TRACTISS (Rituximab / Placebo in Sjogren's Syndrome) Version 1.0

• Research type

  Research Study

• Full title

  A randomised double blind placebo controlled clinical trial of anti B-cell therapy in patients with primary Sjögren’s syndrome.

• IRAS ID

  56771

• Contact name

  Simon Bowman

• Sponsor organisation

  Leeds Teaching Hospital NHS Trust

• Eudract number

  2010-021430-64

• ISRCTN Number

  ISRCTN65360827

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Primary SjÇôgren??s Syndrome (PSS) is a condition where the body's immune system malfunctions and begins to attack healthy tissue (an autoimmune response). In PSS the immune system usually targets the tear and saliva glands, leading to a reduction in the production of saliva and tears. This can lead to symptoms of dry mouth and dry eyes. Other parts of the body can also be affected, causing a range of symptoms from fatigue, muscle and joint pain, and numbness and pain in the arms or legs (neuropathy). PSS mainly affects women in middle age (9 to 1 females to males) and is one of the commonest autoimmune diseases (affecting 1 in 170 to 1 in 1000 of adult women). Symptomatic therapies for dry eyes, such as artificial tears, are reasonably effective. By contrast, therapies for dry mouth (sprays, gels or lozenges/pastilles) are poorly effective for most people. Presently there is no effective therapy for fatigue. Studies have found that a drug called Rituximab (a new type of medication called a monoclonal antibody, which removes antibodyproducing white blood cells called Bcells) can help people with rheumatoid arthritis (RA), and since RA and PSS have similarities, it is believed that Rituximab may be able to help patients with PSS. TRACTISS is to look into the effects of Rituximab on tear and salivary production and reduction of fatigue and is funded by the Arthritis Research Campaign (ARUK). In order to make a fair assessment as to whether Rituximab is effective, patients will be randomly allocated into two different groups: One group will receive Rituximab and the other group will receive a placebo (a dummy medication containing no active ingredients). 110 patients from hospitals throughout the UK will be recruited into the study over 30 months. Each patient??s participation in the study will last 48 weeks.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  10/H1307/99

• Date of REC Opinion

  8 Oct 2010

• REC opinion

  Further Information Favourable Opinion