Circadian RA Study in Rheumatoid Arthritis Subjects
NCT03178955 · Status: WITHDRAWN · Type: OBSERVATIONAL
Last updated 2019-06-14
Summary
Primary objective: To determine the changes in circadian activity rhythms and disease activity in rheumatoid arthritis (RA) patients from pre-treatment to one month after Enbrel initiation.
Secondary objectives:
* To determine if there is an association between changes in circadian rhythm and changes in disease activity in active RA after initiation of Enbrel
* To determine if the changes in circadian activity rhythms are associated with systemic inflammation in RA patients
* To determine changes in traditional sleep quality variables from pre-treatment to one month after Enbrel initiation in RA patients
Conditions
Interventions
- DRUG
-
Etanercept
Circadian activity rhythm parameters will be evaluated for 7 days prior to Enbrel treatment through 7 days after initiation of Enbrel treatment and again 28-35 days after the second Enbrel treatment.
Sponsors & Collaborators
-
University of California, Davis
lead OTHER
Principal Investigators
-
Nancy E Lane, M.D. · UC Davis Center for Musculoskeletal Health
-
Katie Stone, Ph.D. · California Pacific Medical Center Research Institute
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-03-27
- Primary Completion
- 2019-04-16
- Completion
- 2019-08-16
- FDA Drug
- Yes
Countries
- United States
Study Locations
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