Polymyalgia RheumaticaNCT05681676
Melanocortin Gene Expression in Lymphocytes of Polymyalgia Patients
An observational study of Polymyalgia Rheumatica, run by Aalborg University.
Trial summary
Polymyalgia rheumatica (PMR) is a systemic inflammatory disorder with unknown etiology and overlapping symptoms with giant cell arthritis and rheumatoid arthritis (RA). The proteomic profile of PMR patients remains uncharacterized and biomarker studies very limited. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Polymyalgia Rheumatica
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2012to 1 Dec 2022
- Phase
- Observational
- 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
- Adult, Older adult
Study population: The inclusion criteria ensured that the PMR patients had a high disease activity. After three months, the patients had obtained significant effect of the glucocorticoid treatment evaluated by physical examinations and clinical biochemistry values (Table 1).
Who may be able to join
- The PMR diagnosis fulfilled the ACR 1987 criteria [20]. Additional inclusion criteria were elevated CRP, and sedimentation rate, ultrasound verified synovitis [21], and ].
Who cannot join
- no cancer related findings on computed tomography (CT) of the abdomen, and chest X-ray to increase specificity as described by ACR 2012 classification criteria [22
About this study
Official title: Is the Melanocortin System Involved in Inflammatory Resolution
Polymyalgia rheumatica (PMR) is a systemic inflammatory disorder with unknown etiology and overlapping symptoms with giant cell arthritis and rheumatoid arthritis (RA). The proteomic profile of PMR patients remains uncharacterized and biomarker studies very limited. The primary aim of this study was to thoroughly investigate the lymphocyte expression of melanocortin receptors, and the serum proteome during glucocorticoid treatment of PMR with a focus on acute-phase reactions, the complement system, and pro-inflammatory cytokines.
Read the detailed description
Polymyalgia rheumatica (PMR) is a prototypic systemic inflammatory disease with overlapping symptoms similar to late onset rheumatoid arthritis (RA), giant cell arthritis (GCA), and cancer [1]. The etiology of PMR remains largely unknown, but it has been suggested that an age-related decline in the adaptive immune system might play a role in an over-compensatory inflammatory innate immune response [2]. Some genes and polymorphisms involved in initiation and regulation of inflammation have been associated with PMR [3,4] and polymorphisms are more predominant in the Northern European than Mediterranean population [5]. PMR has been somewhat successfully treated with glucocorticoids (e.g. prednisone) for more than half a century [6]. Due to the lack of causative molecular knowledge about the driving factors of inflammatory activation, and lack of treatment alternatives, glucocorticoids are still applied as the first line treatment today [7]. Relapses are common during standard glucocorticoid treatment [8], and randomized trials have failed to provide new treatment options [9,10]. However, recent progress in GCA treatment [11] have paved the way for biological treatment of PMR.
Only few serological biomarkers have been associated to PMR pathogenesis and disease activity while the pathogenesis of RA has been more thoroughly investigated. Hence, there is an unmet need to elucidate the pathophysiology of PMR. In this pilot-study, we therefore explored the potential to identify new serological markers at disease onset, which could be responsive to glucocorticoid treatment, which could be linked to PMR pathology. We did this using state-of-the-art quantitative proteomics profiling to investigate serum proteins from PMR patients before and after treatment with glucocorticoids for three months. In addition, we compared these patients with DMARD naïve RA patients, and healthy controls for potential molecular similarities. Hence, we applied advanced, qPCR to investigate lymphocyte expression, and mass spectrometry (MS) to measure serum proteins, and compared the results with serum cytokines.
- Conditions
- Polymyalgia Rheumatica
- Being tested
- Blood samples before and after standard of care of 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.
Blood samples before and after standard of care of polymyalgia rheumaticaOther
Blood samples were taken before glucocorticoid treatment and three months after.
What is being measured
The primary outcome is the main question the study is designed to answer.
Melanocortin receptor expression
Melanocortin receptor expression determined like previously: https://pubmed.ncbi.nlm.nih.gov/27434862/
Measured: 3 months.
Serum proteome
Mass spectrometry investigated serum proteome
Measured: 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start1 Mar 2012
- Primary completion1 Dec 2015
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Kruse Meyer, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681676
- Sponsor's protocol ID
- N-20120074
- Status last verified
- Dec 2022
- First submitted
- 28 Dec 2022
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Crowson CS, Matteson EL, Myasoedova E, Michet CJ, Ernste FC, Warrington KJ, Davis JM 3rd, Hunder GG, Therneau TM, Gabriel SE. The lifetime risk of adult-onset rheumatoid arthritis and other inflammatory autoimmune rheumatic diseases. Arthritis Rheum. 2011 Mar;63(3):633-9. doi: 10.1002/art.30155.
PubMed 21360492Pacheco MJ, Amado JA, Lopez-Hoyos M, Blanco R, Garcia-Unzueta MT, Rodriguez-Valverde V, Martinez-Taboada VM. Hypothalamic-pituitary-adrenocortical axis function in patients with polymyalgia rheumatica and giant cell arteritis. Semin Arthritis Rheum. 2003 Feb;32(4):266-72. doi: 10.1053/sarh.2003.49993.
PubMed 12621591Liang GC, Simkin PA, Hunder GG, Wilske KR, Healey LA. Familial aggregation of polymyalgia rheumatica and giant cell arteritis. Arthritis Rheum. 1974 Jan-Feb;17(1):19-24. doi: 10.1002/art.1780170105. No abstract available.
PubMed 4810661Owen CE, Buchanan RR, Hoi A. Recent advances in polymyalgia rheumatica. Intern Med J. 2015 Nov;45(11):1102-8. doi: 10.1111/imj.12823.
PubMed 26036315Salvarani C, Pipitone N, Versari A, Hunder GG. Clinical features of polymyalgia rheumatica and giant cell arteritis. Nat Rev Rheumatol. 2012 Sep;8(9):509-21. doi: 10.1038/nrrheum.2012.97. Epub 2012 Jul 24.
PubMed 22825731Behn AR, Perera T, Myles AB. Polymyalgia rheumatica and corticosteroids: how much for how long? Ann Rheum Dis. 1983 Aug;42(4):374-8. doi: 10.1136/ard.42.4.374.
PubMed 6882032Dejaco C, Singh YP, Perel P, Hutchings A, Camellino D, Mackie S, Abril A, Bachta A, Balint P, Barraclough K, Bianconi L, Buttgereit F, Carsons S, Ching D, Cid M, Cimmino M, Diamantopoulos A, Docken W, Duftner C, Fashanu B, Gilbert K, Hildreth P, Hollywood J, Jayne D, Lima M, Maharaj A, Mallen C, Martinez-Taboada V, Maz M, Merry S, Miller J, Mori S, Neill L, Nordborg E, Nott J, Padbury H, Pease C, Salvarani C, Schirmer M, Schmidt W, Spiera R, Tronnier D, Wagner A, Whitlock M, Matteson EL, Dasgupta B; European League Against Rheumatism; American College of Rheumatology. 2015 Recommendations for the management of polymyalgia rheumatica: a European League Against Rheumatism/American College of Rheumatology collaborative initiative. Ann Rheum Dis. 2015 Oct;74(10):1799-807. doi: 10.1136/annrheumdis-2015-207492.
PubMed 26359488Salvarani C, Cantini F, Niccoli L, Macchioni P, Consonni D, Bajocchi G, Vinceti M, Catanoso MG, Pulsatelli L, Meliconi R, Boiardi L. Acute-phase reactants and the risk of relapse/recurrence in polymyalgia rheumatica: a prospective followup study. Arthritis Rheum. 2005 Feb 15;53(1):33-8. doi: 10.1002/art.20901.
PubMed 15696567Salvarani C, Macchioni P, Manzini C, Paolazzi G, Trotta A, Manganelli P, Cimmino M, Gerli R, Catanoso MG, Boiardi L, Cantini F, Klersy C, Hunder GG. Infliximab plus prednisone or placebo plus prednisone for the initial treatment of polymyalgia rheumatica: a randomized trial. Ann Intern Med. 2007 May 1;146(9):631-9. doi: 10.7326/0003-4819-146-9-200705010-00005.
PubMed 17470831Kreiner 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 20854662Stone JH, Tuckwell K, Dimonaco S, Klearman M, Aringer M, Blockmans D, Brouwer E, Cid MC, Dasgupta B, Rech J, Salvarani C, Schett G, Schulze-Koops H, Spiera R, Unizony SH, Collinson N. Trial of Tocilizumab in Giant-Cell Arteritis. N Engl J Med. 2017 Jul 27;377(4):317-328. doi: 10.1056/NEJMoa1613849.
PubMed 28745999Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, Healey LA, Kaplan SR, Liang MH, Luthra HS, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum. 1988 Mar;31(3):315-24. doi: 10.1002/art.1780310302.
PubMed 3358796Kermani TA, Warrington KJ. Advances and challenges in the diagnosis and treatment of polymyalgia rheumatica. Ther Adv Musculoskelet Dis. 2014 Feb;6(1):8-19. doi: 10.1177/1759720X13512450.
PubMed 24489611
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Melanocortin System Involved in Inflammatory Resolution
- ClinicalTrials.gov ID
- NCT05681676
- Acronym / sponsor ID
- N-20120074
- Conditions
- Polymyalgia Rheumatica
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 1 Mar 2012 (actual)
- Primary completion
- 1 Dec 2015 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 12 Jan 2023 (actual)
- 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.
Polymyalgia rheumatica (PMR) is a systemic inflammatory disorder with unknown etiology and overlapping symptoms with giant cell arthritis and rheumatoid arthritis (RA). The proteomic profile of PMR patients remains uncharacterized and biomarker studies very limited. The primary aim of this study was to thoroughly investigate the lymphocyte expression of melanocortin receptors, and the serum proteome during glucocorticoid treatment of PMR with a focus on acute-phase reactions, the complement system, and pro-inflammatory cytokines.
Detailed description
Polymyalgia rheumatica (PMR) is a prototypic systemic inflammatory disease with overlapping symptoms similar to late onset rheumatoid arthritis (RA), giant cell arthritis (GCA), and cancer [1]. The etiology of PMR remains largely unknown, but it has been suggested that an age-related decline in the adaptive immune system might play a role in an over-compensatory inflammatory innate immune response [2]. Some genes and polymorphisms involved in initiation and regulation of inflammation have been associated with PMR [3,4] and polymorphisms are more predominant in the Northern European than Mediterranean population [5]. PMR has been somewhat successfully treated with glucocorticoids (e.g. prednisone) for more than half a century [6]. Due to the lack of causative molecular knowledge about the driving factors of inflammatory activation, and lack of treatment alternatives, glucocorticoids are still applied as the first line treatment today [7]. Relapses are common during standard glucocorticoid treatment [8], and randomized trials have failed to provide new treatment options [9,10]. However, recent progress in GCA treatment [11] have paved the way for biological treatment of PMR.
Only few serological biomarkers have been associated to PMR pathogenesis and disease activity while the pathogenesis of RA has been more thoroughly investigated. Hence, there is an unmet need to elucidate the pathophysiology of PMR. In this pilot-study, we therefore explored the potential to identify new serological markers at disease onset, which could be responsive to glucocorticoid treatment, which could be linked to PMR pathology. We did this using state-of-the-art quantitative proteomics profiling to investigate serum proteins from PMR patients before and after treatment with glucocorticoids for three months. In addition, we compared these patients with DMARD naïve RA patients, and healthy controls for potential molecular similarities. Hence, we applied advanced, qPCR to investigate lymphocyte expression, and mass spectrometry (MS) to measure serum proteins, and compared the results with serum cytokines.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The inclusion criteria ensured that the PMR patients had a high disease activity. After three months, the patients had obtained significant effect of the glucocorticoid treatment evaluated by physical examinations and clinical biochemistry values (Table 1).
Key inclusion criteria (1 listed)
- The PMR diagnosis fulfilled the ACR 1987 criteria [20]. Additional inclusion criteria were elevated CRP, and sedimentation rate, ultrasound verified synovitis [21], and ].
Key exclusion criteria (1 listed)
- no cancer related findings on computed tomography (CT) of the abdomen, and chest X-ray to increase specificity as described by ACR 2012 classification criteria [22
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 |
|---|---|---|
| Blood samples before and after standard of care of polymyalgia rheumaticaBlood samples were taken before glucocorticoid treatment and three months after. | Other | – |
Primary outcome
Melanocortin receptor expression
Time frame: 3 months.
Melanocortin receptor expression determined like previously: https://pubmed.ncbi.nlm.nih.gov/27434862/
Serum proteome
Time frame: 3 months.
Mass spectrometry investigated serum proteome
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 12 Jan 2023.
- Background: PubMed 21360492Crowson CS, Matteson EL, Myasoedova E, Michet CJ, Ernste FC, Warrington KJ, Davis JM 3rd, Hunder GG, Therneau TM, Gabriel SE. The lifetime risk of adult-onset rheumatoid arthritis and other inflammatory autoimmune rheumatic diseases. Arthritis Rheum. 2011 Mar;63(3):633-9. doi: 10.1002/art.30155.
- Background: PubMed 12621591Pacheco MJ, Amado JA, Lopez-Hoyos M, Blanco R, Garcia-Unzueta MT, Rodriguez-Valverde V, Martinez-Taboada VM. Hypothalamic-pituitary-adrenocortical axis function in patients with polymyalgia rheumatica and giant cell arteritis. Semin Arthritis Rheum. 2003 Feb;32(4):266-72. doi: 10.1053/sarh.2003.49993.
- Background: PubMed 4810661Liang GC, Simkin PA, Hunder GG, Wilske KR, Healey LA. Familial aggregation of polymyalgia rheumatica and giant cell arteritis. Arthritis Rheum. 1974 Jan-Feb;17(1):19-24. doi: 10.1002/art.1780170105. No abstract available.
- Background: PubMed 26036315Owen CE, Buchanan RR, Hoi A. Recent advances in polymyalgia rheumatica. Intern Med J. 2015 Nov;45(11):1102-8. doi: 10.1111/imj.12823.
- Background: PubMed 22825731Salvarani C, Pipitone N, Versari A, Hunder GG. Clinical features of polymyalgia rheumatica and giant cell arteritis. Nat Rev Rheumatol. 2012 Sep;8(9):509-21. doi: 10.1038/nrrheum.2012.97. Epub 2012 Jul 24.
- Background: PubMed 6882032Behn AR, Perera T, Myles AB. Polymyalgia rheumatica and corticosteroids: how much for how long? Ann Rheum Dis. 1983 Aug;42(4):374-8. doi: 10.1136/ard.42.4.374.
- Background: PubMed 26359488Dejaco C, Singh YP, Perel P, Hutchings A, Camellino D, Mackie S, Abril A, Bachta A, Balint P, Barraclough K, Bianconi L, Buttgereit F, Carsons S, Ching D, Cid M, Cimmino M, Diamantopoulos A, Docken W, Duftner C, Fashanu B, Gilbert K, Hildreth P, Hollywood J, Jayne D, Lima M, Maharaj A, Mallen C, Martinez-Taboada V, Maz M, Merry S, Miller J, Mori S, Neill L, Nordborg E, Nott J, Padbury H, Pease C, Salvarani C, Schirmer M, Schmidt W, Spiera R, Tronnier D, Wagner A, Whitlock M, Matteson EL, Dasgupta B; European League Against Rheumatism; American College of Rheumatology. 2015 Recommendations for the management of polymyalgia rheumatica: a European League Against Rheumatism/American College of Rheumatology collaborative initiative. Ann Rheum Dis. 2015 Oct;74(10):1799-807. doi: 10.1136/annrheumdis-2015-207492.
- Background: PubMed 15696567Salvarani C, Cantini F, Niccoli L, Macchioni P, Consonni D, Bajocchi G, Vinceti M, Catanoso MG, Pulsatelli L, Meliconi R, Boiardi L. Acute-phase reactants and the risk of relapse/recurrence in polymyalgia rheumatica: a prospective followup study. Arthritis Rheum. 2005 Feb 15;53(1):33-8. doi: 10.1002/art.20901.
- Background: PubMed 17470831Salvarani C, Macchioni P, Manzini C, Paolazzi G, Trotta A, Manganelli P, Cimmino M, Gerli R, Catanoso MG, Boiardi L, Cantini F, Klersy C, Hunder GG. Infliximab plus prednisone or placebo plus prednisone for the initial treatment of polymyalgia rheumatica: a randomized trial. Ann Intern Med. 2007 May 1;146(9):631-9. doi: 10.7326/0003-4819-146-9-200705010-00005.
- Background: 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.
- Background: PubMed 28745999Stone JH, Tuckwell K, Dimonaco S, Klearman M, Aringer M, Blockmans D, Brouwer E, Cid MC, Dasgupta B, Rech J, Salvarani C, Schett G, Schulze-Koops H, Spiera R, Unizony SH, Collinson N. Trial of Tocilizumab in Giant-Cell Arteritis. N Engl J Med. 2017 Jul 27;377(4):317-328. doi: 10.1056/NEJMoa1613849.
- Background: PubMed 3358796Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, Healey LA, Kaplan SR, Liang MH, Luthra HS, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum. 1988 Mar;31(3):315-24. doi: 10.1002/art.1780310302.
- Individual participant dataSharing planned: No
Related trials for Polymyalgia Rheumatica
Recruiting
Using Personalized Rehabilitation to Reduce Disease and Increase Activity of Patients With Polymyalgia Rheumatica
Polymyalgia Rheumatica (PMR)
RecruitingPhase 3
Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica
Polymyalgia Rheumatica
Active, not recruitingPhase 3
Open-label, Long-term Safety Study of Secukinumab in Polymyalgia Rheumatica (PMR)
Polymyalgia Rheumatica
RecruitingObservational study
A Qualitative Assessment of the Severity and Impact of Rheumatic Immune-Related Adverse Events Following Immune Checkpoint Inhibitor Immunotherapy
Arthritis, Polymyalgia Rheumatica
RecruitingPhase 3
Justification And Evaluation of Baricitinib Plus Corticosteroids Versus corticosteroiDs Alone in pOlymyalgia RhEumatica
Polymyalgia Rheumatica (PMR)
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Polymyalgia Rheumatica, run by Aalborg University.
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 1 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 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Melanocortin receptor expression (time frame: 3 months.). The study lists 2 primary outcomes in all. 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 NCT05681676, which also lists 13 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 12 Jan 2023; AzTrials last refreshed its copy on 7 Nov 2026.