Rheumatoid ArthritisNCT03178955
Circadian RA Study in Rheumatoid Arthritis Subjects
An observational study of Rheumatoid Arthritis, run by University of California, Davis at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Etanercept
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2017to 16 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Center for Musculoskeletal Health
Sacramento, California, 95817
About this study
Official title: 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
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Etanercept
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
Also called Enbrel
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
change in pseudo F-statistic
indicator of overall robustness of circadian rhythm
Measured: 7 days before, 7 days after and 28-35 days after Enbrel treatment
change in acrophase
time of daily peak circadian activity
Measured: 7 days before, 7 days after and 28-35 days after Enbrel treatment
change in mesor
mean circadian rhythm
Measured: 7 days before, 7 days after and 28-35 days after Enbrel treatment
change in amplitude
indicator of strength of circadian rhythm
Measured: 7 days before, 7 days after and 28-35 days after Enbrel treatment
change in Disease Activity Score (DAS)
RA disease severity
Measured: 7 days before, 7 days after and 28-35 days after Enbrel treatment
Secondary outcomes (5)
change in sleep efficiency as assessed by wrist actigraphy
an index of sleep fragmentation, percentage (%) of time spend sleeping after "lights off"
Measured: 7 days before, 7 days after and 28-35 days after Enbrel treatment
change in general health visual analogue scale (VAS)
subject's general health
Measured: 7 days before, 7 days after and 28-35 days after Enbrel treatment
change in C-reactive protein (CRP)
systemic inflammation
Measured: 7 days before, 7 days after and 28-35 days after Enbrel treatment
change in rheumatoid factor (RF)
measures amount of rheumatoid factor present in the blood
Measured: 7 days before, 7 days after and 28-35 days after Enbrel treatment
change in sleep duration as assessed by wrist actigraphy
how long (minutes) the subject sleeps 24 hour period
Measured: 7 days before, 7 days after and 28-35 days after Enbrel treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start27 Mar 2017
- Primary completion16 Apr 2019
- Study completion16 Aug 2019 (estimated)
Why it stopped: The Investigator decided not to pursue this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy E Lane, M.D., Principal investigator, UC Davis Center for Musculoskeletal HealthKatie Stone, Ph.D., Principal investigator, California Pacific Medical Center Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178955
- Sponsor's protocol ID
- 1023265
- Status last verified
- Jun 2019
- First submitted
- 2 Jun 2017
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Biologic Therapy With Disease Activity and Circadian Rhythm
- ClinicalTrials.gov ID
- NCT03178955
- Acronym / sponsor ID
- 1023265
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The Investigator decided not to pursue this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 16 Apr 2019 (actual)
- Study completion
- 16 Aug 2019 (estimated)
- First posted
- 7 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtanerceptAlso: EnbrelCircadian 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. | Drug | – |
Primary outcome
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
change in acrophase
Time frame: 7 days before, 7 days after and 28-35 days after Enbrel treatment
time of daily peak circadian activity
change in mesor
Time frame: 7 days before, 7 days after and 28-35 days after Enbrel treatment
mean circadian rhythm
change in amplitude
Time frame: 7 days before, 7 days after and 28-35 days after Enbrel treatment
indicator of strength of circadian rhythm
change in Disease Activity Score (DAS)
Time frame: 7 days before, 7 days after and 28-35 days after Enbrel treatment
RA disease severity
5 secondary outcomes
change in sleep efficiency as assessed by wrist actigraphy
Time frame: 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
change in C-reactive protein (CRP)
Time frame: 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
change in sleep duration as assessed by wrist actigraphy
Time frame: 7 days before, 7 days after and 28-35 days after Enbrel treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy E Lane, M.D. principal investigator
UC Davis Center for Musculoskeletal Health
Katie Stone, Ph.D. principal investigator
California Pacific Medical Center Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in pseudo F-statistic (time frame: 7 days before, 7 days after and 28-35 days after Enbrel treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2019.