[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06855433":3,"trial-entities:NCT06855433":218,"trial-summary:NCT06855433":222},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":43,"secondary_outcomes":48,"sex":95,"minimum_age":96,"maximum_age":17,"healthy_volunteers":97,"eligibility_criteria":98,"std_ages":120,"locations":123,"central_contacts":211,"overall_officials":215,"references":216,"see_also_links":217},"NCT06855433","2024P003512","Colchicine to Reduce Your SympToms And Lower Levels of Inflammation, Zeroing in on Effective CPPD Disease Treatment","A Randomized, Double-Blind, Multi-Site Placebo Controlled Trial of Colchicine in Calcium Pyrophosphate Deposition Disease","RECRUITING","2030-09-30","2026-07","2026-07-09","2026-07-20","Brigham and Women's Hospital","OTHER",true,"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.",null,[19],"CPPD - Calcium Pyrophosphate Deposition Disease",[21,22,23,24],"colchicine","CPPD disease","calcium pyrophosphate","pseudogout","INTERVENTIONAL","TREATMENT",[28],"PHASE2",{"count":30,"type":31},150,"ESTIMATED",[33,39],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DRUG","Colchicine Pill","Colchicine 0.6mg tab, overencapsulated to match placebo capsule, taken by mouth once daily",[38],"Colchicine",{"type":34,"name":40,"description":41,"armGroupLabels":42},"Placebo","Placebo capsule, taken by mouth once daily",[40],[44],{"measure":45,"description":46,"timeFrame":47},"Interleukin 18 (IL-18)","Serum IL-18","Baseline and Week 24",[49,51,53,56,59,62,66,69,72,75,79,82,85,88,91,93],{"measure":50,"description":50,"timeFrame":47},"Serum IL-1b",{"measure":52,"description":52,"timeFrame":47},"Serum IL-17A",{"measure":54,"description":55,"timeFrame":47},"High-sensitivity C-reactive protein (hsCRP)","High-sensitivity C-reactive protein in blood",{"measure":57,"description":58,"timeFrame":47},"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",{"measure":60,"description":61,"timeFrame":47},"Immune cell population frequencies","Immune cell clusters among PBMCs",{"measure":63,"description":64,"timeFrame":65},"Pain visual analog scale (pain VAS)","Severity of pain from CPPD disease\u002Fpseudogout, both at rest and with activity, in the past 7 days (range 0-100mm, with 0 indicating no pain)","Baseline, Week 12, Week 24",{"measure":67,"description":68,"timeFrame":65},"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)",{"measure":70,"description":71,"timeFrame":65},"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",{"measure":73,"description":74,"timeFrame":65},"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)",{"measure":76,"description":77,"timeFrame":78},"Patient Global Assessment of Response to Treatment","5 point Likert scale","Week 12, Week 24",{"measure":80,"description":81,"timeFrame":65},"Patient Global Assessment","Patient Global Assessment of CPPD Disease Activity (range: 0-10)",{"measure":83,"description":84,"timeFrame":65},"Physician Global Assessment","Physician's Global Assessment of CPPD Disease Activity (range: 0-10)",{"measure":86,"description":87,"timeFrame":78},"Flare count","Number of acute calcium pyrophosphate crystal arthritis flares",{"measure":89,"description":90,"timeFrame":78},"Adverse events","Number of expected adverse events and unexpected adverse events",{"measure":92,"description":92,"timeFrame":65},"Tender Joint Count",{"measure":94,"description":94,"timeFrame":65},"Swollen Joint Count","ALL","40 Years",false,{"inclusion":99,"exclusion":104,"raw_text":119},[100,101,102,103],"Provide written informed consent","Fulfill ACR\u002FEULAR 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",[105,106,107,108,109,110,111,112,113,114,115,116,117,118],"Age \\\u003C40 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","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:","Patient is considered by investigator to be an unsuitable candidate for the study for any reason","Inclusion Criteria:\n\n* Provide written informed consent\n* Fulfill ACR\u002FEULAR 2023 CPPD classification criteria\n* 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)\n* Pain visual analog scale (pain VAS) \\>=30 at screening\n\nExclusion Criteria:\n\n* Age \\\u003C40 years\n* Chronic diarrhea\n* Gout, rheumatoid arthritis, psoriatic arthritis, or 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, tocilizumab or canakinumab in the past 4 weeks\n* Use of anakinra, oral glucocorticoid, or intra-articular steroid in the past 1 week\n* Ongoing use of strong CYP3A4 inhibitors per FDA package insert for colchicine\n* Ongoing use of P-glycoprotein inhibitors per FDA package insert for colchicine\n* Known allergy to colchicine\n* Planned joint surgery in the next 6 months\n* CPPD clinical presentation isolated to Crowned Dens Syndrome with no additional peripheral joint involvement\n* Screening labs with any of the following:\n\n  1. Hemoglobin \\\u003C 9 g\u002FdL\n  2. WBC \\\u003C3 x 10\\^9\u002FL\n  3. Platelets \\\u003C110 x10\\^9\u002FL\n  4. Creatinine clearance (CrCl) \\\u003C30 mL\u002Fmin\n  5. ALT or AST \\>3x upper limit of normal (ULN)\n* Patient is considered by investigator to be an unsuitable candidate for the study for any reason",[121,122],"ADULT","OLDER_ADULT",[124,145,164,185,194],{"facility":125,"status":8,"city":126,"state":127,"zip":128,"country":129,"contacts":130,"geoPoint":142},"University of Alabama - Birmingham","Birmingham","Alabama","35233","United States",[131,135,139],{"name":132,"role":133,"email":134},"Shelby Gontarz, Clinical Research Coordinator","CONTACT","sgontarz@uab.edu",{"name":136,"role":133,"phone":137,"email":138},"Clementino Vong Do Rosario, Clinical Research Coordinator","(205) 975-6410","cvongdorosario@uabmc.edu",{"name":140,"role":141},"Angelo Gaffo, MD, MsPH","PRINCIPAL_INVESTIGATOR",{"lat":143,"lon":144},33.52066,-86.80249,{"facility":146,"status":8,"city":147,"state":148,"zip":149,"country":129,"contacts":150,"geoPoint":161},"University of California - Los Angeles","Los Angeles","California","90095",[151,155,159],{"name":152,"role":133,"phone":153,"email":154},"Michelle Ramirez, Clinical Research Coordinator","(310) 825-9956","MichelleRa@mednet.ucla.edu",{"name":156,"role":133,"phone":157,"email":158},"Aima Ohiwerei, Clinical Research Coordinator","(310) 825-2598","AOhiwerei@mednet.ucla.edu",{"name":160,"role":141},"John Fitzgerald, MD, PhD",{"lat":162,"lon":163},34.05223,-118.24368,{"facility":165,"status":8,"city":166,"state":167,"zip":168,"country":129,"contacts":169,"geoPoint":182},"Boston University Medical Center\u002FBoston Medical Center","Boston","Massachusetts","02118",[170,174,177,179],{"name":171,"role":133,"phone":172,"email":173},"Sayali Dhamne, Clinical Research Coordinator","(617) 358-9655","scdhamne@bu.edu",{"name":175,"role":133,"email":176},"Sneha Sinha, Clinical Research Coordinator","sneha@bu.edu",{"name":178,"role":141},"Tuhina Neogi, MD",{"name":180,"role":181},"Maureen Dubreil, MD","SUB_INVESTIGATOR",{"lat":183,"lon":184},42.35843,-71.05977,{"facility":13,"status":8,"city":166,"state":167,"zip":168,"country":129,"contacts":186,"geoPoint":193},[187,191],{"name":188,"role":133,"phone":189,"email":190},"Brenna Sharp de Flores, Senior Research Coordinator","617-732-6277","bsharp@bwh.harvard.edu",{"name":192,"role":141},"Sara Tedeschi, MD, MPH",{"lat":183,"lon":184},{"facility":195,"status":8,"city":196,"state":197,"zip":198,"country":129,"contacts":199,"geoPoint":208},"Medical College of Wisconsin","Milwaukee","Wisconsin","53226",[200,204,206],{"name":201,"role":133,"phone":202,"email":203},"Kiley Timler, Clinical Research Coordinator","(414) 955-6875","ktimler@mcw.edu",{"name":205,"role":141},"Ann Rosenthal, MD, FACP",{"name":207,"role":181},"Viktoriya Sabchyshyn, DO",{"lat":209,"lon":210},43.0389,-87.90647,[212,213],{"name":188,"role":133,"phone":189,"email":190},{"name":192,"role":133,"email":214},"stedeschi1@bwh.harvard.edu",[],[],[],{"nct_id":4,"conditions":219,"biomarkers":221},[220],"Calcium pyrophosphate deposition disease",[],{"nct_id":4,"found":15,"summary":223,"prompt_version":233},{"design":224,"status":225,"heading":226,"summary":227,"follow_up":228,"word_count":229,"commitments":230,"compensation":231,"drugs_mentioned":232},"This study is comparing colchicine to a placebo in about 150 participants. It is an interventional study, meaning participants will receive a specific treatment.","completed","Colchicine for Calcium Pyrophosphate Deposition (CPPD) Disease","This study is looking into whether colchicine, a pill taken once daily, can help people with calcium pyrophosphate deposition (CPPD) disease. CPPD disease causes joint inflammation. Researchers want to see if colchicine can lower levels of a protein called interleukin 18 (IL-18) in your blood, which is a sign of inflammation. They also want to know if colchicine can reduce your joint pain. You might be able to join if you are 40 or older, have CPPD, and have experienced joint inflammation or pain in the last three months. The study will compare colchicine to a placebo (a pill with no medicine) to understand its effects. The current status of this study is unclear.","Researchers will measure a specific protein in your blood at the beginning of the study and again at Week 24.",114,"Not specified in the trial record.","Not stated in the trial record.",[40],"v2"]