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A Protocol Based Treatment for Early and Severe Systemic Sclerosis With (Anti-CD20), Rituximab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00379431
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Active, not recruiting
First Posted : September 21, 2006
Last Update Posted : December 5, 2014
Information provided by (Responsible Party):
University Hospital, Ghent

Brief Summary:
Rituximab 1000 mg i.v. will be given on day 1 and 15, week 26 - 28, together with a corticosteroid regimen consisting of methylprednisolone 100 mg i.v. 30 minutes prior to both infusions.

Condition or disease Intervention/treatment Phase
Early and Severe Systemic Sclerosis Drug: Administration of rituximab and methylprednisolone Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Protocol Based Treatment for Early and Severe Systemic Sclerosis With (Anti-CD20), Rituximab
Study Start Date : November 2006
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

Arm Intervention/treatment
Experimental: Administration of rituximab and methylprednisolone Drug: Administration of rituximab and methylprednisolone


Pharmaceutical form: Concentrate for solution for infusion. Maximum duration of treatment: 28 weeks Maximum dose allowed: 2000 mg (use of total dose) Route of administration: intravenous use.

Primary Outcome Measures :
  1. Death [ Time Frame: 28 weeks ]
  2. Heart failure defined as a LVEF< 30% [ Time Frame: 28 weeks ]
  3. Lung failure defined as a resting PaO2< 60mmHg [ Time Frame: 28 weeks ]
  4. Evolution of antibody titers. [ Time Frame: 28 weeks ]
  5. Deterioration, improvement or stabilisation of, disease activity score, 6-m walking distance, SHAQ, LVEF and creatinine clearance [ Time Frame: 28 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • male or female >= 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
  • Antibodies specific for systemic sclerosis: anti-topoisomerase; anti-centromere antibodies
  • Severe disease defined by either one of the following: a modified Rodnan skin score (TSS° >= 14 ), disease activity score >= 3
  • Contraception for women with childbearing potential. Sexual abstinence is an alternative to contraception.
  • Patient has signed informed consent.

Exclusion Criteria:

  • disease duration more than 4 years
  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00379431

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UCL St. Luc Brussel
Brussel, Belgium
UZ Brussel
Brussel, Belgium
University Hospital Ghent
Ghent, Belgium, 9000
UZ Gasthuisberg Leuven
Leuven, Belgium
Sponsors and Collaborators
University Hospital, Ghent
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Principal Investigator: Filip De Keyser, MD, PhD University Hospital, Ghent
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: University Hospital, Ghent Identifier: NCT00379431    
Other Study ID Numbers: 2006/257
First Posted: September 21, 2006    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal