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Circadian RA Study in Rheumatoid Arthritis Subjects

12. juni 2019 opdateret af: 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

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Sacramento, California, Forenede Stater, 95817
        • UC Davis Center for Musculoskeletal Health

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
change in pseudo F-statistic
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
change in sleep efficiency as assessed by wrist actigraphy
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of California, Davis

Efterforskere

  • Ledende efterforsker: Nancy E Lane, M.D., UC Davis Center for Musculoskeletal Health
  • Ledende efterforsker: Katie Stone, Ph.D., California Pacific Medical Center Research Institute

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

27. marts 2017

Primær færdiggørelse (Faktiske)

16. april 2019

Studieafslutning (Forventet)

16. august 2019

Datoer for studieregistrering

Først indsendt

2. juni 2017

Først indsendt, der opfyldte QC-kriterier

5. juni 2017

Først opslået (Faktiske)

7. juni 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. juni 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juni 2019

Sidst verificeret

1. juni 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1023265

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

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Kliniske forsøg med Rheumatoid arthritis

Kliniske forsøg med Etanercept

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