Clinical trial for Rheumatoid Arthritis
Official title ConsideRAte Study - Splenic Stimulation for RA
ClinicalTrials.gov ID: NCT05003310
What this study is testing
What is Baricitinib?
An investigational daily oral medicine being studied for rheumatoid arthritis. is designed to inhibit Janus kinase enzymes to reduce inflammation.
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 study will look at how safe and well tolerated the device is and whether it helps control arthritis symptoms.
- Who it's for
- Adults with active rheumatoid arthritis who have not had enough benefit or have side‑effects from at least two biologic disease‑modifying drugs or JAK inhibitors.
- What's involved
- Participants will have a small device implanted that sends electrical pulses to the spleen. The study has four parts: a randomized control period, an open‑label period, a treat‑to‑target period, and a long‑term follow‑up.
- Time commitment
- The study lasts through four periods, with regular visits for device checks and health assessments, and a long‑term follow‑up after the treatment phase.
- Time commitment: about 24 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 75
You may be able to join if
- RA of at least six months duration, per 2010 ACR/EULAR criteria
- Male or female participants, 22-75 years of age
- Active RA
- Inadequate Response to at least 2 biologic DMARDs and/or JAK-inhibitors (JAKis) including at least one TNF inhibitor
- Have an appropriate washout from previously used biological DMARDs or JAKi
You likely can't join if
- Inability to provide informed consent
- Significant psychiatric disease or substance abuse
- History of unilateral or bilateral vagotomy
- Active or latent tuberculosis
- Known infection with human immunodeficiency virus (HIV); current acute or chronic hepatitis B or hepatitis C; previous hepatitis B
- Positive SARS COV 2 PCR screening test for COVID-19 infection (at the point of screening for this study)
See the full eligibility criteria
- RA of at least six months duration, per 2010 ACR/EULAR criteria
- Male or female participants, 22-75 years of age
- Active RA
- Inadequate Response to at least 2 biologic DMARDs and/or JAK-inhibitors (JAKis) including at least one TNF inhibitor
- Have an appropriate washout from previously used biological DMARDs or JAKi
- Receiving current treatment with standard dose(s) of conventional synthetic DMARD(s) or have documented history of failure due to ineffectiveness or intolerance
- Inability to provide informed consent
- Significant psychiatric disease or substance abuse
- History of unilateral or bilateral vagotomy
- Active or latent tuberculosis
- Known infection with human immunodeficiency virus (HIV); current acute or chronic hepatitis B or hepatitis C; previous hepatitis B
- Positive SARS COV 2 PCR screening test for COVID-19 infection (at the point of screening for this study)
- Currently implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverter-defibrillators)
- Previous splenectomy
The study team makes the final eligibility decision.
Where it is enrolling
- Covina, California, United States
- Whittier, California, United States
- Hagerstown, Maryland, United States
- Brooklyn, New York, United States
- Portland, Oregon, United States
- Altoona, Pennsylvania, United States
- Allen, Texas, United States
- Austin, Texas, United States
- Mesquite, Texas, United States
- Amsterdam, Netherlands
- Eindhoven, Netherlands
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, but confirm specifics with the study team.
How long does this study last?
The study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Covina, California, United States; Whittier, California, United States; Hagerstown, Maryland, United States; Brooklyn, New York, United States; Portland, Oregon, United States; Altoona, Pennsylvania, United States and 5 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.