Recruiting
Phase 2

Glucocorticoid Tapering

Sponsor:

VA Office of Research and Development

Code:

NCT06072768

Conditions

Rheumatoid Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

15-day taper prednisone

150-day taper prednisone

Study Details

Brief summary:

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

Conditions

Rheumatoid Arthritis

Study ID

NCT06072768

Start date

Mar 9, 2023

Status verified date

Nov, 2025

Completion date

Mar 1, 2030

Anticipated

Primary completion date

Mar 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Ability to read and speak English to allow for written informed consent and patient-reported outcomes measures.

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Ability to take oral medication and be willing to adhere to the study intervention regimen
  • Diagnosis of rheumatoid arthritis by a medical provider, confirmed by checking medical records.
  • Current use of an RA treatment regimen of both oral prednisone and 1 other Food and Drug Administration-approved disease-modifying antirheumatic drug (DMARD), with no change in this therapy over the past 90 days

1. Eligible DMARDs include the following: hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, etanercept, adalimumab, infliximab, golimumab, certolizumab pegol, abatacept, tocilizumab, sarilumab, rituximab, tofacitinib, baricitinib, upadacitinib
2. Patients enrolling in the 15-day taper must be taking 7.5mg/day oral prednisone
3. Patients enrolling in the 150-day taper must be taking 5mg/day oral prednisone

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

  • Patients with greater than moderate RA activity as determined by the Clinical Disease Activity Index or by rheumatologist assessment, given high likelihood of taper failure in this population due to increased RA activity alone.
  • Pre-existing primary or secondary adrenal insufficiency diagnosed by a physician, given high risk of worsening with prednisone taper
  • Treatment with another investigational drug or intervention within 90 days
  • Pregnancy
  • Self-reported medical or psychiatric conditions that in the judgment of study personnel would preclude participation in this study (e.g., schizophrenia, malignancy, psychosis, suicidal ideation, history of substance abuse; note that stable anxiety and depression are NOT exclusions)
  • Current, recent (within the last 6 months), or habitual use of artificial nails or nail enhancements. (Artificial nails can influence pressure pain sensitivity at the thumbnail);
  • Any impairment, activity, behavior, or situation that in the judgment of the study team would prevent satisfactory completion of the study protocol

Study Design

Enrollment

200 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: 15-day taper prednisone

This will be for 30 days. Participants will be allocated to the 15-day strategy preferentially until enrollment goals have been met; once completing the 15-day strategy, many participants will also be eligible to complete the 150-day strategy, and may subsequently enroll in it if they wish. Participants that are not eligible for the 15-day strategy, but are eligible for the 150-day strategy, will be enrolled in the 150-day strategy.

experimental: 150-day taper prednisone

This will be for 180 days. Participants who are not eligible for the 15-day strategy, but are eligible for the 150-day strategy, will be enrolled in the 150-day strategy.

Interventions

15-day taper prednisone

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.

150-day taper prednisone

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.

Primary outcome measure

  • Number of participants with subjective taper intolerance [ Time Frame: Day 30 (15-day taper) or day 180 (150-day taper group) ]
  • Number of participants with objective taper intolerance [ Time Frame: Day 30 (15-day taper) or day 180 (150-day taper group) ]
  • Net glucocorticoid dose reduction [ Time Frame: Day 30 (15-day taper) or day 180 (150-day taper group) ]

Central Contacts and Locations

Central contacts

Locations

VA Ann Arbor Healthcare System, Ann Arbor, MI

Recruiting

Ann Arbor, Michigan, United States, 48105-2303

Contacts

Principal Investigator:

Beth Wallace, MD MSc

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

More Information

Sponsor

VA Office of Research and Development

Last update posted

Nov 19, 2025

Last verified

Nov, 2025

Keywords

  • Disease-modifying anti-rheumatic drug
  • Oral prednisone
  • Dose reduction
  • Tapering

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2025-11-19.