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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 30 June 2014
Main ID:  ISRCTN32484878
Date of registration: 25/10/2000
Primary sponsor: Medical Research Council (MRC) (UK)
Public title: Combination Anti-Rheumatic Drugs in Early Rheumatoid Arthritis (RA) CARDERA
Scientific title:
Date of first enrolment: Jan 1 2000
Target sample size: 468
Recruitment status: Completed/Not recruiting
URL:  http://isrctn.org/ISRCTN32484878
Study type:  Interventional
Study design:  Randomised controlled trial  
Countries of recruitment
United Kingdom
Contacts
Name: Ernest  Choy
Address:  Academic Department of Rheumatology King's College Hospital (Dulwich) Cutcombe Road SE5 9RJ London United Kingdom
Telephone: +44 (0)20 7346 6446
Email: ernest.choy@kcl.ac.uk
Affiliation: 
Key inclusion & exclusion criteria
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

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)


Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Orthopaedics, rheumatology
Intervention(s)
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(s)
The proportion of patients with one or more new erosions on X-rays of hands and feet.
Secondary Outcome(s)
Not provided at time of registration
Secondary ID(s)
G9722622
Source(s) of Monetary Support
Medical Research Council (UK)
Secondary Sponsor(s)
N/A
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