Delayed Release Prednisone in PMR
Polymyalgia Rheumatica
About this trial
This is an interventional treatment trial for Polymyalgia Rheumatica focused on measuring Polymyalgia Rheumatica (PMR)
Eligibility Criteria
Inclusion Criteria:
Diagnosis of PMR:
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
- All participants must have PMR in the opinion of the PI
- Are over 50 years old.
- No or stable NSAID or analgesic therapy for at least 7 days.
- 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.
- 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:
- Oral glucocorticoid treatment for more than 1 week within the previous month
- Parenteral glucocorticoid treatment within the last month
- Pregnancy and/or lactation
- Inflammatory diseases such as inflammatory bowel disease, colitis, asthma, rheumatoid arthritis
- 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
- Other auto-immune diseases
- Synovitis or polymyositis
- Positive Cyclic Citrullinated Peptide Antibodies (CCP)
- Muscle weak and elevated creatinine phosphokinase (CPK)
- Cancer (patients with a history of basal cell carcinoma or cancer-free for > 5 years are allowed)
- 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
- Significant renal disease (creatinine greater than150 µmol/L)
- Significant hepatic impairment (ALT/AST greater than twice upper limit of normal)
- 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.
- Use of any other systemic glucocorticoids including inhalants during the screening and treatment phase of the study; chronic intranasal or ophthalmic corticosteroids are allowed.
- Participation in a clinical trial of an investigational drug within the past 30 days
- Working night-time shift employee
- Jet lag (i.e. airplane travel)
- Unable to provide informed consent
Sites / Locations
- Clinical Research Site
- Clinical Research Site
- Clinical Research Site
- Clinical Research Site 2
- Clinical Research Site
- Clinical Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
4mg DR-Prednisone
7mg DR-Prednisone
10mg DR-Prednisone
Subjects in this arm will receive a night-time dose of 4mg delayed-release prednisone for two weeks followed by treatment with 15mg IR-prednisone in the morning for two weeks.
Subjects in this arm will receive a night-time dose of 7mg delayed-release prednisone for two weeks followed by treatment with 15mg IR-prednisone in the morning for two weeks.
Subjects in this arm will receive a night-time dose of 10mg delayed-release prednisone for two weeks followed by treatment with 15mg IR-prednisone in the morning for two weeks.