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

Last updated: November 28, 2022
Sponsor: Lille Catholic University
Overall Status: Completed

Phase

3

Condition

Osteoarthritis

Arthritis And Arthritic Pain (Pediatric)

Treatment

N/A

Clinical Study ID

NCT03128905
RC-P0050
  • Ages > 65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient aged 65 and older
  • Patient with mono/polyarticular CPPD acute arthritis
  • Hospitalized patient (without infectious syndrome considered insufficiently controlledby 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

Exclusion Criteria:

  • Contraindication to colchicine (creatinine clearance below 30ml/min, severe hepaticdysfunction, macrolide or ongoing pristinamycin or macrolid treatment, …) orcorticoids 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 thesynovial fluid.

Study Design

Total Participants: 111
Study Start date:
February 05, 2018
Estimated Completion Date:
May 13, 2022

Study Description

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.

Connect with a study center

  • CHU Amiens-PIcardie

    Amiens, Hauts-de-France 80080
    France

    Site Not Available

  • CH Valenciennes

    Valenciennes, Hauts-de-France 59322
    France

    Site Not Available

  • Hôpital Bichat

    Paris, Ile De France 75018
    France

    Site Not Available

  • CHRU Lille

    Lille, Nord Pas De Calais 59000
    France

    Site Not Available

  • Lille Catholic Hospital

    Lille, Nord Pas De Calais 59462
    France

    Site Not Available

  • CHU Caen

    Caen, Normandie 14033
    France

    Site Not Available

  • Hôpital de Lariboisière

    Paris, Île De France 75010
    France

    Site Not Available

  • Dr Nicolas SEGAUD

    Armentières, 59280
    France

    Site Not Available

  • Dr Rémi LEROY

    Dunkerque, 59240
    France

    Site Not Available

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