ACTH vs Betamethasone in Hospitalized Patients With Acute Gout

NCT04306653 | Unknown

• 1 other identifier: PGNP 738/17112016
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gout Attack

Keywords

gout, ACTH

Outcome Measures

Primary Outcomes (5)

• Pain VAS

  Intensity of pain will be recorded using a Visual Analogue Scale (VAS) (0-10, 0=no pain 10=worst pain)

  12 hours

• Pain VAS

  Intensity of pain will be recorded using a Visual Analogue Scale (VAS) (0-10, 0=no pain 10=worst pain)

  24 hours

• Pain VAS

  Intensity of pain will be recorded using a Visual Analogue Scale (VAS) (0-10, 0=no pain 10=worst pain)

  48 hours

• Pain VAS

  Intensity of pain will be recorded using a Visual Analogue Scale (VAS) (0-10, 0=no pain 10=worst pain)

  72 hours

• Pain VAS

  Intensity of pain will be recorded using a Visual Analogue Scale (VAS) (0-10, 0=no pain 10=worst pain)

  5 days

Secondary Outcomes (20)

• Physician global assessment

  24 hours

• Physician global assessment

  48 hours

• Physician global assessment

  72 hours

• Physician global assessment

  5 days

• Patient global assessment

  24 hours

Study Arms (2)

ACTH

EXPERIMENTAL

patients with acute gout treated with ACTH

Drug: ACTH

Betamethasone

ACTIVE COMPARATOR

patients with acute gout treated with betamethasone

Drug: Betamethasone

Interventions

ACTH DRUG

patients with acute gout will receive 100 IU ACTH IM

ACTH

Betamethasone DRUG

patients with acute gout will receive 6 mg of betamethasone

Betamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>18 years
• able to provide written informed consent
• diagnosis of acute gout according to ACR/EULAR classification criteria -

You may not qualify if:

• pregnancy/lactation
• unable to provide written informed consent -

Sponsors & Collaborators

• University of Patras: lead

Study Sites (1)

University Hospital of Patras

Pátrai, Achaia, 26500, Greece

RECRUITING

Related Publications (12)

• Siegel LB, Alloway JA, Nashel DJ. Comparison of adrenocorticotropic hormone and triamcinolone acetonide in the treatment of acute gouty arthritis. J Rheumatol. 1994 Jul;21(7):1325-7.

  PMID: 7966077 BACKGROUND

• Axelrod D, Preston S. Comparison of parenteral adrenocorticotropic hormone with oral indomethacin in the treatment of acute gout. Arthritis Rheum. 1988 Jun;31(6):803-5. doi: 10.1002/art.1780310618.

  PMID: 2454635 BACKGROUND

• Ritter J, Kerr LD, Valeriano-Marcet J, Spiera H. ACTH revisited: effective treatment for acute crystal induced synovitis in patients with multiple medical problems. J Rheumatol. 1994 Apr;21(4):696-9.

  PMID: 8035395 BACKGROUND

• Getting SJ, Christian HC, Flower RJ, Perretti M. Activation of melanocortin type 3 receptor as a molecular mechanism for adrenocorticotropic hormone efficacy in gouty arthritis. Arthritis Rheum. 2002 Oct;46(10):2765-75. doi: 10.1002/art.10526.

  PMID: 12384937 BACKGROUND

• Getting SJ, Lam CW, Chen AS, Grieco P, Perretti M. Melanocortin 3 receptors control crystal-induced inflammation. FASEB J. 2006 Nov;20(13):2234-41. doi: 10.1096/fj.06-6339com.

  PMID: 17077300 BACKGROUND

• Daoussis D, Antonopoulos I, Yiannopoulos G, Andonopoulos AP. ACTH as first line treatment for acute gout in 181 hospitalized patients. Joint Bone Spine. 2013 May;80(3):291-4. doi: 10.1016/j.jbspin.2012.09.009. Epub 2012 Nov 26.

  PMID: 23195793 BACKGROUND

• Mitroulis I, Kambas K, Chrysanthopoulou A, Skendros P, Apostolidou E, Kourtzelis I, Drosos GI, Boumpas DT, Ritis K. Neutrophil extracellular trap formation is associated with IL-1beta and autophagy-related signaling in gout. PLoS One. 2011;6(12):e29318. doi: 10.1371/journal.pone.0029318. Epub 2011 Dec 16.

  PMID: 22195044 BACKGROUND

• Gavillet M, Martinod K, Renella R, Harris C, Shapiro NI, Wagner DD, Williams DA. Flow cytometric assay for direct quantification of neutrophil extracellular traps in blood samples. Am J Hematol. 2015 Dec;90(12):1155-8. doi: 10.1002/ajh.24185. Epub 2015 Oct 6.

  PMID: 26347989 BACKGROUND

• Khanna D, Fitzgerald JD, Khanna PP, Bae S, Singh MK, Neogi T, Pillinger MH, Merill J, Lee S, Prakash S, Kaldas M, Gogia M, Perez-Ruiz F, Taylor W, Liote F, Choi H, Singh JA, Dalbeth N, Kaplan S, Niyyar V, Jones D, Yarows SA, Roessler B, Kerr G, King C, Levy G, Furst DE, Edwards NL, Mandell B, Schumacher HR, Robbins M, Wenger N, Terkeltaub R; American College of Rheumatology. 2012 American College of Rheumatology guidelines for management of gout. Part 1: systematic nonpharmacologic and pharmacologic therapeutic approaches to hyperuricemia. Arthritis Care Res (Hoboken). 2012 Oct;64(10):1431-46. doi: 10.1002/acr.21772. No abstract available.

  PMID: 23024028 RESULT

• Keenan RT, O'Brien WR, Lee KH, Crittenden DB, Fisher MC, Goldfarb DS, Krasnokutsky S, Oh C, Pillinger MH. Prevalence of contraindications and prescription of pharmacologic therapies for gout. Am J Med. 2011 Feb;124(2):155-63. doi: 10.1016/j.amjmed.2010.09.012.

  PMID: 21295195 RESULT

• Daoussis D, Antonopoulos I, Andonopoulos AP. ACTH as a treatment for acute crystal-induced arthritis: update on clinical evidence and mechanisms of action. Semin Arthritis Rheum. 2014 Apr;43(5):648-53. doi: 10.1016/j.semarthrit.2013.09.006. Epub 2013 Oct 5.

  PMID: 24762710 RESULT

• Daoussis D, Kordas P, Varelas G, Michalaki M, Onoufriou A, Mamali I, Iliopoulos G, Melissaropoulos K, Ntelis K, Velissaris D, Tzimas G, Georgiou P, Vamvakopoulou S, Paliogianni F, Andonopoulos AP, Georgopoulos N. ACTH vs steroids for the treatment of acute gout in hospitalized patients: a randomized, open label, comparative study. Rheumatol Int. 2022 Jun;42(6):949-958. doi: 10.1007/s00296-022-05128-x. Epub 2022 Apr 21.

  PMID: 35445840 DERIVED

MeSH Terms

Conditions

Gout

Interventions

Adrenocorticotropic Hormone; Betamethasone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Dimitrios Daoussis

  University of Patras Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dimitrios Daoussis, MD, PhD

CONTACT

+302613603693; jimdaoussis@hotmail.com

Panagiotis Kordas, MD

CONTACT

+306997265502; panko_doc@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: March 13, 2020
• Study Start: January 5, 2018
• Primary Completion: April 1, 2020
• Study Completion: May 1, 2020
• Last Updated: March 13, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)