Primary Sjögren's Syndrome (pSS)Phase 2NECESSITYNCT05113004
New Clinical End-points in Patients With Primary Sjögren's Syndrome
A Phase 2 study testing Hydroxychloroquine 400mg/d, Leflunomide 20mg/d and Mycophenolate mofetil 2000mg/d in people with Primary Sjögren's Syndrome (pSS), run by Assistance Publique - Hôpitaux de Paris at 7 sites in France.
Trial summary
There are no approved treatments for pSS and the clinical endpoints currently used in clinical trials are inadequate to capture all aspects of the disease that should be evaluated in clinical trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Sjögren's Syndrome (pSS)
- What is being tested?
- Hydroxychloroquine 400mg/d, Leflunomide 20mg/d and Mycophenolate mofetil 2000mg/d
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 7 sitesFrance
- Study dates
- 20 Jan 2022to 1 Oct 2025
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cohort 1
- Having given written informed consent prior to undertaking any study-related procedures.
- Patients with pSS according to ACR/EULAR 2016 criteria or AECG 2002 criteria
- With a high level of symptoms (ESSPRI ≥ 5) and low systemic disease activity (ESSDAI < 5).
- Negative pregnancy test (serum at screening)
- Use highly reliable contraception during research treatment from the screening and for two years after stopping treatment.
Show all 12Show fewer
- Cohort 2
- Having given written informed consent prior to undertaking any study-related procedures.
- Patients with pSS according to ACR/EULAR 2016 criteria or AECG 2002 criteria
- With moderate/high systemic disease activity, as defined by ESSDAI ≥ 5.
- Negative pregnancy test (serum at screening)
- Use highly reliable contraception during research treatment from the screening and for two years after stopping treatment
Who cannot join
- For both cohorts:
- Age < 18 years
- Pregnant or breastfeeding women or women wanted to conceive either during or within two years after the end of the treatment period
- Women of childbearing potential not using highly effective methods of contraception (as defined in section 6.3)
- Participation in another interventional trial
- Contra-indication to HCQ: pre-existing retinopathy, hypersensitivity to HCQ or to any of the excipients of the specialty used
Show all 32Show fewer
- Contra-indication to MMF: hypersensitivity to mycophenolate mofetil, acid mycophenolic, mycophenolate sodium or to any of the excipients of the specialty used
- Contra-indication tor LEF: hypersensitivity to the active substance, the main active metabolite teriflunomide or to any excipients of the specialty used.
- Concomitant treatment with corticosteroids more than 10 mg/day of prednisone equivalent at screening or inclusion (randomisation)
- Concomitant treatment with other immunomodulators including methotrexate, azathioprine, cyclophosphamide, cyclosporine and tacrolimus
- Previous treatment with HCQ, LEF, MMF in the last 3 months
- Previous treatment with rituximab, other B-cell targeted biologic therapy or cyclophosphamide in the last 6 months
- Previous treatment with anti-TNF, abatacept, tocilizumab or belimumab or any other biologic in the setting of a past clinical trial in the last 3 months
- Severe life-threatening systemic involvement requiring cyclophosphamide or high dose corticosteroids, or any drug considered as an exclusion criteria
- Impairment of other severe immunodeficiency states
- Patients with active malignancy or history of malignancy within the last 5 years except non-melanoma skin cancer
- Patients with history of gastrointestinal tract ulceration, hemorrhage and perforation
- Patients with history of cardiomyopathy
- Patients with known hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome
- Serious infection in the past month
- Evidence of active tuberculosis infection
- Active HCV (positive PCR)
- Active HBV infection (positivity for HBS antigen, or positivity for anti-HBC antibody without any HBS antigen)
- HIV infection (positive serology)
- Positive SARS-Cov2 PCR (if vaccinated for COVID-19, no PCR is required; if history of COVID-19 infection, positive serology is sufficient)
- Cytopenia defined as neutrophils < 1.0 G/L, lymphocytes < 0.5 G/L, Hb < 10 g/dl or platelets < 100 G/L
- Moderate to severe renal insufficiency (GFR < 30 ml/min)
- Severe hypogammaglobulinemia defined as gamma globulins or IgG < 5 g/l Reduced hepatic function: AST or ALT > 2x ULN (re-testing is allowed, see section 5.10)
- Prolonged ECG's corrected QT interval (>500 ms)
- Known history of maculopathy
- Patients will be informed of the risk of alcohol consumption and will be recommended to avoid alcohol during the entire study
- Not affiliated to a social security regime (specific for France)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites, 7 recruiting
- Recruiting
Valérie Devauchelle
Brest
Valérie Devauchelle, +33 2 98 34 77 07, valerie.devauchelle-pensec@chu-brest.fr
- Recruiting
Raphaele Seror
Le Kremlin-Bicêtre, Île-de-France Region
Raphaele PH Seror, Phd, +33 1 45 21 21 21
- Recruiting
Eric Hachulla
Lille, 59037
Eric Hachulla, +33 3 20 44 50 48, Eric.HACHULLA@CHRU-LILLE.FR
- Recruiting
Jacques Morel
Montpellier, 34295
Jacques Morel, +33467338710, -morel@chu-montpellier.fr
- Recruiting
Véronique Le Guern
Paris, 75014
Véronique Le Guern, +33 1 58 41 29 72, veronique.le-guern@aphp.fr
- Recruiting
Jacques-Eric Gottenberg
Strasbourg
Jacques-Eric Gottenberg, +33 3 88127953, jegotten@gmail.com
- Recruiting
Christophe Richez
Talence, 33404
Christophe Richez, +33 (0)5 57 82 04 93, christophe.richez@me.com
About this study
Official title: NEw Clinical Endpoints in Patients With Primary Sjögren's Syndrome (pSS): an Interventional Trial Based on stratifYing Patients
There are no approved treatments for pSS and the clinical endpoints currently used in clinical trials are inadequate to capture all aspects of the disease that should be evaluated in clinical trials. The newly developed composite endpoint: Sjögren's Tool for Assessing Response to treatment (STAR) will allow a more specific and meaningful assessment of treatment efficacy in pSS.
Because of the heterogeneity of the disease and of the central role of the interplay between B- and T-cells in the pathogenesis, it is worth to evaluate combination of conventional synthetic immunomodulatory drugs targeting both B- and T-cells.
Read the detailed description
Primary Sjögren's syndrome (pSS) is a systemic autoimmune disease with a female-to-male predominance of 9:1 and a peak incidence at 50 years of age. It is characterized by chronic inflammation and subsequent destruction of exocrine glands, mainly lacrimal and salivary glands, with ocular and oral dryness. Patients also experience joint pain and extreme fatigue. In 20-40% of patients, the inflammatory process extends beyond the exocrine glands and patients experience systemic extra glandular manifestations, with 5-10% developing B-cell lymphoma.
Two populations of pSS patients can be defined. Patients with dryness, fatigue, pain and low systemic activity present no or limited long-term extraglandular damage but they have a profoundly reduced quality of life with marked anxiety, depression, and social isolation (Rischmueller 2016)(Meijer, 2009). Patients with high systemic activity have important long-term damage and bad prognosis. To date, there are no approved disease-modifying treatments.
Current clinical outcome assessment (COA) tools in pSS have shown important weaknesses (e.g. high placebo response rate) which may hamper demonstration of therapeutic benefit. A novel COA called STAR has recently been developed by the NECESSITY consortium (funded by the Innovative Medicines Initiative) and should allow the identification of new therapeutic options for both patient populations.
the investigator aim to demonstrate, thanks to the new STAR outcome measure, efficacy of a combination therapy targeting both B- and T-cells in pSS patients.
- Conditions
- Primary Sjögren's Syndrome (pSS)
- Being tested
- Hydroxychloroquine 400mg/d, Leflunomide 20mg/d, Mycophenolate mofetil 2000mg/d, Placebo of Hydroxychloroquine 400mg/d, Placebo of Leflunomide 20mg/d
- Keywords
- dry eye, Oral Dryness and Saliva Altered, Eular Sjögren Syndrome Disease Activity index, Primary Sjögrens's syndrome
- Medical subject headings
- Dry Eye Syndromes, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine 400mg/dDrug
Hydroxychloroquine (HCQ) is a 4-aminoquinoline belonging to the group of antimalarial agents. Its immunomodulatory activity on B-cells has mainly been attributed to its inhibition of antigen presentation, cytokine production, and recently on Toll-like receptor signaling and IFN secretion that drives B cell activation.
Leflunomide 20mg/dDrug
Leflunomide (LEF) is a derivative of isoxazole and is converted into an active metabolite which blocks de novo synthesis of pyrimidines in activated T lymphocytes, thereby inhibiting T cell proliferation and consequently T cell-dependent B cell formation of autoantibodies.
Mycophenolate mofetil 2000mg/dDrug
Mycophenolate mofetil (MMF) is a morpholinoethyl ester of mycophenolic acid which blocks proliferation of lymphocytes by inhibiting the de novo pathway of purine biosynthesis (Allison, 2000).
Placebo of Hydroxychloroquine 400mg/dDrug
Placebo of Hydroxychloroquine (HCQ) is a 4-aminoquinoline belonging to the group of antimalarial agents. Its immunomodulatory activity on B-cells has mainly been attributed to its inhibition of antigen presentation, cytokine production, and recently on Toll-like receptor signaling and IFN secretion that drives B cell activation.
Placebo of Leflunomide 20mg/dDrug
Placebo of Leflunomide (LEF) is a derivative of isoxazole and is converted into an active metabolite which blocks de novo synthesis of pyrimidines in activated T lymphocytes, thereby inhibiting T cell proliferation
Placebo of Mycophenolate mofetil 2000mg/dDrug
Placebo of Mycophenolate mofetil (MMF) is a morpholinoethyl ester of mycophenolic acid which blocks proliferation of lymphocytes by inhibiting the de novo pathway of purine biosynthesis (Allison, 2000).
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Placebo comparator | Cohort 1 : Patients with High levels of symptoms and low disease activity receive :
Placebo of Leflunomide 20mg/d Placebo of Mycophenolate mofetil 2000mg/d Placebo of hydroxychloroquine 400mg/d Receives: Drug: Placebo of Hydroxychloroquine 400mg/d; Drug: Placebo of Leflunomide 20mg/d; Drug: Placebo of Mycophenolate mofetil 2000mg/d |
| Arm 2 | Other | Cohort 1 : Patients with High levels of symptoms and low disease activity receive :
Leflunomide 20mg/d hydroxychloroquine 400mg/d Placebo of Mycophenolate mofetil 2000 mg/d Receives: Drug: Hydroxychloroquine 400mg/d; Drug: Leflunomide 20mg/d; Drug: Placebo of Mycophenolate mofetil 2000mg/d |
| Arm 3 | Other | Cohort 1 : Patients with High levels of symptoms and low disease activity receive :
Placebo of Leflunomide 20mg/d Mycophenolate mofetil 2000mg/d hydroxychloroquine 400mg/d Receives: Drug: Hydroxychloroquine 400mg/d; Drug: Mycophenolate mofetil 2000mg/d; Drug: Placebo of Leflunomide 20mg/d |
| Arm 4 | Placebo comparator | Cohorte 2 :Patients with moderate or hight activity, regardless of level of symptoms, they receive :
Placebo of Leflunomide 20mg/d Placebo of Mycophenolate mofetil 2000mg/d Placebo of hydroxychloroquine 400mg/d Receives: Drug: Placebo of Hydroxychloroquine 400mg/d; Drug: Placebo of Leflunomide 20mg/d; Drug: Placebo of Mycophenolate mofetil 2000mg/d |
| Arm 5 | Other | Cohorte 2 :Patients with moderate or hight activity, regardless of level of symptoms, they receive :
Leflunomide 20mg/d hydroxychloroquine 400mg/d Placebo of Mycophenolate mofetil 2000 mg/d Receives: Drug: Hydroxychloroquine 400mg/d; Drug: Leflunomide 20mg/d; Drug: Placebo of Mycophenolate mofetil 2000mg/d |
| Arm 6 | Other | Cohorte 2 :Patients with moderate or hight activity, regardless of level of symptoms, they receive :
Placebo of Leflunomide 20mg/d Mycophenolate mofetil 2000mg/d hydroxychloroquine 400mg/d Receives: Drug: Hydroxychloroquine 400mg/d; Drug: Leflunomide 20mg/d; Drug: Placebo of Leflunomide 20mg/d |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1. Proportion of patients achieving a response according to preliminary STAR at week 24 between each active treatment arm and placebo arm.
Measured: During the 24 weeks of the trials
Cohort 2. Proportion of patients achieving a response according to preliminary STAR at week 24 between each active treatment arm and placebo arm.
Measured: During the 24 weeks of the trials
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start20 Jan 2022
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sjögren's Syndrome (pSS)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-center, prospective, randomized, double blinded
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113004
- Sponsor's protocol ID
- APHP190131
- Acronym
- NECESSITY
- Status last verified
- Oct 2024
- First submitted
- 2 Nov 2021
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEw Clinical Endpoints in Patients With Primary Sjögren's Syndrome (pSS): an Interventional Trial Based on stratifYing Patients
- ClinicalTrials.gov ID
- NCT05113004
- Acronym / sponsor ID
- NECESSITY / APHP190131
- Conditions
- Primary Sjögren's Syndrome (pSS)
- Keywords
- dry eye, Oral Dryness and Saliva Altered, Eular Sjögren Syndrome Disease Activity index, Primary Sjögrens's syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 9 Nov 2021 (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.
There are no approved treatments for pSS and the clinical endpoints currently used in clinical trials are inadequate to capture all aspects of the disease that should be evaluated in clinical trials. The newly developed composite endpoint: Sjögren's Tool for Assessing Response to treatment (STAR) will allow a more specific and meaningful assessment of treatment efficacy in pSS.
Because of the heterogeneity of the disease and of the central role of the interplay between B- and T-cells in the pathogenesis, it is worth to evaluate combination of conventional synthetic immunomodulatory drugs targeting both B- and T-cells.
Detailed description
Primary Sjögren's syndrome (pSS) is a systemic autoimmune disease with a female-to-male predominance of 9:1 and a peak incidence at 50 years of age. It is characterized by chronic inflammation and subsequent destruction of exocrine glands, mainly lacrimal and salivary glands, with ocular and oral dryness. Patients also experience joint pain and extreme fatigue. In 20-40% of patients, the inflammatory process extends beyond the exocrine glands and patients experience systemic extra glandular manifestations, with 5-10% developing B-cell lymphoma.
Two populations of pSS patients can be defined. Patients with dryness, fatigue, pain and low systemic activity present no or limited long-term extraglandular damage but they have a profoundly reduced quality of life with marked anxiety, depression, and social isolation (Rischmueller 2016)(Meijer, 2009). Patients with high systemic activity have important long-term damage and bad prognosis. To date, there are no approved disease-modifying treatments.
Current clinical outcome assessment (COA) tools in pSS have shown important weaknesses (e.g. high placebo response rate) which may hamper demonstration of therapeutic benefit. A novel COA called STAR has recently been developed by the NECESSITY consortium (funded by the Innovative Medicines Initiative) and should allow the identification of new therapeutic options for both patient populations.
the investigator aim to demonstrate, thanks to the new STAR outcome measure, efficacy of a combination therapy targeting both B- and T-cells in pSS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
- Model description
- Multi-center, prospective, randomized, double blinded
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Placebo comparator | Drug: Placebo of Hydroxychloroquine 400mg/d, Drug: Placebo of Leflunomide 20mg/d, Drug: Placebo of Mycophenolate mofetil 2000mg/dCohort 1 : Patients with High levels of symptoms and low disease activity receive : Placebo of Leflunomide 20mg/d Placebo of Mycophenolate mofetil 2000mg/d Placebo of hydroxychloroquine 400mg/d |
| Arm 2 | Other | Drug: Hydroxychloroquine 400mg/d, Drug: Leflunomide 20mg/d, Drug: Placebo of Mycophenolate mofetil 2000mg/dCohort 1 : Patients with High levels of symptoms and low disease activity receive : Leflunomide 20mg/d hydroxychloroquine 400mg/d Placebo of Mycophenolate mofetil 2000 mg/d |
| Arm 3 | Other | Drug: Hydroxychloroquine 400mg/d, Drug: Mycophenolate mofetil 2000mg/d, Drug: Placebo of Leflunomide 20mg/dCohort 1 : Patients with High levels of symptoms and low disease activity receive : Placebo of Leflunomide 20mg/d Mycophenolate mofetil 2000mg/d hydroxychloroquine 400mg/d |
| Arm 4 | Placebo comparator | Drug: Placebo of Hydroxychloroquine 400mg/d, Drug: Placebo of Leflunomide 20mg/d, Drug: Placebo of Mycophenolate mofetil 2000mg/dCohorte 2 :Patients with moderate or hight activity, regardless of level of symptoms, they receive : Placebo of Leflunomide 20mg/d Placebo of Mycophenolate mofetil 2000mg/d Placebo of hydroxychloroquine 400mg/d |
| Arm 5 | Other | Drug: Hydroxychloroquine 400mg/d, Drug: Leflunomide 20mg/d, Drug: Placebo of Mycophenolate mofetil 2000mg/dCohorte 2 :Patients with moderate or hight activity, regardless of level of symptoms, they receive : Leflunomide 20mg/d hydroxychloroquine 400mg/d Placebo of Mycophenolate mofetil 2000 mg/d |
| Arm 6 | Other | Drug: Hydroxychloroquine 400mg/d, Drug: Leflunomide 20mg/d, Drug: Placebo of Leflunomide 20mg/dCohorte 2 :Patients with moderate or hight activity, regardless of level of symptoms, they receive : Placebo of Leflunomide 20mg/d Mycophenolate mofetil 2000mg/d hydroxychloroquine 400mg/d |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Cohort 1
- Having given written informed consent prior to undertaking any study-related procedures.
- Patients with pSS according to ACR/EULAR 2016 criteria or AECG 2002 criteria
- With a high level of symptoms (ESSPRI ≥ 5) and low systemic disease activity (ESSDAI < 5).
- Negative pregnancy test (serum at screening)
Key exclusion criteria (32 listed)
- For both cohorts:
- Age < 18 years
- Pregnant or breastfeeding women or women wanted to conceive either during or within two years after the end of the treatment period
- Women of childbearing potential not using highly effective methods of contraception (as defined in section 6.3)
- Participation in another interventional trial
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 |
|---|---|---|
| Hydroxychloroquine 400mg/dHydroxychloroquine (HCQ) is a 4-aminoquinoline belonging to the group of antimalarial agents. Its immunomodulatory activity on B-cells has mainly been attributed to its inhibition of antigen presentation, cytokine production, and recently on Toll-like receptor signaling and IFN secretion that drives B cell activation. | Drug | Arm 2, Arm 3, Arm 5, Arm 6 |
| Leflunomide 20mg/dLeflunomide (LEF) is a derivative of isoxazole and is converted into an active metabolite which blocks de novo synthesis of pyrimidines in activated T lymphocytes, thereby inhibiting T cell proliferation and consequently T cell-dependent B cell formation of autoantibodies. | Drug | Arm 2, Arm 5, Arm 6 |
| Mycophenolate mofetil 2000mg/dMycophenolate mofetil (MMF) is a morpholinoethyl ester of mycophenolic acid which blocks proliferation of lymphocytes by inhibiting the de novo pathway of purine biosynthesis (Allison, 2000). | Drug | Arm 3 |
| Placebo of Hydroxychloroquine 400mg/dPlacebo of Hydroxychloroquine (HCQ) is a 4-aminoquinoline belonging to the group of antimalarial agents. Its immunomodulatory activity on B-cells has mainly been attributed to its inhibition of antigen presentation, cytokine production, and recently on Toll-like receptor signaling and IFN secretion that drives B cell activation. | Drug | Arm 1, Arm 4 |
| Placebo of Leflunomide 20mg/dPlacebo of Leflunomide (LEF) is a derivative of isoxazole and is converted into an active metabolite which blocks de novo synthesis of pyrimidines in activated T lymphocytes, thereby inhibiting T cell proliferation | Drug | Arm 1, Arm 3, Arm 4, Arm 6 |
| Placebo of Mycophenolate mofetil 2000mg/dPlacebo of Mycophenolate mofetil (MMF) is a morpholinoethyl ester of mycophenolic acid which blocks proliferation of lymphocytes by inhibiting the de novo pathway of purine biosynthesis (Allison, 2000). | Drug | Arm 1, Arm 2, Arm 4, Arm 5 |
Primary outcome
Cohort 1. Proportion of patients achieving a response according to preliminary STAR at week 24 between each active treatment arm and placebo arm.
Time frame: During the 24 weeks of the trials
Cohort 2. Proportion of patients achieving a response according to preliminary STAR at week 24 between each active treatment arm and placebo arm.
Time frame: During the 24 weeks of the trials
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydroxychloroquine 400mg/d, Leflunomide 20mg/d and Mycophenolate mofetil 2000mg/d in people with Primary Sjögren's Syndrome (pSS), run by Assistance Publique - Hôpitaux de Paris at 7 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 12 inclusion and 32 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: status not confirmed, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xavier MARIETTE (01.45.21.37.51, xavier.mariette@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort 1. Proportion of patients achieving a response according to preliminary STAR at week 24 between each active treatment arm and placebo arm. (time frame: During the 24 weeks of the trials). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2024.