Is it possible / desirable to move Orencia treatment from the hospital to the home situation?
ID
Bron
Aandoening
Rheumatoid Arthritis
Orencia
Home infusion / thuis infusie
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Satisfaction of all parties (incl. patients) measured with questionnaires during month 1, 3 and 6.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Is it possible / desirable to move Orencia treatment from the hospital to the home situation?
Onderzoeksopzet
6 months.
Onderzoeksproduct en/of interventie
Treatment is moved from the hospital to the home situation.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2445 |
| NTR-old | NTR2562 |
| Ander register | Bristol-Myers Squibb BV : IM101-223 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |