A Protocol Based Treatment for Debilitating Fibrosing Skin Disorders With (Anti-CD 20), Rituximab, Evaluating Safety and Efficacy

NCT00936546 | Completed Phase 2

• 1 other identifier: 2009/183
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the safety and efficacy of the combination of rituximab and methotrexate to treat disabling fibrosing skin disorders.Rituximab will be administered at baseline and month 6. The drug will be considered efficacious if the skin thickness diminishes substantially.

Conditions

Debilitating Fibrosing Skin Disorders (Localised Scleroderma, Eosinophilic Fasciitis)

Outcome Measures

Primary Outcomes (1)

• Testing the safety of anti-CD-20 in a small cohort of patients with debilitating fibrosing skin disorders.

  Safety will be evaluated at baseline, month 3, 6, 12, 15, 18, 24, 36, 48 and 60.

Secondary Outcomes (1)

• Testing the efficacy of anti-CD-20 in a small cohort of patients with debilitating fibrosing skin disorders.

  Efficacy will be evaluated at baseline, month 3, 6, 12, 15, 18, 24, 36, 48 and 60.

Study Arms (1)

Rituximab

EXPERIMENTAL

Drug: Rituximab

Interventions

Rituximab DRUG

Mabthera, Rituximab 1000 mg I.V.

Rituximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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:
• Restriction of mobility
• Disfiguration: eg: facial involvement
• Severe Internal Organ involvement
• Contraception for women with childbearing potential. Sexual abstinence is an alternative to contraception.

You may not qualify if:

• FVC\<, = 50%
• LVEF\<, = 40% of predicted value,
• DLCO\<, = 40% of predicted value
• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

• website of the University Hospital Ghent

MeSH Terms

Conditions

Scleroderma, Localized; Eosinophilic Fasciitis

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Filip De Keyser, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2009
• First Posted: July 10, 2009
• Study Start: June 1, 2009
• Primary Completion: June 3, 2015
• Study Completion: June 3, 2015
• Last Updated: July 13, 2021

Record last verified: 2021-07

Locations

BE (1)