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) (MusiClock)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01110993
First received: April 6, 2010
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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).


Condition
Multiple Sclerosis, Relapsing-Remitting

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Non-interventional, Multicenter Study to Evaluate QoL and Influence of Cognitive Status on QoL in Patients With RRMS During 2 Years Treatment With RNF

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: Baseline to 24 months of RNF treatment (At baseline, 12 and 24 months) ] [ Designated as safety issue: No ]
    To evaluate the QoL by assessing the changes in MusiQoL Questionaire scores


Secondary Outcome Measures:
  • Assessment of Cognitive Status [ Time Frame: Baseline to 24 months of RNF treatment (At baseline, 12 and 24 months) ] [ Designated as safety issue: No ]
    To evaluate cognitive status by assessing the changes in MMSE and 10-PCT scores

  • Influence of cognitive impairment on QoL in subjects with RRMS [ Time Frame: Baseline to 24 months of RNF treatment (At baseline, 12 and 24 months) ] [ Designated as safety issue: No ]
    To evaluate the influence of cognitive impairment on QoL in subjects with RRMS by assessing the correlation between changes in MusiQoL and those in 10-PCT and MMSE

  • Assessment of Expanded Disability Status Scale [ Time Frame: Baseline to 24 months of RNF treatment (At baseline, 12 and 24 months) ] [ Designated as safety issue: No ]
  • Assessment of number of relapses [ Time Frame: Baseline to 24 months of RNF treatment (At baseline, 12 and 24 months) ] [ Designated as safety issue: No ]
  • Assessment of results of Evoked Potentials (visual, auditory, somatosensory/ if they are routinely done) [ Time Frame: Baseline to 24 months of RNF treatment (At baseline, 12 and 24 months) ] [ Designated as safety issue: No ]
  • Assessment of Magnetic Resonance Imaging results [ Time Frame: Baseline to 24 months of RNF treatment (At baseline, 12 and 24 months) ] [ Designated as safety issue: No ]
    MRI results will be assessed to depict new Gd-enhancing lesions, new T2 lesions, enlarging T2 (BOD) lesions, new T1 hypointense lesions, enlarging T1 hypointense lesions, atrophy /if they are routinely done


Enrollment: 65
Study Start Date: November 2010
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects with Multiple Sclerosis undergoing treatment with Rebif in Poland.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01110993

Locations
Poland
Medical University, Department of Neurology
Lublin, Poland
Sponsors and Collaborators
Merck KGaA
Investigators
Principal Investigator: Zbigniew Stelmasiak, Prof. Medical University, Department of Neurology, Lublin, Poland
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01110993     History of Changes
Other Study ID Numbers: EMR 701068-516
Study First Received: April 6, 2010
Last Updated: January 31, 2014
Health Authority: Poland: Ministry of Health

Keywords provided by Merck KGaA:
Multiple Sclerosis, Interferon-beta 1-a

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014