BridgeMD
New treatment option for Rheumatoid Arthritis
Official title Dynamic Treatment Regiments for Glucocorticoid Tapering
ClinicalTrials.gov ID: NCT06072768
What this study is testing
What is 15-day taper prednisone?
15-day taper prednisone is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for rheumatoid arthritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- Current or recent (past year) use of systemic glucocorticoid (oral, intravenous, or intramuscular administration) \>2 weeks for an indication other...
- Patients with greater than moderate RA activity as determined by the Clinical Disease Activity Index or by rheumatologist assessment, given high...
- 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...
See the full eligibility 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
- Eligible DMARDs include the following: hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, etanercept, adalimumab, infliximab, golimumab, certolizumab pegol, abatacept, tocilizumab, sarilumab, rituximab...
- 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
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.