The use of a randomised controlled trial of autologous stem cell transplantation (ASCT) versus mobilisation alone to investigate the pathogenic role of T-cells in patients with severe rheumatoid arthritis

ISRCTN ISRCTN52892553
DOI https://doi.org/10.1186/ISRCTN52892553
Secondary identifying numbers N0436118138
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
04/07/2011
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Musculoskeletal 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 P Emery
Scientific

Rheumatology and Rehabilitation Research Unit
36 Clarendon Road
Leeds
LS2 9LN
United Kingdom

Phone +44 0113 392 3995
Email p.emery@leeds.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectives1. To assess the ability of a mobilising dose of cyclophosphamide to reduce disease activity and increase response to previously ineffective therapy in comparison to full ASCT.
2. To assess the ability of maintenance therapy post ASCT to prevent relapse.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedMusculoskeletal Diseases: Rheumatoid arthritis (RA)
InterventionLaboratory study; Randomised controlled trial, Random allocation to:
A. Autologous stem cell transplantation
B. Mobilisation alone
Intervention typeOther
Primary outcome measureRA quality of life questionnaire, health assessment questionnaire. Tender and swollen joint counts. Inflammatory markers. Histological analysis.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/12/2001
Completion date01/07/2006
Reason abandoned (if study stopped)Insufficient recruitment

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaPatients with rheumatoid arthritis who have failed conventional therapy. Patients will be enrolled from specialist RA clinics.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/12/2001
Date of final enrolment01/07/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Rheumatology and Rehabilitation Research Unit
Leeds
LS2 9LN
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Charity

Leeds Teaching Hospitals NHS Trust (UK)

No information available

Arthritis Research Campaign

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