Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-01-01 @ 12:38 AM
Study NCT ID:
NCT06855433
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-04
First Post:
2025-02-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Colchicine to Reduce Your SympToms And Lower Levels of Inflammation, Zeroing in on Effective CPPD Disease Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002805', 'term': 'Chondrocalcinosis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003078', 'term': 'Colchicine'}], 'ancestors': [{'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Data Coordinating Center'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-03', 'studyFirstSubmitDate': '2025-02-26', 'studyFirstSubmitQcDate': '2025-02-26', 'lastUpdatePostDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interleukin 18 (IL-18)', 'timeFrame': 'Baseline and Week 24', 'description': 'Serum IL-18'}], 'secondaryOutcomes': [{'measure': 'Serum IL-1b', 'timeFrame': 'Baseline and Week 24', 'description': 'Serum IL-1b'}, {'measure': 'Serum IL-17A', 'timeFrame': 'Baseline and Week 24', 'description': 'Serum IL-17A'}, {'measure': 'High-sensitivity C-reactive protein (hsCRP)', 'timeFrame': 'Baseline and Week 24', 'description': 'High-sensitivity C-reactive protein in blood'}, {'measure': 'IL-1b gene signature expression in PBMCs', 'timeFrame': 'Baseline and Week 24', 'description': 'Expression of a panel of genes involved in IL-1b production or signaling, as percentage of total gene expression per cell'}, {'measure': 'Immune cell population frequencies', 'timeFrame': 'Baseline and Week 24', 'description': 'Immune cell clusters among PBMCs'}, {'measure': 'Pain visual analog scale (pain VAS)', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': 'Pain VAS (range 0-100mm) reflecting pain in the past 24 hours due to CPPD disease'}, {'measure': 'Patient Reported Outcome Measurement Information System (PROMIS)-Pain Interference', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': 'PROMIS-Pain Interference Short Form 6b, assessing pain interference in the past 7 days. (T-score range 0-100, with higher scores indicating greater pain interference)'}, {'measure': 'Patient Reported Outcome Measurement Information System (PROMIS)-Physical Function', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': 'PROMIS-Physical Function Short Form 10a (T-score range 0-100, with higher scores indicating better physical function)'}, {'measure': 'Patient Global Assessment of Response to Treatment', 'timeFrame': 'Week 12, Week 24', 'description': '5 point Likert scale'}, {'measure': 'Patient Global Assessment', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': 'Patient Global Assessment of CPPD Disease Activity (range: 0-10)'}, {'measure': 'Assessor Global Assessment', 'timeFrame': 'Baseline, Week 12, Week 24', 'description': "Assessor's Global Assessment of CPPD Disease Activity (range: 0-10)"}, {'measure': 'Flare count', 'timeFrame': 'Week 12, Week 24', 'description': 'Number of acute calcium pyrophosphate crystal arthritis flares'}, {'measure': 'Adverse events', 'timeFrame': 'Week 12, Week 24', 'description': 'Number of expected adverse events and unexpected adverse events'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colchicine', 'CPPD disease', 'calcium pyrophosphate', 'pseudogout'], 'conditions': ['CPPD - Calcium Pyrophosphate Deposition Disease']}, 'descriptionModule': {'briefSummary': '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:\n\n* Does colchicine reduce the level of interleukin 18 (IL-18) in the blood of individuals with CPPD disease?\n* Does colchicine reduce pain scores in individuals with CPPD disease?\n\nResearchers 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.\n\nParticipants will:\n\n* Take colchicine or a placebo every day for 6 months\n* Visit the clinic 3 times in 6 months for joint examinations, surveys, and blood tests. Each visit will last 2-3 hours.\n* Speak on the telephone with researchers for about 4 times over 6 months. Each phone call will last about 5 minutes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provide written informed consent\n* Fulfill ACR/EULAR 2023 CPPD classification criteria\n* Acute or chronic joint inflammation in the past 3 months, not attributable to another condition\n* Pain visual analog scale (pain VAS) \\>=30 at screening\n\nExclusion Criteria:\n\n* age \\<40 years\n* chronic diarrhea\n* gout, rheumatoid arthritis, or psoriatic arthritis\n* cirrhosis\n* 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)\n* pregnant or breast-feeding\n* use of methotrexate, hydroxychloroquine, or anakinra in the past month\n* use of oral glucocorticoid in the past week\n* use of strong CYP3A4 inhibitors per FDA package insert for colchicine\n* use of P-glycoprotein inhibitors per FDA package insert for colchicine\n* known allergy to colchicine\n\nScreening labs with any of the following:\n\n* hemoglobin \\< 11.5 g/dL\n* WBC \\<3 x 10\\^9/L\n* platelets \\<110 x10\\^9/L\n* creatinine clearance (CrCl) \\<30 mL/min\n* ALT or AST \\>3x upper limit of normal (ULN)'}, 'identificationModule': {'nctId': 'NCT06855433', 'acronym': 'CRYSTALLIZE', 'briefTitle': 'Colchicine to Reduce Your SympToms And Lower Levels of Inflammation, Zeroing in on Effective CPPD Disease Treatment', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'A Randomized, Double-Blind, Multi-Site Placebo Controlled Trial of Colchicine in Calcium Pyrophosphate Deposition Disease', 'orgStudyIdInfo': {'id': '2024P003512'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Colchicine', 'description': 'Colchicine', 'interventionNames': ['Drug: Colchicine Pill']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Colchicine Pill', 'type': 'DRUG', 'description': 'Colchicine 0.6mg tab, overencapsulated to match placebo capsule, taken by mouth once daily', 'armGroupLabels': ['Colchicine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo capsule, taken by mouth once daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jacklyn Stratton, Senior Project Manager', 'role': 'CONTACT', 'email': 'jstratton1@bwh.harvard.edu', 'phone': '617-525-8784'}, {'name': 'Sara Tedeschi, MD, MPH', 'role': 'CONTACT', 'email': 'stedeschi1@bwh.harvard.edu'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Rheumatology Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Sara Tedeschi, M.D., M.P.H.', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}