The purpose of this clinical trial is to better understand how people with rheumatoid arthritis (RA) respond to gradual dose reduction, or "tapering", of steroid medications like prednisone. Some people with RA have symptoms when steroid dose is reduced, while others don't. This trial will look at different patient characteristics, including levels of inflammation in the body, differences in the way the brain processes sensory information, and certain hormone levels, to help researchers better understand why different people have these different responses to steroid tapering. The hypotheses include: * Greater or equal to ( ) 30% of participants in each arm will develop taper intolerance (either subjective, objective, or both) during the study period * Greater or equal to 60% of participants will reduce Glucocorticoid dose by at least 5 Milligrams per day during the study period
This trial was changed, so that participants could participate remotely without coming into the clinic. For participants coming into the clinic, the clinical disease activity index (CDAI) will be used to measure objective intolerance to tapering. For remote participants, the Rheumatoid Arthritis Disease Activity Index (RADAI) will be used instead of the CDAI.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
200
The 15-day taper group will assess the effect of an approximately 50% oral prednisone dose reduction over 15 days, and will be followed for an additional 15 days after the last dose reduction.
The 150-day taper group will assess the effect of reducing oral prednisone by 1 milligram (mg) every 30 days over 150 days, and will be followed for an additional 30 days after the last dose reduction.
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States
RECRUITINGUniversity of Michigan
Ann Arbor, Michigan, United States
RECRUITINGNumber of participants with subjective taper intolerance
Subjective intolerance, the first point when a participant replies elects to stop glucocorticoid taper due to associated symptoms. This will be assessed using a one-question questionnaire with binary "yes" and "no" responses.
Time frame: Day 30 (15-day taper) or day 180 (150-day taper group)
Number of participants with objective taper intolerance
The first point when a participant develops any one of: increased RA activity (either clinical disease activity index \[CDAI\] increase of \>2, or rheumatoid arthritis disease activity index \[RADAI\] of 1.5); RA flare (either CDAI increase of \>1, or RADAI increase of \>1 at a time when participant classifies as flaring; Clinical adrenal insufficiency.
Time frame: Day 30 (15-day taper) or day 180 (150-day taper group)
Net glucocorticoid dose reduction
The difference (in mg/day) between a participant's prednisone dose at enrollment, and either (1) the dose at which participants first develop taper intolerance, or (2) the dose at the end of study involvement, if participants do not develop taper intolerance.
Time frame: Day 30 (15-day taper) or day 180 (150-day taper group)
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