|
ISRCTN
|
ISRCTN32484878
|
|
DOI
|
10.1186/ISRCTN32484878
|
|
ClinicalTrials.gov identifier
|
|
|
EudraCT number
|
|
|
Public title
|
Combination Anti-Rheumatic Drugs in Early Rheumatoid Arthritis (RA)
|
|
Scientific title
|
|
|
Acronym
|
CARDERA
|
|
Serial number at source
|
G9722622
|
|
Study hypothesis
|
To investigate if the combination of cyclosporin and/or oral steroids with methotrexate in early rheumatoid arthritis (RA) reduces the proportion of patients who develop new erosions within two years.
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Orthopaedics, rheumatology
|
|
Participants - inclusion criteria
|
1. RA by the 1987 criteria of the American College of Rheumatology
2. Disease duration of less than 24 months
3. The clinical need for treatment with a slow-acting anti-rheumatic drug (SAARD) as shown by evidence of active RA
4. Patients must be willing and able to give informed consent
5. Age greater than 18
|
|
Participants - exclusion criteria
|
1. Other forms of inflammatory arthritis (e.g. psoriatic arthritis, systemic lupus erythematosus)
2. Current oral steroids for RA or other conditions (e.g. asthma)
3. Contra-indications to methotrexate
4. Other serious medical disorders (e.g. hepatic failure, cardiac failure, current malignant disease)
5. Females of child bearing potential who are not taking adequate contraceptive protection
6. Contra-indications to cyclosporin therapy
7. Neutrophil count less than 1.5 x 10^12 per decilitre or platelet count less than 100 x 10^12 per decilitre
8. Abnormal liver function test (gamma glutamyl transferase [gGT] greater than 3 x or aspartate aminotransferase [AST]/alanine aminotransferase [ALT] greater than 2 x upper limit of normal)
|
|
Anticipated start date
|
01/01/2000
|
|
Anticipated end date
|
23/02/2005
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
468
|
|
Interventions
|
Patients will be randomised to receive:
1. Methotrexate alone
2. Methotrexate plus prednisolone
3. Methotrexate plus cyclosporin
4. Methotrexate plus prednisolone plus cyclosporin
|
|
Primary outcome measure(s)
|
The proportion of patients with one or more new erosions on X-rays of hands and feet.
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Medical Research Council (UK)
|
|
Trial website
|
|
|
Publications
|
Results in http://www.ncbi.nlm.nih.gov/pubmed/17768173
|
|
Contact name
|
Dr
Ernest
Choy
|
|
Address
|
Academic Department of Rheumatology
King's College Hospital (Dulwich)
Cutcombe Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
SE5 9RJ
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7346 6446
|
|
Fax
|
+44 (0)20 7346 6475
|
|
Email
|
ernest.choy@kcl.ac.uk
|
|
Sponsor
|
Medical Research Council (MRC) (UK)
|
|
Address
|
20 Park Crescent
|
|
City/town
|
London
|
|
Zip/Postcode
|
W1B 1AL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7636 5422
|
|
Fax
|
+44 (0)20 7436 6179
|
|
Email
|
clinical.trial@headoffice.mrc.ac.uk
|
|
Sponsor website:
|
http://www.mrc.ac.uk
|
|
Date applied
|
25/10/2000
|
|
Last edited
|
15/04/2008
|
|
Date ISRCTN assigned
|
25/10/2000
|
