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Orencia home infusion.

Orencia home infusion project: Phase IV observational study.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON23292
Enrollment
10
Registered
2010-09-16
Start date
2010-09-20
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis Orencia Home infusion / thuis infusie

Interventions

Treatment is moved from the hospital to the home situation.

Sponsors

Atrium MC Heerlen
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Satisfaction of all parties (incl. patients) measured with questionnaires during month 1, 3 and 6.

Secondary

MeasureTime frame
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.

Contacts

Public ContactM.E. Hartman

Vijzelmolenlaan 9

manon.hartman@bms.com+31 (0)348 574222

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)