ew Clinical End-points in patients with primary Sjögren*s Syndrome: an Interventional Trial based on stratifYing patients

Recruiting

• Conditions: Sjogren's syndrome; 10003816

• Registration Number: NL-OMON55055
• Lead Sponsor: Assistance Publique_Hôpitaux de Paris (APHP), by delegation Clinical Research and Innovation Direction (DRCI)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 30

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
(see addenda 4)
- 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 (as defined in section 6.3) 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
(see addenda 4)
- With moderate/high systemic disease activity, as defined by ESSDAI >= 5.
- Negative pregnancy test (serum at screening)
- Use highly reliable contraception (as defined in section 6.3) 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints:<br /><br>Each cohort is analysed separately<br /><br>* Cohort 1: Proportion of patients achieving a response according to<br /><br>preliminary STAR at week 24 between each active treatment arm and placebo arm.<br /><br>* Cohort 2: Proportion of patients achieving a response according to<br /><br>preliminary STAR at week 24 between each active treatment arm and placebo arm.</p><br>