Alemtuzumab in Multiple Sclerosis Safety System development

Not Applicable

Completed

• Conditions: Multiple Sclerosis; Neurological - Multiple sclerosis

• Registration Number: ACTRN12613001027707
• Lead Sponsor: Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1.Willing to provide informed consent to both treatment with alemtuzumab and inclusion in the PRIME clinical decision support system monitoring procedures
2.Age 18 or older as of the date the consent is signed
3.Definite relapsing remitting MS by McDonald 2010 criteria
4.Cranial MRI scan demonstrating white matter lesions attributable to MS within 1 year of Screening
5.Active MS as signified by at least 2 relapses in the last 2 years and at least 1 relapse in the last 1 year
6.Either:
a.Failure of first line disease-modifying treatment as determined by: at least 1 relapse of MS despite treatment with a TGA-approved treatment for MS (interferons, glatiramer, teriflunomide, fingolimod or natalizumab), or at least 1 relapse in a patient unable to be treated with TGA-approved MS treatments due to intolerance or unacceptable risks of these treatments
b.Previously untreated MS that is associated with at least one gadolinium enhancing lesion on MRI in the last 1 year.
7.Diagnosed disease duration <= 10years
8.Baseline EDSS 0 – 4.0

Exclusion Criteria

a.As per CAMMS03409 amendment 2:
i.Does not wish to receive alemtuzumab
ii.Ongoing participation in any other investigational study
iii.Has received alemtuzumab off-label
iv.Known bleeding disorder (eg, dysfibrinogenemia, factor IX deficiency, hemophilia, Von Willebrand's disease, Disseminated Intravascular Coagulation [DIC], fibrinogen deficiency, or other clotting factor deficiency) or therapeutic anticoagulation
v.Diagnosis of immune thrombocytopenic purpura (ITP), or other autoimmune hematologic abnormality.
vi.History of malignancy, except basal cell skin carcinoma
vii.Intolerance of pulsed corticosteroids, especially a history of steroid psychosis
viii.Significant non-MS autoimmune disease including but not limited to: immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis, or anti-glomerular basement membrane disease (anti-GBM disease, also known as Goodpasture’s disease)
ix.Major psychiatric disorder or epileptic seizures not adequately controlled by treatment
x.Known infection with hepatitis B or C virus, seropositivity for human immunodeficiency virus (HIV).
xi.History of invasive fungal infections
xii.Unwilling to agree to use a reliable and acceptable contraceptive method for at least 6 months following each alemtuzumab treatment cycle (fertile patients only). Reliable and effective contraceptive method(s) include: intrauterine device (IUD), hormonal-based contraception, surgical sterilization, abstinence or double-barrier contraception (condom and occlusive cap [diaphragm or cervical cap with spermicide])
b.Plus (local exclusion criteria)
i.Not resident in NSW
ii.Not able to access Douglass Hanly Moir pathology services
iii.Not able or likely to fulfil the requirements of the study for any other reason
iv.Not able to access electronic reminders and alerts (patient must have both a mobile (cell) phone and a valid regularly checked email address, the patient’s designate person must have at least one of these two methods of contact, prefer both)
v.Allergic or intolerant of any agent required for the completion of this study (i.e alemtuzumab, gadolinium contrast)
vi.No history of primary infection or vaccination with varicella zoster virus, until vaccinated
vii.Other significant active or latent infection until treated
viii.Any other reason that an investigator regards as a contraindication to entering or ability to complete the study
c.The following are not exclusion criteria but caution should be exercised in including patients with these criteria noting that these were exclusion criteria for the alemtuzumab RCTs
i.Prior exposure to natalizumab, fingolimod, mitoxantrone, azathioprine, cladribine, cyclophosphamide, cyclosporine A, methotrexate, or any other immunosuppressive agent
ii.Patients > 50 years of age
iii.Disease duration 5-10 years after diagnosis
iv.EDSS 3.5-4
v.Patients with known thyroid autoimmunity or thyroid antibodies. Such patients are highly likely to develop clinical thyroid autoimmunity and this should be discussed with the patient.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Successful development of an IT architecture to monitor monthly pathology results electronically after treatment of MS patients with alemtuzumab.<br><br>The success will be measured by whether the package works, including integration between pathology company results and our fetching programme and interrogation of the data remotely and generation of remote alerts. [One year from commencement<br>]