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

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.

Conditions

• Chondrocalcinosis

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.

Sponsors & Collaborators

• University Hospital, Lille

  collaborator OTHER

• Hopital Lariboisière

  collaborator OTHER

• Bichat Hospital

  collaborator OTHER

• Valenciennes Hospital Centre

  collaborator UNKNOWN

• Armentières Hospital Centre

  collaborator UNKNOWN

• Dunkerque Hospital Centre

  collaborator UNKNOWN

• Lille Catholic University

  lead OTHER

Principal Investigators

• Eric Houvenagel, Pr · Lille Catholic University

• Tristan Pascart, Dr · Lille Catholic University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-02-05

Primary Completion

2022-05-13

Completion

2022-05-13

Countries

• France

Study Locations