Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PGNP1/8/07
Study information
Scientific title
Efficacy of rituximab in patients with systemic sclerosis: an open label randomised controlled study
Acronym
RTX-Scleroderma
Study hypothesis
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
This study was aproved by the Ethics Committee of Patras University Hospital in February 2008.
Study design
Single-centre, open-label, randomised controlled trial
Primary study design
Interventional
Secondary study design
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 (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
Phase
Phase II
Drug names
Rituximab
Primary outcome measures
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 trial start date
15/03/2008
Overall trial end date
15/06/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
15
Participant exclusion criteria
Aged less than 18 years
Recruitment start date
15/03/2008
Recruitment end date
15/06/2009
Locations
Countries of recruitment
Greece
Trial participating centre
25th Martiou
Patras
26504
Greece
Funders
Funder type
Research organisation
Funder name
Hellenic Society for Rheumatology (Greece)
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