Study Stopped
lack of study recruitment
Delayed Release Prednisone in PMR
A Randomized, Open-label, Dose-ranging Study of Oral Delayed Release Prednisone in Patients With Untreated Polymyalgia Rheumatic (PMR)
1 other identifier
interventional
8
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2016
Shorter than P25 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 18, 2016
CompletedFirst Posted
Study publicly available on registry
March 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2017
CompletedMay 3, 2017
May 1, 2017
11 months
February 18, 2016
May 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Relative reduction in the duration of morning stiffness (minutes)
Assessed daily from screening through End of Study visit, an average of 2 months
Relative IL-6 treatment response.
Assessed at Baseline, Day 14, and Day 28
Changes in plasma IL-6 compared with changes in the severity of morning stiffness
Through study completion, a total of 3 assessments over 28days
Patient reported outcomes in accordance with the OMERACT PMR objectives
Through study completion, an average of 2 months.
Performance characteristics of additional clinical measures of disease outcome.
Through study completion, an average of 2 months
Other Outcomes (1)
Changes in PMR Activity Score (PMRAS) following treatment with DR prednisone and IR prednisone
Through study completion, an average of 2 months
Study Arms (3)
4mg DR-Prednisone
ACTIVE COMPARATORSubjects 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.
7mg DR-Prednisone
ACTIVE COMPARATORSubjects 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.
10mg DR-Prednisone
ACTIVE COMPARATORSubjects 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.
Interventions
delayed release prednisone
standard prednisone
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dinora, Inc.lead
- Analgesic Solutionscollaborator
- PharPoint Research, Inc.collaborator
Study Sites (6)
Clinical Research Site
Miami, Florida, United States
Clinical Research Site
Mineola, New York, United States
Clinical Research Site
Duncansville, Pennsylvania, United States
Clinical Research Site 2
Wyomissing, Pennsylvania, United States
Clinical Research Site
Wyomissing, Pennsylvania, United States
Clinical Research Site
Spokane, Washington, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2016
First Posted
March 9, 2016
Study Start
February 1, 2016
Primary Completion
December 31, 2016
Study Completion
March 31, 2017
Last Updated
May 3, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share