Delayed Release Prednisone in PMR

May 1, 2017 updated by: Dinora, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States
        • Clinical Research Site
    • New York
      • Mineola, New York, United States
        • Clinical Research Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States
        • Clinical Research Site
      • Wyomissing, Pennsylvania, United States
        • Clinical Research Site 2
      • Wyomissing, Pennsylvania, United States
        • Clinical Research Site
    • Washington
      • Spokane, Washington, United States
        • Clinical Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 4mg 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.
Drug: Delayed-Release (DR) Prednisone
delayed release prednisone
Other Names:
  • RAYOS
Drug: Immediate Release (IR) Prednisone
standard prednisone
Active Comparator: 7mg DR-Prednisone
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.
Drug: Delayed-Release (DR) Prednisone
delayed release prednisone
Other Names:
  • RAYOS
Drug: Immediate Release (IR) Prednisone
standard prednisone
Active Comparator: 10mg DR-Prednisone
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.
Drug: Delayed-Release (DR) Prednisone
delayed release prednisone
Other Names:
  • RAYOS
Drug: Immediate Release (IR) Prednisone
standard prednisone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the severity of morning stiffness from baseline to end of study (28days)
Time Frame: Assessed daily from screening through End of Study visit, 28 days total
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative reduction in the duration of morning stiffness (minutes)
Time Frame: Assessed daily from screening through End of Study visit, an average of 2 months
This will be assessed via a questionnaire.
Assessed daily from screening through End of Study visit, an average of 2 months
Relative IL-6 treatment response.
Time Frame: Assessed at Baseline, Day 14, and Day 28
Assessed at Baseline, Day 14, and Day 28
Changes in plasma IL-6 compared with changes in the severity of morning stiffness
Time Frame: Through study completion, a total of 3 assessments over 28days
Through study completion, a total of 3 assessments over 28days
Patient reported outcomes in accordance with the OMERACT PMR objectives
Time Frame: Through study completion, an average of 2 months.
Through study completion, an average of 2 months.
Performance characteristics of additional clinical measures of disease outcome.
Time Frame: Through study completion, an average of 2 months
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

Other Outcome Measures

Outcome Measure
Time Frame
Changes in PMR Activity Score (PMRAS) following treatment with DR prednisone and IR prednisone
Time Frame: Through study completion, an average of 2 months
Through study completion, an average of 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dinora, Inc.

Collaborators

PharPoint Research, Inc.
Analgesic Solutions

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

March 31, 2017

Study Registration Dates

First Submitted

February 18, 2016

First Submitted That Met QC Criteria

March 3, 2016

First Posted (Estimate)

March 9, 2016

Study Record Updates

Last Update Posted (Actual)

May 3, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HZNP-PRE-IIS02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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