NCT05681676

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2012

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
Last Updated

January 12, 2023

Status Verified

December 1, 2022

Enrollment Period

3.8 years

First QC Date

December 28, 2022

Last Update Submit

January 11, 2023

Conditions

Polymyalgia Rheumatica

Outcome Measures

Primary Outcomes (2)

  • Melanocortin receptor expression

    Melanocortin receptor expression determined like previously: https://pubmed.ncbi.nlm.nih.gov/27434862/

    3 months.

  • Serum proteome

    Mass spectrometry investigated serum proteome

    3 months.

Interventions

Blood samples before and after standard of care of polymyalgia rheumaticaOTHER

Blood samples were taken before glucocorticoid treatment and three months after.

Eligibility Criteria

Age50 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • 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.

    PMID: 21360492BACKGROUND

  • Pacheco 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.

    PMID: 12621591BACKGROUND

  • Liang 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.

    PMID: 4810661BACKGROUND

  • Owen CE, Buchanan RR, Hoi A. Recent advances in polymyalgia rheumatica. Intern Med J. 2015 Nov;45(11):1102-8. doi: 10.1111/imj.12823.

    PMID: 26036315BACKGROUND

  • Salvarani 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.

    PMID: 22825731BACKGROUND

  • Behn 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.

    PMID: 6882032BACKGROUND

  • Dejaco 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.

    PMID: 26359488BACKGROUND

  • Salvarani 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.

    PMID: 15696567BACKGROUND

  • Salvarani 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.

    PMID: 17470831BACKGROUND

  • Kreiner 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.

    PMID: 20854662BACKGROUND

  • Stone 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.

    PMID: 28745999BACKGROUND

  • Arnett 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.

    PMID: 3358796BACKGROUND

  • Kermani 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.

    PMID: 24489611BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blod samples including lymphocytes and serum.

MeSH Terms

Conditions

Polymyalgia Rheumatica

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 28, 2022

First Posted

January 12, 2023

Study Start

March 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2022

Last Updated

January 12, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share