FibromyalgiaREFLECTIONSNCT00725101
Fibromyalgia Health Outcome Study on Cost of Treatments
An observational study of Fibromyalgia, run by Eli Lilly and Company at 58 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Treatment for Fibromyalgia
- How many people
- 1,700 participants
- Where
- 58 sitesin 2 countries
- Study dates
- Jun 2008to Apr 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Multiple care centers
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
58 sites in 2 countries.
58 sites in 2 countries
United States49 sites
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Arlington, Texas, 76011
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Baltimore, Maryland, 21222
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Baton Rouge, Louisiana, 70808
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Beckley, West Virginia, 25801
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Blue Ridge, Georgia, 30513
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Boone, North Carolina, 28607
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Charlotte, North Carolina, 28210
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Cincinnati, Ohio, 45219
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Cleveland, Ohio, 44195
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Dallas, Texas, 75278
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Danbury, Connecticut, 06810
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Dover, New Jersey, 07801
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Duncansville, Pennsylvania, 16635
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East Brunswick, New Jersey, 08816
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Evansville, Indiana, 47710
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Findlay, Ohio, 45840
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Fishers, Indiana, 46038
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Flower Mound, Texas, 75028
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Garland, Texas, 75042
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Grand Prairie, Texas, 75050
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Hot Springs, Arkansas, 71913
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Houston, Texas, 77034
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Indianapolis, Indiana, 46260
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Jupiter, Florida, 33458
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Kirkland, Washington, 98034
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Lansing, Michigan, 48910
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Louisville, Kentucky, 40223
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Medford, New Jersey, 08055
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Meridian, Idaho, 83646
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Minot, North Dakota, 58701
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Nampa, Idaho, 83686
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Norfolk, Virginia, 23502
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Peoria, Illinois, 61614
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Reno, Nevada, 89502
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Salt Lake City, Utah, 84102
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Santa Barbara, California, 93108
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Schenectady, New York, 12308
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Seattle, Washington, 98104
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Snellville, Georgia, 30078
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Springfield, Illinois, 62702
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Tampa, Florida, 33609
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Towson, Maryland, 21286
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Tulsa, Oklahoma, 74104
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Washington D.C., District of Columbia, 20006
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Waterbury, Connecticut, 06708
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West Plains, Missouri, 65775
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West Reading, Pennsylvania, 19611
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Wheaton, Maryland, 20902
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Winter Park, Florida, 32792
Puerto Rico9 sites
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Cidra, 00739
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Hato Rey, 00920
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Humacao, 00791
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Levittown, 00949
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Manati, 00674
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Mayagüez, 00680
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Rio Piedras, 00921
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San German, 00683
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Santa Isabel, 00757
About this study
Official title: Real World Examination of Fibromyalgia: Longitudinal Evaluation of Costs and Treatments (The REFLECTIONS Study)
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
- Being tested
- Treatment for Fibromyalgia
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment for FibromyalgiaDrug
FM participants starting any new pharmacologic FM agent.
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia (FM) Participants | FM participants starting any new pharmacologic FM agent. Receives: Drug: Treatment for Fibromyalgia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Number of Medications Taken for Fibromyalgia (FM) Over 12 Months
Measured: 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.
Measured: 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.
Measured: Baseline through 12 months
Secondary outcomes (14)
Reasons for Discontinuing Medications for Fibromyalgia (FM) During the Study
Participants were allowed to select multiple reasons for discontinuing treatment. During the 12-month period post-baseline, a participant could possibly discontinue more than 1 medication, or discontinue the same medication more than once. A reason for discontinuation was given each time a participant stopped taking a medication.
Measured: Baseline through 12 months
Percentage of Participants Who Discontinued Opioids
Measured: Baseline through 12 months
Hazard Ratios for Factors Associated With Discontinued Opioid Use
Factors significantly associated with discontinuation of opioid use were participant age, Brief Pain Inventory-Interference (BPI-I) score, and Patient Health Questionnaire for somatic symptoms (PHQ-15) score.
Measured: Baseline through 12 months
Change From Baseline in Brief Pain Inventory-Interference (BPI-I) Average Subscale Score at 12 Months
Average BPI-I measures self-reported degree of pain interference on function. Interference scores range from 0 (does not interfere) to 10 (completely interferes) for each question assessing interference of pain within past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.
Measured: Baseline, 12 months
Change From Baseline in Brief Pain Inventory-Severity (BPI-S) Average Subscale Score at 12 Months
BPI-S measures self-reported severity of pain. Severity scores range from 0 (no pain) to 10 (severe pain) for each question assessing worst pain, least pain, and average pain in past 24 hours, and current pain.
Measured: Baseline, 12 months
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at 12 Months
FIQ measures self-reported fibromyalgia (FM) status, progress, and outcomes over past week. FIQ comprises 20 items: Items 1-11 measure physical functioning (each rated on 4-point Likert-type scale); Items 12 + 13 measure number (no.) of days participant felt well and no. of days participant felt unable to work due to FM symptoms. Items 14-20 are numerical, 11-point Likert-type scales (marked in 10-millimeter [mm] increments) rating work difficulty, pain intensity, fatigue, morning tiredness, stiffness, anxiety, and depression. Total scores range from 0-80; Higher score=greater negative impact.
Measured: Baseline, 12 months
Change From Baseline in Sheehan Disability Score (SDS) Total Score at 12 Months
The SDS is completed by the participant and assesses the effect of the participant's symptoms on work/social/family life. Total scores range from 0 to 30; Higher score=greater disruption in the participant's work/social/family life.
Measured: Baseline, 12 months
Number of Outpatient Visits Due to Fibromyalgia (FM)
Measured: Baseline through 12 months
Number of Emergency Room (ER) Visits Due to Fibromyalgia (FM)
Measured: Baseline through 12 months
Number of Days of Partial Care for Fibromyalgia (FM) Participants
Partial (day or night) care included day care, day nursing home, and partial hospitalization.
Measured: Baseline through 12 months
Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Missed Paid Work and Used a Paid Caregiver)
Caregiver burden was described as the number of days family members missed paid work and used a paid caregiver (for example, home healthcare nurse) to care for the participant with FM.
Measured: Baseline through 12 months
Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Used an Unpaid Caregiver)
Caregiver burden was described as the number of days family members used an unpaid caregiver (family and friends) to care for the participant with FM.
Measured: Baseline through 12 months
Number of Days Fibromyalgia (FM) Affected Participant Productivity (Stayed in Bed, Reduced Activity, and Received Disability Income)
Participant productivity was described as the number of days the participant stayed in bed, had to reduce normal activity by half, and received disability income due to FM.
Measured: Baseline through 12 months
Number of Days Fibromyalgia (FM) Affected Participant Productivity (Missed Work)
Participant productivity was described as the number of days a participant missed work due to FM.
Measured: Baseline through 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00725101
- Sponsor's protocol ID
- 11540
- Other IDs
- F1J-MC-B020
- Acronym
- REFLECTIONS
- Status last verified
- Apr 2012
- First submitted
- 28 Jul 2008
- Last updated
- 30 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Examination of Fibromyalgia: Longitudinal Evaluation of Costs and Treatments (The REFLECTIONS Study)
- ClinicalTrials.gov ID
- NCT00725101
- Acronym / sponsor ID
- REFLECTIONS / 11540
- Conditions
- Fibromyalgia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,700 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 30 Jul 2008 (estimated)
- Results
- Posted 1 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia (FM) Participants | – | Drug: Treatment for FibromyalgiaFM participants starting any new pharmacologic FM agent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Multiple care centers
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment for FibromyalgiaFM participants starting any new pharmacologic FM agent. | Drug | Fibromyalgia (FM) Participants |
Primary outcome
Cumulative Number of Medications Taken for Fibromyalgia (FM) Over 12 Months
Time frame: 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
Time frame: Baseline through 12 months
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.
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
Time frame: Baseline through 12 months
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.
14 secondary outcomes
Reasons for Discontinuing Medications for Fibromyalgia (FM) During the Study
Time frame: Baseline through 12 months
Percentage of Participants Who Discontinued Opioids
Time frame: Baseline through 12 months
Hazard Ratios for Factors Associated With Discontinued Opioid Use
Time frame: Baseline through 12 months
Change From Baseline in Brief Pain Inventory-Interference (BPI-I) Average Subscale Score at 12 Months
Time frame: Baseline, 12 months
Change From Baseline in Brief Pain Inventory-Severity (BPI-S) Average Subscale Score at 12 Months
Time frame: Baseline, 12 months
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at 12 Months
Time frame: Baseline, 12 months
Change From Baseline in Sheehan Disability Score (SDS) Total Score at 12 Months
Time frame: Baseline, 12 months
Number of Outpatient Visits Due to Fibromyalgia (FM)
Time frame: Baseline through 12 months
Number of Emergency Room (ER) Visits Due to Fibromyalgia (FM)
Time frame: Baseline through 12 months
Number of Days of Partial Care for Fibromyalgia (FM) Participants
Time frame: Baseline through 12 months
Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Missed Paid Work and Used a Paid Caregiver)
Time frame: Baseline through 12 months
Number of Days of Caregiver Burden Due to Fibromyalgia (FM; Family Used an Unpaid Caregiver)
Time frame: Baseline through 12 months
Number of Days Fibromyalgia (FM) Affected Participant Productivity (Stayed in Bed, Reduced Activity, and Received Disability Income)
Time frame: Baseline through 12 months
Number of Days Fibromyalgia (FM) Affected Participant Productivity (Missed Work)
Time frame: Baseline through 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
58 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by Eli Lilly and Company at 58 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Number of Medications Taken for Fibromyalgia (FM) Over 12 Months (time frame: Baseline through 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2012.