Trial of Colchicine Versus Prednisone for the Treatment of Acute CPPD Arthritis
NCT ID: NCT03128905
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
111 participants
INTERVENTIONAL
2018-02-05
2022-05-13
Brief Summary
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International recommendations for the treatment of patients suffering from CPPD are based upon rare studies, not randomized, with small samples, and thus very weak scientific evidence.
The treatment of CPPD arthritis is extrapolated from the experience of gout treatment, another crystal deposition disease.
Among recommended treatments, colchicine and oral steroids are recommended as first-line treatments, while NSAIDs are used with caution in elderly populations of patients.
Colchicine utilization is not risk-free, in particular with old patients and patients with renal impairment.
Drug interactions of colchicine can have serious consequences, especially in a polymedicated old patient's population.
Oral steroids are an interesting alternative in this indication with a potential of being better tolerated, but comparative efficacy with colchicine needs to be studied.
From a broader point of view, colchicine and oral steroids have never been compared in any crystal related arthritis.
This is the first large randomized controlled trial for CPPD acute arthritis.
Detailed Description
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International recommendations for the treatment of patients suffering from CPPD are based upon rare studies, not randomized, with small samples, and thus very weak scientific evidence.
Some factors are known to trigger CPPD arthritis (trauma, surgery, infection, hospitalization). Prevalence increases with age, and case series estimate the presence of chondrocalcinosis in over 20% of 80 plus years population.
International recommendations for the treatment of patients suffering from CPPD are based upon rare studies, not randomized, with small samples, and thus very weak scientific evidence.
The treatment of CPPD arthritis is extrapolated from the experience of gout treatment, another crystal deposition disease (this one related to monosodium urate crystals that deposit after long-standing hyperuricemia.
Among recommended treatments, colchicine and oral steroids are recommended as first-line treatments, while NSAIDs are used with caution in elderly populations of patients.
Colchicine utilization is not risk-free, in particular with old patients and patients with renal impairment. Drug interactions of colchicine can have serious consequences, especially in a polymedicated old patient's population. Oral steroids offer an interesting alternative with the potential of being better tolerated.
However, even oral steroids are recommended, their efficacy in CPPD arthritis isn't demonstrated. Interesting comparative results with NSAIDs were shown for the treatment of gout flares. These results may not be fully extrapolated to CPPD which holds differences with gout. In addition, oral steroids were not compared to colchicine which is the benchmark treatment in many countries for CPPD.
The aim of this study is to compare the efficacy of colchicine and oral steroids for the treatment of CPPD acute arthritis and compare their tolerance profile. It is the first large randomized controlled trial comparing two treatments of CPPD acute arthritis.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Prednisone (corticoids)
Patients assigned to this group will receive Prednisone : Cortancyl 20mg.
Prednisone : Cortancyl 20mg
International non-proprietary name: Prednisone
Molecule owner : SANOFI AVENTIS France 20 mg scored tablet for oral administration, authorized since 02/05/1990, generic drug available.
Composition :
Active principle : Prednisone Excipients: Maize starch, lactose, talc, magnesium stearate.
Colchicine
Patients assigned to this group will receive the Colchicine opocalcium 1mg treatment.
Colchicine opocalcium 1mg
International non-proprietary name: Colchicine
Molecule owner: Mayoly-Spindler Laboratory, 1mg scored tablet for oral administration, authorized 03/02/1995.
Composition :
Active principle : Crystallized colchicine Excipients: Erythrosine aluminium lake, lactose, saccharose, magnesium stearate and povidone.
Interventions
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Colchicine opocalcium 1mg
International non-proprietary name: Colchicine
Molecule owner: Mayoly-Spindler Laboratory, 1mg scored tablet for oral administration, authorized 03/02/1995.
Composition :
Active principle : Crystallized colchicine Excipients: Erythrosine aluminium lake, lactose, saccharose, magnesium stearate and povidone.
Prednisone : Cortancyl 20mg
International non-proprietary name: Prednisone
Molecule owner : SANOFI AVENTIS France 20 mg scored tablet for oral administration, authorized since 02/05/1990, generic drug available.
Composition :
Active principle : Prednisone Excipients: Maize starch, lactose, talc, magnesium stearate.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient with mono/polyarticular CPPD acute arthritis
* Hospitalized patient (without infectious syndrome considered insufficiently controlled by the clinicians and diabetic decompensation)
* Diagnosis confirmed :
* By the evidence of CPP crystals on synovial fluid examination.
* By the existence of a typical clinical arthritis (joint pain, erythema, swelling, maximal intensity in less than 24h) AND presence of chondrocalcinosis signs in knee, wrists, or pubic symphysis on plain X-rays or crowned tooth in cervical rachis scan.
* Pain VAS ≥ 40/100 at the enrollment
* Duration of symptoms evolution for less than 36h.
* No prior intake of oral steroids, colchicine or NSAIDs for this acute arthritis.
* Signed patient's consent.
* Affiliation to a social security scheme.
Exclusion Criteria
* Severe cognitive disorders that does not allow patient to evaluate his pain.
* Patient under guardianship, curatorship
* Patient receiving morphinic analgesia.
* Gout history or presence of monosodium urate crystals at the examination of the synovial fluid.
65 Years
ALL
No
Sponsors
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University Hospital, Lille
OTHER
Hopital Lariboisière
OTHER
Bichat Hospital
OTHER
Valenciennes Hospital Centre
UNKNOWN
Armentières Hospital Centre
UNKNOWN
Dunkerque Hospital Centre
UNKNOWN
Lille Catholic University
OTHER
Responsible Party
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Principal Investigators
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Eric Houvenagel, Pr
Role: PRINCIPAL_INVESTIGATOR
Lille Catholic University
Tristan Pascart, Dr
Role: STUDY_CHAIR
Lille Catholic University
Locations
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CHRU Lille
Lille, Hauts-de-France, France
Lille Catholic Hospital
Lille, Hauts-de-France, France
CH Valenciennes
Valenciennes, Hauts-de-France, France
Dr Nicolas SEGAUD
Armentières, , France
Dr Rémi LEROY
Dunkirk, , France
Hôpital de Lariboisière
Paris, Île-de-France Region, France
Hôpital Bichat
Paris, Île-de-France Region, France
Countries
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References
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Pascart T, Robinet P, Ottaviani S, Leroy R, Segaud N, Pacaud A, Grandjean A, Luraschi H, Rabin T, Deplanque X, Maciejasz P, Visade F, Mackowiak A, Baclet N, Marechaux S, Lefebvre A, Budzik JF, Bardin T, Richette P, Norberciak L, Ducoulombier V, Houvenagel E. Evaluating the safety and short-term equivalence of colchicine versus prednisone in older patients with acute calcium pyrophosphate crystal arthritis (COLCHICORT): an open-label, multicentre, randomised trial. Lancet Rheumatol. 2023 Sep;5(9):e523-e531. doi: 10.1016/S2665-9913(23)00165-0. Epub 2023 Aug 8.
Other Identifiers
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RC-P0050
Identifier Type: -
Identifier Source: org_study_id