- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07394478
Study of the Association Between Sacroiliitis/Axial Spondylarthritis and Giant Cell Arteritis/ Polymyalgia Rheumatica (SAGE PPR)
Study of the Association Between Sacroiliitis/Axial Spondylarthritis and Giant Cell Arteritis/ Polymyalgia Rheumatica: A Case-control Observational Study
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mathilde WLODARCZYK
- Phone Number: 0033130754650
- Email: mathilde.wlodarczyk@ght-novo.fr
Study Locations
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-
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Paris, France
- CRI (Rheumatism and Inflammatory Club)
-
Contact:
- Raphaele SEROR
- Phone Number: 0033145213759
- Email: raphaele.seror@aphp.fr
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Toulouse, France
- GEFA (French Group for the study of large vessel Arteritis)
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Contact:
- Laurent SAILLER
- Phone Number: 0033561779678
- Email: sailler.l@chu-toulouse.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Patients with GCA, spondylarthritis and/or polymyalgia rheumatica
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Description of population in the aim of identify demographic or phenotypic factors different between experimental and control populations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Identification of demographic or phenotypic factors different between experimental and control populations.
|
At baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Omar AL TABAA, Hôpital NOVO
- Principal Investigator: Auriane CHADELAT, Hôpital NOVO
Publications and helpful links
General Publications
- L.A. Healey, Relation of giant cell arteritis to polymyalgia rheumatica, Baillière's Clinical Rheumatology, Volume 5, Issue 3, 1991, Pages 371-378, ISSN 0950-3579
- 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.
- Corli J, Lemeunier L, le Gouellec N, Flipo RM. Giant cell arteritis occurring during psoriatic arthritis treated by adalimumab. Joint Bone Spine. 2015;82:291-2.
- 13 Clementz GL, Gold F, Khaiser N, ZolinWD, Jalovec L. Giant cell arteritis associated with pericarditis and pancreatic insufficiency in a patient with psoriatic arthritis. Rheumatol. 1989;16:128-9.
- 12 Aortitis due to Giant Cell Arteritis and Psoriatic Arthritis: An Uncommon Association M. del Pilar García-Cezón de la Cruz,a Raquel Almodóvar,b,∗Javier García Pérez,c Patricia Fanny Dhimes,d Pedro Zarcob DOI: 10.1016/j.reumae.2016.03.013
- Elkayam O, Paran D, Yaron M, Caspi D. Polymyalgia rheumatica in patients with ankylosing spondylitis: a report of 5 cases. Clin Exp Rheumatol. 1997;15:411-4.
- 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.
- 8. Pawel Mielnik, Anja Myhre Hjelle, Jan Leidulv Nordeide, Coexistence of Takayasu's arteritis and ankylosing spondylitis may not be accidental - Is there a need for a new subgroup in the spondyloarthritis family?, Modern Rheumatology, Volume 28, Issue 2, 4 March 2018, Pages 313-318, https://doi.org/10.1080/14397595.2017.1341592 2018 Mar;28(2):313-318. doi: 10.1080/14397595.2017.1341592. Epub 2017 Jul 18.
- 7. Abacar, K., Kaymaz-Tahra, S., Bayındır, Ö. et al. Frequency and the effects of spondyloarthritis-spectrum disorders on the clinical course and management of Takayasu arteritis: an observational retrospective study. Clin Rheumatol 43, 1571-1578 (2024). https://doi.org/10.1007/s10067-024-06939-y
- 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.
- 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.
- 4. Güzel Esen S, Armagan B, Atas N, Ucar M, Varan Ö, Erden A et al (2019) Increased incidence of spondyloarthropathies in patients with Takayasu arteritis: a systematic clinical survey. Joint Bone Spine 86(4):497-501. https://doi.org/10.1016/j.jbspin.2019. 01.020
- 3. Kwon OC, Lee SW, Park YB, Oh JS, Lee SH, Hong S et al (2018) Extravascular manifestations of Takayasu arteritis: focusing on the features shared with spondyloarthritis. Arthritis Res Ther. 20(1):142. https://doi.org/10.1186/s13075-018-1643-7
- 2. Momeni M, Taylor N and Tehrani M. Cardiopulmonary manifestations of ankylosing spondylitis. Int J Rheumatol 2011; 2011: 728471
- 1. Ozkan Y. Cardiac involvement in ankylosing spondylitis. J Clin Med Res 2016; 8: 427-430
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Bone Diseases
- Musculoskeletal Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Muscular Diseases
- Arthritis
- Joint Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Autoimmune Diseases
- Immune System Diseases
- Autoimmune Diseases of the Nervous System
- Spinal Diseases
- Skin Diseases
- Skin Diseases, Vascular
- Spondylitis
- Vasculitis
- Vasculitis, Central Nervous System
- Arteritis
- Skin and Connective Tissue Diseases
- Spondylarthritis
- Polymyalgia Rheumatica
- Giant Cell Arteritis
Other Study ID Numbers
- CHRD 1625
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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