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

• Conditions: Fibrosing skin disorders

• Registration Number: EUCTR2009-012034-70-BE
• Lead Sponsor: niversity Hospital Ghent

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-17
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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:
oRestriction of mobility
oDisfiguration: eg: facial involvement
oSevere 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

• FVC<, = 50%
• LVEF<, = 40% of predicted value,
• DLCO<, = 40% of predicted value
• Exclusion criteria as specifically described in the protocol for anti-CD-20:
-Lack of peripheral venous access.
-Pregnancy or breast feeding.
-Significant cardiac or pulmonary disease (including obstructive pulmonary disease).
-Evidence of significant uncontrolled concomitant disease such as, but not limited to, nervous system, renal, hepatic, endocrine or gastrointestinal disorders which, in the investigator’s opinion, would preclude patient participation.
-Primary or secondary immunodeficiency (history of, or currently active), including known history of HIV infection.
-Known active infection of any kind (excluding fungal infections of mail beds), or any major episode of infection requiring hospitalization or treatment with i.v. anti-infectives within 4 weeks of baseline or completion of oral anti-infectives within 2 weeks prior to baseline.
-History of deep space/tissue infection (e.g. fasciitis, abscess, osteomyelitis) within 52 weeks prior to baseline.
-History of serious recurrent or chronic infection (for screening for a chest infection a chest radiograph will be performed at screening if not performed within 12 weeks prior to screening).
-History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ (except basal cell and squamous cell carcinoma of the skin that have been excised and cured).
-History of a severe allergic or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of rituximab or to murine proteins.
-Concurrent treatment with any biologic agent or DMARD other than MTX. Treatment must be discontinued 14 days prior to baseline , except for the following: azathioprine for = 28 days; leflunomide for = 8 weeks (or = 14 days after 11 days of standard cholestyramine or activated charcoal washout); infliximab = 8 weeks; adalimumab = weeks.
-Previous treatment with > 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>The following items will be evaluated over time:<br>• Histopathology<br>• Internal organ involvement