Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis.
- Conditions
- Relapsing-Remitting Multiple Sclerosis (RRMS)MedDRA version: 17.1Level: LLTClassification code 10070716Term: Multiple sclerosis pseudo relapseSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2011-002333-19-DK
- Lead Sponsor
- GlaxoSmithKline Research and Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 196
Subjects eligible for enrolment in the study must meet all of the following criteria:
1. Able to provide signed, written informed consent to participate in the study
2. 18-55 years of age.
3. Definite diagnosis of MS according to the 2010 revisions of the McDonald
diagnostic criteria for MS [Polman, 2011].
4. Subjects do not have any manifestation of another type of MS other than RRMS.
5. Subjects must have a relapsing-remitting course of disease with at least one of the following prior to screening:
A. At least one confirmed relapse within the previous year or
B. At least two confirmed relapses within the previous 2 years or
C. At least one relapse in the previous 2 years, with a GdE brain lesion on an MRI scan in the past year.
6. Expanded Disability Status Scale (EDSS) score of 0-5.5 (inclusive) at screening.
7. Neurologically stable with no evidence of relapse for at least 30 days prior to start of Screening and during the Screening Phase (subjects who relapse during the screening
Phase can be re-screened, once the relapse has resolved).
8. A female subject is eligible to enter the study if she is:
A. Of non-childbearing potential
B. Of childbearing potential and NOT pregnant or nursing, has a negative serum pregnancy test at screening, and agrees to one of the following:
a. Complete abstinence from intercourse for the period from consent into the study until 6 months after the last dose of investigational product; or,
b. Consistent and correct use of one of the following acceptable methods of birth control for the period from consent into the study until 6 months after the last dose of investigational product:
i. Oral contraceptives (either combined or progesterone only)
ii. Injectable progesterone
iii. Levonorgestrel implants
iv. Estrogenic vaginal ring
v. Percutaneous contraceptive patches
vi. Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure
rate of <1% per year
vii. Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject’s entry into the study; this male must be the sole partner for the subject
viii. Double barrier method: condom and an occlusive cap (diaphragm or
cervical/vault caps) with a vaginal spermicidal agent
(foam/gel/film/cream/suppository).
A female is considered Non-childbearing potential” if she is status-post hysterectomy, status-post surgical removal of both ovaries, has current, documented tubal ligation, or is postmenopausal and >2 years without menses. Female subjects who are post-menopausal <2 years must be confirmed menopausal by Follicle Stimulating Hormone (FSH) and
estradiol levels.
A female is considered childbearing potential” if she has functional ovaries, ducts, and uterus with no impairment that would cause sterility. This includes women with oligomenorrhea (even severe), and women who are perimenopausal or who have just begun to menstruate.
French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to, or a beneficiary of, a social security category.
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 254
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Subjects meeting any of the following criteria are not eligible and cannot enroll in the study:
1. Unable to undergo MRI scans (e.g. due to pacemaker, severe claustrophobia,hypersensitivity to contrast media, or who lack adequate peripheral venous access).
2. Any clinically significant brain abnormality other than MS found on MRI.
3. Neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML) or confirmed PML (see Appendix 4, Section 11.4, for PML monitoring algorithm).
4. Subjects whom experience a relapse during the Screening Phase. These subjects may be eligible for re-screening after consultation with GSK.
5. History of clinically significant CNS trauma (e.g. traumatic brain injury, cerebral contusion, spinal cord compression) or a history or presence of myelopathy due to spinal cord compression by disk or vertebral disease.
6. Prior treatment with any of the following:
A. Systemic glucocorticoids or Adrenocorticotrophic hormone (ACTH) within one month prior to screening
B. Receipt of a live vaccine within 6 weeks prior to screening
C. Glatiramer acetate (Copaxone) or IFN-ß (Betaferon, Betaseron, Avonex, or Rebif) within 3 months prior to screening
D. Any immunomodulatory therapies, excluding glatiramer acetate or IFN-ß, within
6 months prior to screening including natalizumab and fingolimod (Gilenya),
immunoglobulin, or plasma exchange/plasmapheresis
E. Any monoclonal antibodies at any time, other than natalizumab (Tysabri)
F. Any lymphocyte-depleting therapies, including, but not limited to: cladribine, anti-CD4, total body irradiation, or bone marrow transplantation
G. Any immunosuppressive agents, including, but not limited to: mitoxantrone, azathioprine, cyclosporine, cyclophosphamide, or tacrolimus
7. Past or current history of medically significant adverse effects (including allergic reactions) from:
A. Cetirizine (or equivalent)
B. Paracetamol/acetaminophen
C. Corticosteroids
8. Known hypersensitivity to components of the investigational product.
9. Past or current malignancy, except for
A. Cervical carcinoma Stage 1B or less
B. Non-invasive basal cell and squamous cell skin carcinoma
C. Cancer diagnoses with a duration of complete response (remission) >5 years
D. A history of hematologic malignancy excludes a subject from participation,
regardless of response.
10. Electrocardiogram (ECG) showing a clinically significant abnormality at Screening
or showing an average QTcB or QTcF interval =450 msec (=480 msec for subjects with a Bundle Branch Block) over 3 consecutive ECGs.
11. Significant concurrent, uncontrolled medical condition including, but not limited to, cardiac, renal, hepatic, hematological, gastrointestinal, endocrine, immunodeficiency syndrome, pulmonary, cerebral, psychiatric, or neurological disease which in the opinion of the investigator could affect the subject’s safety, impair the subject’s reliable participation in the trial, impair the evaluation of endpoints, or necessitate the use of medication not allowed by this protocol.
12. History of severe, clinically significant CNS trauma (e.g. cerebral contusion, spinal cord compression) or a history or presence of myelopathy due to spinal cord compression by disk or vertebral disease.
13. Chronic or ongoing active infectious disease requiring long term systemic treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis, or active hepatitis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method