FOCUS Fatigue Outcome in Copaxone USers - Full Text View

Purpose

The study primarily investigates the effect of copaxone on fatigue during treatment, compared to baseline in patients with relapsing-remitting multiple sclerosis.
Secondary outcome measures are:disability, relapse rate, quality of life and depression.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: Glatiramer acetate	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Fatigue Outcomes of Copaxone Users in Relapsing-remitting Multiple Sclerosis

Resource links provided by NLM:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Fatigue Multiple Sclerosis

Drug Information available for: Glatiramer Glatiramer acetate

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:

fatigue impact scale [ Time Frame: at baseline, month 6 and month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

relapse rate [ Time Frame: at baseline, month 6 and month 12 ] [ Designated as safety issue: No ]
quality of life [ Time Frame: at baseline, month 6 and month 12 ] [ Designated as safety issue: No ]
depression [ Time Frame: at baseline, month 6 and month 12 ] [ Designated as safety issue: No ]
disability [ Time Frame: at baseline, month 6 and month 12 ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: at baseline, month 6 and month 12 ] [ Designated as safety issue: No ]


Enrollment:	111
Study Start Date:	June 2003
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: single group	Drug: Glatiramer acetate

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

relapsing-remitting Multiple Sclerosis (MS),
at least 2 relapses in previous 2 years prior to copaxone or interferon beta treatment,
ambulant patients i.e disability score EDSS MAX 5,5,
clinically stable MS
relapse free and steroid free at least 30 days prior to start copaxone treatment

Exclusion Criteria:

hypersensitivity to glatiramer acetate or mannitol,
pregnancy,
fertile female not willing to use effective contraception,
previous treatment with copaxone

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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: NCT00267319

Locations


Czech Republic
Sanofi-Aventis
Praha, Czech Republic

Sponsors and Collaborators

Sanofi

Investigators


Study Director:	Zuzana Priborska	Sanofi

More Information


Responsible Party:	Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00267319 History of Changes
Other Study ID Numbers:	HMR4002A_4002
Study First Received:	December 19, 2005
Last Updated:	December 4, 2009
Health Authority:	Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:


Sclerosis Multiple Sclerosis Fatigue Multiple Sclerosis, Relapsing-Remitting Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases	Autoimmune Diseases Immune System Diseases Signs and Symptoms Glatiramer Acetate Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Immunosuppressive Agents Antirheumatic Agents

ClinicalTrials.gov processed this record on September 23, 2016