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 |
| Protocol serial number | N0436118138 |
| Sponsor | Department of Health (UK) |
| Funders | Leeds Teaching Hospitals NHS Trust (UK), Arthritis Research Campaign |
- 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
Scientific
Rheumatology and Rehabilitation Research Unit
36 Clarendon Road
Leeds
LS2 9LN
United Kingdom
| Phone | +44 0113 392 3995 |
|---|---|
| p.emery@leeds.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
RA quality of life questionnaire, health assessment questionnaire. Tender and swollen joint counts. Inflammatory markers. Histological analysis. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/07/2006 |
| Reason abandoned (if study stopped) | Insufficient recruitment |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | Patients with rheumatoid arthritis who have failed conventional therapy. Patients will be enrolled from specialist RA clinics. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/12/2001 |
| Date of final enrolment | 01/07/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Rheumatology and Rehabilitation Research Unit
Leeds
LS2 9LN
United Kingdom
LS2 9LN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
