Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 13.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: Ofatumumab
Product Code: HuMax-CD20
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Ofatumumab
Sponsors
GlaxoSmithKline UK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with definite diagnosis of relapsing-remitting MS according to McDonald criteria 2. Patients with: • At least two confirmed relapses within the last 24 months or • At least one confirmed relapse within the last 12 months or • One confirmed relapse between 12 and 24 months prior to screening, and at least one documented T1 Gd-enhancing lesion on an MRI performed within 12 months prior to screening. 3. Patients with disability equivalent to Expanded Disability Status Scale (EDSS) score of 0-5.0 (both included) at screening 4. Neurologically stable patients with no evidence of relapse for at least 30 days prior to start of Screening and during the Screening Phase 5. Age 18-55 years 6. Female patients must be either post-menopausal, surgically incapable of bearing children or practicing an acceptable method of birth control e.g. hormonal contraceptives, intrauterine device, spermicide and barrier as long as they are on trial medication and for a period of 1 year following the last infusion of trial drug. Females of childbearing potential must have a negative pregnancy test at screening visit prior to entry into the treatment period 7. Following receipt of verbal and written information about the trial, the patient must provide signed informed consent before any trial related activity is carried out. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Please refer to protocol for full list of exclusion criteria 1. Diagnosis of SPMS, PPMS or PRMS or Neuromyelitis optica 2. Neurological findings consistent with PML 3. Findings on brain MRI scan indicating any other clinically significant brain abnormality other than MS 4. Patients unable to undergo MRI scans 5. Patients who have had the following treatments: • Lymphocyte-depleting therapies (e.g. alemtuzumab (Campath®), anti-CD4, cladribine, total body irradiation, bone marrow transplantation), mitoxantrone or cyclophosphamide • Anti-CD20 treatments or any monoclonal antibodies • Immunoglobulin, azathioprine, cyclosporine, tacrolimus or other immunosuppressive agents, immunomodulatory agents or plasma exchange within six months prior to randomization in the trial apart from Glatiramer Acetate and IFN-beta • Glatiramer Acetate or IFN-beta within three months prior to the randomization • Glucocorticoids or ACTH within one month prior to the screening • Receipt of a live vaccine within one month prior to screening • Plasmapheresis for treatment of relapses within 2 months prior to randomization • Initiation of therapy with Statins or hormone replacement treatment within one month or less prior to screening • Patients who have received other disease modifying therapies for MS may be allowed on a case to case basis 6. Past or current history of medically significant adverse effects (including allergic reactions) from:• Cetirizine • Prednisolone• Paracetamol/acetaminophen• Plasma proteins or a known hypersensitivity to components of the investigational product. 7. Past or current malignancy, except for • Cervical carcinoma Stage 1B or less • Non-invasive basal cell and squamous cell skin carcinoma • Cancer diagnoses with a complete response of a duration of > 5 years. Patients with a prior history of hematological malignancies are excluded regardless of response 8. Clinically significant cardiac disease, including acute myocardial infarction within six months from screening, unstable angina, congestive heart failure, previous venous or arterial thrombosis or arrhythmia requiring therapy. 9. Electrocardiogram (ECG) showing significant abnormality 10. Significant concurrent, uncontrolled medical condition 11. History of severe, clinically significant CNS trauma 12. Chronic or ongoing active infectious disease requiring systemic treatment 13. Female patients who are pregnant or nursing. 14. Use of an investigational drug or other experimental therapy for a condition other than MS within 4 weeks prior to screening. Any prior use of an investigational drug or other experimental therapy for MS at any time should be discussed 15. Current participation in any other interventional clinical study 16. Serum vitamin B12 below lower limit of normal 17. Positive PCR screening for JC Virus as measured by qualitative plasma and/or white blood cell JCV DNA 18. Serologic evidence of Hepatitis B (HB) infection based on the results of testing for HBsAg, anti-HBc and anti-HBs antibodies with eligibility based on the results as follows:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part A: Evaluate the safety of three doses of ofatumumab in patients with relapsing remitting multiple sclerosis (RRMS). ; Secondary Objective: Part A: Evaluate the pharmacokinetic (PK) profile of ofatumumab in patients with RRMS. ;Primary end point(s): Cumulative number of new Gd-enhancing lesions on T1-weighted MRI from week 8 to week 24. | — |
Countries
Belgium, Czech Republic, Denmark, Germany, Sweden, United Kingdom
Contacts
Public ContactAnn Spratley
i3 Research
Outcome results
None listed