Combination anti-rheumatic drugs in early rheumatoid arthritis

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN32484878
• Date of registration: 25/10/2000
• Prospective Registration: No
• Primary sponsor: Medical Research Council (MRC) (UK)
• Public title: Combination anti-rheumatic drugs in early rheumatoid arthritis
• Scientific title: Combination Anti-Rheumatic Drugs in Early Rheumatoid Arthritis
• Date of first enrolment: 01/01/2000
• Target sample size: 468
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN32484878
• Study type: Interventional
• Study design: Randomised controlled trial (Prevention)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Ernest Choy

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: Both

Health Condition(s) or Problem(s) studied

Orthopaedics, rheumatology
Musculoskeletal Diseases
Rheumatoid arthritis

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)