Phase 2
Completed N=129
A Multicentre Study of the Efficacy and Safety of Supplementary Treatment With Cholecalciferol in Patients With Relapsing Multiple Sclerosis Treated With Subcutaneous Interferon Beta-1a 44 µg 3 Times Weekly
Source: ClinicalTrials.gov NCT01198132 ↗Enrolled (actual)
129
Serious AEs
16.7%
Results posted
Dec 2017
Primary outcomePrimary: Annualized Relapse Rate — 0.45; 0.34 Relapse per year — p=0.3797
Summary
The aim of this multicentre, randomised, double-blind, placebo-controlled study is to evaluate the efficacy and safety of supplementary treatment with cholecalciferol (vitamin D3) in subjects with relapsing multiple sclerosis (R MS) treated with subcutaneous (s.c.) interferon beta-1a 44 microgram (mcg) [Rebif] 3 times weekly. The subjects will be divided into 2 groups, one receiving cholecalciferol 100,000 IU twice monthly along with Rebif treatment and the other group will be on placebo along with Rebif treatment. A total of 200 subjects will be recruited in 20-30 centres in France.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annualized Relapse Rate |
0.45; 0.34 | 0.3797 |
| SECONDARY Time to First Documented Relapse |
NA; NA | — |
| SECONDARY Mean Number of Relapses Per Subject |
0.5; 0.5 | — |
| SECONDARY Number of Relapse-Free (Documented) Subjects |
35; 27 | — |
| SECONDARY Cumulative Probability of Progression of Disability (Kaplan-Meier Curves) |
12.7; 9.1 | — |
| SECONDARY Number of New or Extended Lesions by T1- and T2-Weighted Magnetic Resonance Imaging (MRI) |
0.4; 1.9; 0.5; 2.0 | — |
| SECONDARY Changes From Baseline in Measured Lesion Load (T2) |
5305.4; 3520.1; -315.0; 596.3 | — |
| SECONDARY Change From Baseline in Measurement and Evaluation of Cognitive Ability by Paced Auditory Serial Addition Task (PASAT) Total Score At Week 96 |
39.9; 43.3; 6.4; 6.0 | — |
| SECONDARY Change From Baseline in Euro Quality of Life Scale (EuroQol) 5-Dimension-3 Level (EQ-5D-3L) |
0.7834; 0.7937; -0.0051; 0.0043 | — |
| SECONDARY Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Abnormal Clinical Laboratory |
43; 35; 11; 10 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of RRMS according to Poser criteria (clinically definite multiple sclerosis [CDMS] or laboratory supported definite multiple sclerosis [LSDMS]) or according to McDonald criteria (2005).
- Subjects aged between 18 and 65 years.
- Treated with interferon beta-1a 44 mcg (or 22 mcg in case of intolerance to 44 mcg) 3 times weekly subcutaneously for 4 months ± (2 months) at the randomization visit (V1).
- Expanded disability status scale (EDSS) score between 0 and 5.
- At least one documented episode during the last two year.
- Stable disease with no episodes over the last 30 days.
- Serum 25-hydroxyvitamin D less than ( ) 2.5 * upper limit of normal.
- Severe renal impairment defined as creatinine clearance below 30 milliliter per minute (ml/min).
- Inadequate marrow reserves, defined as white blood cells < 0.5 * lower limit of normal.
- Serious or acute heart disease such as uncontrolled cardiac arrhythmia, uncontrolled angina, cardiomyopathy or uncontrolled congestive heart failure.
- History of severe depression, or attempted suicide or ongoing suicidal ideation.
- Epilepsy inadequately controlled by treatment.
- Ongoing or previous alcohol or drug abuse (within the last two years).
- Major medical or psychiatric disease which, in the opinion of investigator, would place the subject at risk or could adversely affect compliance with the study protocol.
- Known hypersensitivity to gadolinium and/or known inability to undergo MRI.
- Any medical condition requiring chronic treatment with systemic corticosteroids.
- Participation in any other studies involving other study products over the 30 days prior to inclusion in this study.
- Legal incapacity or limited legal capacity.
Data sourced from ClinicalTrials.gov (NCT01198132). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.