A Protocol Based Treatment for Early and Severe Systemic Sclerosis With (Anti-CD20), Rituximab
NCT ID: NCT00379431
Last Updated: 2022-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
9 participants
INTERVENTIONAL
2006-11-27
2009-02-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Administration of rituximab and methylprednisolone
Administration of rituximab and methylprednisolone
Rituximab:
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.
Interventions
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Administration of rituximab and methylprednisolone
Rituximab:
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Filip De Keyser, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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UCL St. Luc Brussel
Brussels, , Belgium
UZ Brussel
Brussels, , Belgium
University Hospital Ghent
Ghent, , Belgium
UZ Gasthuisberg Leuven
Leuven, , Belgium
Countries
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References
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Melsens K, De Keyser F, Decuman S, Brusselle G, De Pauw M, Deschepper E, De Wilde K, Elewaut D, Piette Y, Vandecasteele E, Smith V. Assessment of sensitivity to change of the European Scleroderma Study Group activity index. Clin Exp Rheumatol. 2016 Sep-Oct;34 Suppl 100(5):148-151. Epub 2016 Jul 18.
Smith V, Pizzorni C, Riccieri V, Decuman S, Brusselle G, DE Pauw M, Deschepper E, Piette Y, Ruaro B, Sulli A, Vandecasteele E, Melsens K, DE Keyser F, Cutolo M. Stabilization of Microcirculation in Patients with Early Systemic Sclerosis with Diffuse Skin Involvement following Rituximab Treatment: An Open-label Study. J Rheumatol. 2016 May;43(5):995-6. doi: 10.3899/jrheum.151018. No abstract available.
Bonroy C, Smith V, Deschepper E, De Keyser F, Devreese K. Specific Antinuclear Antibody Level Changes after B Cell Depletion Therapy in Systemic Sclerosis Are Associated with Improvement of Skin Thickening. J Rheumatol. 2016 Jan;43(1):247-9. doi: 10.3899/jrheum.150105. No abstract available.
Smith V, Piette Y, van Praet JT, Decuman S, Deschepper E, Elewaut D, De Keyser F. Two-year results of an open pilot study of a 2-treatment course with rituximab in patients with early systemic sclerosis with diffuse skin involvement. J Rheumatol. 2013 Jan;40(1):52-7. doi: 10.3899/jrheum.120778. Epub 2012 Nov 1.
Smith V, Van Praet JT, Vandooren B, Van der Cruyssen B, Naeyaert JM, Decuman S, Elewaut D, De Keyser F. Rituximab in diffuse cutaneous systemic sclerosis: an open-label clinical and histopathological study. Ann Rheum Dis. 2010 Jan;69(1):193-7. doi: 10.1136/ard.2008.095463.
Related Links
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Website University Hospital Ghent
Other Identifiers
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2006/257
Identifier Type: -
Identifier Source: org_study_id