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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:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| change in sleep efficiency as assessed by wrist actigraphy | an index of sleep fragmentation, percentage (%) of time spend sleeping after "lights off" | 7 days before, 7 days after and 28-35 days after Enbrel treatment |
| change in general health visual analogue scale (VAS) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Nancy E Lane, M.D. | UC Davis Center for Musculoskeletal Health | Principal Investigator |
| Katie Stone, Ph.D. | California Pacific Medical Center Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Center for Musculoskeletal Health | Sacramento | California | 95817 | United States |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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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.
subject's general health |
| 7 days before, 7 days after and 28-35 days after Enbrel treatment |
| change in C-reactive protein (CRP) | systemic inflammation | 7 days before, 7 days after and 28-35 days after Enbrel treatment |
| change in rheumatoid factor (RF) | measures amount of rheumatoid factor present in the blood | 7 days before, 7 days after and 28-35 days after Enbrel treatment |
| change in sleep duration as assessed by wrist actigraphy | how long (minutes) the subject sleeps 24 hour period | 7 days before, 7 days after and 28-35 days after Enbrel treatment |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |