ConsideRAte Study - Splenic Stimulation for RA

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

22 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Active Stimulation — DEVICE
  Stimulation will be turned ON and applied during each day of the period.
• 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)

Study Details

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.

Key Dates

Start date

Oct 19, 2021

Status verified

May 2024

Primary completion

Jul 31, 2027

Completion

Apr 30, 2032

Study Design

Enrollment

28 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Active Stimulation; Period 1
  Active stimulation for 12 weeks
• Sham Comparator: Sham Stimulation; Period 1
  Sham stimulation for 12 weeks
• Experimental: Open label active stimulation, Period 2
  Open label active stimulation for 12 additional weeks
• Other: Open label RA Drug, Period 2
  Open label drug treatment with baricitinib for 12 weeks
• Experimental: RA drug combined with active stimulation, Period 3
  Participants on baricitinib during Period 2 will have active stimulation added for 24 weeks
• Experimental: Active stimulation combined with RA drug, Period 3
  Participants on active stimulation during Period 2 will have baricitinib added for 24 weeks
• Other: Long-term Follow-up, Period 4
  Standard of care treatments with or without stimulation

Primary Outcome Measure

Incidence of Adverse Events [Safety and Tolerability] [ Time Frame: Up through the end of Period 1 (Period 1 is up to 12 weeks duration) ]

Central Contacts

• Operations Director
  +1 877 613 9001
  [email protected]

Locations (12)

Find similar trials in Anniston, AL

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