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DeSSciphers 5 observational trials

What does “observational” mean?

Contrary to an interventional study, where the treatment of patients is altered, e.g. by adding a novel drug to your list of medications, an observational study is restricted to recording the effects of the medications that your physician is prescribing you. The patient´s disease will only be monitored very closely to explore, whether an existing treatment may be beneficial or not. The patient stays on his/her medication, as prescribed by his/her physician, and this medication is only changed, if the physician sees a medical need to do so, and medication won´t be changed because of the participation in an observational study.

The five observational trials (OTs) of DeSScipher

In order to improve early detection, prevention and treatment of the key sequelae of the fibrotic and vascular pathology in adult and juvenile systemic sclerosis (SSc), diagnostic approaches and different drugs that are currently applied off-label in the management of SSc will be evaluated and compared systematically in five observational trials (OTs) of DeSScipher.

Two of these OTs (OT1 and OT2) will address prevention and treatment of functionally incapacitating manifestations in the hands, namely digital ulcers and hand arthritis. Three OTs (OT3, OT4 and OT5) will tackle the main life-threatening manifestations interstitial lung disease, pulmonary hypertension and severe heart disease. Juvenile cases will be included in all of these trials depending on the respective numbers of jSSc patients affected by these organ manifestations. All OTs will also generate systematic data on treatment safety in terms of incidence of adverse effects and of withdrawal from treatment due to adverse effects.

concept

 

OT 1 - Prevention and treatment of digital ulcers

Digital ulcers are a frequent problem in systemic sclerosis. They are the cause of functional impairment and substantial loss of quality of life in many patients. That is the reason why this observational trial aims to identify the best treatment strategy for the prevention and healing of digital ulcers.

OT 2 - Improvement of hand dysfunction by arthritis

Besides digital ulcers, arthritis may also affect deterioration of hand function in patients with systemic sclerosis. Thus, this study aims to identify the incidence of arthritis, potential predictors for its onset, and the best treatment strategy of arthritis.

 

OT 3 - Prevention and treatment of interstitial lung disease (lung fibrosis)

Lung fibrosis and resulting shortness of breath is one of the most important organ involvements of systemic sclerosis that reduces quality of life and limits daily activities. This observational trial aims to identify the current state of clinical practice for the prevention and treatment of lung fibrosis, its effect on lung function and disease progression and potential predictors for the response to therapy of the individual patient.

 

OT 4 – Development and prevention of pulmonary hypertension

Several new treatment options have been developed within the last years and have increased the quality of life for systemic sclerosis patients affected by pulmonary hypertension. Unfortunately, pulmonary hypertension is still a severe complication of systemic sclerosis. For this reason, this study focuses on the time before the onset of pulmonary hypertension and looks at whether there are any medications that can prevent or delay the development of pulmonary hypertension.

OT 5 – Development and prevention of severe heart disease

Cardiac involvement is often a silent disease manifestation that is asymptomatic in up to three out of four patients. However, in some cases it can progress to a more severe level. This trial focuses on the early stage of heart disease and the potential of different medications to prevent cardiac events in patients with Systemic Sclerosis.