atalizumab (BG00002) as an Efficacy Switch in Subjects with Relapsing Multiple Sclerosis (MS) after Failure on Other Therapies

• Conditions: MedDRA version: 17.1Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders; Multiple Sclerosis (MS); Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-005586-39-DE
• Lead Sponsor: Biogen Idec Research Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-02
• Last Update Posted: 16 November 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

- Subjects of childbearing potential must practice effective contraception from Day -1 and be willing and able to continue contraception for duration of the study.

- Must have documented diagnosis of relapsing MS (McDonald 2010 Criteria [Polman 2011]) at Screening.

- Must have been treated with Gilenya or BRACET for at least the 12 months prior to Screening with no interruption of treatment greater than 1 month. More than 1 prior disease-modifying therapy is allowed, as long as minimum treatment duration was cumulatively 12 months. Prior treatment with natalizumab is allowed; however, there must be a minimum 1 year since last natalizumab infusion and the Screening visit of this study, and if discontinuation of natalizumab in the past was not due to intolerance, anti-natalizumab antibodies, or efficacy loss.

- Must have had disease activity in the 6 months prior to Screening while on Gilenya or BRACET (as defined by at least 1 Gd+ lesion OR at least 2 new T2 lesions (compared with an MRI done within 12 months of screening) OR clinical relapse, or EDSS progression of 1 point)

- Must have an EDSS score from 0 to 5.5 inclusive at Screening.

NOTE: Other protocol-defined inclusion criteria may 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 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- History or positive test result at Screening for human immunodeficiency virus (HIV). Prior treatment with Tysabri (either commercially or through a clinical study) within 1 year of Day -1.

- Contraindications to treatment with Tysabri as described in the Prescribing Information for each of the participating countries.

- Known allergy to Tysabri or known to be anti-natalizumab antibody positive.

- Diagnosis of primary progressive MS, secondary progressive MS, and/or progressive-relapsing MS.

- An MS relapse that has occurred within the 30 days prior to Day -1 and/or the subject has not stabilized from a previous relapse prior to Day -1.

- Known active malignancies (subjects with cutaneous basal cell carcinoma that has been completely excised prior to study entry remain eligible).

- History of severe opportunistic infections (including PML) or any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator

- Females breastfeeding, pregnant, or planning to become pregnant; women who are not post-menopausal or surgically sterile who are unwilling to practice contraception; women who have a positive pregnancy test result at Day -1.
- Prior history of immunosuppressant use (e.g., mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate, cladribine, rituximab) in the last 12 months prior to Screening. Prior history of alemtuzumab use at any point in the past.

NOTE: Other protocol-defined exclusion criteria may apply

Study & Design

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