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

• Status: Recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lille Catholic University
• Collaborators: Armentières Hospital Centre; Bichat Hospital; Centre Hospitalier Universitaire, Amiens; Dunkerque Hospital Centre; Hopital Lariboisière; University Hospital, Caen; University Hospital, Lille; Valenciennes Hospital Centre
• Treatments: Colchicine; Prednisone

Criteria

Inclusion Criteria:

• Patient aged 65 and older

• 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:

• Contraindication to colchicine (creatinine clearance below 30ml/min, severe hepatic dysfunction, macrolide or ongoing pristinamycin or macrolid treatment, …) or corticoids utilization (uncontrolled diabetes, uncontrolled progressive infection, uncontrolled arterial hypertension…)

• 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.