Contact information
Type
Scientific
Primary contact
Dr Ernest Choy
ORCID ID
Contact details
Academic Department of Rheumatology
King's College Hospital (Dulwich)
Cutcombe Road
London
SE5 9RJ
United Kingdom
+44 (0)20 7346 6446
ernest.choy@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9722622
Study information
Scientific title
Combination Anti-Rheumatic Drugs in Early Rheumatoid Arthritis
Acronym
CARDERA
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.
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
Not specified
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Orthopaedics, rheumatology
Intervention
Patients will be randomised to receive:
1. Methotrexate alone
2. Methotrexate plus prednisolone
3. Methotrexate plus cyclosporin
4. Methotrexate plus prednisolone plus cyclosporin
Intervention type
Drug
Phase
Not Applicable
Drug names
Methotrexate, prednisolone, cyclosporin
Primary outcome measure
The proportion of patients with one or more new erosions on X-rays of hands and feet
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2000
Overall trial end date
23/02/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
468
Participant 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)
Recruitment start date
01/01/2000
Recruitment end date
23/02/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
King's College Hospital (Dulwich)
London
SE5 9RJ
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
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
Basic results (scientific)
Publication list
2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/17768173
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24433430
2016 secondary analysis in: http://www.ncbi.nlm.nih.gov/pubmed/27651924
Publication citations
-
Results
Choy EH, Smith CM, Farewell V, Walker D, Hassell A, Chau L, Scott DL, , Factorial randomised controlled trial of glucocorticoids and combination disease modifying drugs in early rheumatoid arthritis., Ann. Rheum. Dis., 2008, 67, 5, 656-663, doi: 10.1136/ard.2007.076299.
-
Results
Seegobin SD, Ma MH, Dahanayake C, Cope AP, Scott DL, Lewis CM, Scott IC, ACPA-positive and ACPA-negative rheumatoid arthritis differ in their requirements for combination DMARDs and corticosteroids: secondary analysis of a randomized controlled trial., Arthritis Res. Ther., 2014, 16, 1, R13, doi: 10.1186/ar4439.