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New Clinical End-points in patients with primary Sjögren’s Syndrome: an Interventional Trial based on stratifYing patients
EU CTIS ID: 2023-510054-16-00
What this study is testing
To evaluate the efficacy of each active treatment combination (hydroxychloroquine + leflunomide and hydroxychloroquine + mycophenolate mofetil) based on proportion of responder patients according to preliminary STAR at week 24 in the pooled cohorts
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Cohort 1 : Having given written informed consent prior to undertaking any study-related procedures
- Cohort 2 : Use highly reliable contraception during study treatment from the screening and for two years after stopping treatment
- Cohort 1 : Patients with pSS according to ACR/EULAR 2016 criteria or AECG 2002 criteria
- Cohort 1 : With a high level of symptoms (ESSPRI ≥ 5) and low systemic disease activity
- Cohort 1 : Negative pregnancy test (serum at screening)
- Cohort 1 : Use highly reliable contraception during study treatment from the screening and for two years after stopping treatment
You likely can't join if
- Age < 18 years
- Previous treatment with HCQ, LEF, or 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
See the full eligibility criteria
Who can join
- Cohort 1 : Having given written informed consent prior to undertaking any study-related procedures
- Cohort 2 : Use highly reliable contraception during study treatment from the screening and for two years after stopping treatment
- Cohort 1 : Patients with pSS according to ACR/EULAR 2016 criteria or AECG 2002 criteria
- Cohort 1 : With a high level of symptoms (ESSPRI ≥ 5) and low systemic disease activity
- Cohort 1 : Negative pregnancy test (serum at screening)
- Cohort 1 : Use highly reliable contraception during study treatment from the screening and for two years after stopping treatment
- Cohort 2 : Having given written informed consent prior to undertaking any study-related procedures
- Cohort 2 : Patients with pSS according to ACR/EULAR 2016 criteria or AECG 2002 criteria
- Cohort 2 : With moderate/high systemic disease activity, as defined by ESSDAI ≥ 5
- Cohort 2 : Negative pregnancy test (serum at screening)
What rules you out
- Age < 18 years
- Previous treatment with HCQ, LEF, or 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 active 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
- Pregnant or breastfeeding women or women wanting to conceive either during or within two years after the end of the treatment period
- 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
- Prolonged ECG's corrected QT interval (>500 ms)
- Women of childbearing potential not using highly effective methods of contraception
- Known history of maculopathy
- Patients not informed of the risk of alcohol consumption and of the recommendations to avoid alcohol during the entire study
- Not affiliated to a social security regime (specific for France)
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.