Sleep & Immune Mechanisms in Rheumatoid Arthritis: Remicade Substudy
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| City: |
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Los Angeles |
| State: |
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California |
| Zip Code: |
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| Conditions: |
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Rheumatoid Arthritis |
| Purpose: |
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More than half of rheumatoid arthritis (RA) patients complain of sleep disturbance and this
cardinal complaint is associated with fatigue, pain, and depressed mood in patient with
chronic inflammatory disorder. Despite the frequency of this complain, there is limited
efforts to evaluate sleep or the abnormal increases in the expression of proinflamatory
cytokines play a key role in the progression of RA, we hypothesize that the cytokine network
is one physiological system that is associated with sleep disturbances in RA patients.
Proinflamatory cytokines signal the central nervous system and are associated with increased
symptoms of pain, fatigue, and depressed mood in rheumatic patients. Moreover, sleep loss
is coincident with alterations in sympathetic tone, which is thought to contribute to
increases of proinflammatory cytokine activity. The specific aims of the study are to
examine the contribution of cytokines on sleep by administering a TNF antagonist vs. placebo
to probe the action of proinflammatory cytokines on sleep in RA Patients. Examination of
sleep and its consequences for autonomic functioning and proinflamatory cytokine activity
within the framework of an observational and experimental research design will have
implications for understanding the psycho-biological mechanisms that link sleep and the
clinical manifestations of RA. Results from this study will guide the developments of
interventions that target disordered sleep with potential effects on disability in RA.
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| Study Summary: |
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Abnormal sleep is reported by more than half of rheumatoid arthritis patients, in addition
to the traditional symptoms associated with the disease, such as morning stiffness, pain,
and functional debility. When recording brain activity during sleep using
electroencephalography or EEG. Sleep abnormalities have been found independent of pain and
thus the mechanisms to account for disordered sleep in this population are unknown. The
immune system, via pro-inflammatory cytokines, plays a major role in the development of
rheumatoid arthritis. Pro-inflammatory cytokines are molecules that act as signals to
stimulate activity of different arms of the immune system. New medications such as remicade
(infliximab) have been developed which slow disease activity by blocking the activity of
these pro-inflammatory cytokines. This is done by binding to the cytokine TNF and rendering
it biologically inactive. Proinflammatory cytokines also appear to play a role in sleep. A
number of basic and human studies have found that cytokines and sleep exhibit a
bi-directional relationship. However, no study to date has explored this relationship in a
rheumatoid arthritis population. Thus, this research study has the potential to test whether
cytokines influence sleep in rheumatoid arthritis. We will determine if a single dose of a
pro-inflammatory cytokine blocking medication (remicade) affects sleep in rheumatoid
arthritis patients. Interested participants will undergo an eligibility interview to
review in-depth subject participation, RA diagnosis, written Consent. Following
eligibility, patients will undergo a single overnight sleep assessment lasting four nights
at the General Clinical Research Center. After the adaption and baseline nights, on day 3,
patients will be randomized to receive either 10 mg/kg of remicade or placebo and their
sleep will be subsequently monitored for two additional nights ( post-infusion 1 and
post-infusion 2). Participants will then be follow-up for three months after either
remicade or placebo infusions. In this way, the effects of blocking pro-inflammatory
cytokines can be examined for sleep, morning stiffness, pain and fatigue.
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| Criteria: |
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Inclusion Criteria:
1. Rheumatoid arthritis patients will meet American College of Rheumatology revised
criteria (Arnett, Edworthy et al. 1988). This requires at least four of the
following seven criteria: 1) morning joint stiffness; 2) arthritis in 3 or more joint
areas; 3) arthritis of hand joints; 4) symmetric arthritis; 5) rheumatoid nodules; 6)
presence of serum rheumatoid factor and 7) changes on posteroanterior hand and wrist
radiographs. In addition, criteria 1-4 must be present for at least four weeks.
Subjects must be between 18 and 85 years of age.
2. If rheumatoid arthritis patients are receiving treatment with traditional disease
modifying antirheumatic drugs (DMARD), such as methotrexate, sulfasalazine or
hydroxychloroquine, they must be on a stable regime for one month before study and
stable throughout study.
3. If rheumatoid arthritis patients have received treatment with a TNF antagonist or
other biologic medication, they must be drug free for greater than 3 months.
Exclusion Criteria:
1. Steroids - Individuals currently taking greater than an equivalent of 10 mg of
prednisone will be excluded given the potent anti-inflammatory effects of such
medications.
2. Opioids - Individuals using multiple daily dosage schedule of opioid agents such as
oxycodone (Percocet), hydrocodone (Vicodin), morphine, Dilaudid will be excluded.
3. Co-morbid medical disorders - the presence of active unstable and uncontrolled
co-morbid medical conditions such as diabetes, cardiovascular diseases, and cancer
will be exclusionary criteria. In particular, individuals with co-morbid inflammatory
disorders such as Crohn's disease and ulcerative colitis and other autoimmune
disorders will be excluded. Any uncontrolled medical condition that is deemed by the
investigators to interfere with the proposed study procedures, or put the study
participant at undue risk will also be considered exclusionary criteria.
4. Chronic infections - individuals with chronic infections will also be excluded
because of effects on immune markers measured in study.
5. Co-morbid pain disorders - individuals with co-morbid pain disorders such as
fibromyalgia will also be excluded. Individuals with fibromyalgia have been found to
have sleep abnormalities as well as daytime fatigue and pain (Drewes 1999) and thus
could confound findings.
6. Psychiatric disorders - current conditions such as major depressive disorder, bipolar
disorder and risk for suicide will also be considered exclusionary criteria.
7. Gender-based criteria - pregnant or breast-feeding women will also be excluded
because of their effects on neuroendocrine systems and sleep
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| NCT ID: |
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NCT00948610 |
| Primary Contact: |
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Principal Investigator
Michael Irwin, MD
University of California, Los Angeles
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| Backup Contact: |
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N/A |
| Location Contact: |
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Los Angeles, California
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 17, 2013 |
| Modifications to this listing: |
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