Circadian RA Study in Rheumatoid Arthritis Subjects

Rheumatoid Arthritis Clinical Trial

Official title:

The Effects of Biologic Therapy With Disease Activity and Circadian Rhythm

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03178955
• Other study ID #: 1023265
• Status: Withdrawn
• Start date: March 27, 2017
• Est. completion date: August 16, 2019

Study information

• Verified date: June 2019
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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:

• To determine if there is an association between changes in circadian rhythm and changes in disease activity in active RA after initiation of Enbrel

• To determine if the changes in circadian activity rhythms are associated with systemic inflammation in RA patients

• To determine changes in traditional sleep quality variables from pre-treatment to one month after Enbrel initiation in RA patients

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 16, 2019
• Est. primary completion date: April 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 6/28 tender and 6/28 swollen joints (e.g. active rheumatoid arthritis)

• CRP = 1.5mg/L

• Insufficient response or intolerance to =1 disease modifying anti-rheumatic drug (DMARD) which must include methotrexate or hydroxychloroquine, or sulfasalazine or leflunomide and at stable dose for 4 weeks

• If taking Glucocorticoids, stable dose from 0-10mg a day for 2 weeks, and remain stable for the 4 week study

• Appropriate to start on a biologic agent for RA, as determined by patient's physician.

Exclusion Criteria:

• Prior use of a biologic agent for 4 weeks prior to the study

• Evidence of positive tuberculosis (TB) test, purified protein derivative (PPD) or Quantiferon or prophylactic treatment instituted 4 weeks before study, or hepatitis B core antibody

• No medical condition that would prevent completion of the study

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Etanercept
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.

Locations

Country	Name	City	State
United States	UC Davis Center for Musculoskeletal Health	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	change in acrophase	time of daily peak circadian activity	7 days before, 7 days after and 28-35 days after Enbrel treatment
Primary	change in mesor	mean circadian rhythm	7 days before, 7 days after and 28-35 days after Enbrel treatment
Primary	change in amplitude	indicator of strength of circadian rhythm	7 days before, 7 days after and 28-35 days after Enbrel treatment
Primary	change in Disease Activity Score (DAS)	RA disease severity	7 days before, 7 days after and 28-35 days after Enbrel treatment
Secondary	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
Secondary	change in general health visual analogue scale (VAS)	subject's general health	7 days before, 7 days after and 28-35 days after Enbrel treatment
Secondary	change in C-reactive protein (CRP)	systemic inflammation	7 days before, 7 days after and 28-35 days after Enbrel treatment
Secondary	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
Secondary	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