Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The safety and efficacy of anti-CD20 therapy (rituximab) in systemic sclerosis: an interventional open-label single centre phase I trial
Acronym
BSSc
Study hypothesis
Considering the emerging role of B cells in systemic sclerosis, we will evaluate the safety and the efficacy of anti-CD20 therapy (rituximab) in systemic sclerosis patients, that had not previously responded to conventional therapy.
Ethics approval
Catholic University Institutional Committee approved on the 15th January 2006
Study design
Interventional open label single centre phase l trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Systemic sclerosis
Intervention
Patients will be treated with rituximab, two endovenous infusions of 1000 mg, 2 weeks apart, together with 100 mg methylprednisolone at each infusion. Clinical (skin score, disease activity and disease severity score, Global Health Status and Health Assessment Questionnaire, pulmonary function tests), biological (erythrocyte sedimentation rate [ESR], C-reactive protein, anti-CD20 positive cells in skin and blood, immunoglobulin levels and autoantibodies levels) and instrumental (lung computed tomography [CT] and echocardiography) data will be collected for at least 36 months.
Intervention type
Drug
Phase
Phase I
Drug names
Rituximab, methylprednisolone
Primary outcome measure
Safety of the drug and efficacy on skin score (score that evaluates fibrosis on 17 skin areas: 0 = no skin involvement, 3 = severe thickening). All clinical evaluations will be performed every three months.
Secondary outcome measures
1. Efficacy of the drug on activity and severity indices
2. Global Health Status and Health Assessment Questionnaire
3. Evaluation of interleukin-6 (IL-6) and B-cell activating factor (BAFF) blood levels
4. Evaulation of the number of CD20-positive cells either in the blood either in cell infiltrate of skin biopsies
All clinical evaluations will be performed every three months. Pulmonary function tests will be performed every 6 months, while skin biopsies, echocardiography and lung HRCT every 12 months.
Overall trial start date
01/12/2005
Overall trial end date
01/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Systemic sclerosis patients aged 18 - 70 years , either sex
2. Diffuse cutaneous involvement
3. A worsening of skin score higher than 10% despite conventional therapies
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20+ participants
Participant exclusion criteria
Severe pulmonary and cardiac involvement
Recruitment start date
01/12/2005
Recruitment end date
01/12/2010
Locations
Countries of recruitment
Italy
Trial participating centre
Division of Rheumatology
Rome
00168
Italy
Sponsor information
Organisation
Catholic University of the Sacred Heart (Italy)
Sponsor details
Division of Rheumatology
via Moscati
31
Rome
00168
Italy
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Catholic University of the Sacred Heart (Italy) - Division of Rheumatology
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19103636
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19180481
Publication citations
-
Results
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, 69, 1, 193-197, doi: 10.1136/ard.2008.095463.
-
Results
Lafyatis R, Kissin E, York M, Farina G, Viger K, Fritzler MJ, Merkel PA, Simms RW, B cell depletion with rituximab in patients with diffuse cutaneous systemic sclerosis., Arthritis Rheum., 2009, 60, 2, 578-583, doi: 10.1002/art.24249.