Condition category
Musculoskeletal Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
05/07/2016
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

Prof P Emery

ORCID ID

Contact details

Rheumatology and Rehabilitation Research Unit
Old Nurses Home
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
+44 (0)113 392 3995
p.emery@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436146603

Study information

Scientific title

A pilot study assessing the clinical effectiveness of dipyridamole in patients with active disease on methotrexate for rheumatoid arthritis with imaging analysis

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Rheumatoid arthritis

Intervention

Randomised controlled trial

Intervention type

Drug

Phase

Not Applicable

Drug names

Dipyridamole, methotrexate

Primary outcome measures

Clinical efficacy of dipyridamole combined with MTX at 8 weeks, as measured by DAS28 score with EULAR response

Secondary outcome measures

1. Number of patients requiring additional anti-rheumatic therapy
2. Change in the following individual clinical, laboratory and quality of life outcome measurements:
2.1. C-reactive protein (CRP)
2.2. Health Assessment Questionnaire (HAQ)
2.3. Visual Analogue Scale (VAS)
2.4. Early morning stiffness/tender and swollen joint count (66/68) ratio

Overall trial start date

01/01/2004

Overall trial end date

01/03/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Patients attending general Rheumatology clinics will be invited to participate

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

20

Participant 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

Recruitment start date

01/01/2004

Recruitment end date

01/03/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Leeds Teaching Hospitals NHS Trust (UK)

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

05/07/2016: this study never opened to recruitment.