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Giant Cell Arteritis (GCA)SAGE PPRNCT07394478

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

An observational study of Giant Cell Arteritis (GCA) and Spondylarthritis, run by Hôpital NOVO at 2 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Description of population
How many people
10 participants
Where
2 sitesFrance
Study dates
1 Feb 2026to 30 Jun 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Refusal to participate
  • Positive anti CCP

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Mathilde WLODARCZYK contact

0033130754650

mathilde.wlodarczyk@ght-novo.fr

France2 sites

  • CRI (Rheumatism and Inflammatory Club)

    Paris

    Raphaele SEROR, 0033145213759, raphaele.seror@aphp.fr

  • GEFA (French Group for the study of large vessel Arteritis)

    Toulouse

    Laurent SAILLER, 0033561779678, sailler.l@chu-toulouse.fr

Other trials in France

About this study

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

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.

Being tested
Description of population
Keywords
Giant Cell Arteritis (GCA), Spondylarthritis, Polymyalgia rheumatica
Medical subject headings
Giant Cell Arteritis, Spondylarthritis, Polymyalgia Rheumatica

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Description of populationOther

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

Study groups in NCT07394478
Study groupRoleWhat they receive
Patients with GCA, spondylarthritis and/or polymyalgia rheumaticaPatients with GCA, spondylarthritis and/or polymyalgia rheumatica
Receives: Other: Description of population

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2026
  2. Study start1 Feb 2026 (estimated)
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

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-control
Time perspective
Retrospective
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07394478
Sponsor's protocol ID
CHRD 1625
Acronym
SAGE PPR
Status last verified
Feb 2026
First submitted
27 Jan 2026
Last updated
6 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Giant Cell Arteritis (GCA) and Spondylarthritis, run by Hôpital NOVO at 2 sites in France.

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 2 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: opening soon, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mathilde WLODARCZYK (0033130754650, mathilde.wlodarczyk@ght-novo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). 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 NCT07394478, which also lists 15 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 6 Feb 2026.

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