Circadian RA Study in Rheumatoid Arthritis Subjects

June 12, 2019 updated by: University of California, Davis

The Effects of Biologic Therapy With Disease Activity and Circadian Rhythm

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • UC Davis Center for Musculoskeletal Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Investigators will utilized the UC Davis Cohort Discovery Tool to identify patients within the UC Davis healthcare system who meet the inclusion/exclusion criteria. Investigators will then contact the patients' primary care provider and request permission to contact the patient about the study. Investigators will contact potential subjects to determine their interest and complete screenings by phone. Additionally, investigators plan to advertise the study on flyers posted in the hospital and community, as well as online notices on the Center for Musculoskeletal Health website.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change in pseudo F-statistic
Time Frame: 7 days before, 7 days after and 28-35 days after Enbrel treatment
indicator of overall robustness of circadian rhythm
7 days before, 7 days after and 28-35 days after Enbrel treatment
change in acrophase
Time Frame: 7 days before, 7 days after and 28-35 days after Enbrel treatment
time of daily peak circadian activity
7 days before, 7 days after and 28-35 days after Enbrel treatment
change in mesor
Time Frame: 7 days before, 7 days after and 28-35 days after Enbrel treatment
mean circadian rhythm
7 days before, 7 days after and 28-35 days after Enbrel treatment
change in amplitude
Time Frame: 7 days before, 7 days after and 28-35 days after Enbrel treatment
indicator of strength of circadian rhythm
7 days before, 7 days after and 28-35 days after Enbrel treatment
change in Disease Activity Score (DAS)
Time Frame: 7 days before, 7 days after and 28-35 days after Enbrel treatment
RA disease severity
7 days before, 7 days after and 28-35 days after Enbrel treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change in sleep efficiency as assessed by wrist actigraphy
Time Frame: 7 days before, 7 days after and 28-35 days after Enbrel treatment
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
change in general health visual analogue scale (VAS)
Time Frame: 7 days before, 7 days after and 28-35 days after Enbrel treatment
subject's general health
7 days before, 7 days after and 28-35 days after Enbrel treatment
change in C-reactive protein (CRP)
Time Frame: 7 days before, 7 days after and 28-35 days after Enbrel treatment
systemic inflammation
7 days before, 7 days after and 28-35 days after Enbrel treatment
change in rheumatoid factor (RF)
Time Frame: 7 days before, 7 days after and 28-35 days after Enbrel treatment
measures amount of rheumatoid factor present in the blood
7 days before, 7 days after and 28-35 days after Enbrel treatment
change in sleep duration as assessed by wrist actigraphy
Time Frame: 7 days before, 7 days after and 28-35 days after Enbrel treatment
how long (minutes) the subject sleeps 24 hour period
7 days before, 7 days after and 28-35 days after Enbrel treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Davis

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nancy E Lane, M.D., UC Davis Center for Musculoskeletal Health
  • Principal Investigator: Katie Stone, Ph.D., California Pacific Medical Center Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 27, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 16, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 16, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 14, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1023265

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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