An open-label pilot study on the effects of trivalent inactivated influenza vaccination (Influvac®) in rheumatoid arthritis patients treated with rituximab.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25369

Enrollment

Registered

2007-11-14

Start date

2007-10-01

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

1. Rheumatoid Arthritis (NLD: reumatoide artritis)

Interventions

Influenza vaccination.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients have to fulfil the diagnostic criteria for RA as defined by the ACR9; 2. group I: treatment with rituximab (according to RA scheme), in combination with methotrexate, started 4 weeks before inclusion; 3. group II: treatment with rituximab (according to RA scheme), in combination with methotrexate, started 6-9 months before inclusion; 4. group III: second or third treatment with rituximab (according to RA scheme), in combination with methotrexate, started 4 weeks before inclusion; 5. group IV: treatment with monotherapy methotrexate (minimal dose 10 mg/week); 6. informed consent.

Exclusion criteria

Exclusion criteria: 1. Age under 18 years; 2. current infection, defined as fever in combination with clinical focal signs of infection and the need for therapeutic antibiotic treatment; 3. pregnancy; 4. malignancy; 5. known allergy to or former severe reaction following Influvac®.

Design outcomes

Primary

Measure	Time frame
Immune response one to four weeks after vaccination, humoral and cellular.	—

Secondary

Measure	Time frame
1. RA-activity (DAS-28); 2. Side effects influenza vaccination.	—

Contacts

Public ContactS. Assen, van

University Medical Center Groningen (UMCG), Department of Internal Medicine P.O. Box 30001

s.van.assen@int.umcg.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)