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Long term prospective observational cohort study on the safety and efficacy of abatacept subcutaneus in the daily clinical practice of rheumatoid arthritis

Long term prospective observational cohort study on the safety and efficacy of abatacept subcutaneus in the daily clinical practice of rheumatoid arthritis - Abatacept subcutaneous in rheumatoid arthritis

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON39013
Enrollment
100
Registered
2013-08-13
Start date
2013-09-18
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

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 * 18 years old at treatment initiation Patients informed and accepting to participate (Written informed consent) Patients diagnosed with established moderate to severe active RA as per the 1987 ACR criteria/2010 ACR/EULAR Rheumatoid Arthritis Classification Criteria Patients who at their physician*s discretion are initiated with abatacept SC.

Exclusion criteria

Exclusion criteria: Patients currently participating in any interventional clinical trial in RA Contraindications against abatacept SC 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.

Secondary

MeasureTime frame
nvt

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)