Study Stopped
The Investigator decided not to pursue this study.
Circadian RA Study in Rheumatoid Arthritis Subjects
The Effects of Biologic Therapy With Disease Activity and Circadian Rhythm
1 other identifier
observational
N/A
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 27, 2017
CompletedFirst Submitted
Initial submission to the registry
June 2, 2017
CompletedFirst Posted
Study publicly available on registry
June 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 16, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 16, 2019
CompletedJune 14, 2019
June 1, 2019
2.1 years
June 2, 2017
June 12, 2019
Conditions
Outcome Measures
Primary Outcomes (5)
change in pseudo F-statistic
indicator of overall robustness of circadian rhythm
7 days before, 7 days after and 28-35 days after Enbrel treatment
change in acrophase
time of daily peak circadian activity
7 days before, 7 days after and 28-35 days after Enbrel treatment
change in mesor
mean circadian rhythm
7 days before, 7 days after and 28-35 days after Enbrel treatment
change in amplitude
indicator of strength of circadian rhythm
7 days before, 7 days after and 28-35 days after Enbrel treatment
change in Disease Activity Score (DAS)
RA disease severity
7 days before, 7 days after and 28-35 days after Enbrel treatment
Secondary Outcomes (5)
change in sleep efficiency as assessed by wrist actigraphy
7 days before, 7 days after and 28-35 days after Enbrel treatment
change in general health visual analogue scale (VAS)
7 days before, 7 days after and 28-35 days after Enbrel treatment
change in C-reactive protein (CRP)
7 days before, 7 days after and 28-35 days after Enbrel treatment
change in rheumatoid factor (RF)
7 days before, 7 days after and 28-35 days after Enbrel treatment
change in sleep duration as assessed by wrist actigraphy
7 days before, 7 days after and 28-35 days after Enbrel treatment
Interventions
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.
Eligibility Criteria
Investigators will utilized the UC Davis Cohort Discovery Tool to identify patients within the UC Davis healthcare system who meet the inclusion/exclusion criteria. Investigators will then contact the patients' primary care provider and request permission to contact the patient about the study. Investigators will contact potential subjects to determine their interest and complete screenings by phone. Additionally, investigators plan to advertise the study on flyers posted in the hospital and community, as well as online notices on the Center for Musculoskeletal Health website.
You may qualify if:
- /28 tender and 6/28 swollen joints (e.g. active rheumatoid arthritis)
- CRP ≥ 1.5mg/L
- Insufficient response or intolerance to ≥1 disease modifying anti-rheumatic drug (DMARD) which must include methotrexate or hydroxychloroquine, or sulfasalazine or leflunomide and at stable dose for 4 weeks
- If taking Glucocorticoids, stable dose from 0-10mg a day for 2 weeks, and remain stable for the 4 week study
- Appropriate to start on a biologic agent for RA, as determined by patient's physician.
You may not qualify if:
- Prior use of a biologic agent for 4 weeks prior to the study
- Evidence of positive tuberculosis (TB) test, purified protein derivative (PPD) or Quantiferon or prophylactic treatment instituted 4 weeks before study, or hepatitis B core antibody
- No medical condition that would prevent completion of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UC Davis Center for Musculoskeletal Health
Sacramento, California, 95817, United States
Biospecimen
Serum specimens collected for this study will be immediately sent to the UC Davis clinical laboratory for analysis of RH and CRP. From each study visit, 0.5 ml serum will also be stored to potentially use for analyses of additional markers of inflammation such as interleukin-6 (IL-6). Serum samples will be de-identified; therefore only subject ID numbers will be labeled on the vials of serum.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nancy E Lane, M.D.
UC Davis Center for Musculoskeletal Health
- PRINCIPAL INVESTIGATOR
Katie Stone, Ph.D.
California Pacific Medical Center Research Institute
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2017
First Posted
June 7, 2017
Study Start
March 27, 2017
Primary Completion
April 16, 2019
Study Completion
August 16, 2019
Last Updated
June 14, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share