Efficacy of rituximab in patients with systemic sclerosis
| ISRCTN | ISRCTN99672071 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99672071 |
| Secondary identifying numbers | PGNP1/8/07 |
- Submission date
- 20/10/2008
- Registration date
- 30/10/2008
- Last edited
- 31/10/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Dimitrios Daoussis
Scientific
Scientific
25th Martiou
Kato Kastritsi
Rion
Patras
26504
Greece
Study information
| Study design | Single-centre, open-label, randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | 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 | Efficacy of rituximab in patients with systemic sclerosis: an open label randomised controlled study |
| Study acronym | RTX-Scleroderma |
| Study objectives | Systemic sclerosis (SSc) is a chronic systemic autoimmune disease characterised by vasculopathy and progressive fibrosis. Rituximab (RTX) is a chimeric monoclonal antibody (mAb) against human CD20 that depletes peripheral B cells. It has been successfully introduced in the treatment of systemic rheumatic diseases and exhibits an acceptable safety profile. The preliminary encouraging results from the use of RTX in animal models of SSc and in humans with chronic graft-versus-host disease (GVHD) has led us to investigate more thoroughly the potential efficacy of RTX in patients with SSc in an open-label, prospective, randomised, controlled study. |
| Ethics approval(s) | This study was aproved by the Ethics Committee of Patras University Hospital in February 2008. |
| Health condition(s) or problem(s) studied | Systemic sclerosis (SSc) |
| Intervention | The participants were randomly allocated to the following two arms (ratio 1:1): Rituximab arm: four weekly intravenous (IV) pulses of rituximab (375 mg/m^2) x 6 (24 weeks in total) and standard treatment Control arm: standard treatment alone Patients were fully evaluated at baseline and 24 weeks. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Rituximab |
| Primary outcome measure | 1. Changes in skin histology including collagen deposition and lymphocytic infiltration 2. Changes in pulmonary function as assessed by PFT Timepoints of assessment for primary and secondary outcomes: baseline and 24 weeks. |
| Secondary outcome measures | 1. Clinical assessment of skin involvement by the Modified Rodnan Skin Score (MRSS) 2. Changes in HRCT scores 3. Changes in serum levels of soluble markers 4. Changes in overall functional impairment, assessed by the Health Assessment Questionnaire (HAQ) Timepoints of assessment for primary and secondary outcomes: baseline and 24 weeks. |
| Overall study start date | 15/03/2008 |
| Completion date | 15/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 15 |
| Key inclusion criteria | 1. Both males and females 2. Detection of anti-Scl-70 autoantibodies in their sera 3. Presence of SSc-associated interstitial lung disease (ILD) as indicated by findings in either high-resolution computed tomography (HRCT) of the chest or pulmonary function tests (PFT) or both 4. Absence of any changes in medications and/or dosage of treatment administered during the last 12 months before enrolment |
| Key exclusion criteria | Aged less than 18 years |
| Date of first enrolment | 15/03/2008 |
| Date of final enrolment | 15/06/2009 |
Locations
Countries of recruitment
- Greece
Study participating centre
25th Martiou
Patras
26504
Greece
26504
Greece
Sponsor information
University Hospital of Patras (Greece)
University/education
University/education
Rheumatology Departmant
Department of Rheumatology
Rion
Patras
26504
Greece
"ROR" |
https://ror.org/03c3d1v10 |
|---|
Funders
Funder type
Research organisation
Hellenic Society for Rheumatology (Greece)
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 |
