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Not yet recruiting NCT07394478

Study of the Association Between Sacroiliitis/Axial Spondylarthritis and Giant Cell Arteritis/ Polymyalgia Rheumatica

Observational Giant Cell Arteritis (GCA) Spondylarthritis Polymyalgia Rheumatica

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Description of population.
Who it may be relevant to
Registry conditions: Giant Cell Arteritis (GCA), Spondylarthritis, Polymyalgia Rheumatica. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Study of the Association Between Sacroiliitis/Axial Spondylarthritis and Giant Cell Arteritis/ Polymyalgia Rheumatica: A Case-control Observational Study

Overview

The purpose of the study is to recruit as many patients as possible presenting with sacroiliitis or authentic axial spondylarthritis and giant cell arteritis. The investigators will also be interested in the association of spondylarthritis and polymyalgia rheumatica given the continuum between these two pathologies. The aim is to investigate whether there is an association between giant cell arteritis and spondylarthritis or polymyalgia rheumatica and spondylarthritis.

Detailed description

Large vessel vasculitis primarily includes Takayasu's arteritis and Giant Cell Arteritis (GCA). The literature describes associations between spondyloarthritis and large vessel vasculitis, particularly with Takayasu's arteritis. Case reports have highlighted specific features in patients presenting with both conditions, such as an older age at spondyloarthritis diagnosis and higher C-reactive protein (CRP) levels, for example.

However, to date, no cases of axial spondyloarthritis associated with confirmed GCA have been reported in the literature.

The investigators plan to recruit cases (patients with GCA and/or polymyalgia rheumatica \[PMR\] plus spondyloarthritis) and controls (patients with GCA or PMR alone). The investigators will then analyze their characteristics to investigate a potential association between these diseases.

Interventions

  • Other Description of population
    Description of population in the aim of identify demographic or phenotypic factors different between experimental and control populations.

Primary outcome measures

  • Description of the population of patients with spondylarthritis associated with giant cell arteritis (GCA) or polymyalgia rheumatica (PMR) versus patients with GCA or PMR alone [Time frame: At baseline]

Eligibility criteria

Inclusion criteria

  • Experimental group: Adult patient with spondylitis associated with GCA or PMR Control group: Adult patient with GCA or PMR

Exclusion criteria

  • Refusal to participate
  • Positive anti CCP

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

France · 2 centers
  • CRI (Rheumatism and Inflammatory Club) — Paris
  • GEFA (French Group for the study of large vessel Arteritis) — Toulouse

Publications

  • Healey LA. Relation of giant cell arteritis to polymyalgia rheumatica. Baillieres Clin Rheumatol. 1991 Dec;5(3):371-8. doi: 10.1016/s0950-3579(05)80059-7. PMID 1807815
  • Aydeniz A, Akaltun MS, Gur A, Gursoy S. [Coexistence of polymyalgia rheumatica with ankylosing spondylitis: A case report]. Agri. 2018 Jan;30(1):35-37. doi: 10.5505/agri.2016.69672. Turkish. PMID 29450875
  • Corli J, Lemeunier L, Le Gouellec N, Flipo RM. Giant cell arteritis occurring during psoriatic arthritis treated by adalimumab. Joint Bone Spine. 2015 Jul;82(4):291-2. doi: 10.1016/j.jbspin.2014.11.003. Epub 2015 Feb 14. No abstract available. PMID 25686529
  • Clementz GL, Gold F, Khaiser N, Zolin WD, Jalovec L. Giant cell arteritis associated with pericarditis and pancreatic insufficiency in a patient with psoriatic arthritis. J Rheumatol. 1989 Jan;16(1):128-9. PMID 2716001
  • Garcia-Cezon de la Cruz MDP, Almodovar R, Garcia Perez J, Dhimes PF, Zarco P. Aortitis due to giant cell arteritis and psoriatic arthritis: An uncommon association. Reumatol Clin. 2017 Jul-Aug;13(4):230-232. doi: 10.1016/j.reuma.2016.03.016. Epub 2016 May 4. English, Spanish. PMID 27131857
  • Elkayam O, Paran D, Yaron M, Caspi D. Polymyalgia rheumatica in patients with ankylosing spondylitis: a report of 5 cases. Clin Exp Rheumatol. 1997 Jul-Aug;15(4):411-4. PMID 9272303
  • Eshed I, Druyan A, Stern M, Bordavka M, Lidar M. The prevalence of sacroiliitis on abdominal MRI examinations of patients with Takayasu arteritis. Acta Radiol. 2022 Mar;63(3):387-392. doi: 10.1177/0284185121996270. Epub 2021 Apr 11. PMID 33843285
  • Mielnik P, Hjelle AM, Nordeide JL. Coexistence of Takayasu's arteritis and ankylosing spondylitis may not be accidental - Is there a need for a new subgroup in the spondyloarthritis family? Mod Rheumatol. 2018 Mar;28(2):313-318. doi: 10.1080/14397595.2017.1341592. Epub 2017 Jul 18. PMID 28718336

Identifiers

NCT: NCT07394478 · CHRD 1625

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗