NCT00942591.
Methods | Multi‐center, randomized, rater‐blinded, parallel‐group‐study |
Participants | 80 patients with Relapsing‐Remitting MS (according to McDonald's criteria) At least 1 relapse in the past two year > 3 lesions on spinal or brain‐MRI or both EDSS score between 0 and 3.5 (inclusive) Age between 18 and 55 years Written informed consent Negative pregnancy test results (all women) |
Interventions | Intervention group: interferon beta‐1b and atorvastatin 40 mg Control group: interferon beta‐1b |
Outcomes | Primary outcomes: proportion of patients with new T2 lesions on MRI (at 15 months). Secondary Outcomes: Gd‐enhancing lesions on T1‐weighted images, change of total T2 lesion volume, cortical atrophy, clinical disease progression, number of relapse free patients, relapse rate, time to first relapse, and serial levels of neutralizing antibodies (at 15 months). |
Notes | Sponsored by University Hospital Inselspital, Berne. http://clinicaltrials.gov/ct2/show/NCT00942591 The patients that finished the SWABIMS study are now undergoing for an additional 12 months follow up with unchanged medication (http://clinicaltrials.gov/ct2/show/NCT01111656). Further information received or reported would be analysed in the next update of this review. |