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Delayed Release Prednisone in PMR

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ClinicalTrials.gov Identifier: NCT02702778
Recruitment Status : Terminated (lack of study recruitment)
First Posted : March 9, 2016
Last Update Posted : May 3, 2017
Sponsor:
Collaborators:
Analgesic Solutions
PharPoint Research, Inc.
Information provided by (Responsible Party):
Dinora, Inc.

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.

Condition or disease Intervention/treatment Phase
Polymyalgia Rheumatica Drug: Delayed-Release (DR) Prednisone Drug: Immediate Release (IR) Prednisone Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Dose-ranging Study of Oral Delayed Release Prednisone in Patients With Untreated Polymyalgia Rheumatic (PMR)
Study Start Date : February 2016
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : March 31, 2017


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 Name: 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 Name: 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 Name: RAYOS

Drug: Immediate Release (IR) Prednisone
standard prednisone




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. Relative IL-6 treatment response. [ Time Frame: Assessed at Baseline, Day 14, and Day 28 ]
  3. 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 ]
  4. Patient reported outcomes in accordance with the OMERACT PMR objectives [ Time Frame: Through study completion, an average of 2 months. ]
  5. 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).


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


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02702778


Locations
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United States, Florida
Clinical Research Site
Miami, Florida, United States
United States, New York
Clinical Research Site
Mineola, New York, United States
United States, Pennsylvania
Clinical Research Site
Duncansville, Pennsylvania, United States
Clinical Research Site 2
Wyomissing, Pennsylvania, United States
Clinical Research Site
Wyomissing, Pennsylvania, United States
United States, Washington
Clinical Research Site
Spokane, Washington, United States
Sponsors and Collaborators
Dinora, Inc.
Analgesic Solutions
PharPoint Research, Inc.

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Responsible Party: Dinora, Inc.
ClinicalTrials.gov Identifier: NCT02702778     History of Changes
Other Study ID Numbers: HZNP-PRE-IIS02
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dinora, Inc.:
Polymyalgia Rheumatica (PMR)
Additional relevant MeSH terms:
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Polymyalgia Rheumatica
Giant Cell Arteritis
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arteritis
Vasculitis
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents