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
Scientific
Division of Rheumatology
via Moscati, 31
Rome
00168
Italy
Study information
| Study design | Interventional open label single centre phase l trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The safety and efficacy of anti-CD20 therapy (rituximab) in systemic sclerosis: an interventional open-label single centre phase I trial |
| Study acronym | BSSc |
| Study objectives | 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(s) | Catholic University Institutional Committee approved on the 15th January 2006 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/12/2005 |
| Completion date | 01/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 20+ participants |
| Key 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 |
| Key exclusion criteria | Severe pulmonary and cardiac involvement |
| Date of first enrolment | 01/12/2005 |
| Date of final enrolment | 01/12/2010 |
Locations
Countries of recruitment
- Italy
Study participating centre
Division of Rheumatology
Rome
00168
Italy
00168
Italy
Sponsor information
Catholic University of the Sacred Heart (Italy)
University/education
University/education
Division of Rheumatology
via Moscati, 31
Rome
00168
Italy
| Website | http://www.unicatt.it/ucsc_EV.asp |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
