Sleep and Immunity in Rheumatoid Arthritis : Remicade Substudy

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00948610
• Date of registration: 28/07/2009
• Prospective Registration: No
• Primary sponsor: University of California, Los Angeles
• Public title: Sleep and Immunity in Rheumatoid Arthritis : Remicade Substudy
• Scientific title: Sleep & Immune Mechanisms in Rheumatoid Arthritis: Remicade Substudy
• Date of first enrolment: November 2008
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00948610
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Michael Irwin, MD
• Affiliation: University of California, Los Angeles

Key inclusion & exclusion criteria

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 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



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Remicade

Primary Outcome(s)

Slow Wave Sleep [Time Frame: Post-infusion day 2]

Secondary Outcome(s)

Cellular Inflammation [Time Frame: Post-infusion day 2]

Secondary ID(s)

NHLBI RO1 HL079955

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Heart, Lung, and Blood Institute (NHLBI)

Results

• Results available: Yes
• Date Posted: 12/09/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00948610