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

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ClinicalTrials.gov Identifier: NCT03128905
Recruitment Status : Recruiting
First Posted : April 25, 2017
Last Update Posted : August 22, 2018
Sponsor:
Collaborators:
University Hospital, Lille
Centre Hospitalier Universitaire, Amiens
University Hospital, Caen
Hopital Lariboisière
Bichat Hospital
Valenciennes Hospital Centre
Information provided by (Responsible Party):
Lille Catholic University

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.


Condition or disease Intervention/treatment Phase
Chondrocalcinosis Drug: Colchicine opocalcium 1mg Drug: Prednisone : Cortancyl 20mg Phase 3

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: No masking is used. All involved know the identity of the intervention assignment.
Primary Purpose: Treatment
Official Title: Colchicine or Prednisone for the Treatment of Acute Calcium Pyrophosphate Deposition (CPPD) Arthritis: Open-label, Randomized, Multicenter, Equivalence Trial of Efficacy and Safety
Actual Study Start Date : February 5, 2018
Estimated Primary Completion Date : August 5, 2019
Estimated Study Completion Date : August 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis Steroids

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

Other Name: Mayoly-Spindler laboratory

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

Other Name: Sanofi Aventis France




Primary Outcome Measures :
  1. Change from baseline in the pain VAS at 24 hours [ Time Frame: From the first treatment administration to 24 hours after. ]
    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.


Secondary Outcome Measures :
  1. Proportion of patients with at least one adverse event within 48 hours [ Time Frame: 48 hours following the first administration ]
    Proportion of patients with at least one adverse event within 48 hours following the first drug intake (diarrhea, abdominal pain, nausea, vomiting, a 50% fasting blood glucose increase, excitability, sleep disorders, high blood pressure apparition [above 140/90mmHg], change in creatinine clearance)

  2. Change from baseline of biological inflammatory syndrome at 48 hours [ Time Frame: From the first treatment administration to 48 hours after. ]
    C Reactive Protein change from baseline 48 hours after the first treatment intake.

  3. Number of joints affected and their localizations [ Time Frame: Before, 24 hours and 48 hours after the first administration ]
    Number of affected articulations and their localization before the first intake, after 24 hours and after 48 hours.

  4. Need of emergency morphinic treatment [ Time Frame: 24 hours after the first administration ]
    Proportion of patients requiring analgesia with morphine within the first 24 hours.

  5. Analgesic consumption [ Time Frame: From 24 hours to 48 hours after the first treatment administration ]
    Proportion of patients requiring additional analgesics between the 24th and 48th hour following the 1st intake.

  6. Proportion of patients with an efficacy response of at least 50% [ Time Frame: 24 hours and 48 hours after the first administration. ]
    Proportion of patients with at least a 50% decrease in pain VAS at 24 and 48 hours after the first intake.

  7. Proportion of patients with an efficacy response of at least 20% [ Time Frame: 8, 12 and 24 hours after the first administration. ]
    Proportion of patients with at least a 20% decrease in pain VAS at 8, 12 and 24 hours after the first administration.

  8. Complete crisis resolution within 7 days [ Time Frame: 7 days after 1st administration ]
    Proportion of patient with a complete resolution of the arthritis within the 7 days after 1st intake (defined by a ≤3/10 VAS score)

  9. Initial crisis resolution delay [ Time Frame: 7 days after 1st administration ]
    Delay to the complete resolution of the arthritis from the first drug intake

  10. Absence of crisis recidivism within 7 days [ Time Frame: Within the 7 days following the 1st administration ]
    Relapse rate within the 7 days following the 1st intake (defined by the recurrence of pain with a >3/10 VAS score)



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03128905


Contacts
Contact: Amélie Lansiaux, MD, PhD 03 20 22 57 41 ext +33 Lansiaux.amelie@ghicl.net
Contact: Marine Deseur 03 20 22 57 01 ext +33 deseur.marine@ghicl.net

Locations
France
CH Valenciennes Not yet recruiting
Valenciennes, Hauts-de-France, France, 59322
Contact: Xavier Deprez, MD    03 27 14 33 95 ext +33    deprez-x@ch-valenciennes.fr   
Principal Investigator: Xavier Deprez, MD         
Hôpital Bichat Not yet recruiting
Paris, Ile De France, France, 75018
Contact: Sébastien OTTAVIANI, MD    01 40 25 74 01 ext +33      
CHRU Lille Not yet recruiting
Lille, Nord Pas De Calais, France, 59000
Contact: René-Marc Flipo, MD, PhD    03 20 44 61 20 ext +33    Rene-marc.flipo@chru-lille.fr   
Principal Investigator: René-Marc Flipo, MD, PhD         
Sub-Investigator: François Puisieux, MD, PhD         
Lille Catholic Hospital Recruiting
Lille, Nord Pas De Calais, France, 59462
Contact: Amélie Lansiaux, MD, PhD    03 20 22 57 41 ext +33    Lansiaux.amelie@ghicl.net   
Contact: Marine Deseur    03 20 22 57 01 ext +33    deseur.marine@ghicl.net   
Principal Investigator: Tristan Pascart, MD         
Principal Investigator: Eric Houvenagel, MD, PhD         
Sub-Investigator: Stéphanie Vancompernolle, MD         
Sub-Investigator: Pierre Graux, MD, PhD         
Sub-Investigator: Damien Lucidarme, MD, PhD         
Sub-Investigator: Hélène Bulckaen, MD         
Sub-Investigator: Pierre Robinet, MD         
Sub-Investigator: Philippe Delecluse, MD         
Sub-Investigator: Jean-François Desrousseaux, MD, PhD         
Principal Investigator: Xavier Deplanque, MD         
Sub-Investigator: Jean-Jacques Leduc, MD         
Hôpital de Lariboisière Not yet recruiting
Paris, Île De France, France, 75010
Contact: Pascal RICHETTE, MD, PhD    01 49 95 63 06 ext +33      
Sponsors and Collaborators
Lille Catholic University
University Hospital, Lille
Centre Hospitalier Universitaire, Amiens
University Hospital, Caen
Hopital Lariboisière
Bichat Hospital
Valenciennes Hospital Centre
Investigators
Principal Investigator: Eric Houvenagel, Pr Lille Catholic University
Study Chair: Tristan Pascart, Dr Lille Catholic University

Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT03128905     History of Changes
Other Study ID Numbers: RC-P0050
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lille Catholic University:
Colchicine
Corticoids
Prednisone
CPPD
Calcium Pyrophosphate Deposition Disease

Additional relevant MeSH terms:
Chondrocalcinosis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Prednisone
Colchicine
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action