Polymyalgia RheumaticaPhase 2NCT02702778
Delayed Release Prednisone in PMR
A Phase 2 study testing Delayed-Release (DR) Prednisone and Immediate Release (IR) Prednisone in people with Polymyalgia Rheumatica, run by Dinora, Inc. at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Polymyalgia Rheumatica
- What is being tested?
- Delayed-Release (DR) Prednisone and Immediate Release (IR) Prednisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 2016to 31 Mar 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Clinical Research Site
Duncansville, Pennsylvania
Clinical Research Site
Miami, Florida
Clinical Research Site
Mineola, New York
Clinical Research Site
Spokane, Washington
Clinical Research Site 2
Wyomissing, Pennsylvania
Clinical Research Site
Wyomissing, Pennsylvania
About this study
Official title: 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.
- Conditions
- Polymyalgia Rheumatica
- Being tested
- Delayed-Release (DR) Prednisone, Immediate Release (IR) Prednisone
- Keywords
- Polymyalgia Rheumatica (PMR)
- Medical subject headings
- Polymyalgia Rheumatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed-Release (DR) PrednisoneDrug
Also called RAYOS
delayed release prednisone
Immediate Release (IR) PrednisoneDrug
standard prednisone
| Study group | Role | What they receive |
|---|---|---|
| 4mg DR-Prednisone | Active comparator | 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. Receives: Drug: Delayed-Release (DR) Prednisone; Drug: Immediate Release (IR) Prednisone |
| 7mg DR-Prednisone | Active comparator | 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. Receives: Drug: Delayed-Release (DR) Prednisone; Drug: Immediate Release (IR) Prednisone |
| 10mg DR-Prednisone | Active comparator | 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. Receives: Drug: Delayed-Release (DR) Prednisone; Drug: Immediate Release (IR) Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Assessed daily from screening through End of Study visit, 28 days total
Secondary outcomes (5)
Relative reduction in the duration of morning stiffness (minutes)
This will be assessed via a questionnaire.
Measured: Assessed daily from screening through End of Study visit, an average of 2 months
Relative IL-6 treatment response.
Measured: Assessed at Baseline, Day 14, and Day 28
Changes in plasma IL-6 compared with changes in the severity of morning stiffness
Measured: Through study completion, a total of 3 assessments over 28days
Patient reported outcomes in accordance with the OMERACT PMR objectives
Measured: Through study completion, an average of 2 months.
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).
Measured: Through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completion31 Dec 2016
- Study completion31 Mar 2017
Why it stopped: lack of study recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polymyalgia RheumaticaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dinora, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Analgesic Solutions, PharPoint Research, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702778
- Sponsor's protocol ID
- HZNP-PRE-IIS02
- Status last verified
- May 2017
- First submitted
- 18 Feb 2016
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Dose-ranging Study of Oral Delayed Release Prednisone in Patients With Untreated Polymyalgia Rheumatic (PMR)
- ClinicalTrials.gov ID
- NCT02702778
- Acronym / sponsor ID
- HZNP-PRE-IIS02
- Conditions
- Polymyalgia Rheumatica
- Keywords
- Polymyalgia Rheumatica (PMR)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of study recruitment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Dinora, Inc.University, hospital or other
- Collaborators
- Analgesic Solutions, PharPoint Research, Inc.
- Study start
- Feb 2016
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 9 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 4mg DR-Prednisone | Active comparator | Drug: Delayed-Release (DR) Prednisone, Drug: Immediate Release (IR) PrednisoneSubjects 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 comparator | Drug: Delayed-Release (DR) Prednisone, Drug: Immediate Release (IR) PrednisoneSubjects 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 comparator | Drug: Delayed-Release (DR) Prednisone, Drug: Immediate Release (IR) PrednisoneSubjects 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Diagnosis of PMR:
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delayed-Release (DR) PrednisoneAlso: RAYOSdelayed release prednisone | Drug | 10mg DR-Prednisone, 4mg DR-Prednisone, 7mg DR-Prednisone |
| Immediate Release (IR) Prednisonestandard prednisone | Drug | 10mg DR-Prednisone, 4mg DR-Prednisone, 7mg DR-Prednisone |
Primary outcome
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).
5 secondary outcomes
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
Relative IL-6 treatment response.
Time frame: 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
Patient reported outcomes in accordance with the OMERACT PMR objectives
Time frame: 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
Results and safety
The study was stopped early (reason given: lack of study recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Delayed-Release (DR) Prednisone and Immediate Release (IR) Prednisone in people with Polymyalgia Rheumatica, run by Dinora, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: lack of study recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017.