Evaluating new treatment measures for Primary Sjögren's Syndrome
NEw Clinical Endpoints in Patients With Primary Sjögren's Syndrome (pSS): an Interventional Trial Based on stratifYing Patients
PHASE2 · Assistance Publique - Hôpitaux de Paris · NCT05113004
This study is testing a new way to measure how well different medications work for people with Primary Sjögren's Syndrome to see if they can improve treatment options for everyone, regardless of their disease activity.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Drugs / interventions | rituximab, tocilizumab, belimumab, methotrexate, cyclophosphamide, prednisone |
| Locations | 7 sites (Brest and 6 other locations) |
| Trial ID | NCT05113004 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy of a new composite endpoint called Sjögren's Tool for Assessing Response to treatment (STAR) in patients with Primary Sjögren's Syndrome (pSS). The study will evaluate the effectiveness of various immunomodulatory drugs, including Hydroxychloroquine, Leflunomide, and Mycophenolate mofetil, in treating patients with differing levels of disease activity. By focusing on a more comprehensive assessment of treatment outcomes, the trial seeks to address the inadequacies of current clinical outcome assessment tools. The goal is to identify new therapeutic options for both low and high systemic activity patient populations.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with Primary Sjögren's Syndrome who exhibit either high symptom levels with low systemic activity or moderate to high systemic activity.
Not a fit: Patients under 18 years old, pregnant or breastfeeding women, or those with very low symptom levels may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for patients suffering from Primary Sjögren's Syndrome.
How similar studies have performed: While there have been studies addressing treatment for pSS, the STAR endpoint represents a novel approach that has not been widely tested in previous trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. * 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 Exclusion Criteria: * 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 * 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)
Where this trial is running
Brest and 6 other locations
- Valérie Devauchelle — Brest, France (RECRUITING)
- Eric Hachulla — Lille, France (RECRUITING)
- Jacques Morel — Montpellier, France (RECRUITING)
- Véronique Le Guern — Paris, France (RECRUITING)
- Jacques-Eric Gottenberg — Strasbourg, France (RECRUITING)
- Christophe Richez — Talence, France (RECRUITING)
- Raphaele Seror — Le Kremlin-Bicêtre, Île-de-France Region, France (RECRUITING)
Study contacts
- Study coordinator: Xavier MARIETTE
- Email: xavier.mariette@aphp.fr
- Phone: 01.45.21.37.51
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Primary Sjögren's Syndrome, dry eye, Oral Dryness and Saliva Altered, Eular Sjögren Syndrome Disease Activity index, Primary Sjögrens's syndrome