A protocol based treatment for debilitating fibrosing skin disorders with (anti-CD-20), rituximab

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-012034-70-BE

Enrollment

Registered

2009-04-17

Start date

2009-06-03

Completion date

Unknown

Last updated

2024-12-03

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

Conditions

Fibrosing skin disorders

Interventions

Trade Name: Mabthera Product Name: Rituximab Pharmaceutical Form: Concentrate for solution for infusion CAS Number: 174722-31-7 Other descriptive name: RITUXIMAB Concentration unit: mg milligram(s) Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • (Fe) male >, = 18 years • Fibrosing skin disorder, not fulfilling the ACR criteria for diffuse SSc • Inadequate response to methotrexate (at least 12 weeks 10 mg/w, except if not tolerated or contra-indicated • Debilitating disease defined by either one of the following: o Restriction of mobility o Disfiguration: eg: facial involvement o Severe Internal Organ involvement • Contraception for women with childbearing potential. Sexual abstinence is an alternative to contraception. • Patient has signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • FVC 1 biological agent. - Previous treatment with any cell depleting therapies, including investigational agents. - Treatment with any investigational agent within 28 days of baseline or 5 half-lives of the investigational drug (xhich ever is the longer). - Receipt of any vaccine within 28 days prior to baseline - Intolerance or contraindications to i.v. glucocorticoids. - Positive serum human chorionic gonadotropin (hCG) measured at screening or a positive pregnancy test prior to the first rituximab infusion. - Positive tests for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C serology. - Hemoglobin < 8.0 g/dL. - Concentrations of serum IgG and/or IgM below 5.0 and 0.40 mg/mL, respectively. - Absolute neutrophil count (ANC) < 1.5 X 10³/µL.

Design outcomes

Primary

Measure	Time frame
Main Objective: To test the efficacy and safety of anti-CD-20 in patients with debilitating fibrosing skin disorders;Secondary Objective: ;Primary end point(s): Testing the efficacy and safety of anti-CD-20 in a small cohort of patients with debilitating fibrosing skin disorders. The following items will be evaluated over time: • Histopathology • Internal organ involvement	—

Countries

Belgium

Outcome results

None listed

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