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Orencia home infusion.


- candidate number8461
- NTR NumberNTR2562
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-sep-2010
- Secondary IDsIM101-223 Bristol-Myers Squibb BV
- Public TitleOrencia home infusion.
- Scientific TitleOrencia home infusion project: Phase IV observational study.
- ACRONYM
- hypothesisIs it possible / desirable to move Orencia treatment from the hospital to the home situation?
- Healt Condition(s) or Problem(s) studiedRheumatoid arthritis, Orencia, Home infusion
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialno
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeobservational
- planned startdate 20-sep-2010
- planned closingdate1-jul-2011
- Target number of participants10
- InterventionsTreatment is moved from the hospital to the home situation.
- Primary outcomeSatisfaction of all parties (incl. patients) measured with questionnaires during month 1, 3 and 6.
- Secondary outcome1. 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.
- Timepoints6 months.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES M.E. Hartman
- CONTACT for SCIENTIFIC QUERIES M.E. Hartman
- Sponsor/Initiator Atrium Medical Center, Heerlen
- Funding
(Source(s) of Monetary or Material Support)
Bristol-Myers, Squibb
- PublicationsN/A
- Brief summaryThis 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)
- RECORD16-sep-2010 - 24-okt-2010


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