Delayed Release Prednisone in PMR

Polymyalgia Rheumatica Clinical Trial

Official title:

A Randomized, Open-label, Dose-ranging Study of Oral Delayed Release Prednisone in Patients With Untreated Polymyalgia Rheumatic (PMR)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02702778
• Other study ID #: HZNP-PRE-IIS02
• Status: Terminated
• Phase: Phase 2
• First received: February 18, 2016
• Last updated: May 1, 2017
• Start date: February 2016
• Est. completion date: March 31, 2017

Study information

• Verified date: May 2017
• Source: Dinora, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A four-week, randomized, controlled, open-label trial of DR prednisone in which patients receive in period 1 one of three-night time doses of treatment (4mg, 7mg or 10mg) for two weeks followed in period 2 by treatment with 15mg IR prednisone in the morning for two weeks. Period 1 is randomized and open-label and period 2 is open label. Before enrollment and randomization patient diagnosis and responsiveness to 15mg IR prednisone in the morning is established. 45 patients will be randomized, 15 patients in each treatment arm.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: March 31, 2017
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Giant Cell Arteritis
• Polymyalgia Rheumatica

Intervention

Drug:
• Delayed-Release (DR) Prednisone
delayed release prednisone
• Immediate Release (IR) Prednisone
standard prednisone

Locations

Country	Name	City	State
United States	Clinical Research Site	Duncansville	Pennsylvania
United States	Clinical Research Site	Miami	Florida
United States	Clinical Research Site	Mineola	New York
United States	Clinical Research Site	Spokane	Washington
United States	Clinical Research Site	Wyomissing	Pennsylvania
United States	Clinical Research Site 2	Wyomissing	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Dinora, Inc.	Analgesic Solutions, PharPoint Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in PMR Activity Score (PMRAS) following treatment with DR prednisone and IR prednisone		Through study completion, an average of 2 months
Primary	Change of the severity of morning stiffness from baseline to end of study (28days)	To determine the relative reduction in the severity of morning stiffness of three night time doses (4mg, 7mg, and 10mg) of DR prednisone after 2 weeks compared to the reduction after treatment with IR prednisone15mg in the morning for 2 weeks in newly diagnosed PMR patients (with no evidence of other systemic inflammatory diseases such as RA) who are known to be responsive to standard treatment with IR prednisone15mg in the morning. This will be assessed using a 10cm Visual Analog Scale (VAS).	Assessed daily from screening through End of Study visit, 28 days total
Secondary	Relative reduction in the duration of morning stiffness (minutes)	This will be assessed via a questionnaire.	Assessed daily from screening through End of Study visit, an average of 2 months
Secondary	Relative IL-6 treatment response.		Assessed at Baseline, Day 14, and Day 28
Secondary	Changes in plasma IL-6 compared with changes in the severity of morning stiffness		Through study completion, a total of 3 assessments over 28days
Secondary	Patient reported outcomes in accordance with the OMERACT PMR objectives		Through study completion, an average of 2 months.
Secondary	Performance characteristics of additional clinical measures of disease outcome.	Additional characteristics such as pain and fatigue will be assessed using a 10cm Visual Analog Scale (VAS).	Through study completion, an average of 2 months