A protocol based treatment for early and severe systemic sclerosis with (anti-CD-20) rituximab

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-003836-31-BE

Enrollment

Registered

2006-08-02

Start date

2006-09-06

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

systemic sclerosis MedDRA version: 8.1 Level: LLT Classification code 10042953 Term: Systemic sclerosis

Interventions

Trade Name: MabThera Product Name: Rituximab Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Rituximab CAS Number: 174722-31-7 Concentration unit: mg milligram(s) Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Female/male >, = 18 years • SSc according to the ARA criteria for systemic sclerosis • Disease duration less than 4 years (from the appearance of skin changes (oedema, fibrosis) • Inadequate response to methotrexate (at least 12 weeks 10 mg/w, except if not tolerated or contra-indicated • Antibodies specific for systemic sclerosis: anti-topoisomerase; anti-centromere antibodies • Severe disease defined by either one of the following: o A modified Rodnan skin score (TSS° >,= 14 ) o Disease activity score >,= 3 • 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) 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: • Disease duration more than 4 years • 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 assess the efficacy and the toxicity of anti-CD-20 in patients with early and severe systemic sclerosis;Secondary Objective: ;Primary end point(s): Testing the efficacy and safety of anti-CD-20. The following items will be evaluated over time: • Death • Heart failure defined as a LVEF< 30% • Lung failure defined as a resting PaO2< 60mmHg • Evolution of antibody titers and of relevant cell markers • Deterioration, improvement or stabilisation of, disease activity score, 6M walking distance, SHAQ, LVEF and creatinine clearance as defined in the protocol	—

Measure

Time frame

Main Objective: To assess the efficacy and the toxicity of anti-CD-20 in patients with early and severe systemic sclerosis;Secondary Objective: ;Primary end point(s): Testing the efficacy and safety of anti-CD-20. The following items will be evaluated over time: • Death • Heart failure defined as a LVEF< 30% • Lung failure defined as a resting PaO2< 60mmHg • Evolution of antibody titers and of relevant cell markers • Deterioration, improvement or stabilisation of, disease activity score, 6M walking distance, SHAQ, LVEF and creatinine clearance as defined in the protocol

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Countries

Belgium

Outcome results

None listed

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