No registrations found.
ID
Source
Health condition
Rheumatoid Arthritis
Orencia
Home infusion / thuis infusie
Sponsors and support
Intervention
Outcome measures
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.
Background 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.
Study objective
Is it possible / desirable to move Orencia treatment from the hospital to the home situation?
Study design
6 months.
Intervention
Treatment is moved from the hospital to the home situation.
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2445 |
| NTR-old | NTR2562 |
| Other | Bristol-Myers Squibb BV : IM101-223 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |