A dose blinded extension study to the CBAF312A2201 study to evaluate long-term safety, tolerability and efficacy of BAF312 given orally once daily in patients with relapsing multiple sclerosis. - ND

• Conditions: multiple sclerosis; MedDRA version: 12.1Level: LLTClassification code 10028245Term: Multiple sclerosis

• Registration Number: EUCTR2009-014392-51-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-11
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 275

Inclusion Criteria

1. Patients completed the treatment in the core study CBAF312A2201; 2. Written informed consent provided at least on day 1 of this extension study; 3. Female patients at risk of becoming pregnant must have a negative pregnancy test and use simultaneously two forms of effective contraception
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

1. Premature discontinuation of the study drug during the core study (CBAF312A2201); 2. Chronic disease of the immune system other than MS which may require immunosuppressive treatment; 3. Presence of malignancy; 4. Newly diagnosed diabetes mellitus or a blood glucose obtained suspicious for diabetes (≥ 126 mg/dl or ≥ 7 mmol/L if fasting; ≥ 200 mg/dl or ≥ 11.1 mmol/L if random); 5. Active systemic bacterial, viral or fungal infections, or known to have AIDS, or having a positive HIV antibody test; 6. Any medically unstable condition, that may interfere with the patient s ability to cooperate and comply with the study procedures, as assessed by the treating physician 7. Any of the following cardiovascular conditions: a. myocardial infarction within the past 6 months prior to entry in the extension or with current unstable ischemic heart disease; b. cardiac failure (Class III, according to New York Heart Association Classification) or any severe cardiac disease as determined by the investigator; c. arrhythmia requiring treatment with Class III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibulitide, azimilide, dofelitide); 8. Any of the following pulmonary conditions: a. Severe respiratory disease or pulmonary fibrosis diagnosed during the core study; b. Tuberculosis suspected during core study; c. Abnormal chest x-ray or high resolution computer tomography (HRCT) suggestive of active pulmonary disease in the core study; 9. History of alcohol abuse during the core study; 10. Chronic liver disease such as Hepatitis B, Hepatitis C infection, or having positive referring laboratory tests acquired during the core study; 11. Use of other investigational drugs during the study.

Study & Design

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