| Primary | the American College of Rheumatology (ACR) 20 Response | Response is defined as achieving at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/L). | | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Treatment | Active stimulation for 1 min once per day Implant Procedure: The SetPoint System (study device) contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). All eligible subjects will undergo the surgery under general anesthesia in outpatient settings. Conventional Synthetic DMARD: All subjects will continue to take at least one type of conventional synthetic DMARD at the same stable dose as for 4 weeks prior to consent Active stimulation: Active stimulation for 1 min once per day | | OG001 | Control | Non-active stimulation for 1 min once per day Implant Procedure: The SetPoint System (study device) contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). All eligible subjects will undergo the surgery under general anesthesia in outpatient settings. Conventional Synthetic DMARD: All subjects will continue to take at least one type of conventional synthetic DMARD at the same stable dose as for 4 weeks prior to consent Non-active stimulation: Non-active stimulation for 1 min once per day |
| | | Title | Denominators | Categories |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Cochran-Mantel-Haenszel | | 0.0209 | The study is considered successful if there is a statistically significant improvement in the proportion of subjects with ACR20 response in favor of the SetPoint System at the one-sided alpha of 0.025. | Risk Difference (RD) | 11.8 | | | 2-Sided | 95 | 0.6 | 23.1 | | | | | Superiority | The null hypothesis (H0) is that there is no difference between the treatment and control groups versus the alternative hypothesis (H1) that treatment group response rate exceeds the control group response rate. |
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| Secondary | DAS28-CRP Good or Moderate Response as Defined by European League Against Rheumatism (EULAR) | The Disease Activity Score in 28 joints calculated with C-reactive protein (DAS28-CRP) good or moderate response as defined by EULAR based on a composite score of 4 items: tender and swollen joint counts of 28 joints (scale 0=best to 28=worst), subject global assessment (0=best to 10=worst) and high-sensitivity C-reactive protein (hsCRP) concentration (mg/L). A total score ranges from 0 to 10 and is computed as follows: DAS28-CRP = 0.56 * sqrt(TJC28) + 0.28 * sqrt(SJC28) + 0.36 * ln(CRP+1) + 0.014 * SGA + 0.96 A subject is considered having a moderate treatment response if:
- DAS28-CRP score improvement from baseline to Week 12 is > 0.6 and ≤ 1.2, and the DAS28-CRP score at Week 12 is ≤ 5.1; or
- DAS28-CRP score improvement from baseline to Week 12 is > 1.2, and the DAS28-CRP score at Week 12 is > 3.2.
A subject is considered having a good treatment response if: • DAS28-CRP score improvement from baseline to Week 12 is > 1.2 and the DAS28-CRP score at Week 12 is ≤ 3.2 | | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Treatment | Active stimulation for 1 min once per day Implant Procedure: The SetPoint System (study device) contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). All eligible subjects will undergo the surgery under general anesthesia in outpatient settings. Conventional Synthetic DMARD: All subjects will continue to take at least one type of conventional synthetic DMARD at the same stable dose as for 4 weeks prior to consent Active stimulation: Active stimulation for 1 min once per day |
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| Secondary | DAS28-CRP Response (MCID -1.2) at Week 12 | The Disease Activity Score in 28 joints calculated with C-reactive protein (DAS28-CRP) response is based on the minimal clinically important difference (MCID) of -1.2 from baseline. DAS28-CRP is based on a composite score of 4 items: tender and swollen joint counts of 28 joints (scale 0=best to 28=worst), subject global assessment (0=best to 10=worst) and high-sensitivity C-reactive protein (hsCRP) concentration (mg/L). A total score ranges from 0 to 10 and is computed as follows: DAS28-CRP = 0.56 * sqrt(TJC28) + 0.28 * sqrt(SJC28) + 0.36 * ln(CRP+1) + 0.014 * SGA + 0.96 | | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Treatment | Active stimulation for 1 min once per day Implant Procedure: The SetPoint System (study device) contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). All eligible subjects will undergo the surgery under general anesthesia in outpatient settings. Conventional Synthetic DMARD: All subjects will continue to take at least one type of conventional synthetic DMARD at the same stable dose as for 4 weeks prior to consent Active stimulation: Active stimulation for 1 min once per day | | OG001 | Control | Non-active stimulation for 1 min once per day Implant Procedure: The SetPoint System (study device) contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). All eligible subjects will undergo the surgery under general anesthesia in outpatient settings. Conventional Synthetic DMARD: All subjects will continue to take at least one type of conventional synthetic DMARD at the same stable dose as for 4 weeks prior to consent Non-active stimulation: Non-active stimulation for 1 min once per day |
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| Secondary | Health Assessment Questionnaire Disability Index (HAQ-DI) Response (MCID -0.22) | HAQ-DI response based on the MCID of -0.22 from baseline. The HAQ-DI is a questionnaire validated for RA self-assessment by subjects that contains 20 questions in the following 8 functional areas:
- Dressing and grooming
- Arising
- Eating
- Walking
- Hygiene
- Reach
- Grip
- Common daily activities
Scoring within each functional area is from 0 (without any difficulty) to 3 (unable to do). The total score is obtained by summing 8 area scores and dividing by 8. The total HAQ-DI score ranges from 0 to 3 and corresponds to the current degree of disability:
- 0 to < 1 Mild difficulties to moderate disability
- 1 to < 2 Moderate disability
- 2 to 3 Severe to very severe disability
| | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Treatment | Active stimulation for 1 min once per day Implant Procedure: The SetPoint System (study device) contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). All eligible subjects will undergo the surgery under general anesthesia in outpatient settings. Conventional Synthetic DMARD: All subjects will continue to take at least one type of conventional synthetic DMARD at the same stable dose as for 4 weeks prior to consent Active stimulation: Active stimulation for 1 min once per day | | OG001 | Control | |
|
| Secondary | ACR20 Response at Week 12 From Day 0 | Response is defined as achieving at least 20% improvement from Day 0 to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worse), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/mL). | | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Treatment | Active stimulation for 1 min once per day Implant Procedure: The SetPoint System (study device) contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). All eligible subjects will undergo the surgery under general anesthesia in outpatient settings. Conventional Synthetic DMARD: All subjects will continue to take at least one type of conventional synthetic DMARD at the same stable dose as for 4 weeks prior to consent Active stimulation: Active stimulation for 1 min once per day | | OG001 | Control | Non-active stimulation for 1 min once per day Implant Procedure: The SetPoint System (study device) contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). All eligible subjects will undergo the surgery under general anesthesia in outpatient settings. Conventional Synthetic DMARD: All subjects will continue to take at least one type of conventional synthetic DMARD at the same stable dose as for 4 weeks prior to consent Non-active stimulation: Non-active stimulation for 1 min once per day |
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| Other Pre-specified | Bone Erosion Progression, All Completers | RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand. A total score for each pathology is generated by the summation of individual joint/bone scores as follows:
- Synovitis: 8 joints each scored on a scale from 0 = normal to 3 = severe, resulting in a total score from 0 to 24.
- Bone erosion: 25 bones each scored on a scale from 0 (0-10% eroded volume) to 10 (91-100% eroded volume), resulting in a total score from 0 to 250.
- Osteitis: 25 bones scored on a scale from 0 (no osteitis) to 3 (68-100% of bone volume involved), resulting in a total score from 0 to 75.
- CARLOS (cartilage loss): 25 joints each scored on a scale from 0 (no damage) to 4 (complete ankylosis or fusion), resulting in a total score from 0 to 100.
The proportion of bone erosion progressors is the % subjects with an increase of > 0.5 on the bone erosion score, comparing baseline to Week 12. An increase of > 0.5 represents disease progression. | ITT with MRI images at both Baseline and Week 12 | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Treatment | Active stimulation for 1 min once per day Implant Procedure: The SetPoint System (study device) contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). All eligible subjects will undergo the surgery under general anesthesia in outpatient settings. Conventional Synthetic DMARD: All subjects will continue to take at least one type of conventional synthetic DMARD at the same stable dose as for 4 weeks prior to consent Active stimulation: Active stimulation for 1 min once per day |
|
| Other Pre-specified | Bone Erosion Progression, All Completers With Erosive Phenotype | RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand. A total score for each pathology is generated by the summation of individual joint/bone scores as follows:
- Synovitis: 8 joints each scored on a scale from 0 = normal to 3 = severe, resulting in a total score from 0 to 24.
- Bone erosion: 25 bones each scored on a scale from 0 (0-10% eroded volume) to 10 (91-100% eroded volume), resulting in a total score from 0 to 250.
- Osteitis: 25 bones scored on a scale from 0 (no osteitis) to 3 (68-100% of bone volume involved), resulting in a total score from 0 to 75.
- CARLOS (cartilage loss): 25 joints each scored on a scale from 0 (no damage) to 4 (complete ankylosis or fusion), resulting in a total score from 0 to 100.
The proportion of bone erosion progressors is the % subjects with an increase of > 0.5 on the bone erosion score, comparing baseline to Week 12. An increase of > 0.5 represents disease progression. | ITT with MRI images at both Baseline and Week 12 | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Treatment, Erosive Phenotype | Subgroup of subjects receiving active stimulation for 1 min once per day that have an erosive phenotype. Subjects meeting the subgroup criteria for having an erosive phenotype had a baseline synovitis score of 2 or more on any joint; or, if none of the joints score greater than 2, had at least 4 joints with a score of 1 at baseline; or had any joint with osteitis (score of 1 or more) at baseline. | |
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| Other Pre-specified | Bone Erosion Progression, All Completers That Previously Only Failed 1 b/tsDMARD | RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand. A total score for each pathology is generated by the summation of individual joint/bone scores as follows:
- Synovitis: 8 joints each scored on a scale from 0 = normal to 3 = severe, resulting in a total score from 0 to 24.
- Bone erosion: 25 bones each scored on a scale from 0 (0-10% eroded volume) to 10 (91-100% eroded volume), resulting in a total score from 0 to 250.
- Osteitis: 25 bones scored on a scale from 0 (no osteitis) to 3 (68-100% of bone volume involved), resulting in a total score from 0 to 75.
- CARLOS (cartilage loss): 25 joints each scored on a scale from 0 (no damage) to 4 (complete ankylosis or fusion), resulting in a total score from 0 to 100.
The proportion of bone erosion progressors is the % subjects with an increase of > 0.5 on the bone erosion score, comparing baseline to Week 12. An increase of > 0.5 represents disease progression. | ITT with MRI images at both Baseline and Week 12 | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Treatment, 1 Prior b/tsDMARD | Subgroup of subjects receiving active stimulation for 1 min once per day that have previously only failed 1 b/tsDMARD | | OG001 | Control, 1 Prior b/tsDMARD | Subgroup of subjects receiving non-active stimulation for 1 min once per day that have previously only failed 1 b/tsDMARD |
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| Other Pre-specified | Change in Erosion Score, All Completers | RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand (synovitis, bone erosion, osteitis, and cartilage loss). A total score for each pathology is generated by the summation of individual joint/bone scores: • Bone erosion: 25 bones each scored on a scale from 0 (0-10% eroded volume) to 10 (91-100% eroded volume), resulting in a total score from 0 to 250. | ITT with MRI images at both Baseline and Week 12 | Posted | | Mean | Standard Deviation | score on a scale | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Treatment | Active stimulation for 1 min once per day Implant Procedure: The SetPoint System (study device) contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). All eligible subjects will undergo the surgery under general anesthesia in outpatient settings. Conventional Synthetic DMARD: All subjects will continue to take at least one type of conventional synthetic DMARD at the same stable dose as for 4 weeks prior to consent Active stimulation: Active stimulation for 1 min once per day | | OG001 | Control | Non-active stimulation for 1 min once per day Implant Procedure: The SetPoint System (study device) contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). All eligible subjects will undergo the surgery under general anesthesia in outpatient settings. Conventional Synthetic DMARD: All subjects will continue to take at least one type of conventional synthetic DMARD at the same stable dose as for 4 weeks prior to consent Non-active stimulation: Non-active stimulation for 1 min once per day |
|
| Other Pre-specified | Change in Erosion Score, All Completers With Erosive Phenotype | RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand (synovitis, bone erosion, osteitis, and cartilage loss). A total score for each pathology is generated by the summation of individual joint/bone scores: • Bone erosion: 25 bones each scored on a scale from 0 (0-10% eroded volume) to 10 (91-100% eroded volume), resulting in a total score from 0 to 250. | ITT with MRI images at both Baseline and Week 12 | Posted | | Mean | Standard Deviation | score on a scale | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Treatment, Erosive Phenotype | Subgroup of subjects receiving active stimulation for 1 min once per day that have an erosive phenotype. Subjects meeting the subgroup criteria for having an erosive phenotype had a baseline synovitis score of 2 or more on any joint; or, if none of the joints score greater than 2, had at least 4 joints with a score of 1 at baseline; or had any joint with osteitis (score of 1 or more) at baseline. | | OG001 | Control, Erosive Phenotype | Subgroup of subjects receiving non-active stimulation for 1 min once per day that have an erosive phenotype. Subjects meeting the subgroup criteria for having an erosive phenotype had a baseline synovitis score of 2 or more on any joint; or, if none of the joints score greater than 2, had at least 4 joints with a score of 1 at baseline; or had any joint with osteitis (score of 1 or more) at baseline. |
|
| Other Pre-specified | Change in Erosion Score, All Completers That Previously Only Failed 1 b/tsDMARD | RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand (synovitis, bone erosion, osteitis, and cartilage loss). A total score for each pathology is generated by the summation of individual joint/bone scores: • Bone erosion: 25 bones each scored on a scale from 0 (0-10% eroded volume) to 10 (91-100% eroded volume), resulting in a total score from 0 to 250. | ITT with MRI images at both Baseline and Week 12 | Posted | | Mean | Standard Deviation | score on a scale | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Treatment, 1 Prior b/tsDMARD | Subgroup of subjects receiving active stimulation for 1 min once per day that have previously only failed 1 b/tsDMARD. | | OG001 | Control, 1 Prior b/tsDMARD | Subgroup of subjects receiving non-active stimulation for 1 min once per day that have previously only failed 1 b/tsDMARD |
| |
| Other Pre-specified | Change in Synovitis Score, All Completers | RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand (synovitis, bone erosion, osteitis, and cartilage loss). A total score for each pathology is generated by the summation of individual joint/bone scores: • Synovitis: 8 joints each scored on a scale from 0 = normal to 3 = severe, resulting in a total score from 0 to 24. | ITT with MRI images at both Baseline and Week 12 | Posted | | Mean | Standard Deviation | score on a scale | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Treatment | Active stimulation for 1 min once per day Implant Procedure: The SetPoint System (study device) contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). All eligible subjects will undergo the surgery under general anesthesia in outpatient settings. Conventional Synthetic DMARD: All subjects will continue to take at least one type of conventional synthetic DMARD at the same stable dose as for 4 weeks prior to consent Active stimulation: Active stimulation for 1 min once per day | | OG001 | Control | Non-active stimulation for 1 min once per day Implant Procedure: The SetPoint System (study device) contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). All eligible subjects will undergo the surgery under general anesthesia in outpatient settings. Conventional Synthetic DMARD: All subjects will continue to take at least one type of conventional synthetic DMARD at the same stable dose as for 4 weeks prior to consent Non-active stimulation: Non-active stimulation for 1 min once per day |
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| Other Pre-specified | Change in Synovitis Score, All Completers With Erosive Phenotype | RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand (synovitis, bone erosion, osteitis, and cartilage loss). A total score for each pathology is generated by the summation of individual joint/bone scores: • Synovitis: 8 joints each scored on a scale from 0 = normal to 3 = severe, resulting in a total score from 0 to 24. | ITT with MRI images at both Baseline and Week 12 | Posted | | Mean | Standard Deviation | score on a scale | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Treatment, Erosive Phenotype | Subgroup of subjects receiving active stimulation for 1 min once per day that have an erosive phenotype. Subjects meeting the subgroup criteria for having an erosive phenotype had a baseline synovitis score of 2 or more on any joint; or, if none of the joints score greater than 2, had at least 4 joints with a score of 1 at baseline; or had any joint with osteitis (score of 1 or more) at baseline. | | OG001 | Control, Erosive Phenotype | Subgroup of subjects receiving non-active stimulation for 1 min once per day that have an erosive phenotype. Subjects meeting the subgroup criteria for having an erosive phenotype had a baseline synovitis score of 2 or more on any joint; or, if none of the joints score greater than 2, had at least 4 joints with a score of 1 at baseline; or had any joint with osteitis (score of 1 or more) at baseline. |
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| Other Pre-specified | Change in Synovitis Score, All Completers That Previously Only Failed 1 b/tsDMARD | RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand (synovitis, bone erosion, osteitis, and cartilage loss). A total score for each pathology is generated by the summation of individual joint/bone scores: • Synovitis: 8 joints each scored on a scale from 0 = normal to 3 = severe, resulting in a total score from 0 to 24. | ITT with MRI images at both Baseline and Week 12 | Posted | | Mean | Standard Deviation | score on a scale | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Treatment, 1 Prior b/tsDMARD | Subgroup of subjects receiving active stimulation for 1 min once per day that have previously only failed 1 b/tsDMARD. | | OG001 | Control, 1 Prior b/tsDMARD | Subgroup of subjects receiving non-active stimulation for 1 min once per day that have previously only failed 1 b/tsDMARD |
| |
| Other Pre-specified | Change in Osteitis Score, All Completers | RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand (synovitis, bone erosion, osteitis, and cartilage loss). A total score for each pathology is generated by the summation of individual joint/bone scores: • Osteitis: 25 bones scored on a scale from 0 (no osteitis) to 3 (68-100% of bone volume involved), resulting in a total score from 0 to 75. | ITT with MRI images at both Baseline and Week 12 | Posted | | Mean | Standard Deviation | score on a scale | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Treatment | Active stimulation for 1 min once per day Implant Procedure: The SetPoint System (study device) contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). All eligible subjects will undergo the surgery under general anesthesia in outpatient settings. Conventional Synthetic DMARD: All subjects will continue to take at least one type of conventional synthetic DMARD at the same stable dose as for 4 weeks prior to consent Active stimulation: Active stimulation for 1 min once per day | | OG001 | Control | Non-active stimulation for 1 min once per day Implant Procedure: The SetPoint System (study device) contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). All eligible subjects will undergo the surgery under general anesthesia in outpatient settings. Conventional Synthetic DMARD: All subjects will continue to take at least one type of conventional synthetic DMARD at the same stable dose as for 4 weeks prior to consent Non-active stimulation: Non-active stimulation for 1 min once per day |
|
| Other Pre-specified | Change in Osteitis Score, All Completers With Erosive Phenotype | RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand (synovitis, bone erosion, osteitis, and cartilage loss). A total score for each pathology is generated by the summation of individual joint/bone scores: • Osteitis: 25 bones scored on a scale from 0 (no osteitis) to 3 (68-100% of bone volume involved), resulting in a total score from 0 to 75. | ITT with MRI images at both Baseline and Week 12 | Posted | | Mean | Standard Deviation | score on a scale | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Treatment, Erosive Phenotype | Subgroup of subjects receiving active stimulation for 1 min once per day that have an erosive phenotype. Subjects meeting the subgroup criteria for having an erosive phenotype had a baseline synovitis score of 2 or more on any joint; or, if none of the joints score greater than 2, had at least 4 joints with a score of 1 at baseline; or had any joint with osteitis (score of 1 or more) at baseline. | | OG001 | Control, Erosive Phenotype | Subgroup of subjects receiving non-active stimulation for 1 min once per day that have an erosive phenotype. Subjects meeting the subgroup criteria for having an erosive phenotype had a baseline synovitis score of 2 or more on any joint; or, if none of the joints score greater than 2, had at least 4 joints with a score of 1 at baseline; or had any joint with osteitis (score of 1 or more) at baseline. |
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| Other Pre-specified | Change in Osteitis Score, All Completers That Previously Only Failed 1 b/tsDMARD | RAMRIS is a standardized system for RA MRI scoring of 4 different types of joint pathologies in the wrist and the hand (synovitis, bone erosion, osteitis, and cartilage loss). A total score for each pathology is generated by the summation of individual joint/bone scores: • Osteitis: 25 bones scored on a scale from 0 (no osteitis) to 3 (68-100% of bone volume involved), resulting in a total score from 0 to 75. | ITT with MRI images at both Baseline and Week 12 | Posted | | Mean | Standard Deviation | score on a scale | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Treatment, 1 Prior b/tsDMARD | Subgroup of subjects receiving active stimulation for 1 min once per day that have previously only failed 1 b/tsDMARD. | | OG001 | Control, 1 Prior b/tsDMARD | Subgroup of subjects receiving non-active stimulation for 1 min once per day that have previously only failed 1 b/tsDMARD |
| |
| Other Pre-specified | Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA) or Remission | The CDAI score is based on 4 items:
- TJC28, tender joint count of 28 joints (scale 0=best to 28=worst)
- SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst)
- SGA, subject global assessment (0=best to 10=worst)
- EGA, evaluator's global assessment (0=best to 10=worst)
The CDAI score is calculated as follows and ranges from 0 to 76: • CDAI = TJC28 + SJC28 + SGA + EGA The CDAI score corresponds to the current RA activity:
- 0 to ≤ 2.8 Remission
- >2.8 to ≤ 10 Low disease activity (LDA)
- >10 to ≤ 22 Moderate disease activity
- > 22 High disease activity
| | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Treatment | Active stimulation for 1 min once per day Implant Procedure: The SetPoint System (study device) contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). All eligible subjects will undergo the surgery under general anesthesia in outpatient settings. Conventional Synthetic DMARD: All subjects will continue to take at least one type of conventional synthetic DMARD at the same stable dose as for 4 weeks prior to consent Active stimulation: Active stimulation for 1 min once per day | | OG001 | Control | Non-active stimulation for 1 min once per day Implant Procedure: The SetPoint System (study device) contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). All eligible subjects will undergo the surgery under general anesthesia in outpatient settings. Conventional Synthetic DMARD: All subjects will continue to take at least one type of conventional synthetic DMARD at the same stable dose as for 4 weeks prior to consent Non-active stimulation: Non-active stimulation for 1 min once per day |
|
| Other Pre-specified | DAS28-CRP Low Disease Activity (LDA) or Remission | The Disease Activity Score in 28 joints calculated with C-reactive protein (DAS28-CRP) score is a composite index providing a measure of disease activity, comprising:
- TJC28, tender joint count of 28 joints (scale 0=best to 28=worst)
- SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst)
- SGA, subject global assessment (0=best to 10=worst)
- hsCRP (mg/L), high sensitivity C-reactive protein concentration (mg/L)
A total score ranges from 0 to 10 and is computed as follows: DAS28-CRP = 0.56 * sqrt(TJC28) + 0.28 * sqrt(SJC28) + 0.36 * ln(CRP+1) + 0.014 * SGA + 0.96 The DAS28-CRP score corresponds to the current RA activity:
- 0 to < 2.6 Remission
- 2.6 to < 3.2 LDA
- 3.2 to ≤ 5.1 Moderate activity
- > 5.1 High activity
| | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Treatment | Active stimulation for 1 min once per day Implant Procedure: The SetPoint System (study device) contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). All eligible subjects will undergo the surgery under general anesthesia in outpatient settings. Conventional Synthetic DMARD: All subjects will continue to take at least one type of conventional synthetic DMARD at the same stable dose as for 4 weeks prior to consent Active stimulation: Active stimulation for 1 min once per day | | OG001 | Control |
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| Other Pre-specified | the American College of Rheumatology (ACR) 20 Response, All Completers | Response is defined as achieving at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/L). | | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL) | Treatment subjects from ITT population who received active stimulation through Week 12, completed Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG001 | Control to Open Label (COL) | Control subjects from ITT population who received non-active (sham) stimulation through Week 12, switched to active stimulation after completing Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG002 | All (TOL+COL) |
|
| Other Pre-specified | the American College of Rheumatology (ACR) 20 Response, Non-augmented | Response is defined as achieving at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/L). | Subgroup of subjects receiving active stimulation for 1 min once per day, whose study therapy has not been augmented, who completed assessment. | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL), Non-augmented | A subgroup of subjects from the TOL population who did not have study therapy augmented during the outcome measure timeframe. Augmentation of study therapy means the addition of treatment for RA therapy to active stimulation applied after completion of Week 12 assessments, during open-label, long-term follow-up. Augmented therapy may be applied at any time during long-term follow-up. The decision about the need, type and timing of treatment is left to the discretion of the Co-PI Rheumatologist and the subject. Subjects combining active stimulation with the following additions to RA therapy fall into the augmented therapy subgroup for analysis of response rates for key efficacy endpoints at specific timepoints:
- Prednisone equivalent >10 mg/day. If average daily corticosteroid use exceeds 10 mg/day prednisone after a period (time from previous visit up to the day before the current visit), the subject is assigned to the augmented therapy subgroup for that visit.
- Corticosteroid injection. If subject received a corticosteroid injection within 30 days prior to a study visit, the subject is assigned to the augmented therapy subgroup for that visit.
- b/ts/csDMARD. Subjects who receive treatment with biologic, targeted synthetic, or additional conventional synthetic DMARD, or increased dose of background conventional synthetic DMARD will be assigned to the augmented therapy subgroup for all subsequent visits.
|
|
| Other Pre-specified | Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA) or Remission, All Completers | The CDAI score is based on 4 items:
- TJC28, tender joint count of 28 joints (scale 0=best to 28=worst)
- SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst)
- SGA, subject global assessment (0=best to 10=worst)
- EGA, evaluator's global assessment (0=best to 10=worst)
The CDAI score is calculated as follows and ranges from 0 to 76: • CDAI = TJC28 + SJC28 + SGA + EGA The CDAI score corresponds to the current RA activity:
- 0 to ≤ 2.8 Remission
- >2.8 to ≤ 10 Low disease activity (LDA)
- >10 to ≤ 22 Moderate disease activity
- > 22 High disease activity
| | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL) | Treatment subjects from ITT population who received active stimulation through Week 12, completed Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG001 | Control to Open Label (COL) | Control subjects from ITT population who received non-active (sham) stimulation through Week 12, switched to active stimulation after completing Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | |
|
| Other Pre-specified | Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA) or Remission, Non-augmented | The CDAI score is based on 4 items:
- TJC28, tender joint count of 28 joints (scale 0=best to 28=worst)
- SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst)
- SGA, subject global assessment (0=best to 10=worst)
- EGA, evaluator's global assessment (0=best to 10=worst)
The CDAI score is calculated as follows and ranges from 0 to 76: • CDAI = TJC28 + SJC28 + SGA + EGA The CDAI score corresponds to the current RA activity:
- 0 to ≤ 2.8 Remission
- >2.8 to ≤ 10 Low disease activity (LDA)
- >10 to ≤ 22 Moderate disease activity
- > 22 High disease activity
| Subgroup of subjects receiving active stimulation for 1 min once per day, whose study therapy has not been augmented, who completed assessment. | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL), Non-augmented | A subgroup of subjects from the TOL population who did not have study therapy augmented during the outcome measure timeframe. Augmentation of study therapy means the addition of treatment for RA therapy to active stimulation applied after completion of Week 12 assessments, during open-label, long-term follow-up. Augmented therapy may be applied at any time during long-term follow-up. The decision about the need, type and timing of treatment is left to the discretion of the Co-PI Rheumatologist and the subject. Subjects combining active stimulation with the following additions to RA therapy fall into the augmented therapy subgroup for analysis of response rates for key efficacy endpoints at specific timepoints:
- Prednisone equivalent >10 mg/day. If average daily corticosteroid use exceeds 10 mg/day prednisone after a period (time from previous visit up to the day before the current visit), the subject is assigned to the augmented therapy subgroup for that visit.
- Corticosteroid injection. If subject received a corticosteroid injection within 30 days prior to a study visit, the subject is assigned to the augmented therapy subgroup for that visit.
- b/ts/csDMARD. Subjects who receive treatment with biologic, targeted synthetic, or additional conventional synthetic DMARD, or increased dose of background conventional synthetic DMARD will be assigned to the augmented therapy subgroup for all subsequent visits.
|
|
| Other Pre-specified | DAS28-CRP Low Disease Activity (LDA) or Remission, All Completers | The Disease Activity Score in 28 joints calculated with C-reactive protein (DAS28-CRP) score is a composite index providing a measure of disease activity, comprising:
- TJC28, tender joint count of 28 joints (scale 0=best to 28=worst)
- SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst)
- SGA, subject global assessment (0=best to 10=worst)
- hsCRP (mg/L), high sensitivity C-reactive protein concentration (mg/L)
A total score ranges from 0 to 10 and is computed as follows: DAS28-CRP = 0.56 * sqrt(TJC28) + 0.28 * sqrt(SJC28) + 0.36 * ln(CRP+1) + 0.014 * SGA + 0.96 The DAS28-CRP score corresponds to the current RA activity:
- 0 to < 2.6 Remission
- 2.6 to < 3.2 LDA
- 3.2 to ≤ 5.1 Moderate activity
- > 5.1 High activity
| | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL) | Treatment subjects from ITT population who received active stimulation through Week 12, completed Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG001 | Control to Open Label (COL) | Control subjects from ITT population who received non-active (sham) stimulation through Week 12, switched to active stimulation after completing Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. |
|
| Other Pre-specified | DAS28-CRP Low Disease Activity (LDA) or Remission, Non-augmented | The Disease Activity Score in 28 joints calculated with C-reactive protein (DAS28-CRP) score is a composite index providing a measure of disease activity, comprising:
- TJC28, tender joint count of 28 joints (scale 0=best to 28=worst)
- SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst)
- SGA, subject global assessment (0=best to 10=worst)
- hsCRP (mg/L), high sensitivity C-reactive protein concentration (mg/L)
A total score ranges from 0 to 10 and is computed as follows: DAS28-CRP = 0.56 * sqrt(TJC28) + 0.28 * sqrt(SJC28) + 0.36 * ln(CRP+1) + 0.014 * SGA + 0.96 The DAS28-CRP score corresponds to the current RA activity:
- 0 to < 2.6 Remission
- 2.6 to < 3.2 LDA
- 3.2 to ≤ 5.1 Moderate activity
- > 5.1 High activity
| Subgroup of subjects receiving active stimulation for 1 min once per day, whose study therapy has not been augmented, who completed assessment. | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL), Non-augmented | A subgroup of subjects from the TOL population who did not have study therapy augmented during the outcome measure timeframe. Augmentation of study therapy means the addition of treatment for RA therapy to active stimulation applied after completion of Week 12 assessments, during open-label, long-term follow-up. Augmented therapy may be applied at any time during long-term follow-up. The decision about the need, type and timing of treatment is left to the discretion of the Co-PI Rheumatologist and the subject. Subjects combining active stimulation with the following additions to RA therapy fall into the augmented therapy subgroup for analysis of response rates for key efficacy endpoints at specific timepoints:
- Prednisone equivalent >10 mg/day. If average daily corticosteroid use exceeds 10 mg/day prednisone after a period (time from previous visit up to the day before the current visit), the subject is assigned to the augmented therapy subgroup for that visit.
- Corticosteroid injection. If subject received a corticosteroid injection within 30 days prior to a study visit, the subject is assigned to the augmented therapy subgroup for that visit.
- b/ts/csDMARD. Subjects who receive treatment with biologic, targeted synthetic, or additional conventional synthetic DMARD, or increased dose of background conventional synthetic DMARD will be assigned to the augmented therapy subgroup for all subsequent visits.
|
|
| Other Pre-specified | Health Assessment Questionnaire Disability Index (HAQ-DI) MCID Response, All Completers | HAQ-DI response based on the MCID of -0.22 from baseline. The HAQ-DI is a questionnaire validated for RA self-assessment by subjects that contains 20 questions in the following 8 functional areas:
- Dressing and grooming
- Arising
- Eating
- Walking
- Hygiene
- Reach
- Grip
- Common daily activities
Scoring within each functional area is from 0 (without any difficulty) to 3 (unable to do). The total score is obtained by summing 8 area scores and dividing by 8. The total HAQ-DI score ranges from 0 to 3 and corresponds to the current degree of disability:
- 0 to < 1 Mild difficulties to moderate disability
- 1 to < 2 Moderate disability
- 2 to 3 Severe to very severe disability
| | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL) | Treatment subjects from ITT population who received active stimulation through Week 12, completed Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG001 | Control to Open Label (COL) | Control subjects from ITT population who received non-active (sham) stimulation through Week 12, switched to active stimulation after completing Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. |
|
| Other Pre-specified | Health Assessment Questionnaire Disability Index (HAQ-DI) Response (MCID -0.22), Non-augmented | HAQ-DI response based on the MCID of -0.22 from baseline. The HAQ-DI is a questionnaire validated for RA self-assessment by subjects that contains 20 questions in the following 8 functional areas:
- Dressing and grooming
- Arising
- Eating
- Walking
- Hygiene
- Reach
- Grip
- Common daily activities
Scoring within each functional area is from 0 (without any difficulty) to 3 (unable to do). The total score is obtained by summing 8 area scores and dividing by 8. The total HAQ-DI score ranges from 0 to 3 and corresponds to the current degree of disability:
- 0 to < 1 Mild difficulties to moderate disability
- 1 to < 2 Moderate disability
- 2 to 3 Severe to very severe disability
| Subgroup of subjects receiving active stimulation for 1 min once per day, whose study therapy has not been augmented, who completed assessment. | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL), Non-augmented | A subgroup of subjects from the TOL population who did not have study therapy augmented during the outcome measure timeframe. Augmentation of study therapy means the addition of treatment for RA therapy to active stimulation applied after completion of Week 12 assessments, during open-label, long-term follow-up. Augmented therapy may be applied at any time during long-term follow-up. The decision about the need, type and timing of treatment is left to the discretion of the Co-PI Rheumatologist and the subject. Subjects combining active stimulation with the following additions to RA therapy fall into the augmented therapy subgroup for analysis of response rates for key efficacy endpoints at specific timepoints:
- Prednisone equivalent >10 mg/day. If average daily corticosteroid use exceeds 10 mg/day prednisone after a period (time from previous visit up to the day before the current visit), the subject is assigned to the augmented therapy subgroup for that visit.
- Corticosteroid injection. If subject received a corticosteroid injection within 30 days prior to a study visit, the subject is assigned to the augmented therapy subgroup for that visit.
- b/ts/csDMARD. Subjects who receive treatment with biologic, targeted synthetic, or additional conventional synthetic DMARD, or increased dose of background conventional synthetic DMARD will be assigned to the augmented therapy subgroup for all subsequent visits.
|
|
| Other Pre-specified | Study Participants That Are Somewhat to Very Satisfied With the SetPoint System for Treatment of Rheumatoid Arthritis | Patient satisfaction was assessed at Week 24 using five-point Likert rating scale:
- I am very dissatisfied
- I am somewhat dissatisfied
- I am neither satisfied nor dissatisfied
- I am somewhat satisfied
- I am very satisfied
| | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL) | Treatment subjects from ITT population who received active stimulation through Week 12, completed Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG001 | Control to Open Label (COL) | Control subjects from ITT population who received non-active (sham) stimulation through Week 12, switched to active stimulation after completing Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG002 | All (TOL+COL) | Combination of TOL and COL populations |
| |
| Other Pre-specified | Study Participants That Are Neither Satisfied Nor Dissatisfied With the SetPoint System for Treatment of Rheumatoid Arthritis | Patient satisfaction was assessed at Week 24 using five-point Likert rating scale:
- I am very dissatisfied
- I am somewhat dissatisfied
- I am neither satisfied nor dissatisfied
- I am somewhat satisfied
- I am very satisfied
| | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL) | Treatment subjects from ITT population who received active stimulation through Week 12, completed Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG001 | Control to Open Label (COL) | Control subjects from ITT population who received non-active (sham) stimulation through Week 12, switched to active stimulation after completing Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG002 | All (TOL+COL) | Combination of TOL and COL populations |
| |
| Other Pre-specified | Study Participants That Are Somewhat to Very Dissatisfied With the SetPoint System for Treatment of Rheumatoid Arthritis | Patient satisfaction was assessed at Week 24 using five-point Likert rating scale:
- I am very dissatisfied
- I am somewhat dissatisfied
- I am neither satisfied nor dissatisfied
- I am somewhat satisfied
- I am very satisfied
| | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL) | Treatment subjects from ITT population who received active stimulation through Week 12, completed Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG001 | Control to Open Label (COL) | Control subjects from ITT population who received non-active (sham) stimulation through Week 12, switched to active stimulation after completing Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG002 | All (TOL+COL) | Combination of TOL and COL populations |
| |
| Other Pre-specified | Study Participants That Would Recommend the SetPoint System to a Family Member or Friend | Patients were asked a question about whether they would recommend the SetPoint System to family and friends | | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL) | Treatment subjects from ITT population who received active stimulation through Week 12, completed Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG001 | Control to Open Label (COL) | Control subjects from ITT population who received non-active (sham) stimulation through Week 12, switched to active stimulation after completing Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG002 | All (TOL+COL) | Combination of TOL and COL populations |
| |
| Other Pre-specified | the American College of Rheumatology (ACR) 20 Response, All Completers | Response is defined as achieving at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/L). | | Posted | | Count of Participants | | Participants | | Week 36 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL) | Treatment subjects from ITT population who received active stimulation through Week 12, completed Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG001 | Control to Open Label (COL) | Control subjects from ITT population who received non-active (sham) stimulation through Week 12, switched to active stimulation after completing Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG002 | All (TOL+COL) |
|
| Other Pre-specified | the American College of Rheumatology (ACR) 20 Response, Non-augmented | Response is defined as achieving at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/L). | Subgroup of subjects receiving active stimulation for 1 min once per day, whose study therapy has not been augmented, who completed assessment. | Posted | | Count of Participants | | Participants | | Week 36 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL), Non-augmented | A subgroup of subjects from the TOL population who did not have study therapy augmented during the outcome measure timeframe. Augmentation of study therapy means the addition of treatment for RA therapy to active stimulation applied after completion of Week 12 assessments, during open-label, long-term follow-up. Augmented therapy may be applied at any time during long-term follow-up. The decision about the need, type and timing of treatment is left to the discretion of the Co-PI Rheumatologist and the subject. Subjects combining active stimulation with the following additions to RA therapy fall into the augmented therapy subgroup for analysis of response rates for key efficacy endpoints at specific timepoints:
- Prednisone equivalent >10 mg/day. If average daily corticosteroid use exceeds 10 mg/day prednisone after a period (time from previous visit up to the day before the current visit), the subject is assigned to the augmented therapy subgroup for that visit.
- Corticosteroid injection. If subject received a corticosteroid injection within 30 days prior to a study visit, the subject is assigned to the augmented therapy subgroup for that visit.
- b/ts/csDMARD. Subjects who receive treatment with biologic, targeted synthetic, or additional conventional synthetic DMARD, or increased dose of background conventional synthetic DMARD will be assigned to the augmented therapy subgroup for all subsequent visits.
|
|
| Other Pre-specified | Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA) or Remission, All Completers | The CDAI score is based on 4 items:
- TJC28, tender joint count of 28 joints (scale 0=best to 28=worst)
- SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst)
- SGA, subject global assessment (0=best to 10=worst)
- EGA, evaluator's global assessment (0=best to 10=worst)
The CDAI score is calculated as follows and ranges from 0 to 76: • CDAI = TJC28 + SJC28 + SGA + EGA The CDAI score corresponds to the current RA activity:
- 0 to ≤ 2.8 Remission
- >2.8 to ≤ 10 Low disease activity (LDA)
- >10 to ≤ 22 Moderate disease activity
- > 22 High disease activity
| | Posted | | Count of Participants | | Participants | | Week 36 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL) | Treatment subjects from ITT population who received active stimulation through Week 12, completed Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG001 | Control to Open Label (COL) | Control subjects from ITT population who received non-active (sham) stimulation through Week 12, switched to active stimulation after completing Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | |
|
| Other Pre-specified | Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA) or Remission, Non-augmented | The CDAI score is based on 4 items:
- TJC28, tender joint count of 28 joints (scale 0=best to 28=worst)
- SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst)
- SGA, subject global assessment (0=best to 10=worst)
- EGA, evaluator's global assessment (0=best to 10=worst)
The CDAI score is calculated as follows and ranges from 0 to 76: • CDAI = TJC28 + SJC28 + SGA + EGA The CDAI score corresponds to the current RA activity:
- 0 to ≤ 2.8 Remission
- >2.8 to ≤ 10 Low disease activity (LDA)
- >10 to ≤ 22 Moderate disease activity
- > 22 High disease activity
| Subgroup of subjects receiving active stimulation for 1 min once per day, whose study therapy has not been augmented, who completed assessment. | Posted | | Count of Participants | | Participants | | Week 36 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL), Non-augmented | A subgroup of subjects from the TOL population who did not have study therapy augmented during the outcome measure timeframe. Augmentation of study therapy means the addition of treatment for RA therapy to active stimulation applied after completion of Week 12 assessments, during open-label, long-term follow-up. Augmented therapy may be applied at any time during long-term follow-up. The decision about the need, type and timing of treatment is left to the discretion of the Co-PI Rheumatologist and the subject. Subjects combining active stimulation with the following additions to RA therapy fall into the augmented therapy subgroup for analysis of response rates for key efficacy endpoints at specific timepoints:
- Prednisone equivalent >10 mg/day. If average daily corticosteroid use exceeds 10 mg/day prednisone after a period (time from previous visit up to the day before the current visit), the subject is assigned to the augmented therapy subgroup for that visit.
- Corticosteroid injection. If subject received a corticosteroid injection within 30 days prior to a study visit, the subject is assigned to the augmented therapy subgroup for that visit.
- b/ts/csDMARD. Subjects who receive treatment with biologic, targeted synthetic, or additional conventional synthetic DMARD, or increased dose of background conventional synthetic DMARD will be assigned to the augmented therapy subgroup for all subsequent visits.
|
|
| Post-Hoc | Persistence With SetPoint System as a Stand-alone Therapy | Therapy persistence means continuation of therapy after it is initiated. | | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL) | Treatment subjects from ITT population who received active stimulation through Week 12, completed Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG001 | Control to Open Label (COL) | Control subjects from ITT population who received non-active (sham) stimulation through Week 12, switched to active stimulation after completing Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG002 | All (TOL+COL) | Combination of TOL and COL populations |
| |
| Post-Hoc | Persistence With SetPoint System Therapy Augmented With a b/tsDMARD | Therapy persistence means the continuation of therapy after it is initiated. Augmentation of study therapy means the addition of treatment for RA therapy to active stimulation applied after completion of Week 12 assessments, during open-label, long-term follow-up. Augmented therapy may be applied at any time during long-term follow-up. The decision about the need, type and timing of treatment is left to the discretion of the Co-PI Rheumatologist and the subject. Subjects combining active stimulation with the following additions to RA therapy fall into the augmented therapy subgroup for analysis of response rates for key efficacy endpoints at specific timepoints:
- Prednisone equivalent >10 mg/day. If average daily corticosteroid use exceeds 10 mg/day prednisone after a period (time from previous visit up to the day before the current visit), the subject is assigned to the augmented therapy subgroup for that visit.
- Corticosteroid injection. If subject received a corti
| | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL) | Treatment subjects from ITT population who received active stimulation through Week 12, completed Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG001 | Control to Open Label (COL) | Control subjects from ITT population who received non-active (sham) stimulation through Week 12, switched to active stimulation after completing Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. |
|
| Post-Hoc | Persistence With SetPoint System Therapy Augmented With a csDMARD and/or Steroid | Therapy persistence means continuation of therapy after it is initiated. Augmentation of study therapy means the addition of treatment for RA therapy to active stimulation applied after completion of Week 12 assessments, during open-label, long-term follow-up. Augmented therapy may be applied at any time during long-term follow-up. The decision about the need, type and timing of treatment is left to the discretion of the Co-PI Rheumatologist and the subject. Subjects combining active stimulation with the following additions to RA therapy fall into the augmented therapy subgroup for analysis of response rates for key efficacy endpoints at specific timepoints:
- Prednisone equivalent >10 mg/day. If average daily corticosteroid use exceeds 10 mg/day prednisone after a period (time from previous visit up to the day before the current visit), the subject is assigned to the augmented therapy subgroup for that visit.
- Corticosteroid injection. If subject received a corticosteroi
| | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL) | Treatment subjects from ITT population who received active stimulation through Week 12, completed Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG001 | Control to Open Label (COL) | |
|
| Post-Hoc | Persistence With SetPoint System Therapy as a Stand-alone or Augmented Thereapy | Therapy persistence is defined as the continuation of therapy after it is initiated. | | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL) | Treatment subjects from ITT population who received active stimulation through Week 12, completed Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG001 | Control to Open Label (COL) | Control subjects from ITT population who received non-active (sham) stimulation through Week 12, switched to active stimulation after completing Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG002 | All (TOL+COL) | Combination of TOL and COL populations |
| |
| Post-Hoc | Discontinuation of SetPoint System Therapy | Discontinuation means active stimulation was suspended or the SetPoint System Implant was removed | | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL) | Treatment subjects from ITT population who received active stimulation through Week 12, completed Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG001 | Control to Open Label (COL) | Control subjects from ITT population who received non-active (sham) stimulation through Week 12, switched to active stimulation after completing Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG002 | All (TOL+COL) | Combination of TOL and COL populations |
| |
| Other Pre-specified | DAS28-CRP Low Disease Activity (LDA) or Remission, All Completers | The Disease Activity Score in 28 joints calculated with C-reactive protein (DAS28-CRP) score is a composite index providing a measure of disease activity, comprising:
- TJC28, tender joint count of 28 joints (scale 0=best to 28=worst)
- SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst)
- SGA, subject global assessment (0=best to 10=worst)
- hsCRP (mg/L), high sensitivity C-reactive protein concentration (mg/L)
A total score ranges from 0 to 10 and is computed as follows: DAS28-CRP = 0.56 * sqrt(TJC28) + 0.28 * sqrt(SJC28) + 0.36 * ln(CRP+1) + 0.014 * SGA + 0.96 The DAS28-CRP score corresponds to the current RA activity:
- 0 to < 2.6 Remission
- 2.6 to < 3.2 LDA
- 3.2 to ≤ 5.1 Moderate activity
- > 5.1 High activity
| | Posted | | Count of Participants | | Participants | | Week 36 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL) | Treatment subjects from ITT population who received active stimulation through Week 12, completed Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG001 | Control to Open Label (COL) | Control subjects from ITT population who received non-active (sham) stimulation through Week 12, switched to active stimulation after completing Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. |
|
| Other Pre-specified | DAS28-CRP Low Disease Activity (LDA) or Remission, Non-augmented | The Disease Activity Score in 28 joints calculated with C-reactive protein (DAS28-CRP) score is a composite index providing a measure of disease activity, comprising:
- TJC28, tender joint count of 28 joints (scale 0=best to 28=worst)
- SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst)
- SGA, subject global assessment (0=best to 10=worst)
- hsCRP (mg/L), high sensitivity C-reactive protein concentration (mg/L)
A total score ranges from 0 to 10 and is computed as follows: DAS28-CRP = 0.56 * sqrt(TJC28) + 0.28 * sqrt(SJC28) + 0.36 * ln(CRP+1) + 0.014 * SGA + 0.96 The DAS28-CRP score corresponds to the current RA activity:
- 0 to < 2.6 Remission
- 2.6 to < 3.2 LDA
- 3.2 to ≤ 5.1 Moderate activity
- > 5.1 High activity
| Subgroup of subjects receiving active stimulation for 1 min once per day, whose study therapy has not been augmented, who completed assessment. | Posted | | Count of Participants | | Participants | | Week 36 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL), Non-augmented | A subgroup of subjects from the TOL population who did not have study therapy augmented during the outcome measure timeframe. Augmentation of study therapy means the addition of treatment for RA therapy to active stimulation applied after completion of Week 12 assessments, during open-label, long-term follow-up. Augmented therapy may be applied at any time during long-term follow-up. The decision about the need, type and timing of treatment is left to the discretion of the Co-PI Rheumatologist and the subject. Subjects combining active stimulation with the following additions to RA therapy fall into the augmented therapy subgroup for analysis of response rates for key efficacy endpoints at specific timepoints:
- Prednisone equivalent >10 mg/day. If average daily corticosteroid use exceeds 10 mg/day prednisone after a period (time from previous visit up to the day before the current visit), the subject is assigned to the augmented therapy subgroup for that visit.
- Corticosteroid injection. If subject received a corticosteroid injection within 30 days prior to a study visit, the subject is assigned to the augmented therapy subgroup for that visit.
- b/ts/csDMARD. Subjects who receive treatment with biologic, targeted synthetic, or additional conventional synthetic DMARD, or increased dose of background conventional synthetic DMARD will be assigned to the augmented therapy subgroup for all subsequent visits.
|
|
| Other Pre-specified | Health Assessment Questionnaire Disability Index (HAQ-DI) MCID Response, All Completers | HAQ-DI response based on the MCID of -0.22 from baseline. The HAQ-DI is a questionnaire validated for RA self-assessment by subjects that contains 20 questions in the following 8 functional areas:
- Dressing and grooming
- Arising
- Eating
- Walking
- Hygiene
- Reach
- Grip
- Common daily activities
Scoring within each functional area is from 0 (without any difficulty) to 3 (unable to do). The total score is obtained by summing 8 area scores and dividing by 8. The total HAQ-DI score ranges from 0 to 3 and corresponds to the current degree of disability:
- 0 to < 1 Mild difficulties to moderate disability
- 1 to < 2 Moderate disability
- 2 to 3 Severe to very severe disability
| | Posted | | Count of Participants | | Participants | | Week 36 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL) | Treatment subjects from ITT population who received active stimulation through Week 12, completed Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG001 | Control to Open Label (COL) | Control subjects from ITT population who received non-active (sham) stimulation through Week 12, switched to active stimulation after completing Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. |
|
| Other Pre-specified | Health Assessment Questionnaire Disability Index (HAQ-DI) Response (MCID -0.22), Non-augmented | HAQ-DI response based on the MCID of -0.22 from baseline. The HAQ-DI is a questionnaire validated for RA self-assessment by subjects that contains 20 questions in the following 8 functional areas:
- Dressing and grooming
- Arising
- Eating
- Walking
- Hygiene
- Reach
- Grip
- Common daily activities
Scoring within each functional area is from 0 (without any difficulty) to 3 (unable to do). The total score is obtained by summing 8 area scores and dividing by 8. The total HAQ-DI score ranges from 0 to 3 and corresponds to the current degree of disability:
- 0 to < 1 Mild difficulties to moderate disability
- 1 to < 2 Moderate disability
- 2 to 3 Severe to very severe disability
| Subgroup of subjects receiving active stimulation for 1 min once per day, whose study therapy has not been augmented, who completed assessment. | Posted | | Count of Participants | | Participants | | Week 36 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL), Non-augmented | A subgroup of subjects from the TOL population who did not have study therapy augmented during the outcome measure timeframe. Augmentation of study therapy means the addition of treatment for RA therapy to active stimulation applied after completion of Week 12 assessments, during open-label, long-term follow-up. Augmented therapy may be applied at any time during long-term follow-up. The decision about the need, type and timing of treatment is left to the discretion of the Co-PI Rheumatologist and the subject. Subjects combining active stimulation with the following additions to RA therapy fall into the augmented therapy subgroup for analysis of response rates for key efficacy endpoints at specific timepoints:
- Prednisone equivalent >10 mg/day. If average daily corticosteroid use exceeds 10 mg/day prednisone after a period (time from previous visit up to the day before the current visit), the subject is assigned to the augmented therapy subgroup for that visit.
- Corticosteroid injection. If subject received a corticosteroid injection within 30 days prior to a study visit, the subject is assigned to the augmented therapy subgroup for that visit.
- b/ts/csDMARD. Subjects who receive treatment with biologic, targeted synthetic, or additional conventional synthetic DMARD, or increased dose of background conventional synthetic DMARD will be assigned to the augmented therapy subgroup for all subsequent visits.
|
|
| Post-Hoc | Persistence With SetPoint System as a Stand-alone Therapy | Therapy persistence means continuation of therapy after it is initiated. | | Posted | | Count of Participants | | Participants | | Week 36 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL) | Treatment subjects from ITT population who received active stimulation through Week 12, completed Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG001 | Control to Open Label (COL) | Control subjects from ITT population who received non-active (sham) stimulation through Week 12, switched to active stimulation after completing Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG002 | All (TOL+COL) | Combination of TOL and COL populations |
| |
| Post-Hoc | Persistence With SetPoint System Therapy Augmented With a b/tsDMARD | Therapy persistence means the continuation of therapy after it is initiated. Augmentation of study therapy means the addition of treatment for RA therapy to active stimulation applied after completion of Week 12 assessments, during open-label, long-term follow-up. Augmented therapy may be applied at any time during long-term follow-up. The decision about the need, type and timing of treatment is left to the discretion of the Co-PI Rheumatologist and the subject. Subjects combining active stimulation with the following additions to RA therapy fall into the augmented therapy subgroup for analysis of response rates for key efficacy endpoints at specific timepoints:
- Prednisone equivalent >10 mg/day. If average daily corticosteroid use exceeds 10 mg/day prednisone after a period (time from previous visit up to the day before the current visit), the subject is assigned to the augmented therapy subgroup for that visit.
- Corticosteroid injection. If subject received a corti
| | Posted | | Count of Participants | | Participants | | Week 36 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL) | Treatment subjects from ITT population who received active stimulation through Week 12, completed Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG001 | Control to Open Label (COL) | Control subjects from ITT population who received non-active (sham) stimulation through Week 12, switched to active stimulation after completing Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. |
|
| Post-Hoc | Persistence With SetPoint System Therapy Augmented With a csDMARD and/or Steroid | Therapy persistence means continuation of therapy after it is initiated. Augmentation of study therapy means the addition of treatment for RA therapy to active stimulation applied after completion of Week 12 assessments, during open-label, long-term follow-up. Augmented therapy may be applied at any time during long-term follow-up. The decision about the need, type and timing of treatment is left to the discretion of the Co-PI Rheumatologist and the subject. Subjects combining active stimulation with the following additions to RA therapy fall into the augmented therapy subgroup for analysis of response rates for key efficacy endpoints at specific timepoints:
- Prednisone equivalent >10 mg/day. If average daily corticosteroid use exceeds 10 mg/day prednisone after a period (time from previous visit up to the day before the current visit), the subject is assigned to the augmented therapy subgroup for that visit.
- Corticosteroid injection. If subject received a corticosteroi
| | Posted | | Count of Participants | | Participants | | Week 36 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL) | Treatment subjects from ITT population who received active stimulation through Week 12, completed Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG001 | Control to Open Label (COL) | |
|
| Post-Hoc | Persistence With SetPoint System Therapy as a Stand-alone or Augmented Thereapy | Therapy persistence is defined as the continuation of therapy after it is initiated. | | Posted | | Count of Participants | | Participants | | Week 36 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL) | Treatment subjects from ITT population who received active stimulation through Week 12, completed Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG001 | Control to Open Label (COL) | Control subjects from ITT population who received non-active (sham) stimulation through Week 12, switched to active stimulation after completing Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG002 | All (TOL+COL) | Combination of TOL and COL populations |
| |
| Post-Hoc | Discontinuation of SetPoint System Therapy | Discontinuation means active stimulation was suspended or the SetPoint System Implant was removed | | Posted | | Count of Participants | | Participants | | Week 36 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL) | Treatment subjects from ITT population who received active stimulation through Week 12, completed Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG001 | Control to Open Label (COL) | Control subjects from ITT population who received non-active (sham) stimulation through Week 12, switched to active stimulation after completing Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG002 | All (TOL+COL) | Combination of TOL and COL populations |
| |
| Other Pre-specified | the American College of Rheumatology (ACR) 20 Response, All Completers | Response is defined as achieving at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/L). | | Posted | | Count of Participants | | Participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL) | Treatment subjects from ITT population who received active stimulation through Week 12, completed Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG001 | Control to Open Label (COL) | Control subjects from ITT population who received non-active (sham) stimulation through Week 12, switched to active stimulation after completing Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG002 | All (TOL+COL) |
|
| Other Pre-specified | the American College of Rheumatology (ACR) 20 Response, Non-augmented | Response is defined as achieving at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/L). | Subgroup of subjects receiving active stimulation for 1 min once per day, whose study therapy has not been augmented, who completed assessment. | Posted | | Count of Participants | | Participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL), Non-augmented | A subgroup of subjects from the TOL population who did not have study therapy augmented during the outcome measure timeframe. Augmentation of study therapy means the addition of treatment for RA therapy to active stimulation applied after completion of Week 12 assessments, during open-label, long-term follow-up. Augmented therapy may be applied at any time during long-term follow-up. The decision about the need, type and timing of treatment is left to the discretion of the Co-PI Rheumatologist and the subject. Subjects combining active stimulation with the following additions to RA therapy fall into the augmented therapy subgroup for analysis of response rates for key efficacy endpoints at specific timepoints:
- Prednisone equivalent >10 mg/day. If average daily corticosteroid use exceeds 10 mg/day prednisone after a period (time from previous visit up to the day before the current visit), the subject is assigned to the augmented therapy subgroup for that visit.
- Corticosteroid injection. If subject received a corticosteroid injection within 30 days prior to a study visit, the subject is assigned to the augmented therapy subgroup for that visit.
- b/ts/csDMARD. Subjects who receive treatment with biologic, targeted synthetic, or additional conventional synthetic DMARD, or increased dose of background conventional synthetic DMARD will be assigned to the augmented therapy subgroup for all subsequent visits.
|
|
| Other Pre-specified | Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA) or Remission, All Completers | The CDAI score is based on 4 items:
- TJC28, tender joint count of 28 joints (scale 0=best to 28=worst)
- SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst)
- SGA, subject global assessment (0=best to 10=worst)
- EGA, evaluator's global assessment (0=best to 10=worst)
The CDAI score is calculated as follows and ranges from 0 to 76: • CDAI = TJC28 + SJC28 + SGA + EGA The CDAI score corresponds to the current RA activity:
- 0 to ≤ 2.8 Remission
- >2.8 to ≤ 10 Low disease activity (LDA)
- >10 to ≤ 22 Moderate disease activity
- > 22 High disease activity
| | Posted | | Count of Participants | | Participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL) | Treatment subjects from ITT population who received active stimulation through Week 12, completed Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG001 | Control to Open Label (COL) | Control subjects from ITT population who received non-active (sham) stimulation through Week 12, switched to active stimulation after completing Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | |
|
| Other Pre-specified | Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA) or Remission, Non-augmented | The CDAI score is based on 4 items:
- TJC28, tender joint count of 28 joints (scale 0=best to 28=worst)
- SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst)
- SGA, subject global assessment (0=best to 10=worst)
- EGA, evaluator's global assessment (0=best to 10=worst)
The CDAI score is calculated as follows and ranges from 0 to 76: • CDAI = TJC28 + SJC28 + SGA + EGA The CDAI score corresponds to the current RA activity:
- 0 to ≤ 2.8 Remission
- >2.8 to ≤ 10 Low disease activity (LDA)
- >10 to ≤ 22 Moderate disease activity
- > 22 High disease activity
| Subgroup of subjects receiving active stimulation for 1 min once per day, whose study therapy has not been augmented, who completed assessment. | Posted | | Count of Participants | | Participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL), Non-augmented | A subgroup of subjects from the TOL population who did not have study therapy augmented during the outcome measure timeframe. Augmentation of study therapy means the addition of treatment for RA therapy to active stimulation applied after completion of Week 12 assessments, during open-label, long-term follow-up. Augmented therapy may be applied at any time during long-term follow-up. The decision about the need, type and timing of treatment is left to the discretion of the Co-PI Rheumatologist and the subject. Subjects combining active stimulation with the following additions to RA therapy fall into the augmented therapy subgroup for analysis of response rates for key efficacy endpoints at specific timepoints:
- Prednisone equivalent >10 mg/day. If average daily corticosteroid use exceeds 10 mg/day prednisone after a period (time from previous visit up to the day before the current visit), the subject is assigned to the augmented therapy subgroup for that visit.
- Corticosteroid injection. If subject received a corticosteroid injection within 30 days prior to a study visit, the subject is assigned to the augmented therapy subgroup for that visit.
- b/ts/csDMARD. Subjects who receive treatment with biologic, targeted synthetic, or additional conventional synthetic DMARD, or increased dose of background conventional synthetic DMARD will be assigned to the augmented therapy subgroup for all subsequent visits.
|
|
| Other Pre-specified | DAS28-CRP Low Disease Activity (LDA) or Remission, All Completers | The Disease Activity Score in 28 joints calculated with C-reactive protein (DAS28-CRP) score is a composite index providing a measure of disease activity, comprising:
- TJC28, tender joint count of 28 joints (scale 0=best to 28=worst)
- SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst)
- SGA, subject global assessment (0=best to 10=worst)
- hsCRP (mg/L), high sensitivity C-reactive protein concentration (mg/L)
A total score ranges from 0 to 10 and is computed as follows: DAS28-CRP = 0.56 * sqrt(TJC28) + 0.28 * sqrt(SJC28) + 0.36 * ln(CRP+1) + 0.014 * SGA + 0.96 The DAS28-CRP score corresponds to the current RA activity:
- 0 to < 2.6 Remission
- 2.6 to < 3.2 LDA
- 3.2 to ≤ 5.1 Moderate activity
- > 5.1 High activity
| | Posted | | Count of Participants | | Participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL) | Treatment subjects from ITT population who received active stimulation through Week 12, completed Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG001 | Control to Open Label (COL) | Control subjects from ITT population who received non-active (sham) stimulation through Week 12, switched to active stimulation after completing Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. |
|
| Other Pre-specified | DAS28-CRP Low Disease Activity (LDA) or Remission, Non-augmented | The Disease Activity Score in 28 joints calculated with C-reactive protein (DAS28-CRP) score is a composite index providing a measure of disease activity, comprising:
- TJC28, tender joint count of 28 joints (scale 0=best to 28=worst)
- SJC28, swollen joint count of 28 joints (scale 0=best to 28=worst)
- SGA, subject global assessment (0=best to 10=worst)
- hsCRP (mg/L), high sensitivity C-reactive protein concentration (mg/L)
A total score ranges from 0 to 10 and is computed as follows: DAS28-CRP = 0.56 * sqrt(TJC28) + 0.28 * sqrt(SJC28) + 0.36 * ln(CRP+1) + 0.014 * SGA + 0.96 The DAS28-CRP score corresponds to the current RA activity:
- 0 to < 2.6 Remission
- 2.6 to < 3.2 LDA
- 3.2 to ≤ 5.1 Moderate activity
- > 5.1 High activity
| Subgroup of subjects receiving active stimulation for 1 min once per day, whose study therapy has not been augmented, who completed assessment. | Posted | | Count of Participants | | Participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL), Non-augmented | A subgroup of subjects from the TOL population who did not have study therapy augmented during the outcome measure timeframe. Augmentation of study therapy means the addition of treatment for RA therapy to active stimulation applied after completion of Week 12 assessments, during open-label, long-term follow-up. Augmented therapy may be applied at any time during long-term follow-up. The decision about the need, type and timing of treatment is left to the discretion of the Co-PI Rheumatologist and the subject. Subjects combining active stimulation with the following additions to RA therapy fall into the augmented therapy subgroup for analysis of response rates for key efficacy endpoints at specific timepoints:
- Prednisone equivalent >10 mg/day. If average daily corticosteroid use exceeds 10 mg/day prednisone after a period (time from previous visit up to the day before the current visit), the subject is assigned to the augmented therapy subgroup for that visit.
- Corticosteroid injection. If subject received a corticosteroid injection within 30 days prior to a study visit, the subject is assigned to the augmented therapy subgroup for that visit.
- b/ts/csDMARD. Subjects who receive treatment with biologic, targeted synthetic, or additional conventional synthetic DMARD, or increased dose of background conventional synthetic DMARD will be assigned to the augmented therapy subgroup for all subsequent visits.
|
|
| Other Pre-specified | Health Assessment Questionnaire Disability Index (HAQ-DI) MCID Response, All Completers | HAQ-DI response based on the MCID of -0.22 from baseline. The HAQ-DI is a questionnaire validated for RA self-assessment by subjects that contains 20 questions in the following 8 functional areas:
- Dressing and grooming
- Arising
- Eating
- Walking
- Hygiene
- Reach
- Grip
- Common daily activities
Scoring within each functional area is from 0 (without any difficulty) to 3 (unable to do). The total score is obtained by summing 8 area scores and dividing by 8. The total HAQ-DI score ranges from 0 to 3 and corresponds to the current degree of disability:
- 0 to < 1 Mild difficulties to moderate disability
- 1 to < 2 Moderate disability
- 2 to 3 Severe to very severe disability
| | Posted | | Count of Participants | | Participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL) | Treatment subjects from ITT population who received active stimulation through Week 12, completed Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG001 | Control to Open Label (COL) | Control subjects from ITT population who received non-active (sham) stimulation through Week 12, switched to active stimulation after completing Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. |
|
| Other Pre-specified | Health Assessment Questionnaire Disability Index (HAQ-DI) Response (MCID -0.22), Non-augmented | HAQ-DI response based on the MCID of -0.22 from baseline. The HAQ-DI is a questionnaire validated for RA self-assessment by subjects that contains 20 questions in the following 8 functional areas:
- Dressing and grooming
- Arising
- Eating
- Walking
- Hygiene
- Reach
- Grip
- Common daily activities
Scoring within each functional area is from 0 (without any difficulty) to 3 (unable to do). The total score is obtained by summing 8 area scores and dividing by 8. The total HAQ-DI score ranges from 0 to 3 and corresponds to the current degree of disability:
- 0 to < 1 Mild difficulties to moderate disability
- 1 to < 2 Moderate disability
- 2 to 3 Severe to very severe disability
| Subgroup of subjects receiving active stimulation for 1 min once per day, whose study therapy has not been augmented, who completed assessment. | Posted | | Count of Participants | | Participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL), Non-augmented | A subgroup of subjects from the TOL population who did not have study therapy augmented during the outcome measure timeframe. Augmentation of study therapy means the addition of treatment for RA therapy to active stimulation applied after completion of Week 12 assessments, during open-label, long-term follow-up. Augmented therapy may be applied at any time during long-term follow-up. The decision about the need, type and timing of treatment is left to the discretion of the Co-PI Rheumatologist and the subject. Subjects combining active stimulation with the following additions to RA therapy fall into the augmented therapy subgroup for analysis of response rates for key efficacy endpoints at specific timepoints:
- Prednisone equivalent >10 mg/day. If average daily corticosteroid use exceeds 10 mg/day prednisone after a period (time from previous visit up to the day before the current visit), the subject is assigned to the augmented therapy subgroup for that visit.
- Corticosteroid injection. If subject received a corticosteroid injection within 30 days prior to a study visit, the subject is assigned to the augmented therapy subgroup for that visit.
- b/ts/csDMARD. Subjects who receive treatment with biologic, targeted synthetic, or additional conventional synthetic DMARD, or increased dose of background conventional synthetic DMARD will be assigned to the augmented therapy subgroup for all subsequent visits.
|
|
| Post-Hoc | Persistence With SetPoint System as a Stand-alone Therapy | Therapy persistence means continuation of therapy after it is initiated. | | Posted | | Count of Participants | | Participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL) | Treatment subjects from ITT population who received active stimulation through Week 12, completed Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG001 | Control to Open Label (COL) | Control subjects from ITT population who received non-active (sham) stimulation through Week 12, switched to active stimulation after completing Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG002 | All (TOL+COL) | Combination of TOL and COL populations |
| |
| Post-Hoc | Persistence With SetPoint System Therapy Augmented With a b/tsDMARD | Therapy persistence means the continuation of therapy after it is initiated. Augmentation of study therapy means the addition of treatment for RA therapy to active stimulation applied after completion of Week 12 assessments, during open-label, long-term follow-up. Augmented therapy may be applied at any time during long-term follow-up. The decision about the need, type and timing of treatment is left to the discretion of the Co-PI Rheumatologist and the subject. Subjects combining active stimulation with the following additions to RA therapy fall into the augmented therapy subgroup for analysis of response rates for key efficacy endpoints at specific timepoints:
- Prednisone equivalent >10 mg/day. If average daily corticosteroid use exceeds 10 mg/day prednisone after a period (time from previous visit up to the day before the current visit), the subject is assigned to the augmented therapy subgroup for that visit.
- Corticosteroid injection. If subject received a corti
| | Posted | | Count of Participants | | Participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL) | Treatment subjects from ITT population who received active stimulation through Week 12, completed Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG001 | Control to Open Label (COL) | Control subjects from ITT population who received non-active (sham) stimulation through Week 12, switched to active stimulation after completing Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. |
|
| Post-Hoc | Persistence With SetPoint System Therapy Augmented With a csDMARD and/or Steroid | Therapy persistence means continuation of therapy after it is initiated. Augmentation of study therapy means the addition of treatment for RA therapy to active stimulation applied after completion of Week 12 assessments, during open-label, long-term follow-up. Augmented therapy may be applied at any time during long-term follow-up. The decision about the need, type and timing of treatment is left to the discretion of the Co-PI Rheumatologist and the subject. Subjects combining active stimulation with the following additions to RA therapy fall into the augmented therapy subgroup for analysis of response rates for key efficacy endpoints at specific timepoints:
- Prednisone equivalent >10 mg/day. If average daily corticosteroid use exceeds 10 mg/day prednisone after a period (time from previous visit up to the day before the current visit), the subject is assigned to the augmented therapy subgroup for that visit.
- Corticosteroid injection. If subject received a corticosteroi
| | Posted | | Count of Participants | | Participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL) | Treatment subjects from ITT population who received active stimulation through Week 12, completed Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG001 | Control to Open Label (COL) | |
|
| Post-Hoc | Persistence With SetPoint System Therapy as a Stand-alone or Augmented Thereapy | Therapy persistence is defined as the continuation of therapy after it is initiated. | | Posted | | Count of Participants | | Participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL) | Treatment subjects from ITT population who received active stimulation through Week 12, completed Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG001 | Control to Open Label (COL) | Control subjects from ITT population who received non-active (sham) stimulation through Week 12, switched to active stimulation after completing Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG002 | All (TOL+COL) | Combination of TOL and COL populations |
| |
| Post-Hoc | Discontinuation of SetPoint System Therapy | Discontinuation means active stimulation was suspended or the SetPoint System Implant was removed | | Posted | | Count of Participants | | Participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Treatment to Open Label (TOL) | Treatment subjects from ITT population who received active stimulation through Week 12, completed Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG001 | Control to Open Label (COL) | Control subjects from ITT population who received non-active (sham) stimulation through Week 12, switched to active stimulation after completing Week 12 assessments, continued to receive active stimulation during open-label follow-up, and for whom follow-up data are available. | | OG002 | All (TOL+COL) | Combination of TOL and COL populations |
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| Other Pre-specified | the American College of Rheumatology (ACR) 20 Response, Subjects With 1 Prior b/tsDMARD | Response is defined as achieving at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/L). | ITT, subgroup of subjects that previously failed 1 b/tsDMARD | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | Treatment | Active stimulation for 1 min once per day Implant Procedure: The SetPoint System (study device) contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). All eligible subjects will undergo the surgery under general anesthesia in outpatient settings. Conventional Synthetic DMARD: All subjects will continue to take at least one type of conventional synthetic DMARD at the same stable dose as for 4 weeks prior to consent Active stimulation: Active stimulation for 1 min once per day | | OG001 | Control | Non-active stimulation for 1 min once per day Implant Procedure: The SetPoint System (study device) contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). All eligible subjects will undergo the surgery under general anesthesia in outpatient settings. Conventional Synthetic DMARD: All subjects will continue to take at least one type of conventional synthetic DMARD at the same stable dose as for 4 weeks prior to consent Non-active stimulation: Non-active stimulation for 1 min once per day |
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| Other Pre-specified | the American College of Rheumatology (ACR) 20 Response, Subjects With 2 Prior b/tsDMARD | Response is defined as achieving at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/L). | ITT, subgroup of subjects that previously failed 2 b/tsDMARD | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | Treatment | Active stimulation for 1 min once per day Implant Procedure: The SetPoint System (study device) contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). All eligible subjects will undergo the surgery under general anesthesia in outpatient settings. Conventional Synthetic DMARD: All subjects will continue to take at least one type of conventional synthetic DMARD at the same stable dose as for 4 weeks prior to consent Active stimulation: Active stimulation for 1 min once per day | | OG001 | Control | Non-active stimulation for 1 min once per day Implant Procedure: The SetPoint System (study device) contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). All eligible subjects will undergo the surgery under general anesthesia in outpatient settings. Conventional Synthetic DMARD: All subjects will continue to take at least one type of conventional synthetic DMARD at the same stable dose as for 4 weeks prior to consent Non-active stimulation: Non-active stimulation for 1 min once per day |
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| Other Pre-specified | the American College of Rheumatology (ACR) 20 Response, Subjects With 3 Prior b/tsDMARD | Response is defined as achieving at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/L). | ITT, subgroup of subjects that previously failed 3 b/tsDMARD | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | Treatment | Active stimulation for 1 min once per day Implant Procedure: The SetPoint System (study device) contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). All eligible subjects will undergo the surgery under general anesthesia in outpatient settings. Conventional Synthetic DMARD: All subjects will continue to take at least one type of conventional synthetic DMARD at the same stable dose as for 4 weeks prior to consent Active stimulation: Active stimulation for 1 min once per day | | OG001 | Control | Non-active stimulation for 1 min once per day Implant Procedure: The SetPoint System (study device) contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). All eligible subjects will undergo the surgery under general anesthesia in outpatient settings. Conventional Synthetic DMARD: All subjects will continue to take at least one type of conventional synthetic DMARD at the same stable dose as for 4 weeks prior to consent Non-active stimulation: Non-active stimulation for 1 min once per day |
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| Other Pre-specified | the American College of Rheumatology (ACR) 20 Response, Subjects With >=4 Prior b/tsDMARD | Response is defined as achieving at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/L). | ITT, subgroup of subjects that previously failed >=4 b/tsDMARD | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | Treatment | Active stimulation for 1 min once per day Implant Procedure: The SetPoint System (study device) contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). All eligible subjects will undergo the surgery under general anesthesia in outpatient settings. Conventional Synthetic DMARD: All subjects will continue to take at least one type of conventional synthetic DMARD at the same stable dose as for 4 weeks prior to consent Active stimulation: Active stimulation for 1 min once per day | | OG001 | Control | Non-active stimulation for 1 min once per day Implant Procedure: The SetPoint System (study device) contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). All eligible subjects will undergo the surgery under general anesthesia in outpatient settings. Conventional Synthetic DMARD: All subjects will continue to take at least one type of conventional synthetic DMARD at the same stable dose as for 4 weeks prior to consent Non-active stimulation: Non-active stimulation for 1 min once per day |
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