Rheumatoid Arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
Conditions
Interventions
Product Name: Methotrexate
Product Code: Methotrexate
Pharmaceutical Form: Tablet
INN or Proposed INN: METHOTREXATE
CAS Number: 59052
Current Sponsor code: Methotrexate
Concentration unit: mg milligra
Sponsors
King's College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Males and Females aged over 18 years b. Established RA by the criteria of the American College of Rheumatology c. Meet NICE criteria for being prescribed TNF inhibitors • Disease Activity Score (DAS) over 5.1 confirmed on at least two occasions 1 month apart • Failed trials of two disease modifying anti-rheumatic drugs (DMARDs), including Methotrexate (unless contra-indicated). A trial of a DMARD is defined as being normally of 6 months, with 2 months at a standard dose, unless significant toxicity has limited the dose or duration of treatment • No contra-indications to TNF inhibitors (including possibility of pregnancy). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a. Unable or unwilling to give informed consent b. Failure of, or contra-indications to, all proposed DMARD combinations (including possibility of pregnancy) c. Serious inter-current illness d. Patients on high dose steroids (in excess of 10mg prednisolone or equivalent per day at trial entry) e. Current steroid therapy or previous therapy within the last month (oral therapy at a dose in excess of 10mg prednisolone or equivalent per day and/or intra-muscular steroid injections)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This trial will test the hypothesis that patients with active rheumatoid arthritis (RA), who meet the NICE criteria for treatment with tumour necrosis factor (TNF) inhibitors, will gain equivalent benefit from intensive combination therapy (two or more disease modifying anti-rheumatic drugs (DMARDs) and steroids) without increased toxicity. A patient-completed disability measure - the Health Assessment Questionnaire (HAQ)- will provide the principal comparison of the effects of treatment. ;Secondary Objective: Secondary research questions will comprise of a comparison of TNF inhibitors and intensive DMARDs on joint damage, disease activity measures, quality of life assessments, advesre events, treatment costs and cost effectiveness.;Primary end point(s): Change in Health Assessment Questionnaire scores at 12 months | — |
Countries
United Kingdom
Outcome results
None listed