Circadian RA Study in Rheumatoid Arthritis Subjects

NCT03178955 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2019-06-14

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03178955 on ClinicalTrials.gov