Rheumatoid ArthritisPhase 2SMART-RANCT06072768
Dynamic Treatment Regiments for Glucocorticoid Tapering
A Phase 2 study testing 15-day taper prednisone and 150-day taper prednisone in people with Rheumatoid Arthritis, run by VA Office of Research and Development at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- 15-day taper prednisone and 150-day taper prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Mar 2023to 1 Mar 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Eligible DMARDs include the following: hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, etanercept, adalimumab, infliximab, golimumab, certolizumab pegol, abatacept, tocilizumab, sarilumab, rituximab, tofacitinib, baricitinib, upadacitinib
- Patients enrolling in the 15-day taper must be taking 7.5mg/day oral prednisone
- Patients enrolling in the 150-day taper must be taking 5mg/day oral prednisone
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303
Olivia B Dickinson, BA, 734-548-2987, Olivia.Dickinson@va.gov
Beth Wallace, MD MSc
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Olivia B Dickinson, BA, 734-548-2987, lidickin@med.umich.edu
Beth I Wallace, MD, 7345319956, brennerb@med.umich.edu
About this study
Official title: Using SMART Design to Develop Dynamic Treatment Regimens for Glucocorticoid Tapering
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
Read the detailed description
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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- 15-day taper prednisone, 150-day taper prednisone
- Keywords
- Disease-modifying anti-rheumatic drug, Oral prednisone, Dose reduction, Tapering
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15-day taper prednisoneDrug
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 prednisoneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 15-day taper prednisone | Experimental | 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. Receives: Drug: 15-day taper prednisone |
| 150-day taper prednisone | Experimental | 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. Receives: Drug: 150-day taper prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number 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.
Measured: 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.
Measured: 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.
Measured: Day 30 (15-day taper) or day 180 (150-day taper group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start9 Mar 2023
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Michigan
- Responsible party
- Sponsor
- Investigators
- Beth Wallace, MD MSc, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072768
- Sponsor's protocol ID
- IMMA-010-21S
- Other IDs
- CX002430
- Acronym
- SMART-RA
- Status last verified
- Nov 2025
- First submitted
- 2 Oct 2023
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using SMART Design to Develop Dynamic Treatment Regimens for Glucocorticoid Tapering
- ClinicalTrials.gov ID
- NCT06072768
- Acronym / sponsor ID
- SMART-RA / IMMA-010-21S
- Conditions
- Rheumatoid Arthritis
- Keywords
- Disease-modifying anti-rheumatic drug, Oral prednisone, Dose reduction, Tapering
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Michigan
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Mar 2030 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 15-day taper prednisone | Experimental | Drug: 15-day taper prednisoneThis 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. |
| 150-day taper prednisone | Experimental | Drug: 150-day taper prednisoneThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 15-day taper prednisoneThe 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. | Drug | 15-day taper prednisone |
| 150-day taper prednisoneThe 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. | Drug | 150-day taper prednisone |
Primary outcome
Number of participants with subjective taper intolerance
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.
Number of participants with objective taper intolerance
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.
Net glucocorticoid dose reduction
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Beth Wallace, MD MSc principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 15-day taper prednisone and 150-day taper prednisone in people with Rheumatoid Arthritis, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivia B Dickinson, BA ((734) 548-2987, Olivia.Dickinson@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with subjective taper intolerance (time frame: Day 30 (15-day taper) or day 180 (150-day taper group)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.