Norwegian Rituximab study scheduled to begin in August

deleder2k

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The Rituximab study in Norway is scheduled to begin in August.

Just received a letter from the doctor in charge at one of the hospitals. I have attached it, but it is in Norwegian. Here's my quick translation of the content:


To ****


Date: 28 May 2014

It is now just before a large multicenter study of Rituximab starts in Norway . Five hospitals will participate with a total of 144 patients. UNN ( Tromsø), St Olav ( Trondheim), Haukeland ( Bergen ) UUS ( Ullevål , Oslo) and Notodden hospital will all be a part of the multicenter research trial.

Notodden Hospital is responsible for patients which reside in Telemark, Vestfold and Buskerud (counties in Norway). If you live in Telemark / Vestfold / Buskerud and have already submitted an application or request to one of the five study centers, your papers sent to us. We will very soon send letters to the most appropriate patients. These will be called and invited to a in-depth conversation about the study. We will also send a message to those that didn't get in. A draw will decide between the many that are well suited for the study.

Requirements to join this study are many, including that you are aged over 18 and under 65, has been ill for at least two years but not more than 15 years. For those under 20 years of age the disease must have lasted five years . All who join the study must be well diagnosed with M.E. They can't have other serious illnesses that make them not withstand Rituximab, or making it difficult to assess whether the treatment is working. Pregnancy can be dangerous for the baby. Patients must be motivated to conduct the study in two years even if you do not know if you get active treatment or just a placebo (dummy treatment). There can be side effects, and you have participate in many different surveys and questionnaires throughout the period.

Notodden Hospital have had contact with over 150 patients who have a well diagnosed ME disease. We also received patient applications forwarded from Haukeland University Hospital for those living in "our " counties. If you have not been in contact with any of the study centers on this now, is it too late to apply for the study. We have more applicant than we are able to include. Notodden is responsible for 32 patients, of which only 16 will receive Rituximab, 16 will receive placebo (dummy treatment). In autumn 2014 , we expect to start with feasibility studies and infusion of medications.

regards



Hanne Thürmer , MD
Chief Attending Physician
Medical Department Notodden Hospital

Ann Elin Lonar, Study Nurse
Medical Outpatient Clinic Notodden Hospital
 

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