Trial of Colchicine Versus Prednisone for the Treatment of Acute CPPD Arthritis (COLCHICORT)

Lille Catholic University

Status and phase

Completed

Phase 3

Conditions

Chondrocalcinosis

Treatments

Drug: Prednisone : Cortancyl 20mg

Drug: Colchicine opocalcium 1mg

Study type

Interventional

Funder types

Other

Identifiers

NCT03128905

RC-P0050

Details and patient eligibility

About

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.

Full 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.

Enrollment

111 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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.