Completed

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

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What is being tested

Colchicine opocalcium 1mg

+ Prednisone : Cortancyl 20mg

Drug
Who is being recruted

Crystal Arthropathies+2

+ Arthritis

+ Chondrocalcinosis

Over 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: February 2018
See protocol details

Summary

Principal SponsorLille Catholic University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 5, 2018

Actual date on which the first participant was enrolled.

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.

Official TitleColchicine or Prednisone for the Treatment of Acute Calcium Pyrophosphate Deposition (CPPD) Arthritis: Open-label, Randomized, Multicenter, Equivalence Trial of Efficacy and Safety
NCT03128905
Principal SponsorLille Catholic University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

111 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Crystal ArthropathiesArthritisChondrocalcinosisJoint DiseasesMusculoskeletal Diseases

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Patients assigned to this group will receive the Colchicine opocalcium 1mg treatment.

Group II

Experimental
Patients assigned to this group will receive Prednisone : Cortancyl 20mg.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Suspended

CHRU Lille

Lille, FranceOpen CHRU Lille in Google Maps
Suspended

Lille Catholic Hospital

Lille, France
Suspended

CH Valenciennes

Valenciennes, France
Suspended

Dr Nicolas SEGAUD

Armentières, France
Completed7 Study Centers