Condition category
Musculoskeletal Diseases
Date applied
14/06/2009
Date assigned
30/07/2009
Last edited
30/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Gianfranco Ferraccioli

ORCID ID

Contact details

Division of Rheumatology
via Moscati
31
Rome
00168
Italy

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 measures

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

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

http://www.unicatt.it/ucsc_EV.asp

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes