Quality management: improvement of patient care in recently diagnosed rheumatoid arthritis.

Purpose:

To investigate whether intensive treatment with methotrexate (MTX) according to a strict protocol and a computerized decision program is more beneficial compared to conventional treatment with MTX in early rheumatoid arthritis (RA).




Methods:

In this multi-centre study, 301 patients with early rheumatoid arthritis were randomly assigned to the intensive strategy group or the conventional strategy group. Patients of both groups received MTX, the aim of treatment being remission. Patients of the intensive treatment group came to the outpatient clinic once every month; adjustment of the MTX dosage was tailored to the individual patient on the basis of predefined response criteria, using a computerized decision program. Patients of the conventional strategy group, who came to the outpatient clinic once every three months, were treated according to common practice.

It is possible to increase the efficacy of treatment in early RA-patients with MTX when treatment is intensified according to a strict and intensive, computer-assisted protocol. I.e. the number of patients in remission will increase.

N/A

In this study the efficacy of two treatment strategies will be compared: intensive treatment versus conventional treatment with MTX.
In both treatment strategy groups, patients will be treated with MTX. Starting dose MTX in both groups is 7.5 mg/wk.

In the intensive strategy group, based on predefined scores of disease activity with the help of a computer program, MTX will be increased to 15 mg/wk after 6 weeks. Thereafter, MTX is increased, if necessary, every 4 weeks by 5 mg/wk until a maximum dose of 30 mg/wk or until the maximum tolerable dose.

In the conventional treatment group, patients come to the outpatient clinic once every three months. In case of inefficient results of treatment after 3 months, dose MTX is increased until 15 mg/wk. After three months, dose MTX is increased by 5 mg/wk until a maximum of 30 mg/wk or maximum tolerable dose, if necessary. In both groups folinic acid (0.5 mg/day) is prescribed to all patients.

To patients with gastrointestinal side effects or with insufficient efficacy, MTX is given subcutaneaouly. Treatment with NSAIDS is allowed next to study medication. Oral glucocorticoids are not allowed during the trial unless unavoidable which has to be approved then by another rheumatologist. Intra-articular injections should be avoided as much as possible, and if necessary this should be mentioned.