Relapsing Remitting Multiple Sclerosis MedDRA version: 14.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: ISENTRESS
Product Name: raltegravir
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: lactose monohydrate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients between 18-55 years of age. • Diagnosis of MS, according to the revised McDonald Criteria 2010. • EDSS score of 0-6.0 inclusive. • 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 • Gd-enhanced lesion on screening MRI if MRI not used to meet screening criteria above. • 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. • 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. • Must give written informed consent and authorize the release and use of protected health information, as required by local law. • Able and willing to undergo blood, saliva and urine sampling at regular intervals as defined by the protocol. • Able and willing to receive Gadolinium enhanced MRI’s at regular intervals as defined by the protocol. • Able to comply with study requirements. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • Pregnant or breastfeeding or unwilling to use contraception. • 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. • No pulsed intravenous or oral steroids in the 30 days preceding the baseline assessment. • 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 2.5 times ULN • Exposure to any other investigational drug within 30 days of enrolment in the study. • Prior history of malignancy unless an exception is granted by the Chief Investigator. • History of uncontrolled drug or alcohol abuse within 6 months prior to enrolment into the study. • Patients treated with Rifampicin in past four weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess whether treatment with raltegravir in patients with active MS has the effect of reducing the total number or rate of development of new or recurrent Gd-enhanced lesions on brain MRI over the period of treatment, compared to baseline.;Secondary Objective: 1. Demonstrate a reduction in the cumulative number of new or enlarging T2 weighted lesions on brain MRI over the period of treatment with Raltegravir compared with baseline. 2. Assess other MRI parameters of disease activity e.g. cumulative number of T2 lesions, cumulative number of Gd-T1 enhancing lesions, and percent of subjects with scans free from enhancing lesions in Raltegravir treated subjects vs. baseline. 3. Determine the effect of raltegravir therapy on specific inflammatory markers of MS activity. 4. Determine the effect of raltegravir on specific indicators of endogenous retroviral activity and activity of herpes viruses. 5. Explore preliminary clinical responses in relapsing-remitting multiple sclerosis subjects treated with Raltegravir, compared with baseline as measured by: a) Multiple Sclerosis Functional Composite (MSFC) b) Kurtzke Extended Disability Status Scale (EDSS) c) Multiple Sclerosis Quality of Life Inventory (MSQLI) ;Primary end point(s): The number of new or recurrent Gd-enhancing lesions that appear on brain T1-weighted MRI over the period of treatment with raltegravir, compared to baseline.;Timepoint(s) of evaluation of this end point: This endpoint will be measured and baseline and then every 4 weeks for the duration of the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Demonstrate a reduction in the cumulative number of new or enlarging T2 weighted lesions on brain MRI over the period of treatment with Raltegravir compared with baseline. 2. Assess other MRI parameters of disease activity e.g. cumulative number of T2 lesions, cumulative number of Gd-T1 enhancing lesions, and percent of subjects with scans free from enhancing lesions in Raltegravir treated subjects vs. baseline. 3. Determine the effect of raltegravir therapy on specific inflammatory markers of MS activity. 4. Determine the effect of raltegravir on specific indicators of endogenous retroviral activity and activity of herpes viruses. 5. Explore preliminary clinical responses in relapsing-remitting multiple sclerosis subjects treated with Raltegravir, compared with baseline as measured by: a) Multiple Sclerosis Functional Composite (MSFC) b) Kurtzke Extended Disability Status Scale (EDSS) c) Multiple Sclerosis Quality of Life Inventory (MSQLI);Timepoint(s) of evaluation of this end point: Gd-enhanced MRI's and blood tests to collect data for the secondary endpoints will be carried out at baseline and then every 4 weeks for the duration of the trial | — |
Countries
United Kingdom
Contacts
Public ContactAilsa Weatherall
Barts Health NHS Trust
Outcome results
None listed