was taken at
a cumulative lifetime dosing above 100 mg/m2

3. 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)

4. within 3 months before screening:

- azathioprine, methotrexate

- plasma exchange

- any other experimental intervention, in particular experimental drugs

5. within 1 month before screening:

- Interferon-ß 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;

- Having an estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2;

- 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;

- Any reason why, in the investigator's opinion, the subject should not participate.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All
Health Condition(s) or Problem(s) studied
Multiple Sclerosis
Intervention(s)
Drug: Glatiramer Acetate (Copaxone®)
Drug: Glatiramer Acetate (GTR)
Drug: Placebo
Primary Outcome(s)
The Number of T1-Gadolinium Enhancing Lesions During Months 7-9 [Time Frame: 9 months]
Secondary Outcome(s)
Secondary ID(s)
2011-000888-27
GTR001
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 31/10/2016
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01489254
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