Long Term Observational Study Of The Safety And Efficacy Of An Active Implantable Vagal Nerve Stimulation Device In Patients With Rheumatoid Arthritis

Long Term Observational Study Of The Safety And Efficacy Of An Active Implantable Vagal Nerve Stimulation Device In Patients With Rheumatoid Arthritis - SPM-006

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43838

Enrollment

Registered

2012-02-16

Start date

2012-02-27

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

painful swollen joints

Interventions

The patients will continue to use their previously implanted Cyberonics device for this study.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients must have participated in study SPM-005, including patients who either completed that study or withdrew before completion of that study.

Exclusion criteria

Exclusion criteria: Inability to provide informed consent;Significant psychiatric illness or substance abuse

Design outcomes

Primary

Measure	Time frame
Primary Endpoint • Change in DAS 28 score from the baseline of the preceding study (SPM-005) to each follow-up visit	—

Secondary

Measure	Time frame
Secondary Endpoints • The ACR 20, ACR 50, and ACR 70 response rates calculated based on RA assessments at the baseline of the preceding study compared to those at each follow-up visit on the current study • The EULAR response rate calculated based on RA assessments at the baseline of the preceding study compared to those at each follow-up visit on the current study • Change in Euro-QoL score from the baseline of the preceding study to each follow-up visit Safety Endpoints The following Safety Endpoints will be assessed: • Adverse Events • Serious Adverse Events • Device Deficiencies	—

Measure

Time frame

Secondary Endpoints • The ACR 20, ACR 50, and ACR 70 response rates calculated based on RA assessments at the baseline of the preceding study compared to those at each follow-up visit on the current study • The EULAR response rate calculated based on RA assessments at the baseline of the preceding study compared to those at each follow-up visit on the current study • Change in Euro-QoL score from the baseline of the preceding study to each follow-up visit Safety Endpoints The following Safety Endpoints will be assessed: • Adverse Events • Serious Adverse Events • Device Deficiencies

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)