RECALL study BeSt and IMPROVED

A dramatic change has taken place in the treatment of rheumatoid arthritis (RA)
in the last twenty-five years. Disease-modifying antirheumatic drugs are
prescribed earlier and more often initially in combination with other drugs.
Moreover, the introduction of the treat-to-target principle in clinical
practice further improved the treatment. Achieving (sustained) drug-free
remission (SDFR) with prevention of clinically relevant radiological
progression, functional decline, and normalized survival now seem to be
feasible goals in the treatment of RA, however with limited follow-up. As RA
can have a chronic and progressive disease course, long-term outcomes needs to
be investigated to establish the benefits and possible adverse effects of
current treatment practices.

The objective is to evaluate long-term outcomes in patients with early RA or
undifferentiated arthritis (UA) after initial targeted treatment aimed at low
disease activity or remission. Moreover, we aim to further establish benefits
and possible adverse effects of treatment to target on the long-term,
concerning treatment strategies and the course of disease activity over time,
and gain insight in the long-term effects on total joint replacement, bone
mineral density, presence of extra-articular rheumatoid manifestations,
toxicity, self-reported outcome measures. It is hypothesized that the initial
results of limited radiological progression and functional decline will prolong
over-time with limited toxicity. Furthermore it is expected that mortality in
these cohorts is equal to mortality in the general Dutch population.

This RECALL study is an observational study of the BeSt and IMPROVED patient
cohorts. Patient files will be consulted retrospectively to acquire data on
disease activity and joint damage, treatment steps, side effects and
comorbidities in the years after the initial study period. Additional data on
long-term disease outcomes, functional ability and quality of life will be
accumulated prospectively if not available from standard care. New follow-up
data will be obtained every five years until all patients are lost to
follow-up.

As this study is mostly observational, there is no interference with standard
treatment for early RA or UA. Most prospective assessments will be conducted
during regular patient visits at the out-clinical of the treating
rheumatologist. Some patients may have been discharged from regular follow up,
these patients will be invited to participate either by coming to the
outpatient clinic or by allowing a home visit by one of the study members.
Blood samples and radiographs of hands and feet (radiographs of large joints
and spine if indicated) and a bone mineral density scan if not collected as
part of the regular control visits to the treating rheumatologist, will be
taken during a recall visit at the outpatient clinic or a specialized
laboratory. Questionnaires regarding symptoms of RA, comorbidities and
treatment side effects, functional ability and quality of life can be filled
out at the outpatient clinic or at home. This will take approximately 1 hour.
Total time investment of the recall study visits and filling out the
questionnaires is approximately 3 hours
This RECALL study intends to update the outcomes of treatment to target as was
required during the BeSt and IMPROVED studies, aiming to provide insights in
effect of modern treatment strategies on the changes in disease outcomes of RA,
and its impact on patients* lives.