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Long term prospective observational cohort study of the safety and efficacy of golimumab in the daily clinical practice of rheumatoid arthritis with emphasis on the lipid profile

Long term prospective observational cohort study of the safety and efficacy of golimumab in the daily clinical practice of rheumatoid arthritis with emphasis on the lipid profile - Golimumab in rheumatoid arthritis

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON36406
Enrollment
200
Registered
2011-02-16
Start date
2011-03-01
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

inflammatory rheumatic disease

Interventions

None listed

Sponsors

Jan van Breemen Instituut
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: patients with rheumatoid arthritis in whom golimumab treatment is started. written informed consent.

Exclusion criteria

Exclusion criteria: contraindications against golimumab treatment

Design outcomes

Primary

MeasureTime frame
Efficacy will be determined in comparison to baseline by measuring disease activity, radiological progression and functional capacity during follow-up. Safety will be determined by the occurrence of side effects. Changes in lipid profile markers during the four years of treatment will be analyzed versus baseline.

Secondary

MeasureTime frame
nvt

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)