Clinical Trials

Rheumatology Clinical Trials

The Rheumatology Institute at Rambam Health Care Campus provides medical services for patients with a variety of auto-immune, auto-inflammatory rheumatic and degenerative rheumatic diseases. The Institute offers a wide range of services: dedicated hospital beds, a general rheumatology clinic, a fibro-vascular clinic in partnership with the Pulmonary Institute, a specialized collagen-enterologic clinic together with the Gastroenterology Institute, and community consulting clinics for the Clalit and Maccabi health funds.
The Rheumatology Institute also includes a large out-patient clinic with facilities to provide parenteral treatments such as injections and infusions, and diagnostic procedures using musculoskeletal ultrasound, ultrasound-guided joint arthrocentesis and injections, capillaroscopy, ECG, skin biopsies, blood samples for troponin, PRO BNP, etc. 

Since 2000, the Rheumatology Institute has been actively participating in clinical studies initiated by pharma companies. To that end, a research center has been established at the institute, in which over 80 clinical studies have been conducted in a wide variety of fields, including osteoarthritis, rheumatoid arthritis, systemic lupus erythematosus, lupus nephritis, early diffuse systemic sclerosis, interstitial lung disease in systemic sclerosis, digital ulcers in systemic sclerosis, Behcet’s disease, psoriatic arthropathy and ankylosing spondylitis.

The whole spectrum of clinical trials has been performed during the last 20 years, including Phase I, Phase II, Phase III and Phase IV studies. Among the drugs assessed at the site: Viox (Rofecoxib), Art 50 (Diacerin), Arcoxia (Etoricoxib), Infliximab (Remicade), Tocilizumab (Actemra), Simpony (Golimumab), Rituximab (Mabthera), Rituximab Biosimilar (Truxima), Talz (Ixekizumab), Cosentyx (Secukinumab), Tofacitinib (Xeljance), Upadacitinib (Rinvoq), Baricitinib (Olumient), Anifrolumab (Saphnelo), Apremilast (Otezla), Macitentan (Opsumit), Nintedanib (Ofev), Guselkumab (Tremfya), Risankizumab (Skyrizi), and ABBV-3373. Almost all the drugs assessed in clinical trials at our site were later approved by the FDA and EMA and were included in the Israeli healthcare basket.

The clinical trial team is currently involved in a variety of clinical trials (Phase I, II, III, IV) for the treatment of Systemic Sclerosis with and without Interstitial Ling Disease, Systemic Lupus Erythematosus, Lupus Nephritis, Sjogren’s Syndrome, Dermatomyositis and Polymyositis, Familial Mediterranean Fever, and Psoriatic Arthropathy. The majority of these studies are already active and in the process of recruiting patients.

During the Covid-19 pandemic, the site’s assessment of the Pfizer vaccine was analyzed in a study initiated at our Institute and its results were published in Annals of Rheumatic Diseases (IF 28) in 2021 (Dr. Y. Braun). We found that the Covid vaccine was effective and safe for the majority of patients treated with antirheumatic drugs, including biologic agents, while signs of poor vaccine response were reported in patients treated with rituximab. Another study initiated by the Institute is examining the cellular response to the Pfizer vaccine in patients treated with rituximab and anti-TNF agents. This study has completed patient recruitment and is now in the process of conducting bio-experiments and data analysis. The effects of subcutaneous and intravenous use of tocilizumab during the pandemic were analyzed and published in Clinical and Experimental Rheumatology (IF 4.5) in 2022 (Dr. R. Daood).
During the last three years, the Institute’s team has engaged in scientific collaboration with the Hadassah Medical Center (Prof. C. Gur) and the Weizmann Institute (Prof I. Amit). A study on single cell analysis of blood and skin biopsies from patients with systemic sclerosis described a new type of skin fibroblasts SCAF which is unique in its morphology, and probably has a protective function, since their quantity was significantly reduced in patients with severe skin involvement. The study was published in Cell (IF 66) in 2021. The site also collaborates with start-up companies in the field of lupus and scleroderma.
The Institute team is highly active in the Israeli Rheumatology Society’s collaborative programs, including the biologic treatments registry (results of this ongoing project were published in several top medical journals) and musculoskeletal ultrasound use.
Since 2004, the Institute staff (Prof. Balbir, Dr. Y. Braun) play an active part in the European Scleroderma Trial and Research (EUSTAR) group: a cohort of more than 420 scleroderma patients undergo annual assessments. Results of this long-term project were published in top rheumatology journals and reflected different clinical and epidemiological aspects of systemic sclerosis. We have a bank of serum from patients with systemic sclerosis at our site.
Recently, the site joined European research initiatives in the field of inflammatory myopathy (Dr. Y. Tavor) and a registry of patients with dermatomyositis and polymyositis was established with dedicated assessment and blood sampling storage.
The Institute staff has initiated a telemedicine study to validate patients’ joint assessment in inflammatory joint diseases. There is also an ongoing study on LL-37 in patients with systemic sclerosis.
All physicians at our Institute have GCP certificates and experience with clinical trials; several experienced nurses also have GCP certificates. Furthermore, the site has a dedicated and experienced team of study coordinators (Mrs. V. Shataylo, Mrs. R. Erlich).


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