AortitisTILTNCT06271018
TocILizumab in aorTitis in GCA (TILT)
An observational study of Aortitis and Giant Cell Arteritis (GCA), run by Groupe français d'étude des Maladies Inflammatoires de loeil at 1 site in France.
Trial summary
This is a french multicenter observational study assessing safety and efficacy of biosimilar of Tocilizumab in Giant Cell Arteritis (GCA) with active aortitis, including 14 reference centers from the Groupe d'Etude Français des vascularites des gros vaisseaux (GEFA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortitis, Giant Cell Arteritis (GCA)
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 27 Mar 2024to 27 Mar 2028
- 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: Adult patients with active aortitis associated with GCA, requiring treatment with Tocilizumab biosimilar within the scope of its market authorization (standard of care)
Who may be able to join
- Patients ≥18 years
- Signed informed consent
- Affiliation with the French national social security system
- Adequate and effective contraceptive measures
- For women of childbearing age, a negative serum pregnancy test.
- Diagnosis of GCA according to 2022 ACR/EULAR criteria
Show all 9Show fewer
- Active newly diagnosed or relapsing Aortitis related to GCA proved by imaging (Tep-scan, angio-CT or magnetic resonance imaging angiography)
- No neoplasia
- No contraindication to Tocilizumab
Who cannot join
- Pregnancy or breastfeeding ;
- History of severe immunosuppression, HIV or HBsAg positive
- Non response or intolerance to previous therapy with tocilizumab
- Positive QuantiFERON test result (QFT-TBGIn-Tube)
- Have received live vaccines within 3 months prior to the start of the trial
- History of malignancy in the last 5 years
Show all 12Show fewer
- Severe renal impairment (creatinine clearance <30mL/min/1.73m²)
- Liver dysfunction defined as aspartate transaminase (AST) or alanine transaminase (ALT) levels ≥ 5 at the upper limit of normal
- Blood count abnormality:
- Platelet count < 50 x 10.3/mm3
- Neutropenia < 1000/mm3
- Hemoglobin < 8 g/dl
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Département de Medecine interne et d'immunologie clinique - hôpital La Pitié Salpetrière
Paris, 75013
David Saadoun, +33142178042, david.saadoun@aphp.fr
About this study
Official title: Prospective, Observational Study Assessing Safety and Efficacy of Biosimilar of Tocilizumab in Giant Cell Arteritis (GCA) With Active Aortitis
This is a french multicenter observational study assessing safety and efficacy of biosimilar of Tocilizumab in Giant Cell Arteritis (GCA) with active aortitis, including 14 reference centers from the Groupe d'Etude Français des vascularites des gros vaisseaux (GEFA).
Giant Cell Arteritis (GCA), formerly known as temporal arteritis, is the most common form of systemic vasculitis in patients aged ≥ 50 years. GCA is defined by granulomatous arteritis that affects large#sized and medium#sized blood vessels with a predisposition to affect the cranial arteries. Aortitis accounted for more than 50% of GCA patients with the new imaging techniques. Aortitis is typically diagnosed using imaging tests such as magnetic resonance imaging (MRI) or Computed Tomography (CT) scans. Aortitis is an inflammation of the aorta, leading to a range of symptoms such as fever, weight loss, fatigue, and chest pain. In severe cases, aortic aneurysms or aortic dissection can occur, which can be life-threatening.
Read more
Multiple reports have demonstrated the presence of abnormal pro-inflammatory cytokine production in large-vessel vasculitis patients, particularly those with GCA, including interleukin-1 (IL-1), IL-6, IL-18, tumor necrosis factor-α (TNF-α), and interferon-γ, by T lymphocytes and macrophages. IL-6 has been implicated as a crucial cytokine in the pathogenesis of aortitis and targeting its signaling has shown promising results in treating the condition. IL-6 inhibitors such as tocilizumab have been found to effectively reduce disease activity and improve clinical outcomes in GCA patients.
The GIACTA study (GiAnt cell arteritis roActemra (tocilizumab) study) was a randomized, double-blind, placebo-controlled trial that evaluated the efficacy and safety of tocilizumab in the treatment of GCA. The study included 251 patients with newly diagnosed or relapsing GCA and found that treatment with tocilizumab significantly increased the proportion of patients who achieved sustained remission from GCA at 52 weeks, compared to placebo. Additionally, tocilizumab was associated with a lower incidence of disease flares and a reduced need for glucocorticoid therapy.
Following the positive results of the GIACTA study, tocilizumab was approved for the treatment of GCA in adults with active disease, including aortitis, who have not responded to glucocorticoids, or for whom glucocorticoid therapy is not appropriate, by regulatory agencies around the world, including the US Food and Drug Administration and the European Medicines Agency.
However, the efficacy of IL-6 inhibitors on aorta inflammation as assessed by modern and powerful imaging techniques has never been specifically studied in GCA.
This observational study will provide important informations on the impact of Tyenne® (tocilizumab) associated with short term low dose steroids on clinical manifestations and vessel inflammation and damage in aortitis of GCA.
Read the detailed description
This is a prospective, observational study involving patients with active aortitis related to GCA.
After verification of the inclusion and exclusion criteria, and signature of the consent form, patients are included in the study. Patients will be followed and managed according to standard of care (visits and exams).
Oral corticosteroids must be at a stable dose for at least 2 weeks prior to the first administration of study drug at D0.
- All patients will receive oral prednisone ≥ 10 mg/day (or oral corticosteroid equivalent) with a maximum of 60 mg/day of prednisone or equivalent.
- A standardized prednisone reduction schedule (see below) will be applied to all groups as long as the disease is inactive, until prednisone is stopped. The aim is to taper off corticosteroids within eight weeks.
- At D0, MSB11456 / 1 injection S/C weekly will be initiated
- Blood samples will be taken every month up to week 52 for assessment of toxicity and inflammation markers.
- Assessment of adverse events will be done routinely at weeks 12, 24, 36, 52 and 104.
- Clinical evaluation will be performed routinely at weeks 12, 24, 36, 52 and 104.
- Targeted imaging studies (angio-CT) will be performed routinely at 6, 12 and 24 months after the start of treatment and if new symptoms appear.
- FDG Pet scan will be performed routinely at 6, 12 and 24 months after the start of treatment
- Angio-CT and FDG Pet scan will be proofread centrally. A standardized prednisone reduction schedule (see below) will be applied to all patients as long as the disease is inactive, until prednisone is stopped :
Baseline prednisone dose Corresponding dose (mg/day) at each week
CG(mg/d) ____60_____50_____40_____30_____25_____20_____15____10____7.5 (at baseline)
60__________W0
50__________W1____W0
40__________W2____W1____W0
30__________W3____W2____W1____W0
25___________ - ____W3____W2____W1____W0
20__________W4____W4____W3____W2____W1____W0
15__________W5____W5____W4____W3____W2____W1____W0
10__________W6____W6____W5____W4____W3____W2____W2____W0
7.5__________ - _____ - ______ - _____W5____W4____W3____W3____W1____W0
5 ___________W7____W7____W6____W6____W5____W4____W4____W2____W2
0 ___________W8____W8____W7____W7____W6____W6____W5____W4____W4
Sample size:
The investigators anticipated a remission rate of 70% at weel 24 based on pooled data from Viliger et al (1) and Stone et al (2). Viliger et al reported 85% of GCA remission at week 12 and week 52 with tocilizumab(1). Stone et al reported 56% of remission of GCA at week 52 under tocilizumab weekly with less than 10% of relpases between week 24 and week 52 (2). A total of 80 patients will ensure estimating the 24-week remission rate with a precision of +/- 11% using an exact 95% confidence intervalgiven the expected 70% remission rate.
Statistical analysis:
Descriptive analyses will be performed with counts and percent for discrete variables and median and interquartile range for continuous variables. The primary endpoint will be described with the 24-week remission proportion point estimate and its exact 95% confidence interval (95%CI) (Clopper Pearson). Secondary endpoints will be described using a similar approach for binary endpoints,continuous endpoints will be decsribed unsing median (IQR) and also mean (SD) with approximate Gaussian 95%CI for the mean.Kaplan Meier estimator or cumulative incidence estimates allowing competing risks when appropriate (i.e. treatment discontinuation due to toxicity), will be used for right-ecensored time to event variables, with 95% confidence intervals.
- Conditions
- Aortitis, Giant Cell Arteritis (GCA)
- Keywords
- Giant Cell Arteritis (GCA), Aortitis, Tocilizumab
- Medical subject headings
- Aortitis, Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Aortitis in GCA | Adult patients with active aortitis associated with GCA, requiring treatment with Tocilizumab biosimilar used within the scope of its market authorization (standard of care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the proportion of patients with remission of GCA
Proportion of patients with remission of GCA at week 24. EULAR consensus definitions for remission in GCA and other types of LVV is defined as the absence of all clinical signs and symptoms attributable to active LVV, normalization of ESR and CRP values, and no evidence of progressive aortic damage at angio CT and Tep FDG.
Measured: week 24
Secondary outcomes (6)
To assess the cumulative incidence of relapse
Cumulative incidence of relapse
Measured: Weeks 12, 24, 36 , 52 and 104
To assess the proportion of GCA in remission (according to EULAR consensus definitions) after treatment start
Proportion of GCA in remission according to EULAR consensus definitions) after treatment start
Measured: Weeks 12, 24, 36 , 52 and 104
To assess the cumulative dose of prednisone
Cumulative prednisone dose
Measured: Weeks 12, 24, 36, 52 and 104
To assess the cumulative incidence of severe adverse events
- Glucocorticoid Toxicity Index (GTI) at Weeks 24, 52 and 104;
- Cumulative incidence of severe adverse events at Weeks 12, 24, 36 , 52 and 104, defined as those of grades III, IV or V, according to the Common Terminology Criteria for Adverse Events (CTCAE);
Measured: Weeks 12, 24, 36, 52 and 104
To assess the proportion of radiological vascular progression
Proportion of radiological vascular progression defined by :
- new vascular lesions detected in CTA
- new vascular lesions detected in Tep-scan
Measured: Weeks 12, 24, 36 , 52 and 104
To assess the cumulative incidence of vascular revascularization procedures
Cumulative incidence of vascular revascularization procedures needs (either endovascular or surgical) required due to inflammatory vascular activity
Measured: Weeks 24, 52 and 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start27 Mar 2024
- Primary completion27 Sep 2026 (estimated)
- Study completion27 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AortitisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe français d'étude des Maladies Inflammatoires de loeil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271018
- Sponsor's protocol ID
- GMIO-2024-0001
- Acronym
- TILT
- Status last verified
- Dec 2024
- First submitted
- 14 Feb 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Villiger PM, Adler S, Kuchen S, Wermelinger F, Dan D, Fiege V, Butikofer L, Seitz M, Reichenbach S. Tocilizumab for induction and maintenance of remission in giant cell arteritis: a phase 2, randomised, double-blind, placebo-controlled trial. Lancet. 2016 May 7;387(10031):1921-7. doi: 10.1016/S0140-6736(16)00560-2. Epub 2016 Mar 4.
PubMed 26952547Stone JH, Tuckwell K, Dimonaco S, Klearman M, Aringer M, Blockmans D, Brouwer E, Cid MC, Dasgupta B, Rech J, Salvarani C, Schett G, Schulze-Koops H, Spiera R, Unizony SH, Collinson N. Trial of Tocilizumab in Giant-Cell Arteritis. N Engl J Med. 2017 Jul 27;377(4):317-328. doi: 10.1056/NEJMoa1613849.
PubMed 28745999Hellmich B, Agueda A, Monti S, Buttgereit F, de Boysson H, Brouwer E, Cassie R, Cid MC, Dasgupta B, Dejaco C, Hatemi G, Hollinger N, Mahr A, Mollan SP, Mukhtyar C, Ponte C, Salvarani C, Sivakumar R, Tian X, Tomasson G, Turesson C, Schmidt W, Villiger PM, Watts R, Young C, Luqmani RA. 2018 Update of the EULAR recommendations for the management of large vessel vasculitis. Ann Rheum Dis. 2020 Jan;79(1):19-30. doi: 10.1136/annrheumdis-2019-215672. Epub 2019 Jul 3.
PubMed 31270110
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational Study Assessing Safety and Efficacy of Biosimilar of Tocilizumab in Giant Cell Arteritis (GCA) With Active Aortitis
- ClinicalTrials.gov ID
- NCT06271018
- Acronym / sponsor ID
- TILT / GMIO-2024-0001
- Conditions
- Aortitis, Giant Cell Arteritis (GCA)
- Keywords
- Giant Cell Arteritis (GCA), Aortitis, Tocilizumab
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Groupe français d'étude des Maladies Inflammatoires de loeilUniversity, hospital or other
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- 27 Sep 2026 (estimated)
- Study completion
- 27 Mar 2028 (estimated)
- First posted
- 21 Feb 2024 (actual)
- 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.
This is a french multicenter observational study assessing safety and efficacy of biosimilar of Tocilizumab in Giant Cell Arteritis (GCA) with active aortitis, including 14 reference centers from the Groupe d'Etude Français des vascularites des gros vaisseaux (GEFA).
Giant Cell Arteritis (GCA), formerly known as temporal arteritis, is the most common form of systemic vasculitis in patients aged ≥ 50 years. GCA is defined by granulomatous arteritis that affects large#sized and medium#sized blood vessels with a predisposition to affect the cranial arteries. Aortitis accounted for more than 50% of GCA patients with the new imaging techniques. Aortitis is typically diagnosed using imaging tests such as magnetic resonance imaging (MRI) or Computed Tomography (CT) scans. Aortitis is an inflammation of the aorta, leading to a range of symptoms such as fever, weight loss, fatigue, and chest pain. In severe cases, aortic aneurysms or aortic dissection can occur, which can be life-threatening.
Multiple reports have demonstrated the presence of abnormal pro-inflammatory cytokine production in large-vessel vasculitis patients, particularly those with GCA, including interleukin-1 (IL-1), IL-6, IL-18, tumor necrosis factor-α (TNF-α), and interferon-γ, by T lymphocytes and macrophages. IL-6 has been implicated as a crucial cytokine in the pathogenesis of aortitis and targeting its signaling has shown promising results in treating the condition. IL-6 inhibitors such as tocilizumab have been found to effectively reduce disease activity and improve clinical outcomes in GCA patients.
The GIACTA study (GiAnt cell arteritis roActemra (tocilizumab) study) was a randomized, double-blind, placebo-controlled trial that evaluated the efficacy and safety of tocilizumab in the treatment of GCA. The study included 251 patients with newly diagnosed or relapsing GCA and found that treatment with tocilizumab significantly increased the proportion of patients who achieved sustained remission from GCA at 52 weeks, compared to placebo. Additionally, tocilizumab was associated with a lower incidence of disease flares and a reduced need for glucocorticoid therapy.
Following the positive results of the GIACTA study, tocilizumab was approved for the treatment of GCA in adults with active disease, including aortitis, who have not responded to glucocorticoids, or for whom glucocorticoid therapy is not appropriate, by regulatory agencies around the world, including the US Food and Drug Administration and the European Medicines Agency.
However, the efficacy of IL-6 inhibitors on aorta inflammation as assessed by modern and powerful imaging techniques has never been specifically studied in GCA.
This observational study will provide important informations on the impact of Tyenne® (tocilizumab) associated with short term low dose steroids on clinical manifestations and vessel inflammation and damage in aortitis of GCA.
Detailed description
This is a prospective, observational study involving patients with active aortitis related to GCA.
After verification of the inclusion and exclusion criteria, and signature of the consent form, patients are included in the study. Patients will be followed and managed according to standard of care (visits and exams).
Oral corticosteroids must be at a stable dose for at least 2 weeks prior to the first administration of study drug at D0.
- All patients will receive oral prednisone ≥ 10 mg/day (or oral corticosteroid equivalent) with a maximum of 60 mg/day of prednisone or equivalent.
- A standardized prednisone reduction schedule (see below) will be applied to all groups as long as the disease is inactive, until prednisone is stopped. The aim is to taper off corticosteroids within eight weeks.
- At D0, MSB11456 / 1 injection S/C weekly will be initiated
- Blood samples will be taken every month up to week 52 for assessment of toxicity and inflammation markers.
- Assessment of adverse events will be done routinely at weeks 12, 24, 36, 52 and 104.
- Clinical evaluation will be performed routinely at weeks 12, 24, 36, 52 and 104.
- Targeted imaging studies (angio-CT) will be performed routinely at 6, 12 and 24 months after the start of treatment and if new symptoms appear.
- FDG Pet scan will be performed routinely at 6, 12 and 24 months after the start of treatment
- Angio-CT and FDG Pet scan will be proofread centrally. A standardized prednisone reduction schedule (see below) will be applied to all patients as long as the disease is inactive, until prednisone is stopped :
Baseline prednisone dose Corresponding dose (mg/day) at each week
CG(mg/d) ____60_____50_____40_____30_____25_____20_____15____10____7.5 (at baseline)
60__________W0
50__________W1____W0
40__________W2____W1____W0
30__________W3____W2____W1____W0
25___________ - ____W3____W2____W1____W0
20__________W4____W4____W3____W2____W1____W0
15__________W5____W5____W4____W3____W2____W1____W0
10__________W6____W6____W5____W4____W3____W2____W2____W0
7.5__________ - _____ - ______ - _____W5____W4____W3____W3____W1____W0
5 ___________W7____W7____W6____W6____W5____W4____W4____W2____W2
0 ___________W8____W8____W7____W7____W6____W6____W5____W4____W4
Sample size:
The investigators anticipated a remission rate of 70% at weel 24 based on pooled data from Viliger et al (1) and Stone et al (2). Viliger et al reported 85% of GCA remission at week 12 and week 52 with tocilizumab(1). Stone et al reported 56% of remission of GCA at week 52 under tocilizumab weekly with less than 10% of relpases between week 24 and week 52 (2). A total of 80 patients will ensure estimating the 24-week remission rate with a precision of +/- 11% using an exact 95% confidence intervalgiven the expected 70% remission rate.
Statistical analysis:
Descriptive analyses will be performed with counts and percent for discrete variables and median and interquartile range for continuous variables. The primary endpoint will be described with the 24-week remission proportion point estimate and its exact 95% confidence interval (95%CI) (Clopper Pearson). Secondary endpoints will be described using a similar approach for binary endpoints,continuous endpoints will be decsribed unsing median (IQR) and also mean (SD) with approximate Gaussian 95%CI for the mean.Kaplan Meier estimator or cumulative incidence estimates allowing competing risks when appropriate (i.e. treatment discontinuation due to toxicity), will be used for right-ecensored time to event variables, with 95% confidence intervals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aortitis in GCA | – | –Adult patients with active aortitis associated with GCA, requiring treatment with Tocilizumab biosimilar used within the scope of its market authorization (standard of care) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with active aortitis associated with GCA, requiring treatment with Tocilizumab biosimilar within the scope of its market authorization (standard of care)
Key inclusion criteria (9 listed)
- Patients ≥18 years
- Signed informed consent
- Affiliation with the French national social security system
- Adequate and effective contraceptive measures
- For women of childbearing age, a negative serum pregnancy test.
Key exclusion criteria (12 listed)
- Pregnancy or breastfeeding ;
- History of severe immunosuppression, HIV or HBsAg positive
- Non response or intolerance to previous therapy with tocilizumab
- Positive QuantiFERON test result (QFT-TBGIn-Tube)
- Have received live vaccines within 3 months prior to the start of the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the proportion of patients with remission of GCA
Time frame: week 24
Proportion of patients with remission of GCA at week 24. EULAR consensus definitions for remission in GCA and other types of LVV is defined as the absence of all clinical signs and symptoms attributable to active LVV, normalization of ESR and CRP values, and no evidence of progressive aortic damage at angio CT and Tep FDG.
6 secondary outcomes
To assess the cumulative incidence of relapse
Time frame: Weeks 12, 24, 36 , 52 and 104
To assess the proportion of GCA in remission (according to EULAR consensus definitions) after treatment start
Time frame: Weeks 12, 24, 36 , 52 and 104
To assess the cumulative dose of prednisone
Time frame: Weeks 12, 24, 36, 52 and 104
To assess the cumulative incidence of severe adverse events
Time frame: Weeks 12, 24, 36, 52 and 104
To assess the proportion of radiological vascular progression
Time frame: Weeks 12, 24, 36 , 52 and 104
To assess the cumulative incidence of vascular revascularization procedures
Time frame: Weeks 24, 52 and 104
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Results publication: PubMed 26952547Villiger PM, Adler S, Kuchen S, Wermelinger F, Dan D, Fiege V, Butikofer L, Seitz M, Reichenbach S. Tocilizumab for induction and maintenance of remission in giant cell arteritis: a phase 2, randomised, double-blind, placebo-controlled trial. Lancet. 2016 May 7;387(10031):1921-7. doi: 10.1016/S0140-6736(16)00560-2. Epub 2016 Mar 4.
- Results publication: PubMed 28745999Stone JH, Tuckwell K, Dimonaco S, Klearman M, Aringer M, Blockmans D, Brouwer E, Cid MC, Dasgupta B, Rech J, Salvarani C, Schett G, Schulze-Koops H, Spiera R, Unizony SH, Collinson N. Trial of Tocilizumab in Giant-Cell Arteritis. N Engl J Med. 2017 Jul 27;377(4):317-328. doi: 10.1056/NEJMoa1613849.
- Results publication: PubMed 31270110Hellmich B, Agueda A, Monti S, Buttgereit F, de Boysson H, Brouwer E, Cassie R, Cid MC, Dasgupta B, Dejaco C, Hatemi G, Hollinger N, Mahr A, Mollan SP, Mukhtyar C, Ponte C, Salvarani C, Sivakumar R, Tian X, Tomasson G, Turesson C, Schmidt W, Villiger PM, Watts R, Young C, Luqmani RA. 2018 Update of the EULAR recommendations for the management of large vessel vasculitis. Ann Rheum Dis. 2020 Jan;79(1):19-30. doi: 10.1136/annrheumdis-2019-215672. Epub 2019 Jul 3.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortitis and Giant Cell Arteritis (GCA), run by Groupe français d'étude des Maladies Inflammatoires de loeil 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 9 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 20 Dec 2024. 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?
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 David SAADOUN, Professor (+33142178042, david.saadoun@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the proportion of patients with remission of GCA (time frame: week 24). 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 NCT06271018, which also lists 3 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 20 Dec 2024.