Early treatment of patients with undifferentiated arthritis (UA) with Methotrexate (MTX).

In patients with RA many studies have demonstrated the benefit of early initiation of Disease Modifying Anti-Rheumatic Drugs (DMARDs), resulting in a better prognosis. Patients included in these studies generally fulfilled the 1987 ACR classification criteria for RA. Although RA patients benefit from early aggressive treatment, it is unknown whether UA patients who might evolve into RA will also benefit from such a treatment strategy. In the present study, patients with undifferentiated arthritis fulfilling the ACR 1958 criteria for probable RA were treated with either methotrexate or placebo. We hypothesized that patients treated with MTX will have less duration and less severe arthritis, will not or less evolve into RA, will develop less radiographic progression in joint damage, and are more likely to go into remission.

We hypothesized that patients treated with Methotrexate (MTX) will have less duration and less severe arthritis, will not or less evolve into RA, will develop less radiographic progression in joint damage, and are more likely to go into remission.

N/A

The patients started with either 15 mg MTX or 6 placebo tablets. Every three months the medication was increased with 5 mg or 2 tablets respectively if the disease activity score (DAS) was higher than 2,4. After 12 months, the study medication was phased out. If a patient is diagnosed with RA during the follow up, the treatment was continued with verum MTX. In case of side effects that might be related to MTX, the treatment was adjusted. Patients were followed up for 18 months. At inclusion, 3, 6, 9, 12 and 18 months a tender and swollen joint count and health assessment questionnaires were performed and blood was donated for clinical and scientific research. Every 6 months radiographs of hands and feet were taken.