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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00936546
First received: July 9, 2009
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Debilitating Fibrosing Skin Disorders (Localised Scleroderma, Eosinophilic Fasciitis)
Drug: Rituximab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Protocol Based Treatment for Debilitating Fibrosing Skin Disorders With (Anti-CD 20), Rituximab, Evaluating Safety and Efficacy

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Testing the safety of anti-CD-20 in a small cohort of patients with debilitating fibrosing skin disorders. [ Time Frame: Safety will be evaluated at baseline, month 3, 6, 12, 15, 18, 24, 36, 48 and 60. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Testing the efficacy of anti-CD-20 in a small cohort of patients with debilitating fibrosing skin disorders. [ Time Frame: Efficacy will be evaluated at baseline, month 3, 6, 12, 15, 18, 24, 36, 48 and 60. ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: June 2009
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rituximab Drug: Rituximab
Mabthera, Rituximab 1000 mg I.V.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:
  • Restriction of mobility
  • Disfiguration: eg: facial involvement
  • Severe Internal Organ involvement
  • Contraception for women with childbearing potential. Sexual abstinence is an alternative to contraception.

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.
  • Treatment with any investigational agent within 28 days of baseline or 5 half-lives of the investigational drug (which 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00936546

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Filip De Keyser, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00936546     History of Changes
Other Study ID Numbers: 2009/183
Study First Received: July 9, 2009
Last Updated: February 6, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board

Additional relevant MeSH terms:
Disease
Skin Diseases
Eosinophilia
Fasciitis
Scleroderma, Localized
Pathologic Processes
Leukocyte Disorders
Hematologic Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on October 16, 2014