Fibromyalgia Health Outcome Study on Cost of Treatments - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00725101

Purpose

The REFLECTIONS Study is a 12-month, prospective observational study that will be utilized in approximately 100 care settings in the United States (US) and Puerto Rico. It is designed to examine treatment patterns and health outcomes of adult patients diagnosed by their physician with fibromyalgia (FM) and who are starting any "new pharmacologic agent" for FM.

The primary benefit of this study is enhanced understanding of the disease state of FM and the role that pharmacologic treatment plays, which may help to optimize the management of FM. This study will address current gaps in a rapidly growing body of literature for FM.

Condition	Intervention
Fibromyalgia	Drug: Treatment for Fibromyalgia

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Real World Examination of Fibromyalgia: Longitudinal Evaluation of Costs and Treatments (The REFLECTIONS Study)

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

To describe how FM is treated in patients from naturalistic outpatient care settings who are "newly prescribed" pharmacologic treatments for FM and who are followed for 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To examine patient characteristics, FM profile, and physician characteristics that influence baseline and longitudinal treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To describe reasons for 'new' pharmacologic treatment in FM patients at baseline and changes post-baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To examine patient and physician characteristics that are associated with a reduction in opioid use [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To examine treatment, patient and physician characteristics associated with changes in patient clinical characteristics, burden and economic measures. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	1707
Study Start Date:	June 2008
Study Completion Date:	April 2011
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Fibromyalgia Patients Fibromyalgia patients starting any new pharmacologic agent for FM as deemed appropriate by physician.	Drug: Treatment for Fibromyalgia As prescribed by physician.

Eligibility

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

Study Population

Multiple care centers

Criteria

Inclusion Criteria:

Meet criteria for FM, in the opinion of the investigator
Must be prescribed a 'new' treatment for FM
Male and female patients at least 18 years of age
Willing to complete the ICD form and any other required forms to be eligible for participation in the study
Currently under the care of the participating physician
Cognitively able to understand and complete patient self-rated scales in English or Spanish via CATI
Available for 12 months to participate in the study

Exclusion Criteria:

Are investigator site personnel directly affiliated with the study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
Are Lilly employees
Terminally ill
Currently participating in other research studies or if they begin a research study while participating in this study
Unable to respond via telephone for CATI
Incompetent for interview as deemed by the participating physician
Unwilling to provide written Informed Consent or other required forms to participate in the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00725101

Show 58 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00725101 History of Changes
Other Study ID Numbers:	11540, F1J-MC-B020
Study First Received:	July 28, 2008
Last Updated:	May 23, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases

Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on February 09, 2012