Condition category
Skin and Connective Tissue Diseases
Date applied
20/10/2008
Date assigned
30/10/2008
Last edited
31/10/2008
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

Dr Dimitrios Daoussis

ORCID ID

Contact details

25th Martiou
Kato Kastritsi
Rion
Patras
26504
Greece

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

Sponsor information

Organisation

University Hospital of Patras (Greece)

Sponsor details

Rheumatology Departmant
Department of Rheumatology
Rion
Patras
26504
Greece

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes