Relapsing Multiple Sclerosis
Conditions
Interventions
Product Code: RO0506997
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: RO0506997
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical f
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Protocol section 4.1.1: MS-related Inclusion Criteria 1) Diagnosis of relapsing MS types 1-4 based on “McDonald criteria” as revised in 2005 (Appendix 1), without taking into account the screening MRI results 2) EDSS score of = 6.5 (Appendix 2) 3) Between 12 months and 1 month previous: 1 or more MS attack (which has been documented in prior medical records) or a brain MRI with a gadolinium-enhancing lesion consistent with an MS lesion (based on radiology report or investigator review of MRI) Protocol section 4.1.3: Other Inclusion Criteria 1) Signed written informed consent 2) Men or women 18-59 years of age i) If female: postmenopausal (i.e. spontaneous amenorrhea for the past year confirmed by an FSH level greater than 40 mIU/mL unless the patient is receiving HRT), surgically sterile (i.e. tubal ligation, hysterectomy) or if of childbearing potential, must use abstinence or two methods of contraception throughout the trial. These should include one primary (e.g. systemic hormonal contraception, vasectomy of the male partner) AND one secondary barrier method (e.g. latex condoms, spermicide) OR a double barrier method (e.g. latex condom plus spermicide (e.g. foam, suppository, gel cream)) may be used. (1) Definition of postmenopausal for patients participating in the study at sites in Germany: spontaneous amenorrhea for 2 years, FSH levels > 40 m IU/mL and estrogen levels =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Protocol section 4.1.2: MS-related Exclusion Criteria 1) MS attack or systemic corticosteroids within 1 month 2) MS treatments which are given to primarily treat symptoms: a) Within 3 months: if part of an IRB/EC approved trial b) Otherwise may remain on the regimen if it is unchanged within 1 month and is unlikely to change before week 16. This includes cannabis-related agents as well as categories such as over-the-counter, herbal and nutritional supplement. The following refer to any other agents given to treat MS (approved or unapproved): 3) Within 3 months: interferon beta, glatiramer acetate, or plasmapheresis 4) Within 12 months: intravenous immunoglobulin, cytapheresis, azathiaprine, cladribine, cyclophosphamide, methotrexate, mitoxantrone, mycophenolate, pixantrone, sirolimus, tacrolimus or other agents typically used to prevent transplant rejection or as cancer chemotherapy, excluding hormonal treatments 5) Ever having received: natalizumab, stem cell or bone marrow transplant, total lymphoid irradiation, vaccine therapy for MS or monoclonal antibodies whose effects may be longer than 1 year such as alemtuzumab, daclizumab or rituxan (rituximab) 6) Within 3 months: any other agents given for non-symptomatic treatment of MS which were not included above in items 3-5 such as HMGCoA-reductase inhibitors, “glitazone”-type antidiabetics, 4-aminopyridine or products related to 4- aminopyridine, antibiotics, hormone treatment, as well as categories such as overthe- counter, herbal and nutritional supplement. However, if the agent is being taken primarily to treat another medical condition, then it is allowed as long as the dose is unchanged within 3 months and is unlikely to change before week 16 Protocol section 4.1.4: Other Exclusion Criteria 1) Women who are pregnant or may breastfeed before week 16 2) Within 1 month: an infection requiring systemic anti-infective treatment or a vaccination. Exceptions are treatment of an uncomplicated urinary tract infection or upper respiratory tract infection. 3) Within 3 months: participation in any IRB/EC investigational drug trial or treatment with anti-TNF or other potentially immune modulating agents not already mentioned 4) Within 6 months: alcohol abuse or drug abuse as assessed by the investigator using, for example, DSM-IV criteria for substance abuse 5) History of HIV infection or Hepatitis C Infection, Tuberculosis (TB), or progressive multifocal leukoencephalopathy (PML) 6) History of hereditary or acquired immunodeficiency, except for that caused by pharmaceutical intervention; or currently present hereditary or acquired immunodeficiency, including that caused by pharmaceutical intervention 7) A medical or neurological condition a) that may significantly interfere with the absorption of an oral medication, b) which is likely to require a new medication or hospitalization over the next 6 months or c) that may interfere with the assessment of MS 8) Presence of pacemakers or foreign metal objects in the eyes, skin, or body which would contraindicate an MRI scan or renal impairement which would contraindicate gadolinium injection 9) Current or history of cancer, excluding localized non-melanoma skin cancer Protocol section 4.2.2: Exclusion Criteria at Baseline 1) Since screening, except for the use of systemic corticosteroids for an MS attack (see section 5), use of any new treatment which has been approved for or is being evaluated for an effect on MS 2) Since screening, developmen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of RO0506997 on MS by assessing the number of new gadolinium-enhancing lesions developing while on treatment (specifically the sum of new lesions seen on the weeks 4, 8 and 12 MRIs).;Secondary Objective: Effect on other MRI lesions, MS clinical status and safety.;Primary end point(s): The primary endpoint is the cumulative number MRI enhancing lesions. Other endpoints are the cumulative number of active MRI lesions and the proportion of active MRIs. Clinical endpoints are the rate of MS attacks and change of MS status on the EDSS scale. | — |
Countries
Czech Republic, Germany, Slovakia, Spain, United Kingdom
Outcome results
None listed