A pilot study assessing the clinical effectiveness of dipyridamole in patients with active disease on methotrexate for rheumatoid arthritis with imaging analysis
| ISRCTN | ISRCTN28468355 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28468355 |
| Protocol serial number | N0436146603 |
| Sponsor | Department of Health |
| Funder | Leeds Teaching Hospitals NHS Trust (UK) |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 05/07/2016
- 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
Prof P Emery
Scientific
Scientific
Rheumatology and Rehabilitation Research Unit
Old Nurses Home
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
| Phone | +44 (0)113 392 3995 |
|---|---|
| p.emery@leeds.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A pilot study assessing the clinical effectiveness of dipyridamole in patients with active disease on methotrexate for rheumatoid arthritis with imaging analysis |
| Study objectives | Methotrexate (MTX) has being commonly used in the treatment of rheumatoid arthritis (RA) for more than 20 years, and is safe and well tolerated. Although weekly low dose MTX is now first-line therapy because of its efficacy and safety, some patients still do not respond enough or cannot tolerate taking the sufficient dose of MTX because of its side effects. Since recently available biological therapy such as anti-tumour necrosis factor (TNF) agents are not only effective, but also expensive (approx annual cost of £9,000/year) this treatment is only available for the patients with long standing resistant disease. It would be still desirable to find an approach which can reduce or suspend the needs of the biologics. A series of studies have shown that adenosine is released in high concentrations from cells and tissues after treatment with MTX. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Rheumatoid arthritis |
| Intervention | Randomised controlled trial |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Dipyridamole, methotrexate |
| Primary outcome measure(s) |
Clinical efficacy of dipyridamole combined with MTX at 8 weeks, as measured by DAS28 score with EULAR response |
| Key secondary outcome measure(s) |
1. Number of patients requiring additional anti-rheumatic therapy |
| Completion date | 01/03/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 20 |
| Key inclusion criteria | Patients attending general Rheumatology clinics will be invited to participate |
| Key exclusion criteria | 1. Pregnant or nursing women 2. Concomitant serious medical conditions presently severe, progressive or uncontrolled 3. Contraindication to proposed therapeutic agents 4. Taking theophylline and/or treated for asthma |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 01/03/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom
LS1 3EX
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/07/2016: this study never opened to recruitment.
