Fibromyalgia Health Outcome Study on Cost of Treatments (REFLECTIONS)

Lilly

Status: Completed

Conditions: Fibromyalgia

Treatments: Drug: Treatment for Fibromyalgia

Study type: Observational

Funder types: Industry

Identifiers

NCT00725101

11540

F1J-MC-B020 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,700 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

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
• 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 design

1,700 participants in 1 patient group

Fibromyalgia (FM) Participants

Description:

FM participants starting any new pharmacologic FM agent.

Treatment:

Drug: Treatment for Fibromyalgia