Condition category
Musculoskeletal Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
04/07/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes