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Long term prospective follow-up study of tocilizumab (RoActermraR) administered to patients with rheumatoid arthritis in daily clinical practice.

Long term prospective follow-up study of tocilizumab (RoActermraR) administered to patients with rheumatoid arthritis in daily clinical practice. - tocilizumab in rheumatoid arthritis

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON34333
Enrollment
200
Registered
2010-04-28
Start date
2010-08-25
Completion date
Unknown
Last updated
2024-11-18

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

Conditions

inflammatory disease

Interventions

None listed

Sponsors

Jan van Breemen Instituut
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: rheumatoid arthritis and treatment with tocilizumab

Exclusion criteria

Exclusion criteria: contraindications for treatment with tocilizumab No signed informed consent

Design outcomes

Primary

MeasureTime frame
Efficacy will be determined in comparison to baseline by comparing disease activity, radiological progression and functional capacity during follow-up. Safety will be determined by the occurrence of (serious) side effects.

Secondary

MeasureTime frame
There will be a particular focus of the effect of tocilizumab on lipid profile, bone density changes as well as risk factors for cardiovascular disease and osteoporosis. prognostic determinators will be assessed.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)