AuthorisedTherapeutic exploratory (Phase II)Interventional

A randomized, parallel-group, open-label, Phase IIb pilot trial to evaluate the effectiveness in reducing systemic disease activity with methotrexate compared with hydroxychloroquine in adult male and female participants with moderate-to-severe primary Sjögren’s disease (MOSAIC STUDY)

Sjögren's disease is an autoimmune condition where the body's immune system attacks its own moisture-producing glands, often causing dry eyes, a dry mouth, joint pain, and extreme tiredness. Sometimes it can affect other organs as well. The MOSAIC study is comparing two well-known medications: methotrexate (given as a weekly injection) and hydroxychloroquine (taken as daily tablets). Both medicines are already widely used to treat other joint and immune conditions. The trial aims to discover which medicine is better at reducing disease activity throughout the body in adults with moderate-to-severe Sjögren's disease. Participants will take one of the two medicines for 74 weeks (around 17 months). Doctors will track changes in joint swelling, saliva production, fatigue, and general well-being to help find the best treatment options for people living with this long-term condition.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon

Enrolment target

Start

15 Oct 2026

Sjogren's disease

What is this study about?

Sjögren's disease is a chronic autoimmune condition. In healthy bodies, the immune system defends against infection, but in Sjögren's, it mistakenly attacks healthy glands that make saliva and tears. Beyond dry eyes and dry mouth, it can cause severe exhaustion, aching joints, and inflammation in other organs across the body. Currently, there are few clear guidelines on which medicine works best for more severe symptoms.

The MOSAIC study is a Phase II clinical trial designed to compare two established treatments head-to-head: methotrexate and hydroxychloroquine. Methotrexate is given as a weekly injection under the skin using a pre-filled pen or syringe. Hydroxychloroquine is taken every day as a tablet. Because this is an 'open-label' study, both you and your doctor will know which treatment you are receiving.

Researchers will follow participants for 74 weeks (just under a year and a half) to measure how well each medicine controls body-wide disease activity. They will look at changes in saliva levels, joint inflammation, fatigue, and pain scores. The findings from this study could help doctors and the NHS provide clearer, more effective treatment plans for people with Sjögren's disease in the future.

Key takeaways

The MOSAIC trial compares methotrexate injections with hydroxychloroquine tablets for Sjögren's disease.
The goal is to see which drug better reduces body-wide inflammation, dryness, and fatigue.
The study lasts for approximately 74 weeks and involves regular clinic visits and tests.
It is open to adults aged 18 and over with moderate-to-severe primary Sjögren's disease.
Taking part is voluntary, and you may leave the study at any time without affecting your NHS care.

Who may be eligible?

This study is open to adults aged 18 and older who have been diagnosed with moderate-to-severe primary Sjögren's disease. 'Primary' means the condition did not develop as a result of another disease, such as rheumatoid arthritis or lupus.

Both men and women can join. Because the study focuses on active disease, participants must have symptoms that affect their daily life or show signs of ongoing inflammation that needs medical treatment.

Certain people may not be able to take part. For instance, because methotrexate can harm an unborn baby, women who are pregnant or planning a pregnancy cannot join, and effective contraception is required. People with significant liver, kidney, or blood problems may also be excluded to ensure safety.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you aged 18 or over?
Have you been diagnosed with primary Sjögren's disease?
Do you have moderate to severe symptoms such as marked dryness, joint pain, or fatigue?
Are you able and willing to attend regular hospital appointments for around 74 weeks?
If you are able to have children, are you willing to use effective contraception during the study?

Answer every question to see your result.

What does participation involve?

If you join the MOSAIC trial, you will be randomly placed into one of two treatment groups by a computer. One group will take hydroxychloroquine tablets by mouth each day. The other group will receive methotrexate as a weekly injection under the skin, which you or a carer can learn to give at home.

The study lasts for around 74 weeks (about 17 months). During this time, you will visit the hospital clinic regularly for routine check-ups. At these visits, the study team will test your blood, measure your saliva production, examine your joints, and ask you to fill in questionnaires about your tiredness, dryness, and quality of life.

Your health will be watched very closely throughout the trial to check how well the treatment is working and to keep an eye out for any unwanted side effects.

Potential risks and benefits

Taking part may help improve your Sjögren's symptoms, and you will receive regular, detailed health checks from specialist doctors. However, there is no guarantee that your symptoms will improve. Both study drugs carry potential side effects. Methotrexate can cause nausea, mild mouth sores, temporarily thinned hair, and changes to liver or blood cell counts, and it requires reliable contraception. Hydroxychloroquine can occasionally cause stomach upsets and requires regular eye checks during long-term use. Injections can also cause mild bruising or redness. You are free to leave the trial at any point without giving a reason, and doing so will not affect your normal NHS care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What is Sjögren's disease?

It is an autoimmune condition where the body's immune system attacks moisture-producing glands, leading to dry eyes, a dry mouth, fatigue, and joint pain.

Will I get to choose which medicine I take?

No. A computer will randomly assign you to receive either methotrexate injections or hydroxychloroquine tablets to ensure the comparison is fair.

How long will I be in the study?

The study lasts for 74 weeks, which is roughly 17 months of treatment and regular monitoring visits.

Will I have to give myself injections?

If you are assigned to methotrexate, you will receive pre-filled syringes or pens. The clinical team will train you or a family member to give the injection safely at home.

Can I leave the study if I change my mind?

Yes. Taking part is completely voluntary. You can withdraw at any time, and your standard medical care will continue as normal.