The safety and efficacy of anti-CD20 therapy (rituximab) in systemic sclerosis

ISRCTN ISRCTN77554566
DOI https://doi.org/10.1186/ISRCTN77554566
Secondary identifying numbers N/A
Submission date
14/06/2009
Registration date
30/07/2009
Last edited
30/07/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Gianfranco Ferraccioli
Scientific

Division of Rheumatology
via Moscati, 31
Rome
00168
Italy

Study information

Study designInterventional open label single centre phase l trial
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe safety and efficacy of anti-CD20 therapy (rituximab) in systemic sclerosis: an interventional open-label single centre phase I trial
Study acronymBSSc
Study objectivesConsidering 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(s)Catholic University Institutional Committee approved on the 15th January 2006
Health condition(s) or problem(s) studiedSystemic sclerosis
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhasePhase I
Drug / device / biological / vaccine name(s)Rituximab, methylprednisolone
Primary outcome measureSafety 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 measures1. 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 study start date01/12/2005
Completion date01/12/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit70 Years
SexBoth
Target number of participants20+ participants
Key inclusion criteria1. 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
Key exclusion criteriaSevere pulmonary and cardiac involvement
Date of first enrolment01/12/2005
Date of final enrolment01/12/2010

Locations

Countries of recruitment

  • Italy

Study participating centre

Division of Rheumatology
Rome
00168
Italy

Sponsor information

Catholic University of the Sacred Heart (Italy)
University/education

Division of Rheumatology
via Moscati, 31
Rome
00168
Italy

Website http://www.unicatt.it/ucsc_EV.asp
ROR logo "ROR" https://ror.org/03h7r5v07

Funders

Funder type

University/education

Catholic University of the Sacred Heart (Italy) - Division of Rheumatology

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2009 Yes No
Results article results 01/01/2010 Yes No