Circadian RA Study in Rheumatoid Arthritis Subjects

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"Can a patient’s response to biological agents be rapidly determined by assessing circadian activity?"
Age:
18 to 80 years old
Gender:
Any
Healthy Volunteers:
No
Keywords:
Rheumatoid arthritis
Type:
Drug study
Investigator:
Description
Rheumatoid arthritis (RA) is a chronic and debilitating disease. However, the symptoms of RA show variation over the course of the day, with worsening symptoms in the morning. This worsening of symptoms in the morning is correlated with an increase in inflammation in the body.
Biologic therapies, such as etanercept (Enbrel) , appear to improve energy, pain and quality of life in patients with RA, and these changes may occur before a doctor is able to detect changes during the patient’s physical examination. It is possible that a patient’s response to biological agents can be rapidly determined by assessing circadian activity (also called “rest-activity circadian rhythms” or RAR).
Currently, wrist actigraphy bands, which are worn for a period of time, can reliably provide information about RAR. Wrist actigraphy bands are small electronic devices worn on the wrist (similar to a watch) that records your level of activity throughout the day. Studies in osteoarthritis and in rheumatoid arthritis have found subjects with joint pain to have significant differences in RAR, and disrupted RAR has been associated with disease activity.
Our main study aim is to provide information about 24-hour circadian activity rhythms before and after 3-4 weeks of biologic therapy in study subjects with active rheumatoid arthritis. The study will assess patients who are starting on etanercept (Enbrel) that has been prescribed by their doctor.
This study requires
Biologic therapy (etanercept (Enbrel)as prescribed by MD

Assessment of circadian rhythm by wearing a wrist actigraph/keeping diary for 7 days prior to biologic therapy and 30 days afterwards

Two study visits (joint examination and a fasting blood draw to measure markers of inflammation)
Who can participate?
Inclusion Criteria:

- 6/28 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.


Exclusion Criteria:

- 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
Compensation
$50 in gift cards ($25 per study visit) for your time and effort. You may be asked for your social security number for payment purposes. It will not be used for any other purpose without your permission
Resources
Schedule
Study duration and period
Approximately 37 days (7 days before and 30 days after starting etanercept/Enbrel)
Recruitment period
From March 27, 2017
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Research Topic
Conditions:
  • Rheumatoid Arthritis

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