Polymyalgia RheumaticaNCT00982332
Efficacy of Micro-Pulse Steroid Therapy as Induction Therapy in Patients With Polymyalgia Rheumatica
A study testing Betamethasone in people with Polymyalgia Rheumatica, run by Bnai Zion Medical Center at 1 site in Israel.
Trial summary
The study will examine the efficacy of a single intramuscular injection of betamethasone dipropionate/betamethasone sodium phosphate at the dose of 20mg/8mg (injection volume 4 ml) as an induction therapy in patients with polymyalgia rheumatica. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Polymyalgia Rheumatica
- What is being tested?
- Betamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2010to Mar 2012
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- clinical diagnosis of polymyalgia rheumatica
Who cannot join
- decompensated diabetes mellitus
- decompensated arterial hypertension
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Bnai Zion Medical Center
Haifa, 38041
Gleb Slobodin, MD, 972-506267284, gleb.slobodin@b-zion.org.il
Doron Rimar, MD
About this study
Official title: Efficacy of Micro-pulse Steroid Therapy as Induction Therapy in Patients With Polymyalgia Rheumatica
The study will examine the efficacy of a single intramuscular injection of betamethasone dipropionate/betamethasone sodium phosphate at the dose of 20mg/8mg (injection volume 4 ml) as an induction therapy in patients with polymyalgia rheumatica. Twenty patients will be randomized to receive an injection of betamethasone or placebo (isotonic NaCl solution) immediately after diagnosis. Both groups will receive the standard-of-care steroid therapy, starting from 10 mg of prednisone every day (qd), tapered down by 2.5 mg monthly if the disease is not active (scheduled monthly follow-ups by a rheumatologist). Primary outcome measures: the total cumulative dose of glucocorticosteroids and disease duration.
- Conditions
- Polymyalgia Rheumatica
- Being tested
- Betamethasone, isotonic sodium chloride solution (placebo)
- Keywords
- polymyalgia rheumatica
- Medical subject headings
- Polymyalgia Rheumatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetamethasoneDrug
Also called diprospan injection
betamethasone dipropionate 20 mg + betamethasone sodium phosphate 8 md as a single intramuscular injection
isotonic sodium chloride solution (placebo)Drug
4 ml intramuscular
| Study group | Role | What they receive |
|---|---|---|
| betamethasone | Active comparator | patients treated with a single intramuscular injection of betamethasone Receives: Drug: Betamethasone; Drug: isotonic sodium chloride solution (placebo) |
| isotonic sodium chloride solution | Placebo comparator | Not described Receives: Drug: isotonic sodium chloride solution (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
a total dose of glucocorticoids used in the course of the disease
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startMar 2010
- Primary completionSep 2011 (estimated)
- Study completionMar 2012 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00982332
- Sponsor's protocol ID
- POLYMYALGIA1
- Status last verified
- Jul 2010
- First submitted
- 15 Sep 2009
- Last updated
- 20 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Micro-pulse Steroid Therapy as Induction Therapy in Patients With Polymyalgia Rheumatica
- ClinicalTrials.gov ID
- NCT00982332
- Acronym / sponsor ID
- POLYMYALGIA1
- Conditions
- Polymyalgia Rheumatica
- Keywords
- polymyalgia rheumatica
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- Mar 2010
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 23 Sep 2009 (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.
The study will examine the efficacy of a single intramuscular injection of betamethasone dipropionate/betamethasone sodium phosphate at the dose of 20mg/8mg (injection volume 4 ml) as an induction therapy in patients with polymyalgia rheumatica. Twenty patients will be randomized to receive an injection of betamethasone or placebo (isotonic NaCl solution) immediately after diagnosis. Both groups will receive the standard-of-care steroid therapy, starting from 10 mg of prednisone every day (qd), tapered down by 2.5 mg monthly if the disease is not active (scheduled monthly follow-ups by a rheumatologist). Primary outcome measures: the total cumulative dose of glucocorticosteroids and disease duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| betamethasone | Active comparator | Drug: Betamethasone, Drug: isotonic sodium chloride solution (placebo)patients treated with a single intramuscular injection of betamethasone |
| isotonic sodium chloride solution | Placebo comparator | Drug: isotonic sodium chloride solution (placebo) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- clinical diagnosis of polymyalgia rheumatica
Key exclusion criteria (2 listed)
- decompensated diabetes mellitus
- decompensated arterial hypertension
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 |
|---|---|---|
| BetamethasoneAlso: diprospan injectionbetamethasone dipropionate 20 mg + betamethasone sodium phosphate 8 md as a single intramuscular injection | Drug | betamethasone |
| isotonic sodium chloride solution (placebo)4 ml intramuscular | Drug | betamethasone, isotonic sodium chloride solution |
Primary outcome
a total dose of glucocorticoids used in the course of the disease
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2010.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Betamethasone in people with Polymyalgia Rheumatica, run by Bnai Zion Medical Center at 1 site in Israel.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gleb Slobodin, MD (972-506267284, gleb.slobodin@b-zion.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a total dose of glucocorticoids used in the course of the disease (time frame: 12 months). 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 20 Jul 2010.