The ConsideRAte study. A multipart exploratory study to evaluate splenic nerve stimulation in patients with rheumatoid arthritis.
Brief description of study
The ConsideRAte study This study will evaluate the safety, tolerability, and effects of stimulating the splenic neurovascular bundle (NVB) with an active implantable medical device system. 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 with active rheumatoid arthritis (RA) will receive an implantable system and, following a recovery period of at least 28 days after implant of the system, will be randomly assigned at Day 1 (of Period 1) to receive either active stimulation or sham-stimulation via this system for 12 weeks (84 days). Day 1 assessments will be used as baseline. Summary of IB Version 2: Version 1, 16 Dec 2020 Initial Release Version 2, 23 Jul 2021 Add preclinical testing supporting increase target stimulation dose increase from 15 mA to 20 mA Cover Page, Headers, Table of Contents Updated version, Date Page 3 Updated Sponsor signatory to Chief Medical Officer Section 2.4 Removed previous target amplitude Section 2.7 Added brief description of preclinical study (2nd GLP study); brief conclusions Section 6.1 Added mention of new GLP study and brief results Figure 20 Corrected max dose amplitude in from 15 mA to 20 mA Section 9.2 Added brief description of the new preclinical study (GAL1063) Section 9.4 Added more detailed description and results of the new preclinical study (GAL1063) Table numbers and section numbers Adjusted tables numbers and section numbers to account for the section added to describe the new GLP study Section 13.1.5 Updated results and figures from the new GLP study (GAL1063) Section 13.5.2 Updated estimated nerve recruitment rates and figure at the new target amplitude (20 mA) Section 14 Appendix II Added background rationale for GAL1063 study. Change to IB Version 3: Version 1, 16 Dec 2020 Initial Release Version 2, 23 Jul 2021 Add preclinical testing supporting increase target stimulation dose increase from 15 mA to 20 mA Cover Page, Headers, Table of Contents Updated version, Date Page 3 Updated Sponsor signatory to Chief Medical Officer Section 2.4 Removed previous target amplitude Section 2.7 Added brief description of preclinical study (2nd GLP study); brief conclusions Section 6.1 Added mention of new GLP study and brief results Figure 20 Corrected max dose amplitude in from 15 mA to 20 mA Section 9.2 Added brief description of the new preclinical study (GAL1063) Section 9.4 Added more detailed description and results of the new preclinical study (GAL1063) Table numbers and section numbers Adjusted tables numbers and section numbers to account for the section added to describe the new GLP study Section 13.1.5 Updated results and figures from the new GLP study (GAL1063) Section 13.5.2 Updated estimated nerve recruitment rates and figure at the new target amplitude (20 mA) Section 14 Appendix II Added background rationale for GAL1063 study. Version 3; 22 Oct 2021 Revised to include new validation packaging results, and updated tables from V&V testing Cover Page, Headers, Table of Contents Updated version, Date Section 11.1 Updated Table 14 to describe the correction for Failed package testing as complete. Updated Table 15 & 16 to describe the design changes for the packages that were re-tested, and results. Section 11.1.1 Updated Table 18 V&V testing table to include the GAL1063 GLP study and PASS criteria
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