Rheumatoid Arthritis
Conditions
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
Detailed 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 Enbrel (etanercept), 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 the subject's 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. This study will provide information about 24-hour circadian activity rhythms before and after 3-4 weeks of Enbrel treatment in study subjects with active rheumatoid arthritis. The study will assess patients who are starting on Enbrel that has been prescribed by their doctor.
Interventions
DRUGEtanercept
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
University of California, Davis
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in Disease Activity Score (DAS) | 7 days before, 7 days after and 28-35 days after Enbrel treatment | RA disease severity |
| change in pseudo F-statistic | 7 days before, 7 days after and 28-35 days after Enbrel treatment | indicator of overall robustness of circadian rhythm |
| change in acrophase | 7 days before, 7 days after and 28-35 days after Enbrel treatment | time of daily peak circadian activity |
| change in mesor | 7 days before, 7 days after and 28-35 days after Enbrel treatment | mean circadian rhythm |
| change in amplitude | 7 days before, 7 days after and 28-35 days after Enbrel treatment | indicator of strength of circadian rhythm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in sleep efficiency as assessed by wrist actigraphy | 7 days before, 7 days after and 28-35 days after Enbrel treatment | an index of sleep fragmentation, percentage (%) of time spend sleeping after lights off |
| change in general health visual analogue scale (VAS) | 7 days before, 7 days after and 28-35 days after Enbrel treatment | subject's general health |
| change in C-reactive protein (CRP) | 7 days before, 7 days after and 28-35 days after Enbrel treatment | systemic inflammation |
| change in rheumatoid factor (RF) | 7 days before, 7 days after and 28-35 days after Enbrel treatment | measures amount of rheumatoid factor present in the blood |
| change in sleep duration as assessed by wrist actigraphy | 7 days before, 7 days after and 28-35 days after Enbrel treatment | how long (minutes) the subject sleeps 24 hour period |
Countries
United States
Outcome results
None listed