Ongoing Clinical Trials

Clinical Care Section Schleroderma Team Clinical Care Section Research
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Clinical Trials

We remain very busy in the clinical trials unit with several studies at different stages. The unit also continues to expand in order to cope with the number of exciting studies we are currently involved in. The team works alongside the specialist nurses and Doctors. The unit now also has an additional research nurse, Admin support and Data entry/IT person. Despite the long delay we still plan to provide a summary of the results of completed studies. Finally we would like to thank all those who continue to volunteer in our trials.

Below is a summary of our clinical trials activity:

Ongoing Scleroderma Trials

  1. DETECT-An observational study to find out Early, Simple and reliable methods that can be used in the Detection of pulmonary Hypertension.

  2. AIMSPRO-A study to find out if the drug AIMSPRO improves the quality of life in long standing Diffuse Scleroderma and to confirm that it is safe and well tolerated.

  3. DISTOL-A study to find out the effect of a drug called Treprostinil diethanolamine (UT-15C) on digital ulcers in patients with scleroderma.

  4. DUO Register-This is a multi-centre prospective, observational study non-interventional programme to follow-up patients with digital ulcers over the course of the disease. The outcome of this study will inform on how to improve patient care in the long run.

  5. Gleevec (Imatinib)- A trial to evaluate the efficacy and safety of an oral dose of STI571 for diffuse patients with fibrosis

  6. P144- This is a trial to evaluate the efficacy and safety of the topical application of the drug “P144” for skin fibrosis in patients with Scleroderma

Completed Studies for which results will be provided

  1. SStep- This was a six year trial that started in 2002 looking at the use of iloprost tablets in lowering the incidence of heart attacks and angina. We are still waiting for the results of this study including the un-blinded data.

  2. GTN study- This was a Raynauds trial involving a topical gel formation of Nitroglycerine MQX-503, and matching placebo, to prevent Raynauds Phenomenon.

Along side the Scleroderma trials the team also runs all the Pulmonary hypertension trials.

Ongoing Pulmonary Hypertension Trials

  1. SERAPHIN-This is a study to find out the effect of a drug called macitentan in pulmonary arterial hypertension.

  2. FREEDOM STUDIES- These are studies to see the effect of UT-15C sustained release tablets in pulmonary arterial hypertension.

  3. TRIUMPH- An extension study to find out the effect of Treprostinil Inhalation in the Management of severe Pulmonary Arterial Hypertension (PAH)

  4. PATENT- A study to assess the effectiveness and safety of different doses of a new drug (BAY-63-251) given orally to patients with pulmonary hypertension.

  5. Tadelafil-This is a study to evaluate the long term safety and efficacy of a drug called Tadelafil in the treatment of patients with pulmonary hypertension.

  6. VOLT- This is a post marketing observational surveillance programme of a drug called Ambrisantan which is already licensed for treatment of PAH.

If you are interested in participating in any trial please contact the team on 02073177544.