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

25th Martiou
Kato Kastritsi
Rion
Patras
26504
Greece

Study information

Study designSingle-centre, open-label, randomised controlled trial
Primary study designInterventional
Secondary study designRandomised 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 titleEfficacy of rituximab in patients with systemic sclerosis: an open label randomised controlled study
Study acronymRTX-Scleroderma
Study objectivesSystemic 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) studiedSystemic sclerosis (SSc)
InterventionThe 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 typeDrug
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)Rituximab
Primary outcome measure1. 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 measures1. 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 date15/03/2008
Completion date15/06/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants15
Key inclusion criteria1. 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 criteriaAged less than 18 years
Date of first enrolment15/03/2008
Date of final enrolment15/06/2009

Locations

Countries of recruitment

  • Greece

Study participating centre

25th Martiou
Patras
26504
Greece

Sponsor information

University Hospital of Patras (Greece)
University/education

Rheumatology Departmant
Department of Rheumatology
Rion
Patras
26504
Greece

ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan