Contact information
Type
Scientific
Primary contact
Dr P Emery
ORCID ID
Contact details
Rheumatology and Rehabilitation Research Unit
36 Clarendon Road
Leeds
LS2 9LN
United Kingdom
+44 0113 392 3995
p.emery@leeds.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436118138
Study information
Scientific title
Acronym
Study hypothesis
1. 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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Musculoskeletal Diseases: Rheumatoid arthritis (RA)
Intervention
Laboratory study; Randomised controlled trial, Random allocation to:
A. Autologous stem cell transplantation
B. Mobilisation alone
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
RA quality of life questionnaire, health assessment questionnaire. Tender and swollen joint counts. Inflammatory markers. Histological analysis.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/12/2001
Overall trial end date
01/07/2006
Reason abandoned
Insufficient recruitment
Eligibility
Participant inclusion criteria
Patients with rheumatoid arthritis who have failed conventional therapy. Patients will be enrolled from specialist RA clinics.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/12/2001
Recruitment end date
01/07/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Rheumatology and Rehabilitation Research Unit
Leeds
LS2 9LN
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Leeds Teaching Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Arthritis Research Campaign
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