Combination anti-rheumatic drugs in early rheumatoid arthritis

ISRCTN ISRCTN32484878
DOI https://doi.org/10.1186/ISRCTN32484878
Secondary identifying numbers G9722622
Submission date
25/10/2000
Registration date
25/10/2000
Last edited
22/09/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ernest Choy
Scientific

Academic Department of Rheumatology
King's College Hospital (Dulwich)
Cutcombe Road
London
SE5 9RJ
United Kingdom

Phone +44 (0)20 7346 6446
Email ernest.choy@kcl.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typePrevention
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleCombination Anti-Rheumatic Drugs in Early Rheumatoid Arthritis
Study acronymCARDERA
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedOrthopaedics, rheumatology
InterventionPatients will be randomised to receive:
1. Methotrexate alone
2. Methotrexate plus prednisolone
3. Methotrexate plus cyclosporin
4. Methotrexate plus prednisolone plus cyclosporin
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Methotrexate, prednisolone, cyclosporin
Primary outcome measureThe proportion of patients with one or more new erosions on X-rays of hands and feet
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2000
Completion date23/02/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants468
Key inclusion criteria1. 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
Key exclusion criteria1. 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)
Date of first enrolment01/01/2000
Date of final enrolment23/02/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

King's College Hospital (Dulwich)
London
SE5 9RJ
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone +44 (0)20 7636 5422
Email clinical.trial@headoffice.mrc.ac.uk
Website http://www.mrc.ac.uk

Funders

Funder type

Research council

Medical Research Council (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2008 Yes No
Results article results 16/01/2014 Yes No
Other publications secondary analysis 26/08/2016 Yes No

Editorial Notes

22/09/2016: Publication reference added.