Prospective follow-up study of subcutaneous tocilizumab (RoActemra®) treatment in rheumatoid arthritis.

Prospective follow-up study of subcutaneous tocilizumab (RoActemra®) treatment in rheumatoid arthritis. - Subcutaneous tocilizumab in rheumatoid arthritis

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41073

Enrollment

Registered

2014-12-15

Start date

2015-06-22

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

rheumatic disease rheumatoid arthritis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients: - who are diagnosed with RA; - in whom tocilizumab s.c. is prescribed by their treating rheumatologist; and - who gave written informed consent. Both bio-naive patients as patients who failed on previous biologic agents will be included.

Exclusion criteria

Exclusion criteria: Patients with contraindications for tocilizumab treatment. For patients previously treated with intravenous tocilizumab a washout period of 4 weeks is required.

Design outcomes

Primary

Measure	Time frame
- DAS28 score and response is defined as the EULAR criteria of a good or moderate response and a score of	—

Secondary

Measure	Time frame
- The number of adverse events (infections, malignancies, mortality) - ESR and/or CRP - The lipid profile - Inflammation processes - Relation between genetic polymorphisms and the efficacy of tocilizumab - Radiographic progression - Changes in bone mineral density - Cardiovascular risk factors	—

Countries

Netherlands

Outcome results