Background Osteoarthritis (OA) is a heterogeneous group of conditions with
disturbed integrity of articular cartilage and changes in the underlying bone.
The pathogenesis of OA is multifactorial and not just a disease of older
people. Hydroxychloroquine (HCQ) is a disease-modifying anti-rheumatic drug
(DMARD) typically used for the treatment of various rheumatic and dermatologic
diseases. Three studies of HCQ in OA, including one abstract and one letter,
are available and use a wide variety of outcome measures in small patient
populations. Despite initial evidence for good efficacy of HCQ, there has been
no randomized, double-blind, and placebo-controlled trial in a larger patient
group. In the European League Against Rheumatism (EULAR), evidence-based
recommendations for the management of hand OA, HCQ was not included as a
therapeutic option because of the current lack of randomized clinical trials.
Methods/Design OA TREAT is an investigator-initiated, multicenter, randomized,
double-blind, placebo-controlled trial. A total of 510 subjects with
inflammatory and erosive hand OA, according to the classification criteria of
the American College of Rheumatology (ACR), with recent X-ray will be
recruited across outpatient sites, hospitals and universities in Germany.
Patients are randomized 1:1 to active treatment (HCQ 200 to 400 mg per day) or
placebo for 52 weeks. Both groups receive standard therapy (non-steroidal
anti-inflammatory drugs [NSAID], coxibs) for OA treatment, taken steadily two
weeks before enrollment and continued further afterwards. If disease activity
increases, the dose of NSAID/coxibs can be increased according to the drug
recommendation. The co-primary clinical endpoints are the changes in
Australian-Canadian OA Index (AUSCAN, German version) dimensions for pain and
hand disability at week 52. The co-primary radiographic endpoint is the
radiographic progression from baseline to week 52. A multiple endpoint test
and analysis of covariance will be used to compare changes between groups. All
analyses will be conducted on an intention-to-treat basis. Discussion The OA
TREAT trial will examine the clinical and radiological efficacy and safety of
HCQ as a treatment option for inflammatory and erosive OA over 12 months. OA
TREAT focuses on erosive hand OA in contrast to other current studies on
symptomatic hand OA, for example, HERO [Trials 14:64, 2013]
