A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis - N/A

• Conditions: Relapsing-Remitting Multiple Sclerosis; MedDRA version: 8.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis

• Registration Number: EUCTR2006-003697-10-GR
• Lead Sponsor: Biogen Idec Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-31
• Last Update Posted: 31 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1232

Inclusion Criteria

1. Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information [PHI]).
2. Aged 18 to 55 years old, inclusive, at the time of informed consent.
3. Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.
4. Must have a baseline EDSS between 0.0 and 5.0, inclusive.
5. Must have experienced at least 1 relapse within the 12 months prior to randomization, with a prior brain MRI demonstrating lesion(s) consistent with MS, or show evidence of Gd-enhancing lesion(s) of the brain on an MRI performed within the 6 weeks prior to randomization.
6. Male subjects and female subjects of child bearing potential (including female subjects who are not post-menopausal for at least 1 year) must be willing to practice effective contraception (as defined by the Investigator) during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.

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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Medical History
1. Primary progressive, secondary progressive, or progressive relapsing MS (as defined by Lublin and Reingold, 1996). These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Subjects with these conditions may also have superimposed relapses, but are distinguished from relapsing-remitting subjects by the lack of clinically stable periods or clinical improvement.
2. Unable to perform the Timed 25-Foot Walk, Nine-Hole Peg Test (9HPT) with both upper extremities, and PASAT 3.
3. Unable to perform visual function tests.
4. History of malignancy, unless an exception is granted by the Biogen Idec Medical Director. (Subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible.)
5. History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
6. History of abnormal laboratory results indicative of any significant endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, renal, and/or other major disease that would preclude participation in a clinical trial.
7. History of clinically significant cardiovascular, pulmonary, gastrointestinal, dermatologic, psychiatric, neurologic (other than MS), and/or other major disease that would preclude participation in a clinical trial.
8. History of human immunodeficiency virus (HIV).
9. History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization.
10. An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization.
11. Positive for hepatitis C antibody and/or positive for hepatitis B surface antigen (HBsAg) at screening.
12. Any of the following abnormal blood tests at screening:
•alanine transaminase/serum glutamate-pyruvate transaminase (ALT/SGPT), or aspartate transaminase/serum glutamic-oxaloacetic transaminase (AST/SGOT), or gamma-glutamyl-transferase (GGT) =2 times the upper limit of normal (ULN)
•leukocytes <3500/mm³
•eosinophils >0.7 x 10³/µL or >0.7 GI/L.
13. Any of the following abnormal urine tests at screening confirmed by a second urinalysis 2 weeks later:
•proteinuria (1+ or greater)
•hematuria, without known etiology (e.g., urinary tract infection, menses)
•glycosuria, without known etiology (e.g., recent steroid use, elevated serum glucose).
Treatment History
14. Any previous treatment with:
•FUMADERM® or BG00012 (FAG-201)
•glatiramer acetate (Copaxone®).
15. Prior treatment with any of the following:
•total lymphoid irradiation
•cladribine
•T-cell or T-cell receptor vaccination
•any therapeutic monoclonal antibody, with the exception of TYSABRI® (natalizumab) (see exclusion #17).
16. Prior treatment with any of the following within 1 year prior to randomization:
•mitoxantrone
•cyclophosphamide.
17. Prior treatment with any of the following medications or procedures within the 6 months prior to randomization:
•cyclosporine
•azathioprine
•methotrexate
•natalizumab (TYSABRI®)
•intravenous immunoglobulin
•plasmapheresis or cytapheresis.
18. Prior treatment with any of the following within the 3 months prior to randomization:
•interferon-alpha
•interferon-beta.
19. Treatment with any of the following medications within the 50 days prior to randomization:
•steroids (intravenous [IV] or oral corticosteroid treatment inlcuding agents that may act through the corticosteroid pathway [e.g., low dose naltre

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified