We'd like your feedback
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
victoria
macrae
v.macrae@nhs.net
Hannah
Stephenson
HStephenson@ucc.ie
Prof
Wan-Fai
Ng
wan-fai.ng@newcastle.ac.uk
Victoria
Macrae
Victoria.Macrae@newcastle.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Systemic connective tissue disorders
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Primary Sjögren’s syndrome (pSS) is an autoimmune disease affecting exocrine glands resulting in dryness of the eyes and the mouth and complications in different organs. In 30% to 50% of the patients further symptoms may develop and include fatigue, vasculitis, peripheral neuropathy, affected joint, kidney malfunction and interstitial lung disease. Primary Sjögren’s syndrome patients have a 10 to 20-fold higher risk of developing B cell lymphomas, resulting in a shorter life expectancy.
Currently there is no treatment for primary Sjögren’s syndrome and only symptomatic treatments are commercially available. Classical immunosuppressive drugs are used in patients with severe organ involvement but do not always work as efficiently in one patient as they might in another.
During pSS, exocrine glands are infiltrated by B-cells, T-cells, dendritic cells, monocytes/macrophages and NK cells. The interplay between B- and T-cells is central to the pathogenesis of pSS, meaning a combination of drugs targeting both B- and T-cell activities would be helpful for controlling the chronic inflammation.
The primary objective of this study is to determine if two combinations of active drugs targeting B and T-cells can improve the health of patients suffering from primary Sjögren’s syndrome.
As secondary/exploratory objective, the study will also validate new evaluation tools of the signs and activity of the disease. These tools will then be used in future clinical trials to better evaluate new treatments.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Type: Drug;
You can take part if:
You may not be able to take part if:
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 - 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
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Prof
Wan-Fai
Ng
wan-fai.ng@newcastle.ac.uk
victoria
macrae
v.macrae@nhs.net
Hannah
Stephenson
HStephenson@ucc.ie
Victoria
Macrae
Victoria.Macrae@newcastle.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (APHP) (France) and funded by European Commission .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 50637
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
