Autoimmune DiseasesARIESNCT06757426
Prospective Observational Study Evaluating the Safety and Efficacy of Immunomodulatory Therapies in Refractory Inflammatory and Autoimmune Diseases
An observational study of Autoimmune Diseases and Inflammatory Diseases, run by Groupe français d'étude des Maladies Inflammatoires de loeil at 17 sites in France.
Trial summary
Inflammatory and/or autoimmune diseases represent a very broad group of diseases with highly variable clinical features, including - but not limited to - systemic connectivites and vasculitides. As these diseases are rare and heterogeneous, it is difficult to conduct randomized clinical trials in this setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Diseases, Inflammatory Diseases
- How many people
- 80 participants
- Where
- 17 sitesFrance
- Study dates
- 15 Jan 2025to 15 Jul 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: Patients with refractory inflammatory and autoimmune diseases
Who may be able to join
- Patients over 18 years
- Enrolled in the French national social security system
- Diagnosis of an inflammatory/autoimmune disease meeting internationally accepted classification criteria;
- Clinical activity of their disease with biological and/or radiological signs, refractory to conventional therapeutic lines, requiring a new treatment as an addition or replacement according to clinical judgment.
- No formal contraindication to the new therapeutic class.
Who cannot join
- Pregnancy or breast-feeding (for women of childbearing potential, a negative serum pregnancy test will be required);
- History of severe immunosuppression, HIV or HBsAg positive.
- Positive QuantiFERON test result (QFT-TBGIn-Tube) for active tuberculosis (latent tuberculosis under treatment may be included).
- Have received live vaccines in the 3 months preceding the start of treatment.
- History of malignant tumor within the last 5 years.
- Severe renal insufficiency (creatinine clearance <30mL/min/1.73m²)
Show all 11Show fewer
- Liver dysfunction defined by aspartate transaminase (AST) or alanine transaminase (ALT) levels ≥ 5 times the upper limit of normal.
- Blood count abnormality:
- Platelets < 50 x 103/mm3
- Neutropenia < 1000/mm3
- Hemoglobin < 8 g/dL
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
France17 sites
Clinique Axium - Aix-en-provence
Aix-en-Provence, 13100
Thomas SENÉ, MD, +33442957153, dr.sene.axium@almaviva-sante.com
CH Simone Veil de BLOIS
Blois, 41000
Bertrand LIOGER, MD, +33254556365, liogerb@ch-blois.fr
CHU Caen Normandie
Caen, 14000
Hubert DE BOYSSON, Professor, +33231064678, deboysson-h@chu-caen.fr
CH du Mans
Le Mans, 72037
Pierre LOZAC'H, MD, +33243432799, plozach@ch-lemans.fr
APHM_Hôpital La Conception
Marseille, 13005
Pierre-André JARROT, MD, +33491383522, Pierre.JARROT@ap-hm.fr
APHM_Hôpital Nord
Marseille, 13915
Brigitte Granel, Professor, +33491968711, Brigitte.granel@ap-hm.fr
GHSIF Melun
Melun, 77000
Nabil BELFEKI, MD, +33181741818, nabil.belfeki@ghsif.fr
GHI Le Raincy Montfermeil
Montfermeil, 93370
Azeddine DELLAL, MD, +33141708000, azeddine.dellal@ght-gpne.fr
CHU Nantes - Hotel-Dieu
Nantes, 44000
Olivier Espitia, Professor, +33240083379, Olivier.espitia@chu-nantes.fr
APHP_Hopital Lariboisière
Paris, Île-de-France Region, 75010
Chloé Comarmond, MD, +33149958127, chloe.comarmondortoli@aphp.fr
APHP_Hôpital St Antoine
Paris, Île-de-France Region, 75012
Arsene Mekinian, Professor, +33149282153, arsene.mekinian@aphp.fr
APHP_ Hôpital Pitié-Salpêtrière
Paris, Île-de-France Region, 75013
David Saadoun, Professor, +33142178042, david.saadoun@aphp.fr
APHP_Hôpital Bichat
Paris, Île-de-France Region, 75018
Karim Sacre, Professor, +330140258705
APHP_Hopital Ambroise Paré
Paris, Île-de-France Region, 92100
Salim TRAD, Professor, +33149095496, salim.trad@aphp.fr
CHU Rouen_Hôpital Charles Nicolle
Rouen, 76000
Mathilde LECLERQ, MD, +332 32 88 73 96, Mathilde.Leclercq@chu-rouen.fr
Clinique Saint-Exupéry
Saint-Exupéry, 31400
Martin Michaud, MD, +33561173330, Martin.MICHAUD@clinique-saint-exupery.com
CHRU de Tours_Hôpital Bretenneau
Tours, 37000
Julie Magnant, MD, +33218370878, J.MAGNANT@chu-tours.fr
About this study
Inflammatory and/or autoimmune diseases represent a very broad group of diseases with highly variable clinical features, including - but not limited to - systemic connectivites and vasculitides. As these diseases are rare and heterogeneous, it is difficult to conduct randomized clinical trials in this setting. Refractory cases are therefore treated with drugs that are already available on the market for other indications in more frequent and clinically homogeneous diseases, such as inflammatory rheumatism and haematological malignancies.
Prescribing treatments from other specialties (e.g. rheumatology and oncohaematology) is a reality in the clinical practice of internists and immunologists, often representing an excellent solution for difficult-to-treat inflammatory and/or autoimmune diseases. As these molecules are prescribed without the availability of standardized data, it is essential to collect them prospectively to better characterize the efficacy and tolerability of these new therapeutic options in severe inflammatory and/or autoimmune diseases.
Read the detailed description
Inflammatory and/or autoimmune diseases represent a very broad group of diseases with highly variable clinical features, including - but not limited to - systemic connectivites and vasculitis. Individually, they are very rare diseases, generally estimated in terms of the number of cases per 100,000 or 1,000,000 inhabitants. However, if we consider all immune-mediated inflammatory diseases, it is estimated that they affect 4.5% of the world's population .
Despite their extreme heterogeneity in terms of clinical presentation, these diseases share several key pathogenic mechanisms. For example, over the past two decades, adaptive immunity has been successfully targeted with several monoclonal antibodies directed against B lymphocytes (e.g. rituximab, an anti-CD20) and co-stimulation between B and T lymphocytes (e.g. abatacept, a CTLA-4 agonist). Targeting cytokines common to several of these diseases has also proved effective in their management, in particular anti-TNF alpha and anti-IL-6, produced by cells of the innate and adaptive immune systems.
Although these molecules have ushered in a new era in the management of inflammatory and/or autoimmune diseases, not all patients are yet fully controlled, representing a major challenge in clinical practice.
Refractory cases are then treated with drugs that are already available on the market for other indications in more frequent and clinically homogeneous diseases, such as inflammatory rheumatism and haematological malignancies.
Certain therapeutic targets stand out. The first is the cytokine IL-17, which plays a crucial role in the polarization of T helper 17 (Th17) lymphocytes and orchestrates the adaptive response detectable in the blood and target tissues of various inflammatory and/or autoimmune diseases.
Another interesting modern strategy is the inhibition of the Janus kinase and signal transducer/activator of transcription (JAK/STAT) pathways, which act on several downstream cytokine receptors. The development of targeted oral therapies based on small molecules such as JAK inhibitors (JAKi) represents an effective means of simultaneously attenuating several downstream inflammatory pathways, and has enabled a paradigm shift in the treatment of various autoimmune and inflammatory conditions refractory to conventional therapy, with cortisone sparing as well.
Bispecific antibodies (BsAb) are a new class of drugs and one of the most promising immunotherapies for solid tumors and hematological malignancies. BsAbs combine the specificities of two therapeutic antibodies and simultaneously target different antigens or epitopes. They have attracted a great deal of interest over the past decade, thanks to their unique and versatile modes of action.
In summary, the prescription of commercially available treatments from other specialties (e.g. rheumatology and oncohaematology) is a reality in the clinical practice of internists and immunologists, often representing an excellent solution for difficult-to-treat inflammatory and/or autoimmune diseases. As these molecules are prescribed without the availability of standardized data, it is essential to collect them prospectively to better characterize the efficacy and tolerability of these new therapeutic options in inflammatory and/or autoimmune diseases.
- Conditions
- Autoimmune Diseases, Inflammatory Diseases
- Keywords
- autoimmune, inflamatory disease, Refraction
- Medical subject headings
- Autoimmune Diseases
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 |
|---|---|---|
| Adult patients with immune-mediated inflammatory disease refractory to conventional lines of therapy | Adult patients with immune-mediated inflammatory disease refractory to conventional lines of therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of complete remission from the disease at week 24
The primary outcome will be the proportion of complete remission from the disease at week 24 :
- absence of all clinical signs and symptoms ;
- normalization of fibrinogen and CRP values;
- absence of radiological signs of active disease (stable or improved imaging).
Measured: week 24
Secondary outcomes (7)
Evaluate the proportion of patients in clinical, biological or radiological remission
Evaluate the proportion of patients with clinical remission (endpoint #1 of the primary endpoint), biological remission (endpoint #2 of the primary endpoint) or radiological remission (endpoint #3 of the primary endpoint) at weeks 12 and 48 of the indicated treatment start.
Measured: week 12 and week 48
Cumulative incidence of relapse (i.e., recurrence of clinical symptoms associated with biological and/or radiological inflammatory activity following complete remission)
Cumulative incidence of relapse (i.e., recurrence of clinical symptoms associated with biological and/or radiological inflammatory activity following complete remission) at weeks 12, 24, 36 and 52;
Measured: weeks 12, 24, 36 and 52
Cumulative incidence of remission according to primary endpoint definitions
Cumulative incidence of remission according to primary endpoint definitions at weeks 12, 36 and 52
Measured: weeks 12, 36 and 52
Evaluate changes in median disease-specific activity scores
Evaluate changes in median disease-specific activity scores at weeks 12, 24, 36 and 52
Measured: weeks 12, 24, 36 and 52
Cumulative prednisone dose
Cumulative prednisone dose at weeks 12, 24, 36 and 52
Measured: weeks 12, 24, 36 and 52
Cumulative incidence of serious adverse events (i.e., those requiring hospitalization or death) at weeks 12, 24, 36 and 52
Cumulative incidence of serious adverse events (i.e., those requiring hospitalization or death) at weeks 12, 24, 36 and 52
Measured: weeks 12, 24, 36 and 52
Evolution of circulating immune cell populations & cytokines under treatment
Evolution of circulating immune cell populations \& cytokines under treatment by measuring the change in the proportion of B \& T cells \& cytokines in peripheral blood before, during and following treatment.
Measured: Weeks 0, 1, 2, 4, 12, 24, and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start15 Jan 2025 (estimated)
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Autoimmune DiseasesStudies 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
- NCT06757426
- Sponsor's protocol ID
- ARIES
- Other IDs
- 2024-A02472-45
- Acronym
- ARIES
- Status last verified
- Dec 2024
- First submitted
- 18 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Venhoff N, Schmidt WA, Bergner R, Rech J, Unger L, Tony HP, Finzel S, Andreica I, Kofler DM, Weiner SM, Lamprecht P, Schulze-Koops H, App C, Pournara E, Mendelson MH, Sieder C, Maricos M, Thiel J. Safety and efficacy of secukinumab in patients with giant cell arteritis (TitAIN): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Rheumatol. 2023 Jun;5(6):e341-e350. doi: 10.1016/S2665-9913(23)00101-7.
PubMed 38251601Klein C, Brinkmann U, Reichert JM, Kontermann RE. The present and future of bispecific antibodies for cancer therapy. Nat Rev Drug Discov. 2024 Apr;23(4):301-319. doi: 10.1038/s41573-024-00896-6. Epub 2024 Mar 6.
PubMed 38448606Hayter SM, Cook MC. Updated assessment of the prevalence, spectrum and case definition of autoimmune disease. Autoimmun Rev. 2012 Aug;11(10):754-65. doi: 10.1016/j.autrev.2012.02.001. Epub 2012 Feb 23.
PubMed 22387972Watts RA, Hatemi G, Burns JC, Mohammad AJ. Global epidemiology of vasculitis. Nat Rev Rheumatol. 2022 Jan;18(1):22-34. doi: 10.1038/s41584-021-00718-8. Epub 2021 Dec 1.
PubMed 34853411
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study Evaluating the Safety and Efficacy of Immunomodulatory Therapies in Refractory Inflammatory and Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT06757426
- Acronym / sponsor ID
- ARIES / ARIES
- Conditions
- Autoimmune Diseases, Inflammatory Diseases
- Keywords
- autoimmune, inflamatory disease, Refraction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Groupe français d'étude des Maladies Inflammatoires de loeilUniversity, hospital or other
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Jul 2028 (estimated)
- First posted
- 3 Jan 2025 (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.
Inflammatory and/or autoimmune diseases represent a very broad group of diseases with highly variable clinical features, including - but not limited to - systemic connectivites and vasculitides. As these diseases are rare and heterogeneous, it is difficult to conduct randomized clinical trials in this setting. Refractory cases are therefore treated with drugs that are already available on the market for other indications in more frequent and clinically homogeneous diseases, such as inflammatory rheumatism and haematological malignancies.
Prescribing treatments from other specialties (e.g. rheumatology and oncohaematology) is a reality in the clinical practice of internists and immunologists, often representing an excellent solution for difficult-to-treat inflammatory and/or autoimmune diseases. As these molecules are prescribed without the availability of standardized data, it is essential to collect them prospectively to better characterize the efficacy and tolerability of these new therapeutic options in severe inflammatory and/or autoimmune diseases.
Detailed description
Inflammatory and/or autoimmune diseases represent a very broad group of diseases with highly variable clinical features, including - but not limited to - systemic connectivites and vasculitis. Individually, they are very rare diseases, generally estimated in terms of the number of cases per 100,000 or 1,000,000 inhabitants. However, if we consider all immune-mediated inflammatory diseases, it is estimated that they affect 4.5% of the world's population .
Despite their extreme heterogeneity in terms of clinical presentation, these diseases share several key pathogenic mechanisms. For example, over the past two decades, adaptive immunity has been successfully targeted with several monoclonal antibodies directed against B lymphocytes (e.g. rituximab, an anti-CD20) and co-stimulation between B and T lymphocytes (e.g. abatacept, a CTLA-4 agonist). Targeting cytokines common to several of these diseases has also proved effective in their management, in particular anti-TNF alpha and anti-IL-6, produced by cells of the innate and adaptive immune systems.
Although these molecules have ushered in a new era in the management of inflammatory and/or autoimmune diseases, not all patients are yet fully controlled, representing a major challenge in clinical practice.
Refractory cases are then treated with drugs that are already available on the market for other indications in more frequent and clinically homogeneous diseases, such as inflammatory rheumatism and haematological malignancies.
Certain therapeutic targets stand out. The first is the cytokine IL-17, which plays a crucial role in the polarization of T helper 17 (Th17) lymphocytes and orchestrates the adaptive response detectable in the blood and target tissues of various inflammatory and/or autoimmune diseases.
Another interesting modern strategy is the inhibition of the Janus kinase and signal transducer/activator of transcription (JAK/STAT) pathways, which act on several downstream cytokine receptors. The development of targeted oral therapies based on small molecules such as JAK inhibitors (JAKi) represents an effective means of simultaneously attenuating several downstream inflammatory pathways, and has enabled a paradigm shift in the treatment of various autoimmune and inflammatory conditions refractory to conventional therapy, with cortisone sparing as well.
Bispecific antibodies (BsAb) are a new class of drugs and one of the most promising immunotherapies for solid tumors and hematological malignancies. BsAbs combine the specificities of two therapeutic antibodies and simultaneously target different antigens or epitopes. They have attracted a great deal of interest over the past decade, thanks to their unique and versatile modes of action.
In summary, the prescription of commercially available treatments from other specialties (e.g. rheumatology and oncohaematology) is a reality in the clinical practice of internists and immunologists, often representing an excellent solution for difficult-to-treat inflammatory and/or autoimmune diseases. As these molecules are prescribed without the availability of standardized data, it is essential to collect them prospectively to better characterize the efficacy and tolerability of these new therapeutic options in inflammatory and/or autoimmune diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with immune-mediated inflammatory disease refractory to conventional lines of therapy | – | –Adult patients with immune-mediated inflammatory disease refractory to conventional lines of therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with refractory inflammatory and autoimmune diseases
Key inclusion criteria (5 listed)
- Patients over 18 years
- Enrolled in the French national social security system
- Diagnosis of an inflammatory/autoimmune disease meeting internationally accepted classification criteria;
- Clinical activity of their disease with biological and/or radiological signs, refractory to conventional therapeutic lines, requiring a new treatment as an addition or replacement according to clinical judgment.
- No formal contraindication to the new therapeutic class.
Key exclusion criteria (11 listed)
- Pregnancy or breast-feeding (for women of childbearing potential, a negative serum pregnancy test will be required);
- History of severe immunosuppression, HIV or HBsAg positive.
- Positive QuantiFERON test result (QFT-TBGIn-Tube) for active tuberculosis (latent tuberculosis under treatment may be included).
- Have received live vaccines in the 3 months preceding the start of treatment.
- History of malignant tumor within the last 5 years.
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
proportion of complete remission from the disease at week 24
Time frame: week 24
The primary outcome will be the proportion of complete remission from the disease at week 24 : 1. absence of all clinical signs and symptoms ; 2. normalization of fibrinogen and CRP values; 3. absence of radiological signs of active disease (stable or improved imaging).
7 secondary outcomes
Evaluate the proportion of patients in clinical, biological or radiological remission
Time frame: week 12 and week 48
Cumulative incidence of relapse (i.e., recurrence of clinical symptoms associated with biological and/or radiological inflammatory activity following complete remission)
Time frame: weeks 12, 24, 36 and 52
Cumulative incidence of remission according to primary endpoint definitions
Time frame: weeks 12, 36 and 52
Evaluate changes in median disease-specific activity scores
Time frame: weeks 12, 24, 36 and 52
Cumulative prednisone dose
Time frame: weeks 12, 24, 36 and 52
Cumulative incidence of serious adverse events (i.e., those requiring hospitalization or death) at weeks 12, 24, 36 and 52
Time frame: weeks 12, 24, 36 and 52
Evolution of circulating immune cell populations & cytokines under treatment
Time frame: Weeks 0, 1, 2, 4, 12, 24, and 52
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 3 Jan 2025.
- Background: PubMed 38251601Venhoff N, Schmidt WA, Bergner R, Rech J, Unger L, Tony HP, Finzel S, Andreica I, Kofler DM, Weiner SM, Lamprecht P, Schulze-Koops H, App C, Pournara E, Mendelson MH, Sieder C, Maricos M, Thiel J. Safety and efficacy of secukinumab in patients with giant cell arteritis (TitAIN): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Rheumatol. 2023 Jun;5(6):e341-e350. doi: 10.1016/S2665-9913(23)00101-7.
- Background: PubMed 38448606Klein C, Brinkmann U, Reichert JM, Kontermann RE. The present and future of bispecific antibodies for cancer therapy. Nat Rev Drug Discov. 2024 Apr;23(4):301-319. doi: 10.1038/s41573-024-00896-6. Epub 2024 Mar 6.
- Background: PubMed 22387972Hayter SM, Cook MC. Updated assessment of the prevalence, spectrum and case definition of autoimmune disease. Autoimmun Rev. 2012 Aug;11(10):754-65. doi: 10.1016/j.autrev.2012.02.001. Epub 2012 Feb 23.
- Background: PubMed 34853411Watts RA, Hatemi G, Burns JC, Mohammad AJ. Global epidemiology of vasculitis. Nat Rev Rheumatol. 2022 Jan;18(1):22-34. doi: 10.1038/s41584-021-00718-8. Epub 2021 Dec 1.
- LBA0001 EFFICACY AND SAFETY OF UPADACITINIB IN PATIENTS WITH GIANT CELL ARTERITIS (SELECT-GCA): A DOUBLE-BLIND, RANDOMIZED CONTROLLED PHASE 3 TRIALLink provided by the sponsor.
- 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.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Diseases and Inflammatory Diseases, run by Groupe français d'étude des Maladies Inflammatoires de loeil at 17 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 5 inclusion and 11 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 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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 DAVID SAADOUN, Professor (+33142178042 ext. +33, david.saadoun@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of complete remission from the disease at week 24 (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 NCT06757426, which also lists 4 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 3 Jan 2025.