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Not yet recruitingNCT07394478SAGE PPRUpdated Feb 6, 2026

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

An observational study in Giant Cell Arteritis (GCA), Spondylarthritis and Polymyalgia Rheumatica, sponsored by Hôpital NOVO. Not yet recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-06.

Sponsored by Hôpital NOVO · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
10
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Giant Cell Arteritis (GCA)
  • Spondylarthritis
  • Polymyalgia Rheumatica

Keywords

  • Giant Cell Arteritis (GCA)
  • Spondylarthritis
  • Polymyalgia rheumatica
03

In context

Giant Cell Arteritis

147 studies on the registry are indexed under Giant Cell Arteritis; 49 are open to participants now.

This study's planned enrollment of 10 is below the median of 128 across 78 observational studies indexed under Giant Cell Arteritis.

Browse Giant Cell Arteritis studies →

Lead sponsor

Hôpital NOVO is the lead sponsor of 70 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Refusal to participate
  • Positive anti CCP
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
10 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with GCA, spondylarthritis and/or polymyalgia rheumatica

    Patients with GCA, spondylarthritis and/or polymyalgia rheumatica

    Other: Description of population

Interventions

  • OtherDescription of population

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

06

What researchers measure

Primary outcomes

  1. 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

    Identification of demographic or phenotypic factors different between experimental and control populations.

    Time frame: At baseline

07

Study locations

2 sites
  • CRI (Rheumatism and Inflammatory Club)
    Paris, France
  • GEFA (French Group for the study of large vessel Arteritis)
    Toulouse, France
08

References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 28718336 ↗
  • Abacar K, Kaymaz-Tahra S, Bayindir O, Ince B, Kutu ME, Yazici A, Ediboglu ED, Demirci-Yildirim T, Ademoglu Z, Omma A, Yasar-Bilge NS, Kimyon G, Kasifoglu T, Emmungil H, Onen F, Akar S, Cefle A, Alpay-Kanitez N, Celik S, Inanc M, Aksu K, Keser G, Direskeneli H, Alibaz-Oner F. Frequency and the effects of spondyloarthritis-spectrum disorders on the clinical course and management of Takayasu arteritis: an observational retrospective study. Clin Rheumatol. 2024 May;43(5):1571-1578. doi: 10.1007/s10067-024-06939-y. Epub 2024 Apr 2. PubMed 38563865 ↗
  • Riviere E, Arnaud L, Ebbo M, Allanore Y, Claudepierre P, Dernis E, Ziza JM, Miceli-Richard C, Philippe P, Richez C, Soubrier M, Belkhir R, Seror R, Mariette X, Pavy S; Club Rhumatismes et Inflammations. Takayasu Arteritis and Spondyloarthritis: Coincidence or Association? A Study of 14 Cases. J Rheumatol. 2017 Jul;44(7):1011-1017. doi: 10.3899/jrheum.160762. Epub 2017 Apr 15. PubMed 28412700 ↗
  • Gan FY, Fei YY, Li MT, Wang Q, Xu D, Hou Y, Zeng XF, Zhang FC. The characteristics of patients having ankylosing spondylitis associated with Takayasu's arteritis. Clin Rheumatol. 2014 Mar;33(3):355-8. doi: 10.1007/s10067-013-2444-7. Epub 2013 Dec 6. PubMed 24310108 ↗
  • Guzel Esen S, Armagan B, Atas N, Ucar M, Varan O, Erden A, Babaoglu H, Sari A, Karadag O, Haznedaroglu S, Ozturk MA, Akdogan A, Tufan A. Increased incidence of spondyloarthropathies in patients with Takayasu arteritis: a systematic clinical survey. Joint Bone Spine. 2019 Jul;86(4):497-501. doi: 10.1016/j.jbspin.2019.01.020. Epub 2019 Feb 6. PubMed 30735804 ↗
  • Kwon OC, Lee SW, Park YB, Oh JS, Lee SH, Hong S, Lee CK, Yoo B, Kim YG. Extravascular manifestations of Takayasu arteritis: focusing on the features shared with spondyloarthritis. Arthritis Res Ther. 2018 Jul 11;20(1):142. doi: 10.1186/s13075-018-1643-7. PubMed 29996949 ↗
  • Momeni M, Taylor N, Tehrani M. Cardiopulmonary manifestations of ankylosing spondylitis. Int J Rheumatol. 2011;2011:728471. doi: 10.1155/2011/728471. Epub 2011 Apr 12. PubMed 21547038 ↗
  • Ozkan Y. Cardiac Involvement in Ankylosing Spondylitis. J Clin Med Res. 2016 Jun;8(6):427-30. doi: 10.14740/jocmr2488w. Epub 2016 May 25. PubMed 27222669 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Feb 2026; primary completion for Jun 2026, 4 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 27, 2026
First posted
Feb 6, 2026
StartEst.
Feb 1, 2026
Primary completionEst.
Jun 30, 2026
CompletionEst.
Jun 30, 2026
Last update
Feb 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07394478
Lead sponsor
Hôpital NOVO
Collaborators
GEFA, CRI
Responsible party
Sponsor
First posted
Feb 6, 2026
Start date
Feb 1, 2026 (estimated)
Primary completion
Jun 30, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Feb 6, 2026

Study contacts

Mathilde WLODARCZYK
Contact
mathilde.wlodarczyk@ght-novo.fr
0033130754650
Omar AL TABAA
principal investigator · Hôpital NOVO
Auriane CHADELAT
principal investigator · Hôpital NOVO

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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