Condition category
Musculoskeletal Diseases
Date applied
25/10/2000
Date assigned
25/10/2000
Last edited
22/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes

22/09/2016: Publication reference added.