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.
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
- Conditions the study is for
- Giant Cell Arteritis (GCA), Spondylarthritis, Polymyalgia Rheumatica
- 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
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.
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
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 group | Role | What they receive |
|---|---|---|
| Patients with GCA, spondylarthritis and/or polymyalgia rheumatica | Patients 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.
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.
- First posted6 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Giant Cell Arteritis (GCA)Studies 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-control
- Time perspective
- Retrospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Collaborators
- GEFA, CRI
- Responsible party
- Sponsor
- Investigators
- Omar AL TABAA, Principal investigator, Hôpital NOVOAuriane CHADELAT, Principal investigator, Hôpital NOVO
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 1807815Aydeniz 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 29450875Corli 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 25686529Clementz 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 2716001Garcia-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 27131857Elkayam 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 9272303Eshed 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 33843285Mielnik 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 28718336Abacar 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 38563865Riviere 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 28412700Gan 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 24310108Guzel 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 30735804Kwon 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 29996949Momeni 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 21547038Ozkan 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