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EVALUATION OF FEASIBILITY OF RITUXIMAB BY INTRALESIONAL INJECTION IN PATIENTS WITH GRAVES OPHTALMOPATHY - ND

EVALUATION OF FEASIBILITY OF RITUXIMAB BY INTRALESIONAL INJECTION IN PATIENTS WITH GRAVES OPHTALMOPATHY - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-014361-14-IT
Enrollment
Unknown
Registered
2009-12-07
Start date
2010-01-13
Completion date
Unknown
Last updated
2013-07-15

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

Conditions

GRAVES OPHTALMOPATHY MedDRA version: 12.1 Level: LLT Classification code 10065624 Term: Graves-Basedow disease

Interventions

Trade Name: MABTHERA Pharmaceutical Form: Solution for infusion INN or Proposed INN: Rituximab Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical Fo

Sponsors

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Basedow-Graves disease with ophtalmopathy and ophtalmopathy in active phase. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: thyroid disease without ocular involvement, ophtalmopathy in chronic phase, minors, pregnancy, feeding, unstable heart disease.

Design outcomes

Primary

MeasureTime frame
Main Objective: The aim of our work (STUDY STAGE 2) is to assess the feasibility of intralesional injection of Rituximab (10 mg in 1ml sf) in the case of patients with Graves` oftalmopathy in active phase.;Secondary Objective: nd;Primary end point(s): nd—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026