Phase 4
N=200
A Study of Rebif® in Subjects With Relapsing Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Bottom Line
View on ClinicalTrials.gov: NCT02064816 ↗Enrolled (actual)
200
Serious AEs
1.5%
Results posted
Sep 2018
Primary outcome: Primary: Difference in Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Between Rebif Morning Administration and Rebif Evening Administration Groups at Week 12 — 12.3; 11.8 units on scale — p=0.277763
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Rebif® (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Between Rebif Morning Administration and Rebif Evening Administration Groups at Week 12 |
12.3; 11.8 | 0.277763 |
| SECONDARY Difference in Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Between Rebif Morning Administration and Rebif Evening Administration Groups at Week 4 and 8 |
12.4368; 11.0876; 13.0039; 11.6672 | 0.0083 sig |
| SECONDARY Difference in Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Subscale Scores Between Rebif Morning Administration and Rebif Evening Administration Groups at Week 4, 8 and 12 |
10.8459; 10.4456; 11.5363; 11.4515; 11.6380; 11.9625 | 0.4311 |
| SECONDARY Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Week 4, 8 and 12 |
-0.6625; -0.4604; -0.7222; -0.3763; -0.6435; 0.05023 | — |
| SECONDARY Change From Baseline in Fatigue Severity Scale (FSS) Score at Week 4, 8 and 12 |
0.2089; 0.06901; 0.2062; 0.1366; 0.1464; 0.1942 | — |
| SECONDARY Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at Week 4, 8 and 12 |
-0.08889; 0.5747; -0.4513; 0.7092; 0.07841; 0.4293 | — |
| SECONDARY Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQOL) Score at Week 4, 8 and 12 |
1.6283; 0.1174; 1.1439; -2.2945; 0.9670; -1.3948 | — |
| SECONDARY Percentage of Subjects With Treatment Adherence at Week 4, 8 and 12 |
3.3; 5.9; 96.7; 94.1; 2.9; 1.5 | — |
| SECONDARY Change From Baseline in Circulating Levels of Cytokines at Week 12 |
-2.6; -2.6; -3.1; -3.0; 2.8; 2.8 | — |
| SECONDARY Correlation Between Change From Baseline in Circulating Levels of Cytokines (Leptin, Resistin and Adiponectin) and in Flu Like Symptom (FLS) Score at Week 12 |
0.08822; 0.03944; -0.20200; -0.01069; 0.04616; -0.13571 | — |
| SECONDARY Correlation Between Change From Baseline in Circulating Levels of Cytokines and in Other MSTCQ Items, HADS, FSS, PSQI and MusiQOL Scores at Week 12 |
0.00595; -0.10214; -0.22380; 0.04855; -0.13365; -0.14865 | — |
| SECONDARY Change From Baseline in Cytokines (Leptin and Resistin) Levels at Week 12 |
-2.7826; -0.7936; -3.6628; -5.8360 | — |
| SECONDARY Change From Baseline in Cytokine (Adiponectin) Level at Week 12 |
2.7093; 4.3574 | — |
| SECONDARY Change From Baseline in Hormone-Like Cytokine (Interleukin-6, 10 and 12) Levels at Week 12 |
-0.5173; -0.6970; -0.05819; -0.6660; -0.3490; -0.4384 | — |
| SECONDARY Change From Baseline in Total Sleep Time (TST) and Rapid Eye Movement (REM) Sleep Time at Week 12 |
10.0; 33.0; -3.0; 6.0 | — |
| SECONDARY Correlation Between Change From Baseline in Cytokines (Leptin, Resistin and Adiponectin) and Hormone-like Cytokine Levels (Interleukin-6, 10 and 12), and TST and REM Sleep Time at Week 12 |
0.10816; 0.46984; -0.56278; -0.05056; 0.17402; 0.58181 | — |
| SECONDARY Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death and TEAEs Leading to Discontinuation |
82; 77; 1; 2; 0; 0 | — |
Summary
This is an open-label, multi-center, 12-week, randomized, controlled, parallel group, Phase 4 study to assess whether the morning administration of interferon beta 1a (Rebif®) leads to a lower severity of flu-like symptoms (FLS) as compared to the evening administration, in subjects with relapsing multiple sclerosis (RMS).
Eligibility Criteria
Inclusion Criteria
- Males and females between 18 and 60 years of age
- Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential. Furthermore, female subjects must not have been pregnant from at least three months prior to enter in the study
- Subjects have RMS according to the revised McDonald Criteria (2010)
- Subjects with an expanded disability status scale (EDSS) score of less than 6.0
- Subjects naive to treatment and eligible for treatment with Rebif® 44 three times a week, or patients having received glatiramer acetate with a wash-out from at least one month, or patients having received treatment with natalizumab or fingolimod with a wash-out from at least three months
- Subjects able to self-inject treatment using RebiSmart®
- Subjects willing and able to comply with the protocol for the duration of the study
- Subjects have given written informed consent to take part in the study
Exclusion Criteria
- Subjects have any disease other than MS that could better explain his/her signs and symptoms
- Subjects who have received any immunosuppressive agents within 3 months prior to Baseline
- Subjects who have received any corticosteroids within 30 days prior to Baseline
- Subjects have a MS relapse within 30 days prior to Baseline
- Subjects have inadequate liver function and bone marrow reserve as defined in the protocol
- Subjects have moderate to severe renal impairment
- Subjects have any visual or physical impairment that precludes the subjects from self-injecting the treatment using RebiSmart®
- Subjects have hypersensitivity to natural or recombinant interferon, or to any of its excipients
- Subjects have any contra-indications to treatment with interferon (IFN) beta 1a according to Summary of Product Characteristics (SmPC)
- Subjects have any contra-indications to treatment with ibuprofen/paracetamol according to SmPC
- Obese subjects, defined by body mass index greater than 30 kilogram per square meter (kg/m^2)
- Subjects have participated in any other investigational trial within 30 days from Baseline
- Subjects have any other significant disease that in the Investigator's opinion would exclude the subject from the trial
Data sourced from ClinicalTrials.gov (NCT02064816). 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.