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Determination of tocilizumab trough levels during dose tapering in patients with rheumatoid arthritis (OPTIRA study)

Determination of tocilizumab trough levels during dose tapering in patients with rheumatoid arthritis (OPTIRA study) - OPTIRA study

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON53280
Enrollment
46
Registered
2023-07-24
Start date
2024-09-17
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

gewrichtsaandoeningen chronic inflammatory joint disease rheumatic disorder Rheumatoid arthritis

Interventions

Tocilizumab will be tapered every 3 months according to an existing dose optimization protocol for tocilizumab. Tocilizumab trough levels will be measured before every next dose tapering step. If d

Sponsors

Franciscus Gasthuis & Vlietland
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - >=18 years of age - Diagnosed with rheumatoid arthritis and treated for it in Franciscus Gasthuis and Vlietland - Treated with intravenous or subcutaneous tocilizumab - Low disease activity for at least the last 6 months while using tocilizumab with a current DAS28-ESR

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

MeasureTime frame
The primary endpoints of this study are: - the percentage of patients in whom tocilizumab is successfully tapered after 12 months (successful = lower dose than at baseline with a concurrent DAS28-ESR

Secondary

MeasureTime frame
The secondary endpoints of this study are: - the mean or median dose reduction or interval extension of tocilizumab between baseline and 12 months (in mg and percentages). - the mean or median change in disease activity scores between baseline and 12 months.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)