|- candidate number||8461|
|- NTR Number||NTR2562|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-sep-2010|
|- Secondary IDs||IM101-223 Bristol-Myers Squibb BV|
|- Public Title||Orencia home infusion.|
|- Scientific Title||Orencia home infusion project: Phase IV observational study.|
|- hypothesis||Is it possible / desirable to move Orencia treatment from the hospital to the home situation?
|- Healt Condition(s) or Problem(s) studied||Rheumatoid arthritis, Orencia, Home infusion|
|- Inclusion criteria||1. Age 18 years or older;|
2. Moderate / severe RA;
3. MTX or TNF-alpha Inadequate responders;
4. At least two treatments with Orencia received in hospital;
5. Working phone available at patients home;
6. GP informed about participation in trial;
7. Patient has a clean and working refridgerator and a clean space to prepare Orencia;
8. Patient signed Informed Consent.
|- Exclusion criteria||1. Patient showed adverse events or infusional reaction while treated with Orencia in the hospital;|
2. Patient has a cardiovascular problem or an uncontrolled infection;
3. The patient is pregnant or breast feeding;
4. The patient shows a hypersensitivity reaction to Orencia;
5. The patients history contains an analphylactic reaction or a significant allergic reaction;
6. The pation is treated with a biological DMARD;
7. The patient was vaccinated with a live vaccine in the 3 months previous to Orencia treatment;
8. The patients has a poistive TB screening and is not accurately treated;
9. The patient is treated for other indications then specified in the SmPC.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||20-sep-2010|
|- planned closingdate||1-jul-2011|
|- Target number of participants||10|
|- Interventions||Treatment is moved from the hospital to the home situation.|
|- Primary outcome||Satisfaction of all parties (incl. patients) measured with questionnaires during month 1, 3 and 6.
|- Secondary outcome||1. Preparation Orencia (experience is documented in the patientbook every visit, the book is collected at the end of the visit);|
2. No logistic problems (logistics are monitored by Medizorg every visit);
3. Cost aspect (costs are documented by Medizorg for every visit).
Objectives focus only on the location of the treatment.
|- Timepoints||6 months.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| M.E. Hartman|
|- CONTACT for SCIENTIFIC QUERIES|| M.E. Hartman|
|- Sponsor/Initiator ||Atrium Medical Center, Heerlen|
(Source(s) of Monetary or Material Support)
|- Brief summary||This study evaluates if it possible en desirable to move the Orencia treatement from the hospital to the patients home.
A total of 10 patients will be enrolled before the end of the year. Those patients will be treated at home with Orencia for 6 months. Before a patient can be treated at home patients will receive two infusions in the hospital. During month 1, 3 and 6 questionnaires are completed to monitor the satisfaction of the participants.|
|- Main changes (audit trail)|
|- RECORD||16-sep-2010 - 24-okt-2010|