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IgG4:IgG mRNA ratio as disease activity marker in vasculitis

IgG4:IgG mRNA ratio as disease activity marker in vasculitis - IgG4 and vasculitis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON46036
Enrollment
200
Registered
2018-12-06
Start date
2019-05-22
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

blood vessel inflammation Vasculitis

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Subjects must be older than 18 years of age - They must have a form of the following vasculitides: * Granulomatosis with polyangiitis * Eosinophilic Granulomatosis with Polyangiitis * Giant Cell Arteritis * Takayasu Arteritis - OR polymyalgia rheumatica

Exclusion criteria

Exclusion criteria: • (Previous) presence of (concomitant) auto-immune disease • Under any administrative or legal supervision. • Conditions/situations such as: o Patients with conditions/concomitant diseases making them non evaluable for the primary endpoint o Impossibility to meet specific protocol requirements (e.g. blood sampling) o Patient is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol o Uncooperative or any condition that could make the patient potentially non-compliant to the study procedures

Design outcomes

Primary

MeasureTime frame
Primary: completion of inclusions and sampling (section 5.1) Arm A: 120-140 participants This arm consists of one inclusion visit and an additional visit within 12 months in case of change of disease activity. Arm B: 60-80 participants This arm consists of 5-7 visits and will consist of individuals that have de novo or established disease at inclusion.

Secondary

MeasureTime frame
nvt

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)