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Delayed Release Prednisone in PMR

Primary Purpose

Polymyalgia Rheumatica

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Delayed-Release (DR) Prednisone
Immediate Release (IR) Prednisone
Sponsored by
Dinora, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polymyalgia Rheumatica focused on measuring Polymyalgia Rheumatica (PMR)

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

4mg DR-Prednisone

7mg DR-Prednisone

10mg DR-Prednisone

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Relative reduction in the duration of morning stiffness (minutes)
This will be assessed via a questionnaire.
Relative IL-6 treatment response.
Changes in plasma IL-6 compared with changes in the severity of morning stiffness
Patient reported outcomes in accordance with the OMERACT PMR objectives
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).

Full Information

First Posted
February 18, 2016
Last Updated
May 1, 2017
Sponsor
Dinora, Inc.
Collaborators
Analgesic Solutions, PharPoint Research, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02702778
Brief Title
Delayed Release Prednisone in PMR
Official Title
A Randomized, Open-label, Dose-ranging Study of Oral Delayed Release Prednisone in Patients With Untreated Polymyalgia Rheumatic (PMR)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
lack of study recruitment
Study Start Date
February 2016 (undefined)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
March 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dinora, Inc.
Collaborators
Analgesic Solutions, PharPoint Research, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polymyalgia Rheumatica
Keywords
Polymyalgia Rheumatica (PMR)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4mg DR-Prednisone
Arm Type
Active Comparator
Arm Description
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.
Arm Title
7mg DR-Prednisone
Arm Type
Active Comparator
Arm Description
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.
Arm Title
10mg DR-Prednisone
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Delayed-Release (DR) Prednisone
Other Intervention Name(s)
RAYOS
Intervention Description
delayed release prednisone
Intervention Type
Drug
Intervention Name(s)
Immediate Release (IR) Prednisone
Intervention Description
standard prednisone
Primary Outcome Measure Information:
Title
Change of the severity of morning stiffness from baseline to end of study (28days)
Description
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).
Time Frame
Assessed daily from screening through End of Study visit, 28 days total
Secondary Outcome Measure Information:
Title
Relative reduction in the duration of morning stiffness (minutes)
Description
This will be assessed via a questionnaire.
Time Frame
Assessed daily from screening through End of Study visit, an average of 2 months
Title
Relative IL-6 treatment response.
Time Frame
Assessed at Baseline, Day 14, and Day 28
Title
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
Title
Patient reported outcomes in accordance with the OMERACT PMR objectives
Time Frame
Through study completion, an average of 2 months.
Title
Performance characteristics of additional clinical measures of disease outcome.
Description
Additional characteristics such as pain and fatigue will be assessed using a 10cm Visual Analog Scale (VAS).
Time Frame
Through study completion, an average of 2 months
Other Pre-specified Outcome Measures:
Title
Changes in PMR Activity Score (PMRAS) following treatment with DR prednisone and IR prednisone
Time Frame
Through study completion, an average of 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Clinical Research Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Clinical Research Site
City
Mineola
State/Province
New York
Country
United States
Facility Name
Clinical Research Site
City
Duncansville
State/Province
Pennsylvania
Country
United States
Facility Name
Clinical Research Site 2
City
Wyomissing
State/Province
Pennsylvania
Country
United States
Facility Name
Clinical Research Site
City
Wyomissing
State/Province
Pennsylvania
Country
United States
Facility Name
Clinical Research Site
City
Spokane
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Delayed Release Prednisone in PMR

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