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)

NCT01110993 | Completed

• 1 other identifier: EMR 701068-516
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple Sclerosis, Interferon-beta 1-a

Outcome Measures

Primary Outcomes (1)

• Quality of Life

  To evaluate the QoL by assessing the changes in MusiQoL Questionaire scores

  Baseline to 24 months of RNF treatment (At baseline, 12 and 24 months)

Secondary Outcomes (6)

• Assessment of Cognitive Status

  Baseline to 24 months of RNF treatment (At baseline, 12 and 24 months)

• Influence of cognitive impairment on QoL in subjects with RRMS

  Baseline to 24 months of RNF treatment (At baseline, 12 and 24 months)

• Assessment of Expanded Disability Status Scale

  Baseline to 24 months of RNF treatment (At baseline, 12 and 24 months)

• Assessment of number of relapses

  Baseline to 24 months of RNF treatment (At baseline, 12 and 24 months)

• Assessment of results of Evoked Potentials (visual, auditory, somatosensory/ if they are routinely done)

  Baseline to 24 months of RNF treatment (At baseline, 12 and 24 months)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with Multiple Sclerosis undergoing treatment with Rebif in Poland.

You may not qualify if:

• Subjects aged above 18 years
• Subjects with clinically diagnosed RRMS which is characterised by two or more acute exacerbations in the previous two years
• Written consent to cooperation made by the environmental nurse who takes care about subject in hospital as well as in his home
• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

Medical University, Department of Neurology

Lublin, Poland

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Zbigniew Stelmasiak, Prof.

  Medical University, Department of Neurology, Lublin, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2010
• First Posted: April 27, 2010
• Study Start: November 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 3, 2014

Record last verified: 2014-01

Locations

PL (1)