ESSENCE - EMICIZUMAB SYNOVITIS STUDY: EVALUATION OF CLINICAL EVIDENCE

ESSENCE - EMICIZUMAB SYNOVITIS STUDY: EVALUATION OF CLINICAL EVIDENCE - ESSENCE

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00036847

Enrollment

150

Registered

2025-09-09

Start date

2025-10-24

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

D66

Interventions

Group 1: For the planned retrospective data analysis, patients with a diagnosis of moderate or severe hemophilia A who have been treated with Emicizumab for at least 6 months in 2024 and without inhib

Eligibility

Sex/Gender

All

Age

12 Years to No maximum

Inclusion criteria

Inclusion criteria: · Patients with moderate and severe hemophilia A (defined as <=5% of normal FVIII clotting activity) without inhibitors (between 01.01.2023 – 31.12.2024) treated with prophylaxis therapy · Treated between 01.01.2024 and 31.12.2024 with Emicizumab in Germany for at least 6 months · = 12 years of age (measured at 01.01.2023) · Patient consented to the use of health-related data for this research

Exclusion criteria

Exclusion criteria: · Patients with hemophilia A with inhibitors (Positive inhibitor result (assessed by local laboratory) defined as >=0.6 Bethesda units (BU)/mL in 2023/2024 · Patients with other bleeding disorders · Patients with other inflammatory joint-specific diseases · Patients with preexisting synovitis at time of Emicizumab initiation · Patients on demand therapy (during the observational period 2023/2024)

Design outcomes

Primary

Measure	Time frame
To evaluate the prevalence of synovitis during the last year (2024) of the observational period in ankle, knee and elbow joints in patients >12 years with moderate and severe hemophilia A without inhibitors treated with Emicizumab in Germany	—

Secondary

Measure	Time frame
To describe the characterization of synovitis in patients > 12 years with moderate and severe hemophilia A without inhibitors in Germany. To describe applied treatment options of synovitis diagnosed in patients > 12 years with moderate and severe hemophilia A without inhibitors in Germany To evaluate the effectiveness of synovitis treatment in patients > 12 years with moderate and severe hemophilia A without inhibitors in Germany	—

Measure

Time frame

To describe the characterization of synovitis in patients > 12 years with moderate and severe hemophilia A without inhibitors in Germany. To describe applied treatment options of synovitis diagnosed in patients > 12 years with moderate and severe hemophilia A without inhibitors in Germany To evaluate the effectiveness of synovitis treatment in patients > 12 years with moderate and severe hemophilia A without inhibitors in Germany

—

Countries

Germany

Contacts

Public ContactKirsten Kehrein

Roche Pharma AG

grenzach.study-management@roche.com+491724416506

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026