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COMPLETED
NCT03128905
PHASE3

Trial of Colchicine Versus Prednisone for the Treatment of Acute CPPD Arthritis

Sponsor: Lille Catholic University

View on ClinicalTrials.gov

Summary

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.

Official title: Colchicine or Prednisone for the Treatment of Acute Calcium Pyrophosphate Deposition (CPPD) Arthritis: Open-label, Randomized, Multicenter, Equivalence Trial of Efficacy and Safety

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

111

Start Date

2018-02-05

Completion Date

2022-05-13

Last Updated

2026-04-17

Healthy Volunteers

No

Interventions

DRUG

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.

DRUG

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.

Locations (7)

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