Circadian RA Study in Rheumatoid Arthritis Subjects
Withdrawn before enrolling
Conditions studied: Rheumatoid Arthritis
In brief
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
Key facts
- Study ID
- NCT03178955
- Run by
- University of California, Davis
- People needed
- 0
- Starts
- 2017-03-27
- Expected to finish
- 2019-08-16
- Last updated by the study team
- 2019-06-14
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- UC Davis Center for Musculoskeletal Health — Sacramento, California, United States
Full record on ClinicalTrials.gov
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