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| Name | Class |
|---|---|
| University Hospital, Lille | OTHER |
| Hopital Lariboisière | OTHER |
| Bichat Hospital | OTHER |
| Valenciennes Hospital Centre |
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Chondrocalcinosis, recently renamed the calcium pyrophosphate deposition (CPPD) disease, is a very frequent affection of the elderly and causes very painful arthritis.
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.
Chondrocalcinosis, recently renamed the calcium pyrophosphate deposition (CPPD) disease, is a very frequent affection of the elderly and causes very painful arthritis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colchicine | Active Comparator | Patients assigned to this group will receive the Colchicine opocalcium 1mg treatment. |
|
| Prednisone (corticoids) | Experimental | Patients assigned to this group will receive Prednisone : Cortancyl 20mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine opocalcium 1mg | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the pain VAS at 24 hours | Evolution of the pain Visual Analog Scale (VAS), between baseline and 24 hours after the first treatment administration, without any recourse to other anti-inflammatory treatments. | From the first treatment administration to 24 hours after. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with at least one adverse event within 48 hours | Proportion of patients with at least one adverse event within 48 hours following the first drug intake (diarrhea, abdominal pain, nausea, vomiting, a 50% fasting blood glucose increase, excitability, sleep disorders, high blood pressure apparition [above 140/90mmHg], change in creatinine clearance) | 48 hours following the first administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Houvenagel, Pr | Lille Catholic University | Principal Investigator |
| Tristan Pascart, Dr | Lille Catholic University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU Lille | Lille | Hauts-de-France | 59000 | France | ||
| Lille Catholic Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38251496 | Result | 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. | |
| 40897521 |
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| ID | Term |
|---|---|
| D002805 | Chondrocalcinosis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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| UNKNOWN |
| Armentières Hospital Centre | UNKNOWN |
| Dunkerque Hospital Centre | UNKNOWN |
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No masking is used. All involved know the identity of the intervention assignment.
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|
| Prednisone : Cortancyl 20mg | Drug | 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. |
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| Change from baseline of biological inflammatory syndrome at 48 hours | C Reactive Protein change from baseline 48 hours after the first treatment intake. | From the first treatment administration to 48 hours after. |
| Number of joints affected and their localizations | Number of affected articulations and their localization before the first intake, after 24 hours and after 48 hours. | Before, 24 hours and 48 hours after the first administration |
| Need of emergency morphinic treatment | Proportion of patients requiring analgesia with morphine within the first 24 hours. | 24 hours after the first administration |
| Analgesic consumption | Proportion of patients requiring additional analgesics between the 24th and 48th hour following the 1st intake. | From 24 hours to 48 hours after the first treatment administration |
| Proportion of patients with an efficacy response of at least 50% | Proportion of patients with at least a 50% decrease in pain VAS at 24 and 48 hours after the first intake. | 24 hours and 48 hours after the first administration. |
| Proportion of patients with an efficacy response of at least 20% | Proportion of patients with at least a 20% decrease in pain VAS at 8, 12 and 24 hours after the first administration. | 8, 12 and 24 hours after the first administration. |
| Complete crisis resolution within 7 days | Proportion of patient with a complete resolution of the arthritis within the 7 days after 1st intake (defined by a ≤3/10 VAS score) | 7 days after 1st administration |
| Initial crisis resolution delay | Delay to the complete resolution of the arthritis from the first drug intake | 7 days after 1st administration |
| Absence of crisis recidivism within 7 days | Relapse rate within the 7 days following the 1st intake (defined by the recurrence of pain with a >3/10 VAS score) | Within the 7 days following the 1st administration |
| Lille |
| Hauts-de-France |
| 59462 |
| France |
| CH Valenciennes | Valenciennes | Hauts-de-France | 59322 | France |
| Dr Nicolas SEGAUD | Armentières | 59280 | France |
| Dr Rémi LEROY | Dunkirk | 59240 | France |
| Hôpital de Lariboisière | Paris | Île-de-France Region | 75010 | France |
| Hôpital Bichat | Paris | Île-de-France Region | 75018 | France |
| Result |
| Pascart T, Norberciak L, Richette P, Robinet P, Pacaud A, Marchasson G, Rabin T, Luraschi H, Maciejasz P, Georgel AF, Latourte A, Ea HK, Ottaviani S, Jauffret C, Ducoulombier V. Exploring Patients' Profiles Associated With the Resolution of Acute Calcium Pyrophosphate Arthritis Treated With Colchicine and Prednisone: Post Hoc Analysis of a Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2026 Apr;78(4):501-511. doi: 10.1002/acr.25642. Epub 2025 Dec 18. |