Combination anti-rheumatic drugs in early rheumatoid arthritis

ISRCTN	ISRCTN32484878
DOI	https://doi.org/10.1186/ISRCTN32484878
Protocol serial number	G9722622
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Combination Anti-Rheumatic Drugs in Early Rheumatoid Arthritis
Study acronym	CARDERA
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Methotrexate, prednisolone, cyclosporin
Primary outcome measure(s)	The proportion of patients with one or more new erosions on X-rays of hands and feet
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	23/02/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	468
Key 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
Key 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)
Date of first enrolment	01/01/2000
Date of final enrolment	23/02/2005

King's College Hospital (Dulwich)

London
SE5 9RJ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

22/09/2016: Publication reference added.