Using the Cholinergic Anti-Inflammatory Pathway to Treat Systemic Lupus Musculoskeletal Pain

Inclusion Criteria:

1. Age ≥18 years,

2. SLE (defined by the ACR or SLICC criteria),

3. Musculoskeletal pain ≥ 4 on a non-anchored VAS 10 cm scale

4. BILAG C on Musculoskeletal Domain of the BILAG 2004

5. If on corticosteroids, the dose must be stable and ≤ 10mg/day (prednisone or
equivalent) for at least 28 days before baseline,

6. If on background immunosuppressive treatment the dose must be stable for at least 28
days before baseline

7. Able and willing to give written informed consent and comply with the requirements of
the study protocol.

Exclusion Criteria:

1. Treatment with rituximab within one year of baseline (subjects with previous treatment
with rituximab can enter study only with documentation of B cell repletion),

2. Treatment with cyclophosphamide within 2 months of baseline,

3. Expectation to increase steroids and/or immunosuppressive treatment,

4. Anti-phospholipid syndrome,

5. Fibromyalgia (fibromyalgia will be defined as a score > 13 on the Fibromyalgia Symptom
Scale (FSS).

6. Treatment with an anti-cholinergic medication, including over the counter medications,

7. Implantable electronic devices such as pacemakers, defibrillators, hearing aids,
cochlear implants or deep brain stimulators.

8. Current tobacco or nicotine user,

9. Joint replacement within 60 days prior to study enrollment or planned within the
course of the study,

10. Any planned surgical procedure requiring general anesthesia within the course of the
study,

11. Intra-articular cortisone injections within 28 days of the start of study,

12. Chronic inflammatory disorders apart from SLE affecting the joints,

13. Investigational drug and/or treatment during the 28 days or seven half-lives of the
investigational drug prior to the start of study drug dosing (Day 0), whichever is the
greater length of time,

14. Active infection including hepatitis B or hepatitis C at baseline,

15. Any condition which, in the opinion of the investigator, would jeopardize the
subject's safety following exposure to a study intervention,

16. Pregnancy or lactation,

17. Comorbid disease that may require administration of corticosteroid use,

18. Inability to comply with study and follow-up procedures.