あなたの症状を軽減し、炎症のレベルが低いため、効果的なCPPD疾患治療に焦点を当てるコルヒチン (CRYSTALLIZE)
ピロリン酸カルシウム沈着疾患におけるコルヒチンの無作為化二重盲検プラセボ対照試験
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?
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.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Sara Tedeschi, MD, MPH
- メール：stedeschi1@bwh.harvard.edu
研究連絡先のバックアップ
- 名前：Brenna Sharp de Flores, Senior Research Coordinator
- 電話番号：617-732-6277
- メール：bsharp@bwh.harvard.edu
研究場所
-
-
Alabama
-
Birmingham、Alabama、アメリカ、35233
- 募集
- University of Alabama - Birmingham
-
コンタクト：
- Shelby Gontarz, Clinical Research Coordinator
- メール：sgontarz@uab.edu
-
コンタクト：
- Clementino Vong Do Rosario, Clinical Research Coordinator
- 電話番号：(205) 975-6410
- メール：cvongdorosario@uabmc.edu
-
主任研究者：
- Angelo Gaffo, MD, MsPH
-
-
California
-
Los Angeles、California、アメリカ、90095
- 募集
- University of California - Los Angeles
-
コンタクト：
- Michelle Ramirez, Clinical Research Coordinator
- 電話番号：(310) 825-9956
- メール：MichelleRa@mednet.ucla.edu
-
コンタクト：
- Aima Ohiwerei, Clinical Research Coordinator
- 電話番号：(310) 825-2598
- メール：AOhiwerei@mednet.ucla.edu
-
主任研究者：
- John Fitzgerald, MD, PhD
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ、02118
- 募集
- Boston University Medical Center/Boston Medical Center
-
コンタクト：
- Sayali Dhamne, Clinical Research Coordinator
- 電話番号：(617) 358-9655
- メール：scdhamne@bu.edu
-
コンタクト：
- Sneha Sinha, Clinical Research Coordinator
- メール：sneha@bu.edu
-
主任研究者：
- Tuhina Neogi, MD
-
副調査官：
- Maureen Dubreil, MD
-
Boston、Massachusetts、アメリカ、02118
- 募集
- Brigham and Women's Hospital
-
コンタクト：
- Brenna Sharp de Flores, Senior Research Coordinator
- 電話番号：617-732-6277
- メール：bsharp@bwh.harvard.edu
-
主任研究者：
- Sara Tedeschi, MD, MPH
-
-
Wisconsin
-
Milwaukee、Wisconsin、アメリカ、53226
- 募集
- Medical College of Wisconsin
-
コンタクト：
- Kiley Timler, Clinical Research Coordinator
- 電話番号：(414) 955-6875
- メール：ktimler@mcw.edu
-
主任研究者：
- Ann Rosenthal, MD, FACP
-
副調査官：
- Viktoriya Sabchyshyn, DO
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
-
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
-
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：Placebo
Placebo |
Placebo capsule, taken by mouth once daily |
|
実験的：Colchicine
Colchicine |
Colchicine 0.6mg tab, overencapsulated to match placebo capsule, taken by mouth once daily |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Interleukin 18 (IL-18)
時間枠：Baseline and Week 24
|
Serum IL-18 |
Baseline and Week 24
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Serum IL-1b
時間枠：Baseline and Week 24
|
Serum IL-1b |
Baseline and Week 24
|
|
Serum IL-17A
時間枠：Baseline and Week 24
|
Serum IL-17A |
Baseline and Week 24
|
|
High-sensitivity C-reactive protein (hsCRP)
時間枠：Baseline and Week 24
|
High-sensitivity C-reactive protein in blood |
Baseline and Week 24
|
|
IL-1b gene signature expression in PBMCs
時間枠：Baseline and Week 24
|
Expression of a panel of genes involved in IL-1b production or signaling, as percentage of total gene expression per cell |
Baseline and Week 24
|
|
Immune cell population frequencies
時間枠：Baseline and Week 24
|
Immune cell clusters among PBMCs |
Baseline and Week 24
|
|
Pain visual analog scale (pain VAS)
時間枠：Baseline, Week 12, Week 24
|
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) |
Baseline, Week 12, Week 24
|
|
Brief Pain Inventory (Short Form)
時間枠：Baseline, Week 12, Week 24
|
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) |
Baseline, Week 12, Week 24
|
|
Pain in the past week (PEG [pain intensity [P], interference with enjoyment of life [E], and interference with general activity [G])
時間枠：Baseline, Week 12, Week 24
|
3 question instrument, range 0-10, with 0 indicating no pain and no interference in the past week |
Baseline, Week 12, Week 24
|
|
Patient Reported Outcome Measurement Information System (PROMIS)-Physical Function
時間枠：Baseline, Week 12, Week 24
|
PROMIS-Physical Function Short Form 10a (T-score range 0-100, with higher scores indicating better physical function) |
Baseline, Week 12, Week 24
|
|
Patient Global Assessment of Response to Treatment
時間枠：Week 12, Week 24
|
5 point Likert scale |
Week 12, Week 24
|
|
Patient Global Assessment
時間枠：Baseline, Week 12, Week 24
|
Patient Global Assessment of CPPD Disease Activity (range: 0-10) |
Baseline, Week 12, Week 24
|
|
Physician Global Assessment
時間枠：Baseline, Week 12, Week 24
|
Physician's Global Assessment of CPPD Disease Activity (range: 0-10) |
Baseline, Week 12, Week 24
|
|
Flare count
時間枠：Week 12, Week 24
|
Number of acute calcium pyrophosphate crystal arthritis flares |
Week 12, Week 24
|
|
Adverse events
時間枠：Week 12, Week 24
|
Number of expected adverse events and unexpected adverse events |
Week 12, Week 24
|
|
Tender Joint Count
時間枠：Baseline, Week 12, Week 24
|
Tender Joint Count |
Baseline, Week 12, Week 24
|
|
Swollen Joint Count
時間枠：Baseline, Week 12, Week 24
|
Swollen Joint Count |
Baseline, Week 12, Week 24
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。