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| ID | Type | Description | Link |
|---|---|---|---|
| CX002430 | Other Grant/Funding Number | VA CSR&D |
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| Name | Class |
|---|---|
| University of Michigan | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 15-day taper prednisone | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Day 30 (15-day taper) or day 180 (150-day taper group) |
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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
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olivia B Dickinson, BA | Contact | (734) 548-2987 | Olivia.Dickinson@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Beth Wallace, MD MSc | VA Ann Arbor Healthcare System, Ann Arbor, MI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Ann Arbor Healthcare System, Ann Arbor, MI | Recruiting | Ann Arbor | Michigan | 48105-2303 | United States |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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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.
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None (open label)
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| 150-day taper prednisone | Drug | 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. |
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| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |