Sleep and Immunity in Rheumatoid Arthritis : Remicade Substudy

NCT00948610 | Completed Results DMC

• 1 other identifier: NHLBI RO1 HL079955
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Slow Wave Sleep

  Slow wave sleep in minutes at post-infusion day 2 in placebo vs. remicade

  Post-infusion day 2

Secondary Outcomes (1)

• Cellular Inflammation

  Post-infusion day 2

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo-participant will receive placebo saline solution via IV route.

Drug: Remicade

Remicade

ACTIVE COMPARATOR

Remicade-Participant will be given 10 mg/kg of drug via IV route.

Drug: Remicade

Interventions

Remicade DRUG

Remicade/ Infliximab Study Material 10mg/kg Total Volume=250cc in saline I.V. route.

Also known as: Infliximab

Placebo; Remicade

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• Opioids - Individuals using multiple daily dosage schedule of opioid agents such as oxycodone (Percocet), hydrocodone (Vicodin), morphine, Dilaudid will be excluded.
• Chronic infections - individuals with chronic infections will also be excluded because of effects on immune markers measured in study.
• 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.
• Gender-based criteria - pregnant or breast-feeding women will also be excluded because of their effects on neuroendocrine systems and sleep

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of California, Los Angeles, General Clinical Research Center

Los Angeles, California, 900095, United States

Location

Related Publications (4)

• Irwin MR, Wang M, Ribeiro D, Cho HJ, Olmstead R, Breen EC, Martinez-Maza O, Cole S. Sleep loss activates cellular inflammatory signaling. Biol Psychiatry. 2008 Sep 15;64(6):538-40. doi: 10.1016/j.biopsych.2008.05.004. Epub 2008 Jun 17.

  PMID: 18561896 BACKGROUND

• Irwin MR, Carrillo C, Olmstead R. Sleep loss activates cellular markers of inflammation: sex differences. Brain Behav Immun. 2010 Jan;24(1):54-7. doi: 10.1016/j.bbi.2009.06.001. Epub 2009 Jun 9.

  PMID: 19520155 BACKGROUND

• Irwin MR, Davis M, Zautra A. Behavioral Comorbidities in Rheumatoid Arthritis: A Psychoneuroimmunological Perspective. Psychiatr Times. 2008 Aug 1;25(9):1. No abstract available.

  PMID: 19590742 BACKGROUND

• Davis MC, Zautra AJ, Younger J, Motivala SJ, Attrep J, Irwin MR. Chronic stress and regulation of cellular markers of inflammation in rheumatoid arthritis: implications for fatigue. Brain Behav Immun. 2008 Jan;22(1):24-32. doi: 10.1016/j.bbi.2007.06.013. Epub 2007 Aug 15.

  PMID: 17706915 BACKGROUND

Related Links

• UCLA Cousins Center for PNI

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

A number of limitations exist: the sample size was relatively small; only women were included; and the exclusive use of infliximab limits generalizability to other TNF antagonists, due to differing biochemical and mechanistic profiles.

Results Point of Contact

• Title: Michael R. Irwin
• Organization: UCLA

mirwin1@ucla.edu

3108258281

Study Officials

• Michael Irwin, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Residence

Study Record Dates

• First Submitted: July 28, 2009
• First Posted: July 29, 2009
• Study Start: November 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: December 2, 2017
• Results First Posted: September 12, 2017

Record last verified: 2017-10

Locations

US (1)