Polymyalgia RheumaticaPhase 3NCT00524381
Etanercept Treatment in the Early Course of Polymyalgia Rheumatica
A Phase 3 study testing Etanercept (Enbrel) in people with Polymyalgia Rheumatica, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to evaluate the effect of the tumor necrosis factor alpha (TNF) antagonist, etanercept, on the early clinical course of polymyalgia rheumatica (PMR). PMR is a common inflammatory disease with an unknown etiology that is characterized by aching, tender, and stiff proximal muscle. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Polymyalgia Rheumatica
- What is being tested?
- Etanercept (Enbrel)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2007to Sep 2009
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Persons with active polymyalgia rheumatica (patients only).
- Signed informed consent and written authorization.
Who cannot join
- Other inflammatory conditions than polymyalgia rheumatica, including symptoms of giant cell arteritis, e.g. head aches, jaw claudication and visual disturbances.
- Current malignancy or history of malignancy.
- Neuromuscular conditions.
- Infections with systemic impact.
- Uncontrolled diabetes mellitus.
- Uncontrolled hypertension.
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- Current tuberculosis or history of tuberculosis.
- Severe heart failure (NYHA class 3 and 4).
- Current use of glucocorticoids, biological drugs, and immunosuppressive drugs.
- Polymyalgia rheumatica.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Bispebjerg Hospital, Department of Rheumatology
Copenhagen NV, DK-2400
About this study
Official title: The Effect of Etanercept on the Early Clinical Course of Polymyalgia Rheumatica (Pilot Study)
The purpose of this study is to evaluate the effect of the tumor necrosis factor alpha (TNF) antagonist, etanercept, on the early clinical course of polymyalgia rheumatica (PMR).
PMR is a common inflammatory disease with an unknown etiology that is characterized by aching, tender, and stiff proximal muscle. Some evidence suggests that TNF plays a central role in the pathophysiology of PMR.
The preferred treatment with glucocorticoids (GCs) is adequate for most patients, but a subset of patients have a more prolonged, relapsing disease course. These patients require treatment with GCs for 1 to 2 years. GC related adverse events are frequent during treatment.
- Conditions
- Polymyalgia Rheumatica
- Being tested
- Etanercept (Enbrel), Sodium chloride (placebo)
- Medical subject headings
- Polymyalgia Rheumatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etanercept (Enbrel)Drug
TNF-alpha antagonist, subcutaneous injection, 25 mg twice/week, 14 days.
Sodium chloride (placebo)Drug
NaCl, isotonic saline, subcutaneous injection, 1 ml twice/week, 14 days.
What is being measured
The primary outcome is the main question the study is designed to answer.
Polymyalgia rheumatica activity score (PMR-AS)
Measured: 14 days
Secondary outcomes (3)
Plasma concentrations of various cytokines, chemokines, and adipokines
Measured: 14 days
Quantitative use of analgesics
Measured: 14 days
Insulin sensitivity (HOMA)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2007 (estimated)
- Study startAug 2007
- Primary completionJul 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Henrik Galbo, Professor, Study director, Bispebjerg Hospital, Department of Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00524381
- Sponsor's protocol ID
- PMR-ENBREL-1
- Status last verified
- Feb 2010
- First submitted
- 30 Aug 2007
- Last updated
- 23 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kreiner FF, Galbo H. Activity of the neuroendocrine axes in patients with polymyalgia rheumatica before and after TNF-alpha blocking etanercept treatment. Arthritis Res Ther. 2012 Aug 15;14(4):R186. doi: 10.1186/ar4017.
PubMed 22894827Kreiner F, Galbo H. Effect of etanercept in polymyalgia rheumatica: a randomized controlled trial. Arthritis Res Ther. 2010;12(5):R176. doi: 10.1186/ar3140. Epub 2010 Sep 20.
PubMed 20854662
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Etanercept on the Early Clinical Course of Polymyalgia Rheumatica (Pilot Study)
- ClinicalTrials.gov ID
- NCT00524381
- Acronym / sponsor ID
- PMR-ENBREL-1
- Conditions
- Polymyalgia Rheumatica
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 3 Sep 2007 (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 purpose of this study is to evaluate the effect of the tumor necrosis factor alpha (TNF) antagonist, etanercept, on the early clinical course of polymyalgia rheumatica (PMR).
PMR is a common inflammatory disease with an unknown etiology that is characterized by aching, tender, and stiff proximal muscle. Some evidence suggests that TNF plays a central role in the pathophysiology of PMR.
The preferred treatment with glucocorticoids (GCs) is adequate for most patients, but a subset of patients have a more prolonged, relapsing disease course. These patients require treatment with GCs for 1 to 2 years. GC related adverse events are frequent during treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Persons with active polymyalgia rheumatica (patients only).
- Signed informed consent and written authorization.
Key exclusion criteria (10 listed)
- Other inflammatory conditions than polymyalgia rheumatica, including symptoms of giant cell arteritis, e.g. head aches, jaw claudication and visual disturbances.
- Current malignancy or history of malignancy.
- Neuromuscular conditions.
- Infections with systemic impact.
- Uncontrolled diabetes mellitus.
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 |
|---|---|---|
| Etanercept (Enbrel)TNF-alpha antagonist, subcutaneous injection, 25 mg twice/week, 14 days. | Drug | – |
| Sodium chloride (placebo)NaCl, isotonic saline, subcutaneous injection, 1 ml twice/week, 14 days. | Drug | – |
Primary outcome
Polymyalgia rheumatica activity score (PMR-AS)
Time frame: 14 days
3 secondary outcomes
Plasma concentrations of various cytokines, chemokines, and adipokines
Time frame: 14 days
Quantitative use of analgesics
Time frame: 14 days
Insulin sensitivity (HOMA)
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2010.
- Derived from this study: PubMed 22894827Kreiner FF, Galbo H. Activity of the neuroendocrine axes in patients with polymyalgia rheumatica before and after TNF-alpha blocking etanercept treatment. Arthritis Res Ther. 2012 Aug 15;14(4):R186. doi: 10.1186/ar4017.
- Derived from this study: PubMed 20854662Kreiner F, Galbo H. Effect of etanercept in polymyalgia rheumatica: a randomized controlled trial. Arthritis Res Ther. 2010;12(5):R176. doi: 10.1186/ar3140. Epub 2010 Sep 20.
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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.
Henrik Galbo, Professor study director
Bispebjerg Hospital, Department of Rheumatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Etanercept (Enbrel) in people with Polymyalgia Rheumatica, run by Bispebjerg Hospital at 1 site in Denmark.
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 2 inclusion and 10 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: finished, as of the sponsor's last update on 23 Feb 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 Denmark. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Polymyalgia rheumatica activity score (PMR-AS) (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00524381, which also lists 2 linked publications.
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 23 Feb 2010; AzTrials last refreshed its copy on 8 Nov 2026.