Prednisolone Versus Colchicine for Acute Gout in Primary Care

NCT05698680 | Recruiting Phase 4 DMC

• 4 other identifiers: 202102COPAGO01KG20222024-514738-18-002021-005556-11
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 65

Brief Summary

Gout is the most common form of rheumatic disease in which monosodium urate crystals are deposited in the joints followed by acute inflammatory reactions. There are various approved drugs that can be prescribed for pain relief during an acute gout attack. However to date, no direct comparison of efficacy of colchicine and prednisolone for the treatment of acute gout attacks has been investigated. Furthermore, majority of previous research studies were not only conducted in tertiary centres but also excluded patients with common comorbidities due to contraindications with naproxen. This pragmatic, prospective, double-blind, parallel-group, randomized, non-inferiority trial will investigate whether prednisolone (treatment drug) is comparable or only acceptably worse than treatment with colchicine (comparison drug) in patients presenting with acute gout. Patients presenting with acute gout to their general practitioners in 60 practices across 3 university sites (Greifswald, Göttingen, and Würzburg) will be invited to participate. Patients often excluded by previous studies due to contraindications with naproxen will also be able to participate. The investigators will compare the absolute levels of the most severe pain on day 3 (in the last 24 hours) measured with an 11-item numerical rating scale as the primary endpoint. Day 0 is the day patients take their study medication for the first time. They are then asked to fill out a study diary at the same time each day to quantify their pain. Pain scores will then be used as comparison between the two medications.

Conditions

Acute Gout

Keywords

Primary care; Prednisolone; Colchicine; Pragmatic

Outcome Measures

Primary Outcomes (1)

• Most severe pain in the last 24 hours

  To investigate whether the efficacy of prednisolone in General Practitioner's care is equally good or only marginally weaker than treatment with low-dose colchicine, the most severe pain in the last 24 hours on day 3 after baseline on an 11-point numerical rating scale is used and compared across groups. The study participants take their study medication for the first time on day 0 and are then asked to fill out their diary daily at the same time to quantify their pain. 0 stands for no pain and 10 for the strongest pain imaginable.

  Day 3

Secondary Outcomes (7)

• Average response to treatment

  Day 1, 2, 3, 4, 5, 6

• Swelling and tenderness of the joint

  Day 3

• Physical function

  Day 1 and 6

• Patients' global assessment of treatment success

  Day 6

• Most severe pain in the last 24 hours depending on disease duration

  Day 1 and 6

Other Outcomes (4)

• Dual Energy Computed Tomography Investigation: Presence of monosodium urate crystals

  one assessment during days 7 - 13

• Dual Energy Computed Tomography Investigation: Patient characteristics

  one assessment during days 7 - 13

• Dual Energy Computed Tomography Investigation: Use of uricostats and uricosurics

  one assessment during days 7 - 13

Study Arms (2)

Prednisolone 30mg (Day 0-4)

EXPERIMENTAL

As both drugs have different dosing regimens, the investigators provide identical blisters for both drugs including the active substance and corresponding placebos. This way, all study participants receive the same number of tablets and the possibility of drug prediction is more difficult. This is achieved by using tablets that are identical in taste and appearance (double-dummy design). Participants randomised to the prednisolone arm will receive prednisolone plus a colchicine placebo. The prednisolone placebos contain a bittering agent due to the bitter taste of prednisolone to ensure a similar taste. The dosage is according to EULAR guideline and also within the recommended range of the DEGAM guideline. The cumulative total dose taken per participant within the clinical trial is 150 mg for prednisolone.

Drug: Prednisolone 30 mg Tablet

Colchicine 1.5 mg (Day 0), 1.0 mg (Day 1-4)

ACTIVE COMPARATOR

As both drugs have different dosing regimens, the investigators provide identical blisters for both drugs including the active substance and corresponding placebos. This way, all study participants receive the same number of tablets and the possibility of drug prediction is more difficult. This is achieved by using tablets that are identical in taste and appearance (double-dummy design). Participants randomised to the colchicine arm will receive colchicine plus prednisolone placebo. The dosage is according to EULAR guideline and also within the recommended range of the DEGAM guideline. The cumulative total dose taken per participant within the clinical trial is 5.5mg for colchicine.

Drug: Colchicine 0.5 mg Oral Tablet

Interventions

Prednisolone 30 mg Tablet DRUG

See treatment arm "Prednisolone"

Also known as: + Placebo

Prednisolone 30mg (Day 0-4)

Colchicine 0.5 mg Oral Tablet DRUG

See treatment arm "Colchicine"

Also known as: + Placebo

Colchicine 1.5 mg (Day 0), 1.0 mg (Day 1-4)

Eligibility Criteria

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

You may qualify if:

• Adult patients ≥ 18 years of age
• Clinical diagnosis of acute attack of gout (symptoms: pain, swelling, tenderness, redness or local hyperthermia).
• Acute pain in hand or foot (podagra, chiragra)
• The onset of pain was no more than 2 days ago (e.g., presentation on Monday afternoon, onset of pain on Saturday morning)
• Willingness to participate in the study and ability to give written informed consent.

You may not qualify if:

• Known intolerance or contraindication to either medication
• Known intolerance to the placebo (e.g. lactose intolerance).
• Existing (or less than 2 weeks ago) oral treatment with corticosteroids or colchicine.
• Known chronic kidney disease (CKD stage 4 or greater) or an available value of estimated glomerular filtration rate (eGFR) \< 30ml/min/1.73 m².
• Known haematopoietic disorder or available values of platelets \< 30,000 µl or leucocytes \< 4000 µl, or Hb \<5 mmol/l/ or 8 g/dl
• Uncontrolled high blood pressure (systolic blood pressure permanently above 160 mmHg).
• Known liver cirrhosis or severe liver disease or available liver enzymes results (ie. Serum Glutamate Oxalate Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase(SGPT)) being elevated by more than twice the respective reference range
• Known current gastric or duodenal ulcer (diagnosed in the last 4 weeks)
• Current chemotherapy or chemotherapy completed less than 3 months ago
• Known HIV infection
• Solid organ transplant with immune suppression
• Desire to have children within the next 6 months in both men and women
• Existing pregnancy or breastfeeding
• Participation in other studies according to the German Medicines Act in the last 3 months
• Participation in the COPAGO study with past gout attack

Sponsors & Collaborators

• University Medicine Greifswald: lead
• University of Göttingen: collaborator
• Wuerzburg University Hospital: collaborator

Study Sites (65)

Arztpraxis Burgtorstr. 2

Ittlingen, Baden-Wurttemberg, 74930, Germany

RECRUITING

Hausarztpraxis Neckarsteinacher Str. 22

Neckargemünd, Baden-Wurttemberg, 69151, Germany

RECRUITING

Hausarztpraxis Kleinfeldlein 3

Bad Bocklet, Bavaria, 97708, Germany

RECRUITING

Hausarztpraxis Kapellenstraße 3

Bad Kissingen, Bavaria, 97688, Germany

RECRUITING

Hausarztpraxis Ludwigstraße 18

Bad Kissingen, Bavaria, 97688, Germany

RECRUITING

Hausarztpraxis Goethestraße 15 G

Bad Neustadt an der Saale, Bavaria, 97616, Germany

RECRUITING

Hausarztpraxis Ahornstraße 1

Bischofsheim, Bavaria, 97653, Germany

RECRUITING

Hausarztpraxis Mechenharder Straße 174

Erlenbach am Main, Bavaria, 63906, Germany

RECRUITING

Hausarztpraxis Hauptstraße 12

Gössenheim, Bavaria, 97780, Germany

RECRUITING

Hausarztpraxis Bahnhofstraße 24

Hammelburg, Bavaria, 97762, Germany

RECRUITING

Hausarztpraxis Torgraben 3

Haßfurt, Bavaria, 97437, Germany

RECRUITING

Hausarztpraxis Kaiserstraße 43

Kitzingen, Bavaria, 97318, Germany

RECRUITING

Hausarztpraxis Rathausstraße 31

Leinach, Bavaria, 97274, Germany

RECRUITING

Hausarztpraxis Herrngasse 11 A

Rimpar, Bavaria, 97222, Germany

RECRUITING

Hausarztpraxis Spitalstr. 9

Schweinfurt, Bavaria, 97241, Germany

RECRUITING

Hausarztpraxis Sulzdorfer Straße 6a

Stadtlauringen, Bavaria, 97488, Germany

RECRUITING

Hausarztpraxis Dorfgraben 2a

Würzburg, Bavaria, 97076, Germany

RECRUITING

Universitätsklinikum Würzburg

Würzburg, Bavaria, 97080, Germany

RECRUITING

Hausarztpraxis Moltkestraße 5

Würzburg, Bavaria, 97082, Germany

RECRUITING

Hausarztpraxis Point 3

Zellingen, Bavaria, 97225, Germany

RECRUITING

Hausarztpraxis Wissmannstraße 14

Bad Lauterberg im Harz, Lower Saxony, 37431, Germany

RECRUITING

Hausarztpraxis Hoher Weg 17

Bilshausen, Lower Saxony, 37343, Germany

RECRUITING

Hausarztpraxis Bohlendamm 2

Gleichen, Lower Saxony, 37130, Germany

RECRUITING

Hausarztpraxis Liererstr. 28

Goslar, Lower Saxony, 38690, Germany

RECRUITING

Universitätsmedizin Göttingen

Göttingen, Lower Saxony, 37073, Germany

RECRUITING

Hausarztpraxis Ewaldstr. 40a

Göttingen, Lower Saxony, 37075, Germany

RECRUITING

Hausarztpraxis Hennebergstr. 14a

Göttingen, Lower Saxony, 37077, Germany

RECRUITING

Hausarztpraxis Backhausstraße 21

Göttingen, Lower Saxony, 37081, Germany

RECRUITING

Hausarztpraxis Godehardtstraße 26

Göttingen, Lower Saxony, 37081, Germany

RECRUITING

Hausarztpraxis Professor-Eberlein-Str. 6

Hannoversch Münden, Lower Saxony, 34346, Germany

RECRUITING

Hausarztpraxis Steinstraße 19

Hannoversch Münden, Lower Saxony, 34346, Germany

RECRUITING

Hausarztpraxis Vor dem Tore 2

Hardegsen, Lower Saxony, 37181, Germany

RECRUITING

Hausarztpraxis Eckert Osteroder Str. 9

Herzberg am Harz, Lower Saxony, 37412, Germany

RECRUITING

Hausarztpraxis Poppe Osteroder Str. 9

Herzberg am Harz, Lower Saxony, 37412, Germany

RECRUITING

Hausarztpraxis Hauptstraße 34

Krebeck, Lower Saxony, 37434, Germany

RECRUITING

Hausarztpraxis Neue Straße 22

Moringen, Lower Saxony, 37186, Germany

RECRUITING

Hausarztpraxis Bahnhofstraße 6

Scheden, Lower Saxony, 37127, Germany

RECRUITING

Hausarztpraxis Kampstr. 32

Seesen, Lower Saxony, 38723, Germany

RECRUITING

Hausarztpraxis Bluthsluster Straße 2

Anklam, Mecklenburg-Vorpommern, 17389, Germany

RECRUITING

Hausarztpraxis Am Westhafen 1

Barth, Mecklenburg-Vorpommern, 18356, Germany

RECRUITING

Hausarztpraxis Schlossstraße 43

Dargun, Mecklenburg-Vorpommern, 17159, Germany

RECRUITING

Krankenhaus Universitätsmedizin Greifswald

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

RECRUITING

Hausarztpraxis Am Mühlentor 5

Greifswald, Mecklenburg-Vorpommern, 17489, Germany

RECRUITING

Hausarztpraxis Anklamer Straße 66

Greifswald, Mecklenburg-Vorpommern, 17489, Germany

RECRUITING

Hausarztpraxis Lange Straße 53

Greifswald, Mecklenburg-Vorpommern, 17489, Germany

RECRUITING

Hausarztpraxis Markt 1

Greifswald, Mecklenburg-Vorpommern, 17489, Germany

RECRUITING

Hausarztpraxis Ernst-Thälmann-Ring 66

Greifswald, Mecklenburg-Vorpommern, 17491, Germany

RECRUITING

Hausarztpraxis Schulstraße 1a

Groß Kiesow, Mecklenburg-Vorpommern, 17495, Germany

RECRUITING

Hausarztpraxis Pommersche Straße 18

Gützkow, Mecklenburg-Vorpommern, 17506, Germany

RECRUITING

Hausarztpraxis Prohner Straße 43

Klausdorf, Mecklenburg-Vorpommern, 18445, Germany

RECRUITING

Hausarztpraxis August-Levin-Straße 22c

Loitz, Mecklenburg-Vorpommern, 17121, Germany

RECRUITING

Hausarztpraxis Bahnhofstraße 16

Lübstorf, Mecklenburg-Vorpommern, 19069, Germany

RECRUITING

Hausarztpraxis Oberreihe 41

Lühmannsdorf, Mecklenburg-Vorpommern, 17495, Germany

RECRUITING

Hausarztpraxis Juri-Gagarin-Ring 24

Neubrandenburg, Mecklenburg-Vorpommern, 17036, Germany

RECRUITING

Hausarztpraxis Störstraße 2

Plate, Mecklenburg-Vorpommern, 19086, Germany

RECRUITING

Hausarztpraxis Werdohler Straße 3

Stavenhagen, Mecklenburg-Vorpommern, 17153, Germany

RECRUITING

Hausarztpraxis Marienstraße 2-4

Stralsund, Mecklenburg-Vorpommern, 18439, Germany

RECRUITING

Hausarztpraxis Dorfstraße 57

Trent, Mecklenburg-Vorpommern, 18569, Germany

RECRUITING

Hausarztpraxis Birkenweg 5

Trinwillershagen, Mecklenburg-Vorpommern, 18320, Germany

RECRUITING

Hausarztpraxis Otto-Lilienthal-Straße 3

Trollenhagen, Mecklenburg-Vorpommern, 17039, Germany

RECRUITING

Hausarztpraxis Ueckerstraße 48

Ueckermünde, Mecklenburg-Vorpommern, 17373, Germany

RECRUITING

Hausarztpraxis Lange Straße 55

Waren, Mecklenburg-Vorpommern, 17192, Germany

RECRUITING

Hausarztpraxis Wilhelmstraße 3

Wolgast, Mecklenburg-Vorpommern, 17438, Germany

RECRUITING

Hausarztpraxis Lambertweg 6

Höxter, North Rhine-Westphalia, 37671, Germany

RECRUITING

Hausarztpraxis Straße der Einheit 56

Uder, Thuringia, 37318, Germany

RECRUITING

Related Publications (29)

• Richter A, Truthmann J, Hummers E, Pereira JFM, Gagyor I, Schuster F, Witte A, Bohm S, Greser A, Kamin P, Stracke S, Dorr M, Bulow R, Engeli S, Chenot JF, Ittermann T. Prednisolone Versus Colchicine for Acute Gout in Primary Care: statistical analysis plan for the pragmatic, multicenter, randomized, and double-blinded COPAGO non-inferiority trial. Trials. 2024 Apr 3;25(1):229. doi: 10.1186/s13063-024-08066-0.

  PMID: 38570873 BACKGROUND

• Truthmann J, Freyer Martins Pereira J, Richter A, Schuster F, Witte A, Bohm S, Greser A, Kamin P, Stracke S, Dorr M, Bulow R, Engeli S, Gagyor I, Hummers E, Chenot JF. Prednisolone Versus Colchicine for Acute Gout in Primary Care (COPAGO): protocol for a two-arm multicentre, pragmatic, prospective, randomized, double-blind, controlled clinical trial of prednisolone and colchicine for non-inferiority with a parallel group design. Trials. 2023 Oct 5;24(1):643. doi: 10.1186/s13063-023-07666-6.

  PMID: 37798801 BACKGROUND

• Dalbeth N, Merriman TR, Stamp LK. Gout. Lancet. 2016 Oct 22;388(10055):2039-2052. doi: 10.1016/S0140-6736(16)00346-9. Epub 2016 Apr 21.

  PMID: 27112094 BACKGROUND

• Campion EW, Glynn RJ, DeLabry LO. Asymptomatic hyperuricemia. Risks and consequences in the Normative Aging Study. Am J Med. 1987 Mar;82(3):421-6. doi: 10.1016/0002-9343(87)90441-4.

  PMID: 3826098 BACKGROUND

• Fisher MC, Rai SK, Lu N, Zhang Y, Choi HK. The unclosing premature mortality gap in gout: a general population-based study. Ann Rheum Dis. 2017 Jul;76(7):1289-1294. doi: 10.1136/annrheumdis-2016-210588. Epub 2017 Jan 25.

  PMID: 28122760 BACKGROUND

• ten Klooster PM, Vonkeman HE, Voshaar MA, Bode C, van de Laar MA. Experiences of gout-related disability from the patients' perspective: a mixed methods study. Clin Rheumatol. 2014 Aug;33(8):1145-54. doi: 10.1007/s10067-013-2400-6.

  PMID: 24077900 BACKGROUND

• Richette P, Doherty M, Pascual E, Barskova V, Becce F, Castaneda-Sanabria J, Coyfish M, Guillo S, Jansen TL, Janssens H, Liote F, Mallen C, Nuki G, Perez-Ruiz F, Pimentao J, Punzi L, Pywell T, So A, Tausche AK, Uhlig T, Zavada J, Zhang W, Tubach F, Bardin T. 2016 updated EULAR evidence-based recommendations for the management of gout. Ann Rheum Dis. 2017 Jan;76(1):29-42. doi: 10.1136/annrheumdis-2016-209707. Epub 2016 Jul 25.

  PMID: 27457514 BACKGROUND

• van Echteld I, Wechalekar MD, Schlesinger N, Buchbinder R, Aletaha D. Colchicine for acute gout. Cochrane Database Syst Rev. 2014 Aug 15;(8):CD006190. doi: 10.1002/14651858.CD006190.pub2.

  PMID: 25123076 BACKGROUND

• Finkelstein Y, Aks SE, Hutson JR, Juurlink DN, Nguyen P, Dubnov-Raz G, Pollak U, Koren G, Bentur Y. Colchicine poisoning: the dark side of an ancient drug. Clin Toxicol (Phila). 2010 Jun;48(5):407-14. doi: 10.3109/15563650.2010.495348.

  PMID: 20586571 BACKGROUND

• Terkeltaub RA, Furst DE, Bennett K, Kook KA, Crockett RS, Davis MW. High versus low dosing of oral colchicine for early acute gout flare: Twenty-four-hour outcome of the first multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-comparison colchicine study. Arthritis Rheum. 2010 Apr;62(4):1060-8. doi: 10.1002/art.27327.

  PMID: 20131255 BACKGROUND

• Engel B, Prautzsch H. [Acute gout in primary care]. 2013. Available from: https://www.awmf.org/uploads/tx_szleitlinien/053_032bl_S1_akute_Gicht_2014-05.pdf

  BACKGROUND

• van Durme CM, Wechalekar MD, Buchbinder R, Schlesinger N, van der Heijde D, Landewe RB. Non-steroidal anti-inflammatory drugs for acute gout. Cochrane Database Syst Rev. 2014 Sep 16;(9):CD010120. doi: 10.1002/14651858.CD010120.pub2.

  PMID: 25225849 BACKGROUND

• Janssens HJ, Janssen M, van de Lisdonk EH, van Riel PL, van Weel C. Use of oral prednisolone or naproxen for the treatment of gout arthritis: a double-blind, randomised equivalence trial. Lancet. 2008 May 31;371(9627):1854-60. doi: 10.1016/S0140-6736(08)60799-0.

  PMID: 18514729 BACKGROUND

• McKenzie BJ, Wechalekar MD, Johnston RV, Schlesinger N, Buchbinder R. Colchicine for acute gout. Cochrane Database Syst Rev. 2021 Aug 26;8(8):CD006190. doi: 10.1002/14651858.CD006190.pub3.

  PMID: 34438469 BACKGROUND

• Janssens HJEM, Fransen J, Janssen M, Neogi T, Schumacher HR, Jansen TL, Dalbeth N, Taylor WJ. Performance of the 2015 ACR-EULAR classification criteria for gout in a primary care population presenting with monoarthritis. Rheumatology (Oxford). 2017 Aug 1;56(8):1335-1341. doi: 10.1093/rheumatology/kex164.

  PMID: 28431109 BACKGROUND

• Dalbeth N, Schumacher HR, Fransen J, Neogi T, Jansen TL, Brown M, Louthrenoo W, Vazquez-Mellado J, Eliseev M, McCarthy G, Stamp LK, Perez-Ruiz F, Sivera F, Ea HK, Gerritsen M, Scire CA, Cavagna L, Lin C, Chou YY, Tausche AK, da Rocha Castelar-Pinheiro G, Janssen M, Chen JH, Cimmino MA, Uhlig T, Taylor WJ. Survey Definitions of Gout for Epidemiologic Studies: Comparison With Crystal Identification as the Gold Standard. Arthritis Care Res (Hoboken). 2016 Dec;68(12):1894-1898. doi: 10.1002/acr.22896. Epub 2016 Oct 28.

  PMID: 27014846 BACKGROUND

• Roddy E, Clarkson K, Blagojevic-Bucknall M, Mehta R, Oppong R, Avery A, Hay EM, Heneghan C, Hartshorne L, Hooper J, Hughes G, Jowett S, Lewis M, Little P, McCartney K, Mahtani KR, Nunan D, Santer M, Williams S, Mallen CD. Open-label randomised pragmatic trial (CONTACT) comparing naproxen and low-dose colchicine for the treatment of gout flares in primary care. Ann Rheum Dis. 2020 Feb;79(2):276-284. doi: 10.1136/annrheumdis-2019-216154. Epub 2019 Oct 30.

  PMID: 31666237 BACKGROUND

• Richette P, Flipo RN, Patrikos DK. Characteristics and management of gout patients in Europe: data from a large cohort of patients. Eur Rev Med Pharmacol Sci. 2015 Feb;19(4):630-9.

  PMID: 25753881 BACKGROUND

• Nyberg F, Horne L, Morlock R, Nuevo J, Storgard C, Aiyer L, Hines DM, Ansolabehere X, Chevalier P. Comorbidity Burden in Trial-Aligned Patients with Established Gout in Germany, UK, US, and France: a Retrospective Analysis. Adv Ther. 2016 Jul;33(7):1180-98. doi: 10.1007/s12325-016-0346-1. Epub 2016 May 26.

  PMID: 27230988 BACKGROUND

• Johnson TR. Dual-energy CT: general principles. AJR Am J Roentgenol. 2012 Nov;199(5 Suppl):S3-8. doi: 10.2214/AJR.12.9116.

  PMID: 23097165 BACKGROUND

• Dalbeth N, Doyle AJ. Imaging tools to measure treatment response in gout. Rheumatology (Oxford). 2018 Jan 1;57(suppl_1):i27-i34. doi: 10.1093/rheumatology/kex445.

  PMID: 29272513 BACKGROUND

• Pascart T, Grandjean A, Capon B, Legrand J, Namane N, Ducoulombier V, Motte M, Vandecandelaere M, Luraschi H, Godart C, Houvenagel E, Norberciak L, Budzik JF. Monosodium urate burden assessed with dual-energy computed tomography predicts the risk of flares in gout: a 12-month observational study : MSU burden and risk of gout flare. Arthritis Res Ther. 2018 Sep 17;20(1):210. doi: 10.1186/s13075-018-1714-9.

  PMID: 30223875 BACKGROUND

• Uhlig T, Eskild T, Karoliussen LF, Sexton J, Kvien TK, Haavardsholm EA, Dalbeth N, Hammer HB. Two-year reduction of dual-energy CT urate depositions during a treat-to-target strategy in gout in the NOR-Gout longitudinal study. Rheumatology (Oxford). 2022 Apr 18;61(SI):SI81-SI85. doi: 10.1093/rheumatology/keab533.

  PMID: 34247224 BACKGROUND

• Ogdie A, Taylor WJ, Weatherall M, Fransen J, Jansen TL, Neogi T, Schumacher HR, Dalbeth N. Imaging modalities for the classification of gout: systematic literature review and meta-analysis. Ann Rheum Dis. 2015 Oct;74(10):1868-74. doi: 10.1136/annrheumdis-2014-205431. Epub 2014 Jun 10.

  PMID: 24915980 BACKGROUND

• Choi HK, Burns LC, Shojania K, Koenig N, Reid G, Abufayyah M, Law G, Kydd AS, Ouellette H, Nicolaou S. Dual energy CT in gout: a prospective validation study. Ann Rheum Dis. 2012 Sep;71(9):1466-71. doi: 10.1136/annrheumdis-2011-200976. Epub 2012 Mar 2.

  PMID: 22387729 BACKGROUND

• Glazebrook KN, Kakar S, Ida CM, Laurini JA, Moder KG, Leng S. False-negative dual-energy computed tomography in a patient with acute gout. J Clin Rheumatol. 2012 Apr;18(3):138-41. doi: 10.1097/RHU.0b013e318253aa5e.

  PMID: 22426590 BACKGROUND

• Huppertz A, Hermann KG, Diekhoff T, Wagner M, Hamm B, Schmidt WA. Systemic staging for urate crystal deposits with dual-energy CT and ultrasound in patients with suspected gout. Rheumatol Int. 2014 Jun;34(6):763-71. doi: 10.1007/s00296-014-2979-1. Epub 2014 Mar 12.

  PMID: 24619560 BACKGROUND

• Bongartz T, Glazebrook KN, Kavros SJ, Murthy NS, Merry SP, Franz WB 3rd, Michet CJ, Veetil BM, Davis JM 3rd, Mason TG 2nd, Warrington KJ, Ytterberg SR, Matteson EL, Crowson CS, Leng S, McCollough CH. Dual-energy CT for the diagnosis of gout: an accuracy and diagnostic yield study. Ann Rheum Dis. 2015 Jun;74(6):1072-7. doi: 10.1136/annrheumdis-2013-205095. Epub 2014 Mar 25.

  PMID: 24671771 BACKGROUND

• Jia E, Zhu J, Huang W, Chen X, Li J. Dual-energy computed tomography has limited diagnostic sensitivity for short-term gout. Clin Rheumatol. 2018 Mar;37(3):773-777. doi: 10.1007/s10067-017-3753-z. Epub 2017 Aug 12.

  PMID: 28803339 BACKGROUND

Related Links

• Information about the study for patients and treating physicians in German

MeSH Terms

Interventions

Prednisolone; Tablets; Colchicine

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Alkaloids; Heterocyclic Compounds

Study Officials

• Sylvia Stracke

  University Medicine Greifswald

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-François Chenot, MPH

CONTACT

00493834 86; Jean-Francois.Chenot@med.uni-greifswald.de

Julia Truthmann, MSc

CONTACT

00493834 86; Julia.Truthmann@med.uni-greifswald.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: There are 2 active and effective treatments (colchicine vs. prednisolone). The allocation to the treatment arms is 1:1, and study participants are randomised to either group. Randomisation is intended to reduce selection and allocation bias. As both drugs have different dosing regimens, the investigators provide identical blisters for both drugs including the active substance and corresponding placebos. This way, all study participants receive the same number of tablets and the possibility of drug prediction is more difficult. This is achieved by using tablets that are identical in taste and appearance (double-dummy design). Participants randomised to the colchicine arm will receive colchicine plus prednisolone placebo. Participants randomised to the prednisolone arm will receive prednisolone plus a colchicine placebo. The prednisolone placebos contain a bittering agent due to the bitter taste of prednisolone to ensure a similar taste.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This clinical trial is a two-arm multicentre, pragmatic, prospective, randomised, double-blind, controlled clinical trial of prednisolone and colchicine for non-inferiority with a parallel group design (phase IV). According to the guidelines of the German Society of General Medicine (DEGAM), the decision to start gout treatment is made clinically. As this is a pragmatic study, eligibility will be determined during a routine clinical examination. The clinical diagnosis is made without new laboratory tests, joint puncture with synovial analysis or imaging. 314 patients with an acute gout attack are going to be recruited in 60 General Practitioner's practices across 3 university sites (Greifswald, Göttingen, and Würzburg). All study participants receive active treatments, but are randomised into either the prednisolone group (treatment group) or the colchicine group (comparison group). The study lasts 4 weeks for each participant.

Study Record Dates

• First Submitted: December 27, 2022
• First Posted: January 26, 2023
• Study Start: January 18, 2023
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

DE (65)