Prednisolone Versus Colchicine for Acute Gout in Primary Care

Acute Gout Clinical Trial

— COPAGO  

Official title:

Pragmatic, Randomized, Multicenter, Double-blind, Controlled, Clinical Trial of Prednisolone Versus Colchicine for Acute Gout in Primary Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05698680
• Other study ID #: 202102COPAGO
• Secondary ID: 2021-005556-11
• Status: Recruiting
• Phase: Phase 4
• Start date: January 18, 2023
• Est. completion date: February 28, 2026

Study information

• Verified date: February 2024
• Source: University Medicine Greifswald
• Contact: Jean-François Chenot, MPH
• Phone: 00493834 86
• Email: Jean-Francois.Chenot[@]med.uni-greifswald.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

SCIENTIFIC BACKGROUND: Gout is one of the most common rheumatic diseases, affecting 3-6% of men and 1-2% of women in western countries. Due to the severe pain and impaired quality of life, the individual burden of disease during an acute gout attack is very high. Currently, there are several approved medications available for the treatment of acute gout attacks. The EULAR (European League Against Rheumatism) guideline recommends colchicine as the drug of first choice for acute gout attacks. But according to it, non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids can also be used. In contrast, DEGAM (German Society for General Medicine and Family Medicine) recommends using prednisolone. Most commonly, gout attacks are treated in general practices. However, studies on the treatment of acute gout attacks have so far been conducted mainly in specialised centres, and thus in a selective patient group. The gold standard for the diagnosis of gout in rheumatology centres is the detection of monosodium urate crystals in aspirated joint fluid. In primary care, however, the diagnosis of gout is made on the basis of clinical symptoms alone. Because of the risk of injury and infection, joint puncture is not usually performed on patients in a general practice setting. Prednisolone and low-dose colchicine were selected for the study due to a high prevalence of patients with contraindications to NSAIDs, including, cardiovascular disease, oral anticoagulation, chronic kidney disease or a history of gastrointestinal disease. Approximately 20-30% of patients with gout are poorly suited for NSAID administration and in previous studies, those patients were excluded. RESEARCH QUESTION: This non-inferiority trial is going to investigate whether prednisolone (treatment drug) is comparable or only acceptably worse than treatment with colchicine (comparator drug). Both treatments will be compared on the basis of the absolute pain scores achieved on day 3 of follow-up. Unlike most studies conducted in tertiary care centres, this study is going to be set in primary care. The dosage of the study's medications will be according to the recommendations of the EULAR and DEGAM guidelines. Both drugs are in tablet form. Since a preference of the treating physicians regarding the use of prednisolone or colchicine is suspected, the study will be conducted in a double-blinded manner. Due to the different intake regimen, placebos will be used in addition to the effective medications (double-dummy method). DUAL ENERGY COMPUTED TOMOGRAPHY: The dual energy computed tomography (DECT) is able to detect monosodium urate crystals. The amount of monosodium urate crystals in the joint (volume) is an indicator of disease burden and can also be used to make treatment decisions regarding uric acid-lowering therapy (ULT) to avoid the occurrence of potential future gout attacks. Although imaging techniques, such as DECT, show promise in classifying symptomatic gout, studies to date are small and mainly involve people with long-standing, established disease from a hospital setting. In those with the first acute gout attack, diagnostic sensitivity ranges from 35.7 % to 61.5 %. Due to the unclear diagnostic sensitivity in first attacks, the DECT examination will not be mandatory in the present study. It will be offered to all participants as optional. About 10% of the participants are expected to have a gout attack in the hand. Since the joints of the feet are the main site of manifestation of acute gout attacks, crystal deposits in the feet are also expected in these study participants. In order to ensure comparability of the volume measurement, the dual energy CT examination is therefore limited to the feet. The aim of the dual energy CT examination is to describe the frequency and volume of monosodium urate crystals in patients with gout in primary care. In a sensitivity analysis, the primary endpoint in patients with positive DECT findings will be analysed. Furthermore, the association between the duration of gout diagnosis and crystal volume as a marker for disease burden will be investigated. The investigation of the frequency and volume of monosodium urate crystals provides the basis for the design of further studies on the usefulness of DECT for the indication and monitoring of uric acid-lowering therapies in primary care. STUDY PROCEDURE: During the study, the participants will attend their General Practitioner's practice twice (baseline and one-off on day 6-8), as well as, an optional visit for a DECT at the university medical centre in the local region (Greifswald or Göttingen; day 7-13) and a one-off telephone interview on day 27-34. The study period for the individual participant will be 4 weeks. On day 0 (day of first presentation at the general practice), patients with an acute gout attack in the hand or foot present to their general practitioner. If the diagnosis of gout is confirmed and patients are eligible for participation in the study, they will be consented and randomly assigned to one of two treatment groups. While patient group 1 is treated with prednisolone for 5 days, patient group 2 receives colchicine for 5 days. So that neither the patient nor the general practitioner knows the allocation, both treatment groups also receive a placebo (dummy medication). A laboratory test will also be performed to determine serum uric acid levels, as well as, inflammatory markers and renal function. The aim of blood collection and determination of laboratory parameters is to descriptively describe the patient population and to perform subgroup analyses with regard to the primary endpoint. During days 1 to 6, patients are requested to complete a patient diary. The primary and secondary endpoints (pain, joint swelling, joint tenderness) and, if further analgesia is needed, the use of additional pain medication will be recorded in the diary. Participants who have a blood pressure monitor will be asked to measure and record their blood pressure daily. On day 6, the patients are also asked to assess potential functional limitations caused by the gout attack and to give a global assessment of the treatment success. After one week, patients return for their follow-up visit (visit 2) to their general practitioners. They are examined again and are asked to return their study diary and any remaining medication packets. After 4 weeks, the patients will be contacted by telephone by our study nurses and asked about the clinical course of their gout attack (recurrence of an acute gout attack, further treatment, duration of incapacity to work, adverse events). The telephone call lasts about 15 minutes. In addition, study participants will receive the optional offer to have a one-time dual-energy CT examination of their feet on days 7-13 to check for the presence of uric acid crystals. Imaging of both feet using a Siemens Dual Source SOMATOM Definition Flash or SOMATOM Force will be performed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 314
• Est. completion date: February 28, 2026
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Acute Gout
• Arthritis, Gouty
• Gout

Intervention

Drug:
• Prednisolone 30 mg Tablet
See treatment arm "Prednisolone"
• Colchicine 0.5 mg Oral Tablet
See treatment arm "Colchicine"

Locations

Country	Name	City	State
Germany	Hausarztpraxis Bluthsluster Straße 2	Anklam	Mecklenburg-Vorpommern
Germany	Hausarztpraxis Kleinfeldlein 3	Bad Bocklet	Bayern
Germany	Hausarztpraxis Kapellenstraße 3	Bad Kissingen	Bayern
Germany	Hausarztpraxis Ludwigstraße 18	Bad Kissingen	Bayern
Germany	Hausarztpraxis Wissmannstraße 14	Bad Lauterberg Im Harz	Niedersachsen
Germany	Hausarztpraxis Goethestraße 15 G	Bad Neustadt An Der Saale	Bayern
Germany	Hausarztpraxis Rhönstraße 11	Bad Neustadt An Der Saale	Bayern
Germany	Hausarztpraxis Hoher Weg 17	Bilshausen	Niedersachsen
Germany	Hausarztpraxis Ahornstraße 1	Bischofsheim	Bayern
Germany	Hausarztpraxis Schlossstraße 43	Dargun	Mecklenburg-Vorpommern
Germany	Hausarztpraxis Mechenharder Straße 174	Erlenbach am Main	Bayern
Germany	Hausarztpraxis Bohlendamm 2	Gleichen	Niedersachsen
Germany	Hausarztpraxis Liererstr. 28	Goslar	Niedersachsen
Germany	Hausarztpraxis Backhausstraße 21	Göttingen	Niedersachsen
Germany	Hausarztpraxis Ewaldstr. 40a	Göttingen	Niedersachsen
Germany	Hausarztpraxis Godehardtstraße 26	Göttingen	Niedersachsen
Germany	Hausarztpraxis Hennebergstr. 14a	Göttingen	Niedersachsen
Germany	Universitätsmedizin Göttingen	Göttingen	Niedersachsen
Germany	Hausarztpraxis Am Mühlentor 5	Greifswald	Mecklenburg-Vorpommern
Germany	Hausarztpraxis Anklamer Straße 66	Greifswald	Mecklenburg-Vorpommern
Germany	Hausarztpraxis Ernst-Thälmann-Ring 66	Greifswald	Mecklenburg-Vorpommern
Germany	Hausarztpraxis Lange Straße 53	Greifswald	Mecklenburg-Vorpommern
Germany	Hausarztpraxis Markt 1	Greifswald	Mecklenburg-Vorpommern
Germany	Krankenhaus Universitätsmedizin Greifswald	Greifswald	Mecklenburg-Vorpommern
Germany	Hausarztpraxis Schulstraße 1a	Groß Kiesow	Mecklenburg-Vorpommern
Germany	Hausarztpraxis Pommersche Straße 18	Gützkow	Mecklenburg-Vorpommern
Germany	Hausarztpraxis Bahnhofstraße 24	Hammelburg	Bayern
Germany	Hausarztpraxis Professor-Eberlein-Str. 6	Hann. Münden	Niedersachsen
Germany	Hausarztpraxis Steinstraße 19	Hann. Münden	Niedersachsen
Germany	Hausarztpraxis Vor dem Tore 2	Hardegsen	Niedersachsen
Germany	Hausarztpraxis Torgraben 3	Haßfurt	Bayern
Germany	Hausarztpraxis Eckert Osteroder Str. 9	Herzberg am Harz	Niedersachsen
Germany	Hausarztpraxis Poppe Osteroder Str. 9	Herzberg Am Harz	Niedersachsen
Germany	Hausarztpraxis Lambertweg 6	Höxter	Nordrhein-Westfalen
Germany	Hausarztpraxis Schulstraße 4	Igersheim	Baden-Württemberg
Germany	Arztpraxis Burgtorstr. 2	Ittlingen	Baden-Württemberg
Germany	Hausarztpraxis Im Siek 10	Katlenburg-Lindau	Niedersachsen
Germany	Hausarztpraxis Kaiserstraße 43	Kitzingen	Bayern
Germany	Hausarztpraxis August-Levin-Straße 22c	Loitz	Mecklenburg-Vorpommern
Germany	Hausarztpraxis Bahnhofstraße 16	Lübstorf	Mecklenburg-Vorpommern
Germany	Hausarztpraxis Oberreihe 41	Lühmannsdorf	Mecklenburg-Vorpommern
Germany	Hausarztpraxis Pinnow 41	Murchin	Mecklenburg-Vorpommern
Germany	Hausarztpraxis Neckarsteinacher Str. 22	Neckargemünd	Baden-Württemberg
Germany	Hausarztpraxis Juri-Gagarin-Ring 24	Neubrandenburg	Mecklenburg-Vorpommern
Germany	Hausarztpraxis Störstraße 2	Plate	Mecklenburg-Vorpommern
Germany	Hausarztpraxis Werdohler Straße 3	Reuterstadt Stavenhagen	Mecklenburg-Vorpommern
Germany	Hausarztpraxis Herrngasse 11 A	Rimpar	Bayern
Germany	Hausarztpraxis Bahnhofstraße 6	Scheden	Niedersachsen
Germany	Hausarztpraxis Spitalstr. 9	Schweinfurt	Bayern
Germany	Hausarztpraxis Kampstr. 32	Seesen	Niedersachsen
Germany	Hausarztpraxis Sulzdorfer Straße 6a	Stadtlauringen	Bayern
Germany	Hausarztpraxis Birkenweg 5	Trinwillershagen	Mecklenburg-Vorpommern
Germany	Hausarztpraxis Otto-Lilienthal-Straße 3	Trollenhagen	Mecklenburg-Vorpommern
Germany	Hausarztpraxis Straße der Einheit 56	Uder	Thüringen
Germany	Hausarztpraxis Ueckerstraße 48	Ueckermünde	Mecklenburg-Vorpommern
Germany	Hausarztpraxis Markt 3	Usedom	Mecklenburg-Vorpommern
Germany	Hausarztpraxis Lange Straße 55	Waren	Mecklenburg-Vorpommern
Germany	Hausarztpraxis Wilhelmstraße 3	Wolgast	Mecklenburg-Vorpommern
Germany	Hausarztpraxis Dorfgraben 2a	Würzburg	Bayern
Germany	Hausarztpraxis Moltkestraße 5	Würzburg	Bayern
Germany	Universitätsklinikum Würzburg	Würzburg	Bayern
Germany	Hausarztpraxis Point 3	Zellingen	Bayern

Sponsors (3)

Lead Sponsor	Collaborator
University Medicine Greifswald	University of Göttingen, Wuerzburg University Hospital

Country where clinical trial is conducted

Germany, 

References & Publications (27)

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dual Energy Computed Tomography Investigation: Presence of monosodium urate crystals	The frequency and volume of monosodium urate crystals (milliliter) in feet joints in patients with gout in primary care will be investigated.	one assessment during days 7 - 13
Other	Dual Energy Computed Tomography Investigation: Patient characteristics	The investigators will investigate the association between the volume of monosodium urate crystals (milliliter) in feet joints and patient characteristics (e.g. age, sex, previous gout attacks).	one assessment during days 7 - 13
Other	Dual Energy Computed Tomography Investigation: Use of uricostats and uricosurics	The investigators will investigate the association between frequency and volume of monosodium urate crystals (milliliter) in feet joints in patients with gout in primary care and (previous) use of uricostats and uricosurics.	one assessment during days 7 - 13
Other	Dual Energy Computed Tomography Investigation: Pain intensity	The investigators will investigate the association between the volume of monosodium urate crystals (milliliter) in feet joints in patients with gout in primary care and pain intensity at baseline (on an 11-point numerical rating scale).	one assessment during days 7 - 13
Primary	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	Average response to treatment	For this purpose, the most severe pain described on an 11-point numerical rating scale across treatment days (from day 1 - 6 of follow-up) 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 1, 2, 3, 4, 5, 6
Secondary	Swelling and tenderness of the joint	Reduction in joint swelling and tenderness measured using 4-point Likert scale on day 3 after baseline per treatment arm, e.g.: Swelling quantified as no joint swelling, palpable, visible, and bulging beyond the joint margins.; Sensitivity to touch of the joint is quantified as no pain, pain, pain and winces, and pain, winces and withdraws,; and subsequent comparison.	Day 3
Secondary	Physical function	Physical function on day 6 compared to baseline will be assessed with the following questions: How much are you now restricted in your normal daily activities by the gout attack?; How much trouble do you have putting on a shoe today?; How much pain do you have when you walk today?; How much trouble do you have grasping and holding something with your affected hand (for example, when unscrewing a bottle)?; All questions will be described on an 11-point numerical rating scale, 0 indicating "not at all/no problem" and 10 indicating "worst pain ever".	Day 1 and 6
Secondary	Patients' global assessment of treatment success	This is going to be measured measured with 5-point Likert scale (excellent, very good, good, fair, poor) on day 6 after baseline and treatment arms will be compared.	Day 6
Secondary	Most severe pain in the last 24 hours depending on disease duration	For this outcome the same model specification as for the primary outcome is applied and the adjustment for age will be substituted with adjustment for disease duration.	Day 1 and 6
Secondary	Frequency of use of additional pain medication by treatment group	The frequency of use of additional pain medication per treatment group will be compared.	Day 1 - 6
Secondary	Frequency of use of non-pharmacological pain therapies	The frequency of use of non-pharmacological pain therapies per treatment group will be compared.	Day 1 - 6