News nr. 46 | January 2015
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The Institute of Molecular Medicine Leads Clinical Trial in Psoriatic Arthritis
The Institute of Molecular Medicine Leads Clinical Trial in Psoriatic Arthritis

To improve and expand knowledge on the treatment of Dactylitis in Patients with Psoriatic Arthritis 

For the first time, the Institute of Molecular Medicine (IMM) at the Faculty of Medicine, University of Lisbon will lead a clinical trial in Portugal that will study patients suffering from psoriatic arthritis who also suffer from active dactylitis, an inflammatory joint disease that occurs in patients with psoriasis. 

The objective of this project is to enhance knowledge about treatment strategies for active dactylitis, a specific clinical condition exhibiting a worse prognosis in these patients.
The clinical trial, called GO-DACT, which began in August 2014 is a landmark for IMM. This is the first time that researchers at the institute have led a clinical trial also promoted by IMM. This project has come about because of IMM’s integration into LACM (Lisbon’s Academic Centre of Medicine); SMH (Santa Maria Hospital) and the FMUL (Faculty of Medicine, University of Lisbon) also belong to LACM. The proximity of these institutions means that two key elements are available to GO-DACT: the clinical component offered by SMH and the research component offered by IMM. 

According to Elsa Vieira de Sousa, GO-DACT coordinator and IMM researcher, in the Rheumatology research area the connection between the three institutions "creates a unique atmosphere for the advancement of knowledge in the areas of the medical sciences, joining the clinical needs for the improvement of health care to the reasoning and technology of molecular studies of an academic nature." She added that "trials carried out in this environment are characterized by research oriented towards the patient, whose design and implementation are guaranteed by the researcher and promoter. Many steps have to be implemented including the drafting of protocols, informed consent and data collection journals have to be secured, and the activities must be submitted to the regulatory authorities. The trial and pharmacovigilance must also be monitored and the presence of academic infrastructure support is essential for this. "
This is a multicenter trial with the participation of eight Rheumatology Centers nationwide, including: Santa Maria Hospital (Lisbon), Egas Moniz Hospital (Lisbon), the Portuguese Institute of Rheumatology (Lisbon), Garcia de Orta Hospital (Almada), Infante Dom Pedro Hospital (Aveiro), São João Hospital (Porto), the University Hospitals of Coimbra (Coimbra) and Conde Bertiandos Hospital (Ponte de Lima). 

It is a random, placebo-controlled, Phase IIIb trial with the view to assessing the efficiency of treatment with golimumab (a blocker of tumor necrosis factor) in combination with methotrexate, as opposed to a monotherapy with methotrexate. This innovative study is primarily focused on evaluating the efficacy in the treatment of dactylitis but also enthesitis, two clinical conditions associated with psoriatic arthritis that may restrict patients’ quality of life very significantly. 

In addition to the collaboration between the institutions that make up LACM and all Hospital Centers and respective research teams involved, in the development of tools fundamental for its implementation this trial was also able to count with the important contribution of the Portuguese Society of Rheumatology (SPR) and the National Register of Rheumatic Patients (, as well as a research grant from Merck-Sharp and Dohme, and the support of NOVA CRU an academia Contract Research Organization, and the local coordinators of the BlueClinical-Clinical Research Partnership study. 

About psoriatic arthritis Psoriatic arthritis is a chronic inflammatory disease of the joints associated with psoriasis. It is estimated that in Portugal about ten thousand people are affected by this disease. It is proposed that up to about 30 percent of people with psoriasis may develop psoriatic arthritis manifestations. Psoriatic arthritis affects men and women and can affect people of any age, although it begins more frequently between 35 and 55 years of age. The clinical manifestations of the disease are characterized by inflammation of the joints and tendons, in particular of bone-bonding enthesis structures. Inflammation may also occur at the level of the spine. 

The manifestation of the worst prognosis particularly associated with active dactylitis is diffuse tumefaction of the finger, resulting in the inflammation of the soft tissues, including tendon sheaths and the adjoining joints, producing a typical "sausage finger" appearance. Current knowledge of the best strategies for the treatment of dactylitis is limited. For this reason the international scientific community recognizes the need to develop clinical trials that can provide information in this area that can lead to an improvement in health care provided to patients. This was the motivation for the implementation of this project.

source: IMM

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Prof. Doutor J. Fernandes e Fernandes
Editorial Commitee: Prof. Doutor J. Fernandes e Fernandes, Prof. Doutor Alexandre Ribeiro, Prof. Doutor António Vaz Carneiro, Prof. Doutor João Ferreira, Dr. Luis Pereira
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