Fibromyalgia Health Outcome Study on Cost of Treatments

NCT00725101 | Completed Results

• 2 other identifiers: 11540F1J-MC-B020
• Study Type: observational
• Target: 1,700
• Locations: 2 countries
• Sites: 58

Brief Summary

The Real World Examination of Fibromyalgia: Longitudinal Evaluation of Costs and Treatments (REFLECTIONS) Study is a 12-month, prospective observational study that will be utilized in approximately 58 care settings in the United States (US) and Puerto Rico. It is designed to examine treatment patterns and health outcomes of adult participants 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 management of FM. This study will address current gaps in a rapidly growing body of literature on FM.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (3)

• Cumulative Number of Medications Taken for Fibromyalgia (FM) Over 12 Months

  Baseline through 12 months

• Odds Ratio From Stepwise Logistic Regression Model of Baseline Medication Use for Fibromyalgia (FM): Duloxetine, Pregabalin, or Milnacipran Versus Any Other Medication

  Significant variables included in the final model were age over 65, physician gender and specialty, use of opioids (excluding tramadol), use of non-steroidal anti-inflammatory drugs (NSAIDs), and number of medications.

  Baseline through 12 months

• Odds Ratios From Stepwise Logistic Regression Model of Longitudinal Adherence to Duloxetine Treatment for Fibromyalgia (FM) Over 12 Months: Generalized Anxiety Disorder-7 (GAD-7) Score, Pregabalin Use, and Non-Steroidal Anti-Inflammatory Drug (NSAID) Use

  Significant variables included in the final model were pregabalin use, NSAID use, and GAD-7 (7-item, self-reported measurement of GAD severity \[not at all severe, severe for several days, severe for more than half the days, severe nearly every day\]; Total score=sum of all 7 items; ranges from 0 to 21; Higher score=greater level of anxiety). Odds ratios were based on medication possession ratio (MPR) ≥0.8 for pregabalin and NSAID use among duloxetine initiators at Baseline; MPR=total supply days/total number of days in 12-month study period.

  Baseline through 12 months

Secondary Outcomes (14)

• Reasons for Discontinuing Medications for Fibromyalgia (FM) During the Study

  Baseline through 12 months

• Percentage of Participants Who Discontinued Opioids

  Baseline through 12 months

• Hazard Ratios for Factors Associated With Discontinued Opioid Use

  Baseline through 12 months

• Change From Baseline in Brief Pain Inventory-Interference (BPI-I) Average Subscale Score at 12 Months

  Baseline, 12 months

• Change From Baseline in Brief Pain Inventory-Severity (BPI-S) Average Subscale Score at 12 Months

  Baseline, 12 months

Study Arms (1)

Fibromyalgia (FM) Participants

FM participants starting any new pharmacologic FM agent.

Drug: Treatment for Fibromyalgia

Interventions

Treatment for Fibromyalgia DRUG

FM participants starting any new pharmacologic FM agent.

Fibromyalgia (FM) Participants

Eligibility Criteria

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

Study Population

Multiple care centers

You may qualify if:

• Meet criteria for fibromyalgia (FM) in the opinion of the investigator
• Must be prescribed a 'new' treatment for FM
• Male and female participants at least 18 years of age
• Willing to complete the Informed Consent Document (ICD) and any other required forms to be eligible for study participation
• Currently under the care of the participating physician
• Cognitively able to understand and complete participant self-rated scales in English or Spanish via computer-assisted telephone interview (CATI)
• Available for 12 months to participate in the study

You may not qualify if:

• 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
• Are Terminally ill
• Currently participating in other research studies or if beginning 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 ICD or other required forms to participate in the study

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (58)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Hot Springs, Arkansas, 71913, United States

Location

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Santa Barbara, California, 93108, United States

Location

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Danbury, Connecticut, 06810, United States

Location

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Waterbury, Connecticut, 06708, United States

Location

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Washington D.C., District of Columbia, 20006, United States

Location

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Jupiter, Florida, 33458, United States

Location

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Tampa, Florida, 33609, United States

Location

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Winter Park, Florida, 32792, United States

Location

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Blue Ridge, Georgia, 30513, United States

Location

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Snellville, Georgia, 30078, United States

Location

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Meridian, Idaho, 83646, United States

Location

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Nampa, Idaho, 83686, United States

Location

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Peoria, Illinois, 61614, United States

Location

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Springfield, Illinois, 62702, United States

Location

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Evansville, Indiana, 47710, United States

Location

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Fishers, Indiana, 46038, United States

Location

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Indianapolis, Indiana, 46260, United States

Location

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Louisville, Kentucky, 40223, United States

Location

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Baton Rouge, Louisiana, 70808, United States

Location

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Baltimore, Maryland, 21222, United States

Location

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Towson, Maryland, 21286, United States

Location

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Wheaton, Maryland, 20902, United States

Location

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Lansing, Michigan, 48910, United States

Location

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West Plains, Missouri, 65775, United States

Location

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Reno, Nevada, 89502, United States

Location

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Dover, New Jersey, 07801, United States

Location

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East Brunswick, New Jersey, 08816, United States

Location

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Medford, New Jersey, 08055, United States

Location

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Schenectady, New York, 12308, United States

Location

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Boone, North Carolina, 28607, United States

Location

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Charlotte, North Carolina, 28210, United States

Location

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Minot, North Dakota, 58701, United States

Location

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Cincinnati, Ohio, 45219, United States

Location

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Cleveland, Ohio, 44195, United States

Location

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Findlay, Ohio, 45840, United States

Location

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Tulsa, Oklahoma, 74104, United States

Location

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Duncansville, Pennsylvania, 16635, United States

Location

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West Reading, Pennsylvania, 19611, United States

Location

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Arlington, Texas, 76011, United States

Location

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Dallas, Texas, 75278, United States

Location

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Flower Mound, Texas, 75028, United States

Location

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Garland, Texas, 75042, United States

Location

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Grand Prairie, Texas, 75050, United States

Location

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Houston, Texas, 77034, United States

Location

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Salt Lake City, Utah, 84102, United States

Location

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Norfolk, Virginia, 23502, United States

Location

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Kirkland, Washington, 98034, United States

Location

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Seattle, Washington, 98104, United States

Location

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Beckley, West Virginia, 25801, United States

Location

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Cidra, 00739, Puerto Rico

Location

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Hato Rey, 00920, Puerto Rico

Location

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Humacao, 00791, Puerto Rico

Location

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Levittown, 00949, Puerto Rico

Location

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Manatí, 00674, Puerto Rico

Location

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Mayagüez, 00680, Puerto Rico

Location

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Rio Piedras, 00921, Puerto Rico

Location

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San Germán, 00683, Puerto Rico

Location

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Santa Isabel, 00757, Puerto Rico

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Fibromyalgia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: July 28, 2008
• First Posted: July 30, 2008
• Study Start: June 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: November 30, 2012
• Results First Posted: June 1, 2012

Record last verified: 2012-04

Locations

PR (9); US (49)