Giant Cells ArteritisBioACGNCT02844023
Biomarkers in Giant Cells Arteritis
A study testing Clinical evaluation, Paraclinical evaluation and Imaging in people with Giant Cells Arteritis, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Giant cells arteritis or Horton disease is a vasculitis that affects great vessels. This is the most frequent vasculitis of the population over the age of 50. This vasculitis is at the origin of an inflammatory infiltrate of arterial tunics, essentially composed of lymphocytes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Giant Cells Arteritis
- What is being tested?
- Clinical evaluation, Paraclinical evaluation and Imaging
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to 14 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient suffering from giant cells arteritis.
Who cannot join
- Healthy volunteer
- Treatment with corticosteroid since more than 8 days for a patient suffering from giant cells arteritis, exept for patients under corticosteroid for a polymyalgia rheumatica.
- Other diseases than giant cells arteritis that could introduce an inflammatory symptom, especially a tumoral process in progress or a chronic inflammatory disease (any other one than giant cells arteritis)
Trial locations and contacts
1 site in 1 country.
About this study
Giant cells arteritis or Horton disease is a vasculitis that affects great vessels. This is the most frequent vasculitis of the population over the age of 50. This vasculitis is at the origin of an inflammatory infiltrate of arterial tunics, essentially composed of lymphocytes. Clinical signs are a deterioration of general state, unusual cephalgias, jaw pain, scalp hyperesthesia, but can also be serious ischemic complication, especially ophthalmologic with the possibility to go blind. Until now, the standard treatment is a high dosage corticosteroid therapy.
Diagnosis is based on criterias of the American College of Rheumatology, dating back to 1990. The relapse rate is important, ranging from 10 to 64 % according to studies. There are also issues of becoming dependent on steroid.
Read more
So it is important to determine new diagnosis markers and a therapeutic following of giant cells arteritis.
With this study several biomarkers of inflammation will be studied in order to determine if one ore many of them have a good sensitivity and special feature for diagnosis and following of giant cells arteritis.
The main goal is to determine a new diagnosis marker for giant cells arteritis.
- Conditions
- Giant Cells Arteritis
- Being tested
- Clinical evaluation, Paraclinical evaluation, Imaging, Ophthalmologic examination, Dosage of biomarkers
- Keywords
- Arteritis, Biomarker, Horton disease
- Medical subject headings
- Arteritis, Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical evaluationBehavioural
With questionnaire.
Paraclinical evaluationOther
Symptom inflammatory, biomarkers.
ImagingDevice
Thoraco-abdominal scanner injected or PET scanner if contraindication for scanner.
Ophthalmologic examinationOther
Dosage of biomarkersBiological
Control patients.
| Study group | Role | What they receive |
|---|---|---|
| Patient with giant gells arteritis | Other | 50 patients with giant gells arteritis Receives: Behavioral: Clinical evaluation; Other: Paraclinical evaluation; Device: Imaging; Other: Ophthalmologic examination |
| Control patients | Other | 50 control patients : blood from French national blood service (EFS) Receives: Biological: Dosage of biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers's serum sampling
For dosage of biomarkers in serum, like serum amyloid A or interleukins.
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startJan 2015
- Primary completion14 Jan 2019
- Study completion14 Jan 2019
Why it stopped: recruitment failure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Giant Cells ArteritisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurence Bouillet, Professor, Principal investigator, Grenoble Hospital University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844023
- Sponsor's protocol ID
- 38RC15.198
- Acronym
- BioACG
- Status last verified
- Apr 2019
- First submitted
- 20 Jul 2016
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Hachulla E, Boivin V, Pasturel-Michon U, Fauchais AL, Bouroz-Joly J, Perez-Cousin M, Hatron PY, Devulder B. Prognostic factors and long-term evolution in a cohort of 133 patients with giant cell arteritis. Clin Exp Rheumatol. 2001 Mar-Apr;19(2):171-6.
PubMed 11326479Graham E, Holland A, Avery A, Russell RW. Prognosis in giant-cell arteritis. Br Med J (Clin Res Ed). 1981 Jan 24;282(6260):269-71. doi: 10.1136/bmj.282.6260.269.
PubMed 6779980Alba MA, Garcia-Martinez A, Prieto-Gonzalez S, Tavera-Bahillo I, Corbera-Bellalta M, Planas-Rigol E, Espigol-Frigole G, Butjosa M, Hernandez-Rodriguez J, Cid MC. Relapses in patients with giant cell arteritis: prevalence, characteristics, and associated clinical findings in a longitudinally followed cohort of 106 patients. Medicine (Baltimore). 2014 Jul;93(5):194-201. doi: 10.1097/MD.0000000000000033.
PubMed 25181312Proven A, Gabriel SE, Orces C, O'Fallon WM, Hunder GG. Glucocorticoid therapy in giant cell arteritis: duration and adverse outcomes. Arthritis Rheum. 2003 Oct 15;49(5):703-8. doi: 10.1002/art.11388.
PubMed 14558057Maffioli L, Mazzone A. Giant-cell arteritis and polymyalgia rheumatica. N Engl J Med. 2014 Oct 23;371(17):1652-3. doi: 10.1056/NEJMc1409206. No abstract available.
PubMed 25337761Kermani TA, Schmidt J, Crowson CS, Ytterberg SR, Hunder GG, Matteson EL, Warrington KJ. Utility of erythrocyte sedimentation rate and C-reactive protein for the diagnosis of giant cell arteritis. Semin Arthritis Rheum. 2012 Jun;41(6):866-71. doi: 10.1016/j.semarthrit.2011.10.005. Epub 2011 Nov 25.
PubMed 22119103Laria A, Zoli A, Bocci M, Castri F, Federico F, Ferraccioli GF. Systematic review of the literature and a case report informing biopsy-proven giant cell arteritis (GCA) with normal C-reactive protein. Clin Rheumatol. 2012 Sep;31(9):1389-93. doi: 10.1007/s10067-012-2031-3. Epub 2012 Jul 22.
PubMed 22820967Yoeruek E, Szurman P, Tatar O, Weckerle P, Wilhelm H. Anterior ischemic optic neuropathy due to giant cell arteritis with normal inflammatory markers. Graefes Arch Clin Exp Ophthalmol. 2008 Jun;246(6):913-5. doi: 10.1007/s00417-007-0762-7. Epub 2008 Apr 2.
PubMed 18386041Kyle V, Cawston TE, Hazleman BL. Erythrocyte sedimentation rate and C reactive protein in the assessment of polymyalgia rheumatica/giant cell arteritis on presentation and during follow up. Ann Rheum Dis. 1989 Aug;48(8):667-71. doi: 10.1136/ard.48.8.667.
PubMed 2782977Kieffer P, Hinschberger O, Ciobanu E, Jaeger-Bizet F, Drabo A, Mostoufizadeh T, Martzolff L. [Clinical and biological efficacy of tocilizumab in giant cell arteritis: report of three patients and literature review]. Rev Med Interne. 2014 Jan;35(1):56-9. doi: 10.1016/j.revmed.2012.12.012. Epub 2013 Sep 26. French.
PubMed 24075627Salvarani C, Magnani L, Catanoso M, Pipitone N, Versari A, Dardani L, Pulsatelli L, Meliconi R, Boiardi L. Tocilizumab: a novel therapy for patients with large-vessel vasculitis. Rheumatology (Oxford). 2012 Jan;51(1):151-6. doi: 10.1093/rheumatology/ker296. Epub 2011 Nov 10.
PubMed 22075063Unizony S, Arias-Urdaneta L, Miloslavsky E, Arvikar S, Khosroshahi A, Keroack B, Stone JR, Stone JH. Tocilizumab for the treatment of large-vessel vasculitis (giant cell arteritis, Takayasu arteritis) and polymyalgia rheumatica. Arthritis Care Res (Hoboken). 2012 Nov;64(11):1720-9. doi: 10.1002/acr.21750.
PubMed 22674883Samson M, Bonnotte B. [Giant-cell arteritis pathogenesis]. Presse Med. 2012 Oct;41(10):937-47. doi: 10.1016/j.lpm.2012.07.005. Epub 2012 Aug 14. French.
PubMed 22902103Martinez-Taboada VM, Alvarez L, RuizSoto M, Marin-Vidalled MJ, Lopez-Hoyos M. Giant cell arteritis and polymyalgia rheumatica: role of cytokines in the pathogenesis and implications for treatment. Cytokine. 2008 Nov;44(2):207-20. doi: 10.1016/j.cyto.2008.09.004. Epub 2008 Nov 4.
PubMed 18986814Ly KH, Liozon E, Fauchais AL, Vidal E. [Pathophysiology of giant cell arteritis]. Rev Med Interne. 2013 Jul;34(7):392-402. doi: 10.1016/j.revmed.2013.02.037. Epub 2013 Mar 23. French.
PubMed 23528439
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers in Giant Cells Arteritis
- ClinicalTrials.gov ID
- NCT02844023
- Acronym / sponsor ID
- BioACG / 38RC15.198
- Conditions
- Giant Cells Arteritis
- Keywords
- Arteritis, Biomarker, Horton disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment failure
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- 14 Jan 2019 (actual)
- Study completion
- 14 Jan 2019 (actual)
- First posted
- 26 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Giant cells arteritis or Horton disease is a vasculitis that affects great vessels. This is the most frequent vasculitis of the population over the age of 50. This vasculitis is at the origin of an inflammatory infiltrate of arterial tunics, essentially composed of lymphocytes. Clinical signs are a deterioration of general state, unusual cephalgias, jaw pain, scalp hyperesthesia, but can also be serious ischemic complication, especially ophthalmologic with the possibility to go blind. Until now, the standard treatment is a high dosage corticosteroid therapy.
Diagnosis is based on criterias of the American College of Rheumatology, dating back to 1990. The relapse rate is important, ranging from 10 to 64 % according to studies. There are also issues of becoming dependent on steroid.
So it is important to determine new diagnosis markers and a therapeutic following of giant cells arteritis.
With this study several biomarkers of inflammation will be studied in order to determine if one ore many of them have a good sensitivity and special feature for diagnosis and following of giant cells arteritis.
The main goal is to determine a new diagnosis marker for giant cells arteritis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with giant gells arteritis | Other | Behavioral: Clinical evaluation, Other: Paraclinical evaluation, Device: Imaging, Other: Ophthalmologic examination50 patients with giant gells arteritis |
| Control patients | Other | Biological: Dosage of biomarkers50 control patients : blood from French national blood service (EFS) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient suffering from giant cells arteritis.
Key exclusion criteria (3 listed)
- Healthy volunteer
- Treatment with corticosteroid since more than 8 days for a patient suffering from giant cells arteritis, exept for patients under corticosteroid for a polymyalgia rheumatica.
- Other diseases than giant cells arteritis that could introduce an inflammatory symptom, especially a tumoral process in progress or a chronic inflammatory disease (any other one than giant cells arteritis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical evaluationWith questionnaire. | Behavioural | Patient with giant gells arteritis |
| Paraclinical evaluationSymptom inflammatory, biomarkers. | Other | Patient with giant gells arteritis |
| ImagingThoraco-abdominal scanner injected or PET scanner if contraindication for scanner. | Device | Patient with giant gells arteritis |
| Ophthalmologic examination | Other | Patient with giant gells arteritis |
| Dosage of biomarkersControl patients. | Biological | Control patients |
Primary outcome
Biomarkers's serum sampling
Time frame: 3 minutes
For dosage of biomarkers in serum, like serum amyloid A or interleukins.
Results and safety
The study was stopped early (reason given: recruitment failure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Background: PubMed 11326479Hachulla E, Boivin V, Pasturel-Michon U, Fauchais AL, Bouroz-Joly J, Perez-Cousin M, Hatron PY, Devulder B. Prognostic factors and long-term evolution in a cohort of 133 patients with giant cell arteritis. Clin Exp Rheumatol. 2001 Mar-Apr;19(2):171-6.
- Background: PubMed 6779980Graham E, Holland A, Avery A, Russell RW. Prognosis in giant-cell arteritis. Br Med J (Clin Res Ed). 1981 Jan 24;282(6260):269-71. doi: 10.1136/bmj.282.6260.269.
- Background: PubMed 25181312Alba MA, Garcia-Martinez A, Prieto-Gonzalez S, Tavera-Bahillo I, Corbera-Bellalta M, Planas-Rigol E, Espigol-Frigole G, Butjosa M, Hernandez-Rodriguez J, Cid MC. Relapses in patients with giant cell arteritis: prevalence, characteristics, and associated clinical findings in a longitudinally followed cohort of 106 patients. Medicine (Baltimore). 2014 Jul;93(5):194-201. doi: 10.1097/MD.0000000000000033.
- Background: PubMed 14558057Proven A, Gabriel SE, Orces C, O'Fallon WM, Hunder GG. Glucocorticoid therapy in giant cell arteritis: duration and adverse outcomes. Arthritis Rheum. 2003 Oct 15;49(5):703-8. doi: 10.1002/art.11388.
- Background: PubMed 25337761Maffioli L, Mazzone A. Giant-cell arteritis and polymyalgia rheumatica. N Engl J Med. 2014 Oct 23;371(17):1652-3. doi: 10.1056/NEJMc1409206. No abstract available.
- Background: PubMed 22119103Kermani TA, Schmidt J, Crowson CS, Ytterberg SR, Hunder GG, Matteson EL, Warrington KJ. Utility of erythrocyte sedimentation rate and C-reactive protein for the diagnosis of giant cell arteritis. Semin Arthritis Rheum. 2012 Jun;41(6):866-71. doi: 10.1016/j.semarthrit.2011.10.005. Epub 2011 Nov 25.
- Background: PubMed 22820967Laria A, Zoli A, Bocci M, Castri F, Federico F, Ferraccioli GF. Systematic review of the literature and a case report informing biopsy-proven giant cell arteritis (GCA) with normal C-reactive protein. Clin Rheumatol. 2012 Sep;31(9):1389-93. doi: 10.1007/s10067-012-2031-3. Epub 2012 Jul 22.
- Background: PubMed 18386041Yoeruek E, Szurman P, Tatar O, Weckerle P, Wilhelm H. Anterior ischemic optic neuropathy due to giant cell arteritis with normal inflammatory markers. Graefes Arch Clin Exp Ophthalmol. 2008 Jun;246(6):913-5. doi: 10.1007/s00417-007-0762-7. Epub 2008 Apr 2.
- Background: PubMed 2782977Kyle V, Cawston TE, Hazleman BL. Erythrocyte sedimentation rate and C reactive protein in the assessment of polymyalgia rheumatica/giant cell arteritis on presentation and during follow up. Ann Rheum Dis. 1989 Aug;48(8):667-71. doi: 10.1136/ard.48.8.667.
- Background: PubMed 24075627Kieffer P, Hinschberger O, Ciobanu E, Jaeger-Bizet F, Drabo A, Mostoufizadeh T, Martzolff L. [Clinical and biological efficacy of tocilizumab in giant cell arteritis: report of three patients and literature review]. Rev Med Interne. 2014 Jan;35(1):56-9. doi: 10.1016/j.revmed.2012.12.012. Epub 2013 Sep 26. French.
- Background: PubMed 22075063Salvarani C, Magnani L, Catanoso M, Pipitone N, Versari A, Dardani L, Pulsatelli L, Meliconi R, Boiardi L. Tocilizumab: a novel therapy for patients with large-vessel vasculitis. Rheumatology (Oxford). 2012 Jan;51(1):151-6. doi: 10.1093/rheumatology/ker296. Epub 2011 Nov 10.
- Background: PubMed 22674883Unizony S, Arias-Urdaneta L, Miloslavsky E, Arvikar S, Khosroshahi A, Keroack B, Stone JR, Stone JH. Tocilizumab for the treatment of large-vessel vasculitis (giant cell arteritis, Takayasu arteritis) and polymyalgia rheumatica. Arthritis Care Res (Hoboken). 2012 Nov;64(11):1720-9. doi: 10.1002/acr.21750.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurence Bouillet, Professor principal investigator
Grenoble Hospital University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical evaluation, Paraclinical evaluation and Imaging in people with Giant Cells Arteritis, run by University Hospital, Grenoble at 1 site 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 3 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: stopped early, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: recruitment failure). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers's serum sampling (time frame: 3 minutes). 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 NCT02844023, which also lists 25 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 18 Apr 2019.