Evaluating the safety and short-term ...
Document type :
Article dans une revue scientifique: Article original
Permalink :
Title :
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 & nbsp;
Author(s) :
Pascart, Tristan [Auteur]
Hôpital Saint Philibert [Lomme]
Robinet, Pierre [Auteur]
Hôpital Saint Philibert [Lomme]
Ottaviani, Sébastien [Auteur]
AP-HP - Hôpital Bichat - Claude Bernard [Paris]
Leroy, Rémi [Auteur]
Segaud, Nicolas [Auteur]
Pacaud, Aurore [Auteur]
Hôpital Saint Philibert [Lomme]
Grandjean, Agathe [Auteur]
Hôpital Saint Philibert [Lomme]
Luraschi, Hélène [Auteur]
Hôpital Saint Vincent de Paul de Lille
Rabin, Thibault [Auteur]
Hôpital Saint Philibert [Lomme]
Deplanque, Xavier [Auteur]
Hôpital Saint Vincent de Paul de Lille
Maciejasz, Pierre [Auteur]
Hôpital Saint Vincent de Paul de Lille
Visade, Fabien [Auteur]
Hôpital Saint Philibert [Lomme]
Evaluation des technologies de santé et des pratiques médicales - ULR 2694 [METRICS]
Mackowiak, Alexandre [Auteur]
Hôpital Saint Philibert [Lomme]
Baclet, Nicolas [Auteur]
Hôpital Saint Vincent de Paul de Lille
Marechaux, Sylvestre [Auteur]
Hôpital Saint Philibert [Lomme]
Lefebvre, Antoine [Auteur]
Hôpital Saint Philibert [Lomme]
Budzik, Jean-Francois [Auteur]
Hôpital Saint Philibert [Lomme]
Bardin, Thomas [Auteur]
Hôpital Lariboisière-Fernand-Widal [APHP]
Richette, Pascal [Auteur]
Hôpital Lariboisière-Fernand-Widal [APHP]
Norberciak, Laurène [Auteur]
Hôpital Saint Philibert [Lomme]
Ducoulombier, Vincent [Auteur]
Hôpital Saint Philibert [Lomme]
Houvenagel, Eric [Auteur]
Hôpital Saint Philibert [Lomme]
Hôpital Saint Philibert [Lomme]
Robinet, Pierre [Auteur]
Hôpital Saint Philibert [Lomme]
Ottaviani, Sébastien [Auteur]
AP-HP - Hôpital Bichat - Claude Bernard [Paris]
Leroy, Rémi [Auteur]
Segaud, Nicolas [Auteur]
Pacaud, Aurore [Auteur]
Hôpital Saint Philibert [Lomme]
Grandjean, Agathe [Auteur]
Hôpital Saint Philibert [Lomme]
Luraschi, Hélène [Auteur]
Hôpital Saint Vincent de Paul de Lille
Rabin, Thibault [Auteur]
Hôpital Saint Philibert [Lomme]
Deplanque, Xavier [Auteur]
Hôpital Saint Vincent de Paul de Lille
Maciejasz, Pierre [Auteur]
Hôpital Saint Vincent de Paul de Lille
Visade, Fabien [Auteur]
Hôpital Saint Philibert [Lomme]
Evaluation des technologies de santé et des pratiques médicales - ULR 2694 [METRICS]
Mackowiak, Alexandre [Auteur]
Hôpital Saint Philibert [Lomme]
Baclet, Nicolas [Auteur]
Hôpital Saint Vincent de Paul de Lille
Marechaux, Sylvestre [Auteur]
Hôpital Saint Philibert [Lomme]
Lefebvre, Antoine [Auteur]
Hôpital Saint Philibert [Lomme]
Budzik, Jean-Francois [Auteur]
Hôpital Saint Philibert [Lomme]
Bardin, Thomas [Auteur]
Hôpital Lariboisière-Fernand-Widal [APHP]
Richette, Pascal [Auteur]
Hôpital Lariboisière-Fernand-Widal [APHP]
Norberciak, Laurène [Auteur]
Hôpital Saint Philibert [Lomme]
Ducoulombier, Vincent [Auteur]
Hôpital Saint Philibert [Lomme]
Houvenagel, Eric [Auteur]
Hôpital Saint Philibert [Lomme]
Journal title :
The Lancet Rheumatology
Abbreviated title :
Lancet Rheumatol.
Volume number :
5
Pages :
-
Publication date :
2023-09-24
ISSN :
2665-9913
English abstract : [en]
Background
Acute calcium pyrophosphate crystal arthritis causes intense joint pain mainly affecting older people. Because guidance and evidence remain scarce, management of this disease relies on expert opinion. We therefore ...
Show more >Background Acute calcium pyrophosphate crystal arthritis causes intense joint pain mainly affecting older people. Because guidance and evidence remain scarce, management of this disease relies on expert opinion. We therefore aimed to compare the safety and short-term equivalence of low-dose colchicine with oral prednisone in older patients with acute calcium pyrophosphate crystal arthritis. Methods We did an open-label, multicentre, randomised, trial (COLCHICORT) at six hospitals in Paris and northern France. We enrolled patients who were admitted to hospital who were 65 years or older and who presented with acute calcium pyrophosphate crystal arthritis with a symptom duration of less than 36 h. Diagnosis of calcium pyrophosphate crystal arthritis was made by the identification of calcium pyrophosphate crystals on synovial fluid analysis or typical clinical presentation (onset of joint pain and swelling). Key exclusion criteria included absence of calcium pyrophosphate crystals on synovial fluid analysis or a history of gout. Participants were randomly allocated (1:1), using a centralised electronic treatment group allocation module, to receive either colchicine 1·5 mg on day 1 and 1 mg on day 2 (ie, the colchicine group) or oral prednisone 30 mg on days 1 and 2 (ie, the prednisone group). The primary outcome was change in joint pain (measured by visual analogue scale [VAS] from 0 mm to 100 mm) at 24 h. Equivalence was determined whether the 95% CI of the between-group difference at 24 h was within the –13 mm to +13 mm margin in the per-protocol analysis. Adverse events were recorded using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0). This trial is completed and is registered with ClinicalTrials.gov, NCT03128905.Show less >
Show more >Background Acute calcium pyrophosphate crystal arthritis causes intense joint pain mainly affecting older people. Because guidance and evidence remain scarce, management of this disease relies on expert opinion. We therefore aimed to compare the safety and short-term equivalence of low-dose colchicine with oral prednisone in older patients with acute calcium pyrophosphate crystal arthritis. Methods We did an open-label, multicentre, randomised, trial (COLCHICORT) at six hospitals in Paris and northern France. We enrolled patients who were admitted to hospital who were 65 years or older and who presented with acute calcium pyrophosphate crystal arthritis with a symptom duration of less than 36 h. Diagnosis of calcium pyrophosphate crystal arthritis was made by the identification of calcium pyrophosphate crystals on synovial fluid analysis or typical clinical presentation (onset of joint pain and swelling). Key exclusion criteria included absence of calcium pyrophosphate crystals on synovial fluid analysis or a history of gout. Participants were randomly allocated (1:1), using a centralised electronic treatment group allocation module, to receive either colchicine 1·5 mg on day 1 and 1 mg on day 2 (ie, the colchicine group) or oral prednisone 30 mg on days 1 and 2 (ie, the prednisone group). The primary outcome was change in joint pain (measured by visual analogue scale [VAS] from 0 mm to 100 mm) at 24 h. Equivalence was determined whether the 95% CI of the between-group difference at 24 h was within the –13 mm to +13 mm margin in the per-protocol analysis. Adverse events were recorded using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0). This trial is completed and is registered with ClinicalTrials.gov, NCT03128905.Show less >
Language :
Anglais
Audience :
Internationale
Popular science :
Non
Administrative institution(s) :
Université de Lille
CHU Lille
CHU Lille
Submission date :
2024-01-20T22:14:09Z
2024-04-09T12:38:38Z
2024-04-09T12:38:38Z