ChondrocalcinosisPhase 3COLCHICORTNCT03128905
Trial of Colchicine Versus Prednisone for the Treatment of Acute CPPD Arthritis
A Phase 3 study testing Colchicine opocalcium 1mg and Prednisone : Cortancyl 20mg in people with Chondrocalcinosis, run by Lille Catholic University at 7 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chondrocalcinosis
- What is being tested?
- Colchicine opocalcium 1mg and Prednisone : Cortancyl 20mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 7 sitesFrance
- Study dates
- 5 Feb 2018to 13 May 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Dr Nicolas SEGAUD
Armentières, 59280
Dr Rémi LEROY
Dunkirk, 59240
CHRU Lille
Lille, Hauts-de-France, 59000
Lille Catholic Hospital
Lille, Hauts-de-France, 59462
Hôpital de Lariboisière
Paris, Île-de-France Region, 75010
Hôpital Bichat
Paris, Île-de-France Region, 75018
CH Valenciennes
Valenciennes, Hauts-de-France, 59322
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Chondrocalcinosis
- Being tested
- Colchicine opocalcium 1mg, Prednisone : Cortancyl 20mg
- Keywords
- Colchicine, Corticoids, Prednisone, CPPD, Calcium Pyrophosphate Deposition Disease
- Medical subject headings
- Chondrocalcinosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine opocalcium 1mgDrug
Also called Mayoly-Spindler laboratory
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.
Prednisone : Cortancyl 20mgDrug
Also called Sanofi Aventis France
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.
| Study group | Role | What they receive |
|---|---|---|
| Colchicine | Active comparator | Patients assigned to this group will receive the Colchicine opocalcium 1mg treatment. Receives: Drug: Colchicine opocalcium 1mg |
| Prednisone (corticoids) | Experimental | Patients assigned to this group will receive Prednisone : Cortancyl 20mg. Receives: Drug: Prednisone : Cortancyl 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the first treatment administration to 24 hours after.
Secondary outcomes (10)
Proportion of patients with at least one adverse event within 48 hours
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)
Measured: 48 hours following the first administration
Change from baseline of biological inflammatory syndrome at 48 hours
C Reactive Protein change from baseline 48 hours after the first treatment intake.
Measured: From the first treatment administration to 48 hours after.
Number of joints affected and their localizations
Number of affected articulations and their localization before the first intake, after 24 hours and after 48 hours.
Measured: Before, 24 hours and 48 hours after the first administration
Need of emergency morphinic treatment
Proportion of patients requiring analgesia with morphine within the first 24 hours.
Measured: 24 hours after the first administration
Analgesic consumption
Proportion of patients requiring additional analgesics between the 24th and 48th hour following the 1st intake.
Measured: From 24 hours to 48 hours after the first treatment administration
Proportion of patients with an efficacy response of at least 50%
Proportion of patients with at least a 50% decrease in pain VAS at 24 and 48 hours after the first intake.
Measured: 24 hours and 48 hours after the first administration.
Proportion of patients with an efficacy response of at least 20%
Proportion of patients with at least a 20% decrease in pain VAS at 8, 12 and 24 hours after the first administration.
Measured: 8, 12 and 24 hours after the first administration.
Complete crisis resolution within 7 days
Proportion of patient with a complete resolution of the arthritis within the 7 days after 1st intake (defined by a ≤3/10 VAS score)
Measured: 7 days after 1st administration
Initial crisis resolution delay
Delay to the complete resolution of the arthritis from the first drug intake
Measured: 7 days after 1st administration
Absence of crisis recidivism within 7 days
Relapse rate within the 7 days following the 1st intake (defined by the recurrence of pain with a >3/10 VAS score)
Measured: Within the 7 days following the 1st administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start5 Feb 2018
- Primary completion13 May 2022
- Study completion13 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ChondrocalcinosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Lille, Hopital Lariboisière, Bichat Hospital, Valenciennes Hospital Centre, Armentières Hospital Centre, Dunkerque Hospital Centre
- Responsible party
- Sponsor
- Investigators
- Eric Houvenagel, Pr, Principal investigator, Lille Catholic UniversityTristan Pascart, Dr, Study chair, Lille Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128905
- Sponsor's protocol ID
- RC-P0050
- Acronym
- COLCHICORT
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2017
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38251496Pascart 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.
PubMed 40897521
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03128905
- Acronym / sponsor ID
- COLCHICORT / RC-P0050
- Conditions
- Chondrocalcinosis
- Keywords
- Colchicine, Corticoids, Prednisone, CPPD, Calcium Pyrophosphate Deposition Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Collaborators
- University Hospital, Lille, Hopital Lariboisière, Bichat Hospital, Valenciennes Hospital Centre, Armentières Hospital Centre, Dunkerque Hospital Centre
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 13 May 2022 (actual)
- Study completion
- 13 May 2022 (actual)
- First posted
- 25 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine | Active comparator | Drug: Colchicine opocalcium 1mgPatients assigned to this group will receive the Colchicine opocalcium 1mg treatment. |
| Prednisone (corticoids) | Experimental | Drug: Prednisone : Cortancyl 20mgPatients assigned to this group will receive Prednisone : Cortancyl 20mg. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicine opocalcium 1mgAlso: Mayoly-Spindler laboratoryInternational 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 | Colchicine |
| Prednisone : Cortancyl 20mgAlso: Sanofi Aventis FranceInternational 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. | Drug | Prednisone (corticoids) |
Primary outcome
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.
10 secondary outcomes
Proportion of patients with at least one adverse event within 48 hours
Time frame: 48 hours following the first administration
Change from baseline of biological inflammatory syndrome at 48 hours
Time frame: From the first treatment administration to 48 hours after.
Number of joints affected and their localizations
Time frame: Before, 24 hours and 48 hours after the first administration
Need of emergency morphinic treatment
Time frame: 24 hours after the first administration
Analgesic consumption
Time frame: From 24 hours to 48 hours after the first treatment administration
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 an efficacy response of at least 20%
Time frame: 8, 12 and 24 hours after the first administration.
Complete crisis resolution within 7 days
Time frame: 7 days after 1st administration
Initial crisis resolution delay
Time frame: 7 days after 1st administration
Absence of crisis recidivism within 7 days
Time frame: Within the 7 days following the 1st administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Results publication: PubMed 38251496Pascart 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.
- Results publication: PubMed 40897521Pascart 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Houvenagel, Pr principal investigator
Lille Catholic University
Tristan Pascart, Dr study chair
Lille Catholic University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Colchicine opocalcium 1mg and Prednisone : Cortancyl 20mg in people with Chondrocalcinosis, run by Lille Catholic University at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the pain VAS at 24 hours (time frame: From the first treatment administration to 24 hours after.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03128905, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.