Circadian RA Study in Rheumatoid Arthritis Subjects
| Status: | Recruiting |
|---|---|
| Conditions: | Arthritis, Rheumatoid Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 1/17/2019 |
| Start Date: | March 27, 2017 |
| End Date: | June 30, 2019 |
| Contact: | Tara S Rogers, Ph.D. |
| Email: | tsrogers@ucdavis.edu |
| Phone: | 916-734-3479 |
The Effects of Biologic Therapy With Disease Activity and Circadian Rhythm
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
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
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.
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.
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
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