RELIEF: interferon beta-1a in relapsing MS, phase 4

Multicenter, Open-label, 12 Week, Phase IV Prospective Randomized Study Aimed at Evaluating Whether sc IFN Beta 1a (Rebif®) Administered in the Morning May Affect the Severity of Flu-like Syndrome and Patient-perceived Invisible Symptoms in Subjects With Relapsing Multiple Sclerosis

CompletedPhase 4Relapsing MSNCT02064816 2013-004450-21

What it found

Missed its main goal

The main measure did not show a significant benefit.

Measure	Estimate	95% CI	p
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	Mean Difference (Final Values) 0.6	-0.46–1.56	0.277763

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

Interferon beta-1a
Interferon alpha/beta receptor agonist

Results by group

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

Week 12

Group	Value	Interval	Number analysed
Rebif Morning Administration	12.3 units on scale	3.87 (Standard Deviation)	99
Rebif Evening Administration	11.8 units on scale	3.02 (Standard Deviation)	88

Rebif Morning Administration

Rebif Evening Administration

p = 0.277763; Mean Difference (Final Values) 0.6 (95% CI -0.46–1.56)

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

Group	Participants at risk	Serious adverse events	Deaths
Rebif Morning Administration	104	1 (1.0%)
Rebif Evening Administration	96	2 (2.1%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

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
Week 12
Quality of life (reported by participants)
Difference in FLS score at week 12, as measured by items 13-16 of the MSTCQ, in subjects injecting Rebif® 44 tiw in the morning compared to the evening.

Other measures (17)

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
Week 4 and 8
Quality of life (reported by participants)
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
Week 4, 8 and 12
PainQuality of life (reported by participants)Safety
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Week 4, 8 and 12
Baseline, Week 4, 8 and 12
Mood and sleep
Change From Baseline in Fatigue Severity Scale (FSS) Score at Week 4, 8 and 12
Baseline, Week 4, 8 and 12
Fatigue
Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at Week 4, 8 and 12
Baseline, Week 4, 8 and 12
Myelin repairMood and sleep
Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQOL) Score at Week 4, 8 and 12
Baseline, Week 4, 8 and 12
Bladder, bowel and sexual functionQuality of life (reported by participants)
Percentage of Subjects With Treatment Adherence at Week 4, 8 and 12
Week 4, 8 and 12
Quality of life (reported by participants)
Change From Baseline in Circulating Levels of Cytokines at Week 12
Baseline and Week 12
Immune response
Correlation Between Change From Baseline in Circulating Levels of Cytokines (Leptin, Resistin and Adiponectin) and in Flu Like Symptom (FLS) Score at Week 12
Baseline and Week 12
Quality of life (reported by participants)Immune response
Correlation Between Change From Baseline in Circulating Levels of Cytokines and in Other MSTCQ Items, HADS, FSS, PSQI and MusiQOL Scores at Week 12
Baseline and Week 12
FatiguePainMood and sleepImmune response

Who could take part

Relapsing MS · 18 to 60

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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).

Papers

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History

Started
May 2014
Main results due
Apr 2016
Finished
Apr 2016
Results posted
Sept 2018

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