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CPPD - Calcium Pyrophosphate Deposition DiseasePhase 2CRYSTALLIZENCT06855433

Colchicine to Reduce Your SympToms And Lower Levels of Inflammation, Zeroing in on Effective CPPD Disease Treatment

A Phase 2 study testing Colchicine Pill in people with CPPD - Calcium Pyrophosphate Deposition Disease, run by Brigham and Women's Hospital at 5 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to learn if colchicine reduces levels of proteins indicating inflammation in the blood in individuals with calcium pyrophosphate deposition (CPPD) disease. The trial will also test the effect of colchicine on joint symptoms in CPPD disease. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Colchicine Pill
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
5 sitesUnited States
Study dates
12 Aug 2026to 30 Sep 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provide written informed consent
  • Fulfill ACR/EULAR 2023 CPPD classification criteria
  • Acute or chronic joint inflammation currently or in the past 3 months, not attributable to another condition (Joint Inflammation defined as: At least 1 joint this is swollen, red, or warm to the touch; with or without corresponding tenderness)
  • Pain visual analog scale (pain VAS) >=30 at screening

Who cannot join

  • Age <40 years
  • Chronic diarrhea
  • Gout, rheumatoid arthritis, psoriatic arthritis, or cirrhosis
  • Ongoing use of colchicine and unwilling to undergo a 30-day wash-out period (note: patients using colchicine at screening can enroll if they agree to a 30-day wash-out before randomization)
  • Pregnant or breast-feeding
  • Use of methotrexate, hydroxychloroquine, tocilizumab or canakinumab in the past 4 weeks
Show all 19Show fewer
  • Use of anakinra, oral glucocorticoid, or intra-articular steroid in the past 1 week
  • Ongoing use of strong CYP3A4 inhibitors per FDA package insert for colchicine
  • Ongoing use of P-glycoprotein inhibitors per FDA package insert for colchicine
  • Known allergy to colchicine
  • Planned joint surgery in the next 6 months
  • CPPD clinical presentation isolated to Crowned Dens Syndrome with no additional peripheral joint involvement
  • Screening labs with any of the following:
  • Hemoglobin < 9 g/dL
  • WBC <3 x 10^9/L
  • Platelets <110 x10^9/L
  • Creatinine clearance (CrCl) <30 mL/min
  • ALT or AST >3x upper limit of normal (ULN)
  • Patient is considered by investigator to be an unsuitable candidate for the study for any reason

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Brenna Sharp de Flores, Senior Research Coordinator contact

617-732-6277

bsharp@bwh.harvard.edu

Sara Tedeschi, MD, MPH contact

stedeschi1@bwh.harvard.edu

5 sites in 1 country

United States5 sites, 5 recruiting

  • University of Alabama - Birmingham

    Birmingham, Alabama, 35233

    Shelby Gontarz, Clinical Research Coordinator, sgontarz@uab.edu

    Clementino Vong Do Rosario, Clinical Research Coordinator, (205) 975-6410, cvongdorosario@uabmc.edu

    Recruiting

  • Boston University Medical Center/Boston Medical Center

    Boston, Massachusetts, 02118

    Sayali Dhamne, Clinical Research Coordinator, (617) 358-9655, scdhamne@bu.edu

    Sneha Sinha, Clinical Research Coordinator, sneha@bu.edu

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02118

    Brenna Sharp de Flores, Senior Research Coordinator, 617-732-6277, bsharp@bwh.harvard.edu

    Sara Tedeschi, MD, MPH

    Recruiting

  • University of California - Los Angeles

    Los Angeles, California, 90095

    Michelle Ramirez, Clinical Research Coordinator, (310) 825-9956, MichelleRa@mednet.ucla.edu

    Aima Ohiwerei, Clinical Research Coordinator, (310) 825-2598, AOhiwerei@mednet.ucla.edu

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Kiley Timler, Clinical Research Coordinator, (414) 955-6875, ktimler@mcw.edu

    Ann Rosenthal, MD, FACP

    Recruiting

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Multi-Site Placebo Controlled Trial of Colchicine in Calcium Pyrophosphate Deposition Disease

The goal of this clinical trial is to learn if colchicine reduces levels of proteins indicating inflammation in the blood in individuals with calcium pyrophosphate deposition (CPPD) disease. The trial will also test the effect of colchicine on joint symptoms in CPPD disease. The main questions it aims to answer are:

  • Does colchicine reduce the level of interleukin 18 (IL-18) in the blood of individuals with CPPD disease?
  • Does colchicine reduce pain scores in individuals with CPPD disease?
Read more

Researchers will compare colchicine once daily to a placebo (a look-alike pill that contains no drug) to see if colchicine works to treat CPPD disease.

Participants will:

  • Take colchicine or a placebo every day for 6 months
  • Visit the clinic 3 times in 6 months for joint examinations, surveys, and blood tests. Each visit will last 2-3 hours.
  • Speak on the telephone with researchers for about 4 times over 6 months. Each phone call will last about 5 minutes.
Being tested
Colchicine Pill, Placebo
Keywords
colchicine, CPPD disease, calcium pyrophosphate, pseudogout
Medical subject headings
Chondrocalcinosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Colchicine PillDrug

    Colchicine 0.6mg tab, overencapsulated to match placebo capsule, taken by mouth once daily

  • PlaceboDrug

    Placebo capsule, taken by mouth once daily

Study groups in NCT06855433
Study groupRoleWhat they receive
ColchicineExperimentalColchicine
Receives: Drug: Colchicine Pill
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Interleukin 18 (IL-18)

    Serum IL-18

    Measured: Baseline and Week 24

Secondary outcomes (16)

  1. Serum IL-1b

    Serum IL-1b

    Measured: Baseline and Week 24

  2. Serum IL-17A

    Serum IL-17A

    Measured: Baseline and Week 24

  3. High-sensitivity C-reactive protein (hsCRP)

    High-sensitivity C-reactive protein in blood

    Measured: Baseline and Week 24

  4. IL-1b gene signature expression in PBMCs

    Expression of a panel of genes involved in IL-1b production or signaling, as percentage of total gene expression per cell

    Measured: Baseline and Week 24

  5. Immune cell population frequencies

    Immune cell clusters among PBMCs

    Measured: Baseline and Week 24

  6. Pain visual analog scale (pain VAS)

    Severity of pain from CPPD disease/pseudogout, both at rest and with activity, in the past 7 days (range 0-100mm, with 0 indicating no pain)

    Measured: Baseline, Week 12, Week 24

  7. Brief Pain Inventory (Short Form)

    Brief Pain Inventory includes two sub-scores: Pain Severity Score (range 0-10, with 0 indicating no pain in the past 24 hours) and Pain Interference Score (range 0-10, with 0 indicating no interference in the past 24 hours)

    Measured: Baseline, Week 12, Week 24

  8. Pain in the past week (PEG [pain intensity [P], interference with enjoyment of life [E], and interference with general activity [G])

    3 question instrument, range 0-10, with 0 indicating no pain and no interference in the past week

    Measured: Baseline, Week 12, Week 24

  9. Patient Reported Outcome Measurement Information System (PROMIS)-Physical Function

    PROMIS-Physical Function Short Form 10a (T-score range 0-100, with higher scores indicating better physical function)

    Measured: Baseline, Week 12, Week 24

  10. Patient Global Assessment of Response to Treatment

    5 point Likert scale

    Measured: Week 12, Week 24

  11. Patient Global Assessment

    Patient Global Assessment of CPPD Disease Activity (range: 0-10)

    Measured: Baseline, Week 12, Week 24

  12. Physician Global Assessment

    Physician's Global Assessment of CPPD Disease Activity (range: 0-10)

    Measured: Baseline, Week 12, Week 24

  13. Flare count

    Number of acute calcium pyrophosphate crystal arthritis flares

    Measured: Week 12, Week 24

  14. Adverse events

    Number of expected adverse events and unexpected adverse events

    Measured: Week 12, Week 24

  15. Tender Joint Count

    Tender Joint Count

    Measured: Baseline, Week 12, Week 24

  16. Swollen Joint Count

    Swollen Joint Count

    Measured: Baseline, Week 12, Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2025
  2. Study start12 Aug 2026
  3. Primary completion30 Apr 2030 (estimated)
  4. Study completion30 Sep 2030 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06855433
Sponsor's protocol ID
2024P003512
Acronym
CRYSTALLIZE
Status last verified
Jul 2026
First submitted
26 Feb 2025
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Colchicine Pill in people with CPPD - Calcium Pyrophosphate Deposition Disease, run by Brigham and Women's Hospital at 5 sites in United States.

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 4 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Brenna Sharp de Flores, Senior Research Coordinator (617-732-6277, bsharp@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Interleukin 18 (IL-18) (time frame: Baseline and Week 24). 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 NCT06855433.

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 21 Sep 2026.

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