Delayed Release Prednisone in PMR

Inclusion Criteria:

1. Diagnosis of PMR:

1. All participants must meet the Bird criteria (7): 3 or more of the following
features are required to make the diagnosis.

- Bilateral shoulder pain/stiffness

- Onset of symptoms <2 weeks

- Initial Erythrocyte Sedimentation Rate (ESR) >40 mm/h

- Stiffness >1 h

- Age >65 years

- Depression and/or weight loss

- Bilateral upper arm tenderness

2. All participants must have PMR in the opinion of the PI

2. Are over 50 years old.

3. No or stable NSAID or analgesic therapy for at least 7 days.

4. Currently active disease defined by a C-reactive protein (CRP) at least 5mg/L, or ESR
at least 29mm in one hour measured at the screening visit or within the previous
week.

5. Respond to one week of 15 mg IR prednisone and one week washout (patient worsens).
Response will be measured as: >70% reduction in morning stiffness severity at the end
of the first week with a >80% return of morning stiffness severity in the second week
(screening procedure). This screening procedure can also be assessed in patients who
have taken up to one week of >15 mg IR prednisone prior to seeing the investigator
for the study, so long as informed consent is obtained before the wash-out period and
all other inclusion criteria are met.

Exclusion Criteria:

1. Oral glucocorticoid treatment for more than 1 week within the previous month

2. Parenteral glucocorticoid treatment within the last month

3. Pregnancy and/or lactation

4. Inflammatory diseases such as inflammatory bowel disease, colitis, asthma, rheumatoid
arthritis

5. Co-existent giant cell arteritis; patients with headache, visual symptoms or jaw
claudication suggestive of giant cell arteritis will not be included in the study

6. Other auto-immune diseases

7. Synovitis or polymyositis

8. Positive Cyclic Citrullinated Peptide Antibodies (CCP)

9. Muscle weak and elevated creatinine phosphokinase (CPK)

10. Cancer (patients with a history of basal cell carcinoma or cancer-free for > 5 years
are allowed)

11. Severe active infection including herpes or other viral or bacterial infection(s),
treatment with antibiotics within the past 6 weeks or have or had a history of
tuberculosis

12. Significant renal disease (creatinine greater than150 µmol/L)

13. Significant hepatic impairment (ALT/AST greater than twice upper limit of normal)

14. Immunization with live vaccines within 8 weeks before the first administration of the
study drug or plan to have an immunization with a live vaccine within 2 weeks after
the last administration of study drug.

15. Use of any other systemic glucocorticoids including inhalants during the screening
and treatment phase of the study; chronic intranasal or ophthalmic corticosteroids
are allowed.

16. Participation in a clinical trial of an investigational drug within the past 30 days

17. Working night-time shift employee

18. Jet lag (i.e. airplane travel)

19. Unable to provide informed consent