ACTH vs Betamethasone in Hospitalized Patients With Acute Gout
Status:
Recruiting
Trial end date:
2020-05-01
Target enrollment:
Participant gender:
Summary
Background: Hospitalized patients usually have significant comorbidities and receive multiple
medications which leads to a high frequency of contraindications to standard treatment
options for acute gout (NSAIDs, colchicine, steroids). Adrenocorticotropic hormone (ACTH) has
long been used in acute gout, exhibiting significant clinical efficacy and an excellent
safety profile. Aim: To assess 1) the clinical efficacy of ACTH in gout compared to
betamethasone in hospitalized patients 2) the safety profile of ACTH vs betamethasone and 3)
the effect of ACTH on immune responses and metabolic parameters. Methods: This is a
randomized, open label comparative study directly comparing ACTH vs betamethasone for acute
gout. The investigators plan to recruit 60 hospitalized patients who will be randomly
assigned to either the ACTH or the betamethasone group on a 1:1 basis. Participants will be
clinically assessed at baseline and at 24, 48, 72h and 5 days time points. (Intensity of
pain, physician and patient global assessment, tenderness, swelling and redness). Serum and
plasma samples will be collected at baseline and at the 24, 48, 72h time points from all
study paticipants. The investigators will assess the effect of ACTH vs betamethasone on
several metabolic parameters concentrating on glucose homeostasis. Results: The study is
currently recruiting patients. Conclusions: If the efficacy and safety profile of ACTH is
verified in this randomized controlled trial, the use of ACTH for the treatment of gout in
the hospital setting will be strongly supported.