An Observational Study to Evaluate Quality of Life (QoL) and Influence of Cognitive Status on QoL in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS) During 2 Years Treatment With Rebif New Formulation (RNF)
An Observational Study to Evaluate Quality of Life (QoL) and Influence of Cognitive Status on QoL in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS) During 2 Years Treatment With Rebif New Formulation (RNF)
This is a prospective, non-interventional, multicenter study to evaluate quality of life
 (QoL) and influence of cognitive status on QoL in subjects with relapsing-remitting multiple
 sclerosis (RRMS) during two years of treatment with Rebif New Formulation (RNF).
Multiple sclerosis (MS) is an acquired demyelinating disease of unclear etiology, occurring
 mainly in adults. Multiple sclerosis occurs in 30-100 people per 100 000. Usually the disease
 attacks young adults aged between 20 and 40 years. The peak of this occurrence is in the
 population of 30-35 year olds.

 The main feature of the disease is multifocal (disseminated) injury of the central nervous
 system. The injury causes various neurological symptoms and signs that go on and off
 (relapsing-remitting form) or progress steadily, and with time cause irreversible damage of
 the nervous system and permanent disability. In neuropsychological studies, 40-65% of MS
 subjects show cognitive impairment with prominent involvement of memory, sustained attention
 and information processing speed. Multiple sclerosis subjects with different disease courses
 have different cognitive profiles.

 Cognitive dysfunction can have a dramatic impact on a subject's QoL, influencing the
 fulfillment in work and social life, independently from physical disability. The methodology
 of cognitive status assessment in MS is based on established sets of tests, which could be
 conduced by qualified neurophysiologists. There is a need of simple test that could be
 quickly conducted by every physician, providing information of cognitive status/ or one of
 its parameters (attention/concentration). That kind of information could be immediately used
 by the physician during the visit to adjust the way of taking history or giving advices to
 subjects.

 During the last 10 years there's been an enormous progress in the MS treatment. New drugs
 appeared that proved to diminish clinical activity of the disease and slow its progress.
 Early treatment with disease modifying therapies may reduce cognitive impairment or slow down
 the progression of cognitive deficits.

 The scope of this study is to evaluate the cognitive status (attention/concentration) and the
 influence of cognitive impairment on QoL in subjects with RRMS during two years of treatment
 with RNF.

 OBJECTIVES

 Primary objective:

 -  To evaluate the QoL in subjects with RRMS during two years of treatment with RNF

 Secondary objectives:

 -  To evaluate the cognitive status (attention/concentration) and the influence of
 cognitive impairment on QoL in subjects with RRMS during two years of treatment with RNF
 Subjects will be treated according to widely-acknowledged standards for MS treatment and
 the choice of drug will depend solely on medical indications. The potential subjects
 will have been prescribed Rebif for the first time by their treating physicians and will
 then be given the option to enter in this observational study. As this is purely an
 observational study, the subjects will be followed by their treating physicians,
 according to current medical practice and Rebif SmPC (Summary of Product
 Characteristics) requirements (i.e monitoring of thyroid and liver enzymes prior to the
 start of therapy, and hepatic function at months 1, 3, 6 and periodically thereafter,
 prescription of antipyretics etc.) After each control visit, the treating physician will
 complete subject's observations chart. The planned schedule of visits will be identical
 to the routine schedule of control visits dictated by the National Health Found: 1st
 Visit - 3 months after RNF therapy start, 2nd Visit - after 6 months, 3rd Visit - after
 9 months, 4th Visit - after 12 months, 5th Visit - after 18 months, 6th Visit - after 24
 months.

 "0" visit - doctors will be asked to complete data from subjects history (doctors will be
 given the proposal of testing (MusiQoL[Multiple Sclerosis International Quality of Life],
 MMSE [Mini Mental State Examination] and 10-PCT [10-Point Clock Test]) most subjects on the
 visit when the disease-modifying drugs [DMD] therapy is instituted).
There are no specific inclusion/exclusion criteria as the trial is a non-interventional,
 observational study. The criteria are based on SmPC and criteria of Polish National Found
 Programme of RRMS Patients Treatment:

 Inclusion Criteria:

 -  Subjects aged above 18 years

 -  Subjects with clinically diagnosed RRMS which is characterised by two or more acute
 exacerbations in the previous two years

 -  Subjects who has never been treated with Rebif (previous treatment with other DMDs
 will not be regarded as an exclusion criterion)

 -  Written consent to cooperation made by the environmental nurse who takes care about
 subject in hospital as well as in his home

 -  Score of 21 or more points, according to National Heath Found Patient inclusion
 criteria for the 2 years program of MS treatment with interferon beta

 Exclusion Criteria:

 Exclusion criteria conform with Rebif's registered contraindications, described in an Sm PC
 approved by Ministry of Health.

 -  Interferon beta-1a is contraindicated during pregnancy

 -  Interferon beta-1a is contraindicated in subjects with confirmed hypersensitivity to
 natural or recombined interferon beta, or to any of the adjuvant substances

 -  Interferon beta-1a is contraindicated in subjects with severe depression and/or
 suicidal thoughts