Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| NAMSA | OTHER |
| Q2 Solutions | INDUSTRY |
Not provided
Not provided
Not provided
This study will evaluate the safety, tolerability, and effects of stimulating the splenic neurovascular bundle (NVB) with the Galvani System, which consists of a lead, implantable pulse generator, external components and accessories. The study will consist of 4 study periods, including a Randomized Control Trial period (Period 1), an Open Label period (Period 2), a Treat-to-target period (Period 3), and a Long-term Follow-up period (Period 4). Participants eligible for implant will have active rheumatoid arthritis (RA) and have an inadequate response or intolerance to at least two biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) or JAK inhibitors (JAKis). A sufficient number of participants will be enrolled so that approximately 28 participants will undergo device implantation.
Participants with active rheumatoid arthritis (RA) who receive the implantable system will be randomly assigned to receive either active stimulation or sham-stimulation for 12 weeks (Period 1).
Following Period 1, all participants will enter an open label phase (Period 2) during which participants who responded to stimulation will continue on stimulation; whereas participants who received sham stimulation, or were stimulation non-responders, will receive a market-approved RA drug for 12 weeks.
At the end of Period 2, participants who respond to their Period 2 therapy but still exhibit signs and symptoms of RA will enter the Treat-to-target period (Period 3); others will proceed to Period 4 (Long-term Follow-up). During the Treat-to-Target period, participants will be treated with dual therapy (stimulation in combination with the market-approved RA drug) for up to 24 weeks.
Period 4 provides long term safety follow up for all study participants for a period of 5 years. Participants may receive stimulation in combination with other approved and standard of care therapies, subject to a favorable benefit-risk assessment in the judgement of the treating rheumatologist.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Stimulation; Period 1 | Experimental | Active stimulation for 12 weeks |
|
| Sham Stimulation; Period 1 | Sham Comparator | Sham stimulation for 12 weeks |
|
| Open label active stimulation, Period 2 | Experimental | Open label active stimulation for 12 additional weeks |
|
| Open label RA Drug, Period 2 | Other | Open label drug treatment with baricitinib for 12 weeks |
|
| RA drug combined with active stimulation, Period 3 | Experimental | Participants on baricitinib during Period 2 will have active stimulation added for 24 weeks |
|
| Active stimulation combined with RA drug, Period 3 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Stimulation | Device | Stimulation will be turned ON and applied during each day of the period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events [Safety and Tolerability] | Adverse Events (AEs) may include clinically significant findings from Laboratory Safety Assessments (clinical chemistry and hematology), vital signs (blood pressure, heart rate, respiratory rate, and body temperature), and 12-Lead EKG | Up through the end of Period 1 (Period 1 is up to 12 weeks duration) |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | During Period 2 (Period 2 is up to 12 weeks in duration beyond Period 1) | |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | During Period 3 (Period 3 is up to 24 weeks in duration beyond Period 2) | |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | During Period 4 (Period 4 is up to 5 years in duration beyond Period 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the 28 Joint Disease Activity Score 28 - C reactive protein (DAS28-CRP) | Baseline to 12 weeks (Period 1) | |
| Change in the level of Lipopolysaccharide (LPS)-inducible release of Tumor Necrosis Factor (TNFα) in whole blood assay | Baseline to 12 weeks (Period 1) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Operations Director | Contact | +1 877 613 9001 | clinical@galvani.bio |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Research Group, LLC | Withdrawn | Anniston | Alabama | 36207 | United States | |
Not provided
Multicenter study with 4 periods. Period 1 is a randomized, controlled double-blind period where participants are assigned randomly to either active or sham stimulation. During the open-label Periods 2 through 4, participants are assigned treatment based on responses to treatments in the prior period
Not provided
Not provided
Not provided
| Experimental |
Participants on active stimulation during Period 2 will have baricitinib added for 24 weeks |
|
| Long-term Follow-up, Period 4 | Other | Standard of care treatments with or without stimulation |
|
| Sham Stimulation | Device | Sham stimulation will be provided during the period |
|
| Baricitinib | Drug | Baricitinib (2 mg) is administered daily during the period. |
|
| Background Treatment | Drug | Stable dose of standard background treatment (e.g., csDMARD therapy) |
|
| Change in the level of LPS-inducible release of TNFα in whole blood assay | Baseline to 24 weeks (Period 2) |
| Change in the level of LPS-inducible release of Interleukin 6 (IL-6) in whole blood assay | Baseline to 12 weeks (Period 1) |
| Change in the level of LPS-inducible release of Interleukin 6 (IL-6) in whole blood assay | Baseline to 24 weeks (Period 2) |
| Change in the level of LPS-inducible release of IL-8 in whole blood assay | Baseline to 12 weeks (Period 1) |
| Change in the level of LPS-inducible release of IL-8 in whole blood assay | Baseline to 24 weeks (Period 2) |
| Change in the level of LPS-inducible release of IL-17 in whole blood assay | Baseline to 12 weeks (Period 1) |
| Change in the level of LPS-inducible release of IL-17 in whole blood assay | Baseline to 24 weeks (Period 2) |
| Change in DAS28-CRP | Baseline to 24 weeks (Period 2) |
| Change in DAS28-CRP | Baseline to 36 weeks (Period 3) |
| Change in DAS28-CRP | Baseline to 48 weeks (Period 3) |
| Change in Health Assessment Questionnaire Disability Index (HAQ-DI) score | Baseline to 12 weeks (Period 1) |
| Change in HAQ-DI score | Baseline to 24 weeks (Period 2) |
| Change in HAQ-DI score | Baseline to 36 weeks (Period 3) |
| Change in HAQ-DI score | Baseline to 48 weeks (Period 3) |
| Change in Short Form 36 (SF-36) physical component score | Baseline to 12 weeks (Period 1) |
| Change in SF-36 physical component score | Baseline to 24 weeks (Period 2) |
| Change in SF-36 physical component score | Baseline to 36 weeks (Period 3) |
| Change in SF-36 physical component score | Baseline to 48 weeks (Period 3) |
| Change in SF-36 mental component score | Baseline to 12 weeks (Period 1) |
| Change in SF-36 mental component score | Baseline to 24 weeks (Period 2) |
| Change in SF-36 mental component score | Baseline to 36 weeks (Period 3) |
| Change in SF-36 mental component score | Baseline to 48 weeks (Period 3) |
| Change in SF-36 domain score | Baseline to 12 weeks (Period 1) |
| Change in SF-36 domain score | Baseline to 24 weeks (Period 2) |
| Change in SF-36 domain score | Baseline to 36 weeks (Period 3) |
| Change in SF-36 domain score | Baseline to 48 weeks (Period 3) |
| To evaluate the usability of the external Galvani System devices and accessories | Summarize feedback collected on a questionnaire pertaining to the use of the external Galvani System devices | Through 48 weeks |
| To evaluate the participants' perception of therapy and sensation | A form is provided to participants at each visit after randomization to describe any sensations that may be associated with the Galvani System | Through 48 weeks |
| Evaluate device performance as assessed by tabulation of device deficiencies | Through 48 weeks |
| Change in DAS28-CRP in participants who remain on active stimulation during Period 2 | week 12 to week 24 |
| Incidence of participants who remain on active stimulation achieving DAS28-CRP score <2.6 at the end of Period 2 | Time Frame: Week 24 |
| Change in DAS28-CRP in participants who are given Drug treatment with baricitinib during Period 2 | week 12 to week 24 |
| Incidence of a change in DAS28-CRP greater than 1.2 units in participants who are given Drug treatment with baricitinib during Period 2 | week 12 to week 24 |
| Incidence of participants who are given drug treatment with baricitinib achieving DAS28-CRP score <2.6 at the end of Period 2 | Week 24 |
| Medvin Research - Covina |
| Recruiting |
| Covina |
| California |
| 91722 |
| United States |
|
| Medvin Research - Whittier | Recruiting | Whittier | California | 90602 | United States |
|
| The Osteoporosis & Clinical Trials Center | Recruiting | Hagerstown | Maryland | 21740 | United States |
|
| NYU Langone | Recruiting | Brooklyn | New York | 11201 | United States |
|
| Oregon Health & Science University | Recruiting | Portland | Oregon | 97239 | United States |
|
| Altoona Center for Clinical Research | Recruiting | Altoona | Pennsylvania | 16635 | United States |
|
| Arthritis & Rheumatology Institute | Recruiting | Allen | Texas | 75013 | United States |
|
| St. David's Healthcare | Recruiting | Austin | Texas | 78705 | United States |
|
| Tekton Research | Recruiting | Austin | Texas | 78745 | United States |
|
| Metroplex Clinical Research Center | Withdrawn | Dallas | Texas | 75231 | United States |
| Southwest Rheumatology Research | Recruiting | Mesquite | Texas | 75150 | United States |
|
| Academic Medical Center (AMC) Dept of Rheumatology & Clinical Immunology | Recruiting | Amsterdam | Netherlands |
|
| Maxima Medical Center, MMC | Recruiting | Eindhoven | Netherlands |
|
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000596027 | baricitinib |
Not provided
Not provided
Not provided