Sleep and Immunity in Rheumatoid Arthritis : Remicade Substudy
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      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 complaint, there is limited
      efforts to evaluate sleep or the abnormal increases in the expression of pro-inflammatory
      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.
      Pro-inflammatory cytokines signal the central nervous system and are associated with
      increased symptoms of pain, fatigue, and depressed mood in rheumatic patients. 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 pro-inflammatory cytokines on sleep in RA
      Patients. Examination of sleep and its consequences for pro-inflammatory 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.
    

Detailed description: 
      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. Pro-inflammatory 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).
    

Intervention name(s): Remicade
Intervention type(s): Drug
Intervention description(s): Remicade/ Infliximab Study Material 10mg/kg Total Volume=250cc in saline I.V. route.
Other intervention name(s): Infliximab
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Rheumatoid Arthritis