15-day taper prednisone
DrugThe 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.
NCT Number: NCT06072768
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
University of Michigan, Ann Arbor, Michigan, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Ability to read and speak English to allow for written informed consent and patient-reported outcomes measures.
Exclusion criteria
Current or recent (past year) use of systemic glucocorticoid (oral, intravenous, or intramuscular administration) >2 weeks for an indication other than RA, to reduce risk of adverse health outcomes related to worsening of the indicated condition
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.
Time frame: Day 30 (15-day taper) or day 180 (150-day taper group)
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)
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)
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.
Contact information is provided by the study sponsor or research team.
VA Office of Research and Development
Fed
Using SMART Design to Develop Dynamic Treatment Regimens for Glucocorticoid Tapering
Acronym: SMART-RA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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