A phase II baseline versus treatment study to determine the efficacy of raltegravir (ISENTRESS) in preventing progression of relapsing remitting multiple sclerosis as determined by gadolinium-enhanced MRI

Plain English Summary

Not provided at time of registration

Study website

Type

Scientific

Contact name

Miss Ailsa Weatherall

ORCID ID

Contact details

Clinical Research Centre
Royal London Hospital
2 Newark Street
London
E1 2AT
United Kingdom
-
ailsa.weatherall@bartshealth.nhs.uk

EudraCT/CTIS number

2012-004847-61

IRAS number

ClinicalTrials.gov number

NCT01767701

Protocol/serial number

14731

Scientific title

A phase II baseline versus treatment study to determine the efficacy of raltegravir (ISENTRESS) in preventing progression of relapsing remitting multiple sclerosis as determined by gadolinium-enhanced MRI

Acronym

INSPIRE: Raltegravir in Relapsing MS

Study hypothesis

This exploratory study will enrol patients with active MS lesions will be enrolled in a baseline versus treatment clinical trial where they will be observed for 3 months, having monthly Gd-enhanced brain MRI, blood, saliva and urine collection and neurological assessments and then treated with active open-label raltegravir (400mg twice daily) and followed up with monthly Gd-enhanced brain MRI, blood, saliva and urine collection and neurological assessments for a further for 3 months.

Ethics approval(s)

12/EE/0544; First MREC approval date 10/01/2013

Study design

Non-randomised; Interventional; Design type: Not specified, Treatment

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Study setting(s)

Hospital

Study type

Treatment

Patient information sheet

Condition

Topic: Neurological; Subtopic: Neurological (all Subtopics); Disease: Nervous system disorders

Intervention

Raltegravir, open-label raltegravir 400mg twice daily; Follow Up Length: 6 month(s); Study Entry : Registration only

Intervention type

Drug

Pharmaceutical study type(s)

Phase

Not Specified

Drug/device/biological/vaccine name(s)

Raltegravir

Primary outcome measure

Gadolinium enhanced MRI; Timepoint(s): MRI every 4 weeks from day 0 to day 168

Secondary outcome measures

Not provided at time of registration

Overall study start date

30/04/2013

Overall study end date

31/01/2014

Reason abandoned (if study stopped)

Participant inclusion criteria

1. Patients between 18-55 years of age.
2. Diagnosis of MS, according to the revised McDonald Criteria 2010.
3. EDSS score of 0-6.0 inclusive.
4. Documented at least one relapse within the past 12 months or at least one Gd-enhanced lesion on the brain MRI detected within 3 months prior to screening date.
5. Gd-enhanced lesion on screening MRI if MRI not used to meet screening criteria above.
6. Female patients of childbearing potential will be expected to be on appropriate contraception (hormonal or barrier method of birth control; abstinence) from time of consent until 6 weeks after treatment discontinuation. (the repeated administration of gadolinium and MRI are not recommended during pregnancy). NOTE: Subjects are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
7. Females of childbearing potential must have a negative urine pregnancy test prior to every MRI scan/ within 7 days prior to being registered for protocol therapy.
8. Must give written informed consent and authorize the release and use of protected health information, as required by local law.
9. Able and willing to undergo blood, saliva and urine sampling at regular intervals as defined by the protocol.
10. Able and willing to receive Gadolinium enhanced MRI’s at regular intervals as defined by the protocol.
11. Able to comply with study requirements.
Target Gender: Male & Female; Upper Age Limit 55 years ; Lower Age Limit 18 years

Participant type(s)

Patient

Age group

Adult

Lower age limit

18 Years

Upper age limit

55 Years

Sex

Both

Target number of participants

Planned Sample Size: 24; UK Sample Size: 24

Total final enrolment

31

Participant exclusion criteria

1. Pregnant or breastfeeding or unwilling to use contraception.
2. Treatment with immunosuppressive, immunomodulatory or experimental treatments within the last 6 months of enrolment in the study, but excluding pulsed intravenous or oral steroids for treatment of MS relapse.
3. No pulsed intravenous or oral steroids in the 30 days preceding the baseline assessment.
4. Patients presenting with medical disorder deemed severe or unstable by the CI such as poorly controlled diabetes or arterial hypertension, severe cardiac insufficiency, unstable ischemic heart disease, abnormal liver function tests (>2.5 times ULN) and abnormal complete blood count (in particular leukopenia, as defined by a lymphocyte count <500, neutrophil <1.5 or platelet count < 100, or thrombocytopenia < 1.5 LLN), or any medical condition which, in the opinion of the chief investigator, would pose additional risk to the patient.
5. Presence of human immunodeficiency virus antibodies.
6. Patients receiving proton pump inhibitors (e.g. omeprazole/esomeprazole)
7. Patients with active hepatitis B or/and C with liver function tests >2.5 times ULN.
8. Exposure to any other investigational drug within 30 days of enrolment in the study.
9. Prior history of malignancy unless an exception is granted by the Chief Investigator.
10. History of uncontrolled drug or alcohol abuse within 6 months prior to enrolment into the study.
11. Patients treated with Rifampicin in past four weeks.

Recruitment start date

30/04/2013

Recruitment end date

31/01/2014

Countries of recruitment

England, United Kingdom

Study participating centre

Clinical Research Centre
London
E1 2AT
United Kingdom

Organisation

Queen Mary University of London (UK)

Sponsor details

R&D Office
Barts & London School of Medicine The QMI building
5 Walden Street
London
E1 2EF
England
United Kingdom

Sponsor type

University/education

Website

ROR

https://ror.org/026zzn846

Funder type

Industry

Funder name

Merck Sharp & Dohme Ltd. (MSD) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs