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

NCT03128905 | Completed Phase 3

• 1 other identifier: RC-P0050
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 7

Brief 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

Keywords

Colchicine; Corticoids; Prednisone; CPPD; Calcium Pyrophosphate Deposition Disease

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the pain VAS at 24 hours

  Evolution of the pain Visual Analog Scale (VAS), between baseline and 24 hours after the first treatment administration, without any recourse to other anti-inflammatory treatments.

  From the first treatment administration to 24 hours after.

Secondary Outcomes (10)

• Proportion of patients with at least one adverse event within 48 hours

  48 hours following the first administration

• Change from baseline of biological inflammatory syndrome at 48 hours

  From the first treatment administration to 48 hours after.

• Number of joints affected and their localizations

  Before, 24 hours and 48 hours after the first administration

• Need of emergency morphinic treatment

  24 hours after the first administration

• Analgesic consumption

  From 24 hours to 48 hours after the first treatment administration

Study Arms (2)

Colchicine

ACTIVE COMPARATOR

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

Drug: Colchicine opocalcium 1mg

Prednisone (corticoids)

EXPERIMENTAL

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

Drug: Prednisone : Cortancyl 20mg

Interventions

Colchicine opocalcium 1mg DRUG

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.

Also known as: Mayoly-Spindler laboratory

Colchicine

Prednisone : Cortancyl 20mg DRUG

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.

Also known as: Sanofi Aventis France

Prednisone (corticoids)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lille Catholic University: lead
• University Hospital, Lille: collaborator
• Hopital Lariboisière: collaborator
• Bichat Hospital: collaborator
• Valenciennes Hospital Centre: collaborator
• Armentières Hospital Centre: collaborator
• Dunkerque Hospital Centre: collaborator

Study Sites (7)

CHRU Lille

Lille, Hauts-de-France, 59000, France

Location

Lille Catholic Hospital

Lille, Hauts-de-France, 59462, France

Location

CH Valenciennes

Valenciennes, Hauts-de-France, 59322, France

Location

Dr Nicolas SEGAUD

Armentières, 59280, France

Location

Dr Rémi LEROY

Dunkirk, 59240, France

Location

Hôpital de Lariboisière

Paris, Île-de-France Region, 75010, France

Location

Hôpital Bichat

Paris, Île-de-France Region, 75018, France

Location

Related Publications (2)

• Pascart T, Robinet P, Ottaviani S, Leroy R, Segaud N, Pacaud A, Grandjean A, Luraschi H, Rabin T, Deplanque X, Maciejasz P, Visade F, Mackowiak A, Baclet N, Marechaux S, Lefebvre A, Budzik JF, Bardin T, Richette P, Norberciak L, Ducoulombier V, Houvenagel E. Evaluating the safety and short-term equivalence of colchicine versus prednisone in older patients with acute calcium pyrophosphate crystal arthritis (COLCHICORT): an open-label, multicentre, randomised trial. Lancet Rheumatol. 2023 Sep;5(9):e523-e531. doi: 10.1016/S2665-9913(23)00165-0. Epub 2023 Aug 8.

  PMID: 38251496 RESULT

• Pascart T, Norberciak L, Richette P, Robinet P, Pacaud A, Marchasson G, Rabin T, Luraschi H, Maciejasz P, Georgel AF, Latourte A, Ea HK, Ottaviani S, Jauffret C, Ducoulombier V. Exploring Patients' Profiles Associated With the Resolution of Acute Calcium Pyrophosphate Arthritis Treated With Colchicine and Prednisone: Post Hoc Analysis of a Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2026 Apr;78(4):501-511. doi: 10.1002/acr.25642. Epub 2025 Dec 18.

  PMID: 40897521 RESULT

MeSH Terms

Conditions

Chondrocalcinosis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies

Study Officials

• Eric Houvenagel, Pr

  Lille Catholic University

  PRINCIPAL INVESTIGATOR

• Tristan Pascart, Dr

  Lille Catholic University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking is used. All involved know the identity of the intervention assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 25, 2017
• Study Start: February 5, 2018
• Primary Completion: May 13, 2022
• Study Completion: May 13, 2022
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)