Performance of the HandScan in tight control treatment of rheumatoid arthritis

Rationale: The treatment of rheumatoid arthritis (RA) has significantly been improved over the past years due to earlier and more intensive treatment including the use of biologicals. Due to the demanding approach, the principle of this tight control treatment and treat-to-target early in the disease has not been adequately implemented in standard rheumatology care yet.
Recently, the HandScan has been developed, to objectively assess disease activity in RA patients in only 1.5 minutes. Our hypothesis is that clinical efficacy of HandScan remission guided treatment is at least as good as and more cost-effective than the conventional ACR/EULAR remission guided treatment. This makes this novel imaging technology more cost-effective allowing implementation in standard rheumatology care.

Objective: Primary: to compare improvement on the Health Assessment Questionnaire (HAQ) between HandScan guided tight control in combination with treat-to-target treatment and the conventional ACR/EULAR remission guided tight control in combination with treat-to-target treatment of RA after 1 ½ years. Secondary: to compare cost effectiveness of both arms, based on customized cost questionnaires. Tertiary: to evaluate radiographic joint damage based on a fully automated radiographic scoring of the hand joints as well as the Sharp van der Heijde score in both study arms.

Study design: Randomized controlled trial comparing the ACR/EULAR remission criteria guided treatment with the HandScan remission guided treatment in rheumatoid arthritis.
Study population: Patients (n=112; ≥18 years) with recently diagnosed RA (DMARD naïve, no significant visual deformations of hand or fingers)
Intervention (if applicable): In both treatment strategy arms patients will be treated with a Methotrexate (MTX)-based tight control strategy (10 mg/wk) with prednisone (10 mg/day). If patients do not reach remission based on EULAR or HandScan predefined criteria, the strategy will be intensified monthly according to predefined steps. If remission has been reached, the treatment will be continued at the same medication level and eventually decreased.

Main study parameters/endpoints: the Health Assessment Questionnaire (HAQ)

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All included patients visit the outpatient clinic every month to assess disease activity as needed for the tight control strategy in clinical practice. At baseline, 3 months, 6, 12, and 18 months, patients are asked to fill in the Health Assessment Questionnaire (HAQ; 1st outcome), the health survey SF36, EQ5D and the questionnaire on direct and indirect costs.
Radiographs of hand and feet are taken at baseline and at 18 months according to clinical practice. Since the HandScan guided treatment is novel, treatment strategy decision may in theory deviate too much from proven standard tight control care leading to undesired over- or under treatment. This will be monitored extensively during the study and the treatment strategy will be adjusted if needed.

Clinical efficacy of the HandScan guided treatment is at least as good and more cost-effective than the conventional DAS guided treatment.

Baseline and monthly visits during 18 months.

Questionnaires are taken at baseline, 3 months, 6 months, 12 months and 18 months.

HandScan guided treatment strategy or conventional ACR/EULAR remission criteria guided treatment strategy. In both treatment strategy arms patients will be treated with a Methotrexate (MTX)-based tight control strategy (10 mg/wk) with prednisone (10 mg/day). If patients do not reach remission based on EULAR or HandScan predefined criteria, the strategy will be intensified monthly according to predefined steps. If remission has been reached, the treatment will be continued at the same medication level and eventually decreased.