ChiCTR2200056875 版本V1.1 版本创建时间2022/10/22 21:04:35 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2200056875 

最近更新日期：

Date of Last Refreshed on：

 2022-10-22 20:56:21 

注册时间：

Date of Registration：

 2022-02-22 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

TUL01101片在类风湿性关节炎患者中单次/多次给药的安全性、耐受性、药代动力学和药效动力学研究及临床疗效初探

Public title：

The safety, tolerability, pharmacokinetics and pharmacokinetics of TUL01101 tablets in patients with rheumatoid arthritis were studied in a single/multiple administration

注册题目简写：

English Acronym：

研究课题的正式科学名称：

TUL01101片在类风湿性关节炎患者中单次/多次给药的安全性、耐受性、药代动力学和药效动力学研究及临床疗效初探

Scientific title：

The safety, tolerability, pharmacokinetics and pharmacokinetics of TUL01101 tablets in patients with rheumatoid arthritis were studied in a single/multiple administration

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

黄舒琪 

研究负责人：

阳国平/张浩 

Applicant：

Huang Shuqi 

Study leader：

Yang Guoping, Zhang Hao 

申请注册联系人电话：

Applicant telephone：

 +86 15778118906

研究负责人电话：

Study leader's
telephone：

+86 731 89918665

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 huangshuqi185@163.com

研究负责人电子邮件：

Study leader's E-mail：

 ygp9880@126.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

湖南省长沙市岳麓区桐梓坡路138号

研究负责人通讯地址：

湖南省长沙市岳麓区桐梓坡路138号

Applicant address：

138 Tongzipo Road, Yuelu District, Changsha, Hu'nan

Study leader's address：

138 Tongzipo Road, Yuelu District, Changsha, Hu'nan

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

中南大学湘雅三医院临床试验研究中心

Applicant's institution：

The Third Xiangya Hospital, Central South University

研究负责人所在单位：

Affiliation of the Leader：

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 22009

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

中南大学湘雅三医院伦理委员会医学伦理分委员会

Name of the ethic committee：

The Third Xiangya Hospital, Central South University Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-01-21 00:00:00

伦理委员会联系人：

王晓敏

Contact Name of the ethic committee：

Wang Xiaomin

伦理委员会联系地址：

湖南省长沙市岳麓区桐梓坡路138号中南大学湘雅三医院伦理委员会医学伦理分委员会

Contact Address of the ethic committee：

138 Tongzipo Road, Yuelu District, Changsha, Hu'nan

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

中南大学湘雅三医院临床试验研究中心

Primary sponsor：

The Third Xiangya Hospital, Central South University

研究实施负责（组长）单位地址：

湖南省长沙市岳麓区桐梓坡路138号

Primary sponsor's address：

138 Tongzipo Road, Yuelu District, Changsha, Hu'nan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖南

市(区县)：

长沙

Country：

China

Province：

Hu'nan

City：

Changsha

单位(医院)：

中南大学湘雅三医院临床试验研究中心

具体地址：

岳麓区桐梓坡路138号

Institution
hospital：

The Third Xiangya Hospital, Central South University

Address：

138 Tongzipo Road, Yuelu District

经费或物资来源：

珠海联邦制药股份有限公司

Source(s) of funding：

Zhuhai Federal Pharmaceutical Co., Ltd

研究疾病：

类风湿性关节炎  

Target disease：

rheumatoid arthritis

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

主要目的 ?评估类风湿性关节炎患者单次/多次服用 TUL01101 片的安全性和耐受性； 次要目的 ?评估类风湿性关节炎患者单次/多次服用 TUL01101 片的药代动力学特征； 探索性目的 ?评估类风湿性关节炎患者单次/多次服用 TUL01101 片的药效动力学情况； ?类风湿性关节炎患者多次服用 TUL01101 后的初步临床疗效。  

Objectives of Study：

Main objectives To evaluate the safety and tolerance of patients with rheumatoid arthritis treated with TUL01101 tablets once or more secondary purpose The pharmacokinetic characteristics of TUL01101 tablets in patients with rheumatoid arthritis were evaluated. Exploratory purpose To evaluate the pharmacokinetics of TUL01101 tablets in patients with rheumatoid arthritis in a single or multiple dose ; the preliminary clinical efficacy of multiple administration of TUL01101 in patients with rheumatoid arthritis.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

有资格参加本次研究的受试者必须符合下列各条入选标准：
1、年龄为 18～65 岁（包括两端），男女不限；
2、受试者符合 2010 年美国风湿病学会（ACR）/欧洲风湿病联盟（EULAR）分类标准，ACR 功能分类为Ⅰ-Ⅲ级；
3、筛选时，活动性 RA 定义为至少有 6/68 个关节在运动时压痛或疼痛和至少 4/66个关节肿胀(注：进行过重大手术治疗的关节、筛选前 2 周内关节内注射过皮质激素的关节、筛选前 2 周内或随机前 6 周内关节内注射过透明质酸的关节都不计算在关节压痛计数（TJC）和关节肿胀计数（SJC）内) ；
4、筛选时，红细胞沉降率(ESR)≥正常值上限（ULN），或 C 反应蛋白(CRP) > 正常值上限（ULN）；
5、体重指数[BMI＝体重/身高平方（kg/m 2 ）]在 18～30 范围内（包括两端）；
6、受试者（包括伴侣）自筛选至完成试验后 6 个月内无生育计划，且愿采用非激素性避孕措施，试验完成后 6 个月内无捐献精子、卵子计划；
7、对本研究已充分了解，自愿参加，已签署书面的知情同意书；
8、受试者能够和研究者进行良好的沟通，并且理解和遵守本研究的各项要求。

Inclusion criteria

Subjects eligible for this study must meet the following criteria :
1 Age is 18 ~ 65 years old ( including both ends ), men and women are not limited ;
2. The subjects met the classification criteria of American College of Rheumatology ( ACR ) / European Union of Rheumatology ( EULAR ) in 2010, and the ACR function was classified as I – III ;
3. During screening, active RA is defined as at least 6 / 68 joints with tenderness or pain during exercise and at least 4 / 66 joints with swelling ( note : joints that have undergone major surgical treatment, joints that have received intra-articular injection of corticosteroids within two weeks before screening, and joints that have received intra-articular injection of hyaluronic acid within two weeks before screening or six weeks before randomization are not counted in the joint tenderness count ( TJC ) and joint swelling count ( SJC ) ) ;
4. When screening, erythrocyte sedimentation rate ( ESR ) ≥ the upper limit of normal value ( ULN ), or C-reactive protein ( CRP ) > the upper limit of normal value ( ULN ) ;
5. BMI [ BMI = weight / height square ( kg / m2 ) ] was in the range of 18 – 30 ( including both ends ) ;
6. Subjects ( including partners ) have no fertility plan from screening to 6 months after the completion of the trial, and are willing to adopt non-hormonal contraceptive measures and donate no sperm and eggs plan within 6 months after the completion of the trial ;
7. This study has been fully understood, voluntary participation, signed written informed consent ;
8. Subjects are able to communicate well with researchers and understand and comply with the objectives of this study

排除标准：

以下任何一条均可将受试者排除，不入选研究：
1、已知有临床意义的药物过敏史或特应性变态反应性疾病史（哮喘、荨麻疹、湿疹性皮炎）或已知对试验用药品成分或类似活性药物的药物过敏者；
2、既往使用以下任何一种药物或治疗：
1）首次给药前 7 个半衰期内接受过 JAK 抑制剂（包括但不限于托法替布）或任何其它类似结构药物；
2）首次给药前 7 个半衰期内使用过传统合成改善病情抗风湿药（csDMARDs），包括但不限于甲氨蝶呤、来氟米特、柳氮磺吡啶、氯喹/羟氯喹、青霉胺；
3）首次给药前 5 个半衰期内或 3 个月内（以时间较长者为准）使用过生物制剂类改善病情抗风湿药（bDMARDs），包括但不限于抗肿瘤坏死因子（TNF）-α拮抗剂、白细胞介素（IL）-l 拮抗剂、IL-6 拮抗剂、抗 CD20 单抗以及 T 细胞共刺激分子抑制剂等）；
4）首次给药前 4 周内接受过任何肠外（如肌肉、静脉注射等）或关节内皮质激素类药物；或正在使用口服皮质激素类药物且每日剂量>10 mg 强的松（或等效剂量）或至随机前 4 周剂量未稳定，或在试验期间不能以原稳定剂量继续用药；
5）正在使用非甾体类抗炎药如对乙酰氨基酚或阿片类等药物且至随机前 4 周内剂量未稳定，或在试验期间不能以原稳定剂量继续用药；
6）首次给药前 4 周内接受过干扰素治疗（如罗扰素、甘乐能、Rebetron、Alferon-N、佩乐能、Avonex、倍泰龙、干复津、派罗欣、安达芬、迪恩安、福康泰等）或使用已知具有较强的免疫抑制或免疫调节作用的药物（如帕夫林、雷公藤、霉酚酸酯、环孢菌素、他克莫司、硫唑嘌呤、6-巯基嘌呤等）；
7）首次给药前 4 周内使用过任何可能对受试药物有影响的处方药、非处方药、中草药、食物或食物补充剂者，如 CYP3A4 抑制剂或诱导剂类药物等；
8）首次给药前 3 个月内接种活疫苗或减毒活疫苗或 1 个月内接种灭活疫苗或计划试验期间接种活疫苗、减毒活疫苗或灭活疫苗。
3、有以下任何一种疾病的病史或证据：
1）有除 RA 外的其他全身性炎症性疾病者；
2）筛选前 1 个月内发生过需要进行系统治疗的病毒、细菌、真菌、寄生虫、支原体或衣原体感染者；
3）有反复发作的带状疱疹、播散性带状疱疹或播散性单纯疱疹病史者，或随机前 2个月内有带状疱疹或单纯疱疹病史者；
4）有淋巴增殖性疾病病史，或有可能是淋巴增殖性疾病的各种体征或症状者；
5）有严重的血液系统疾病（如再生障碍性贫血、骨髓增生异常综合征）或任何可引起溶血或红细胞不稳定的疾病，如疟疾、溶血性贫血，或经研究者判断可能影响药物的吸收、分布、代谢和排泄、或干扰结果评价者；
6）有恶性肿瘤病史者（已治愈的且 5 年内未复发，如非黑色素瘤原位皮肤癌、浅表性膀胱癌、原位宫颈癌等研究者认为可以入组的除外）；
7）有结核（TB）病史或结核高危人群（给药前 2 个月内曾去过疫区者；结核疫区指印度、印度尼西亚、菲律宾和巴基斯坦）；
8）有费尔蒂综合征（Felty 综合征）者；
9）免疫功能低下，研究者认为参加试验可能给受试者带来不可接受的风险者；
10） 随机前 3 个月内出现过失代偿性心力衰竭（纽约心脏病协会分级为Ⅲ~Ⅳ级）、不稳定性心绞痛、脑卒中或短暂性脑缺血发作、心肌梗死、持续性且有临床意义的心律失常、进行过冠状动脉旁路移植术或经皮冠状动脉介入术者；
11）有呼吸系统、肝脏、肾脏、消化道、免疫、内分泌、代谢、精神神经等疾病或病史，且经研究者判断可能影响药物的吸收、分布、代谢和排泄、或干扰结果评价者。
4、筛选时有符合下列标准的任何检查异常且经研究者判断有临床意义者：
1）血红蛋白<8.5 g/dL（85.0 g/L）；
2）白细胞总数<3.0×10 9 /L；
3）中性粒细胞数<1.2×10 9 /L；
4）血小板计数<0.7 倍 LLN，或国际标准化比值（INR）>1.5 或活化部分凝血活酶时间（APTT）>正常上限 10s；
5）丙氨酸氨基转移酶（ALT）或天门冬氨酸氨基转移酶（AST）>2.0 倍 ULN；总胆红素（T-BIL）>1.5 倍 ULN；
6）血肌酐（CREA）> 1.5 × ULN 或肌酐清除率（CCLR）<50 ml/min（应用标准的Cockcroft-Gault 公式）；
7）糖化血红蛋白（HbA1c）> 7%；
8）血电解质（包括但不限于钙离子、磷离子）异常降低且有临床意义者；
9）研究者认为可能对本研究结果评价产生干扰的任何有临床意义的实验室异常值。
5、筛选时乙型肝炎表面抗原检查阳性、丙型肝炎病毒抗体检查阳性、人免疫缺陷病毒抗体检查阳性或梅毒抗体检查阳性者；
6、筛选前 6 个月内接受过任何手术者；
7、筛选前 3 个月内失血或献血超过 400 mL，或接受过血液或血液成份输注者；
8、筛选前 3 个月内参加过任何药物或医疗器械的临床试验且给药者（含安慰剂组）；
9、既往有药物滥用史，或尿药筛查阳性者；
10、首次给药前 3 个月内每日吸烟超过 5 支香烟或等量烟草的或者试验期间不能戒烟者；
11、首次给药前 28 天内女性每周饮酒超过 7 杯或男性每周饮酒超过 14 杯（1 杯=150mL（5 盎司）葡萄酒=360mL（12 盎司）啤酒=45mL（1.5 盎司）烈酒），或首次给药前48小时内服用过任何含酒精的制品，或基线访视时酒精呼气试验为阳性者，或试验期间不能禁酒者；
12、首次给药前 14 天内饮用过量（一天 8 杯以上，1 杯=200 mL）茶、咖啡或含咖啡因的饮料，或食用葡萄柚（西柚）、或富含黄嘌呤的食物或饮料者，或给药前 48小时内及试验期间不能停止食用富含黄嘌呤成分的食物或饮料（如巧克力、茶、咖啡及可乐等）、或葡萄柚（西柚）或柚子以及含葡萄柚或柚子成分的产品（西柚汁、柚子汁等）者；
13、参加研究期间仍需或计划从事剧烈体力活动或运动者；
14、“哺乳期女性”或“妊娠期女性”者；
15、不能耐受静脉穿刺者，有晕针或晕血史者；
16、研究者认为不适合参加临床试验的其他情况。

Exclusion criteria：

Subjects can be excluded from any of the following studies :
1. Persons with known clinical history of drug allergy or atopic allergic diseases ( asthma, urticaria, eczematous dermatitis ) or known drug allergy to test drug ingredients or similar active drugs ;
2. Previous use of any of the following drugs or treatment :
1 ) JAK inhibitors ( including, but not limited to, tofatinib ) or any other similar structural drugs were accepted within seven half-life periods before the first administration ;
2 ) Traditionally synthesized antirheumatic drugs ( csDMARDs ) were used to improve the disease within seven half-life periods before the first administration, including but not limited to methotrexate, leflunomide, sulfasalazine, chloroquine / hydroxychloroquine;
3 ) The anti-rheumatic drugs ( bDMARDs ) used in the five half-life periods or three months before the first administration ( according to the longer duration ), including but not limited to anti-tumor necrosis factor ( TNF ) -α antagonist, interleukin ( IL ) -l antagonist, IL-6 antagonist, anti-CD20 monoclonal antibody and T cell costimulatory molecule inhibitors ;
4 ) received any extraintestinal ( such as muscle, intravenous, etc. ) or intra-articular corticosteroids within 4 weeks before the first administration ; or prednisone ( or equivalent dose > 10 mg per day ) is being used, or the dose is not stable until the first four weeks of randomization, or the drug cannot be continued at the original stable dose during the test ;
5 ) Non-steroidal anti-inflammatory drugs such as paracetamol or opioids are being used and the dose is not stable within 4 weeks before the randomization, or the original stable dose cannot be continued during the test ;
6 ) Interferon therapy ( e. g., roxoretin, Ganlenin, Rebetron, Alferon-N, Pelenin, Avonex, Betaloc, Ganfujin, Paroxim, Andafen, Dean an, Fukangtai, etc. ) or drugs known to have strong immunosuppressive or immunoregulatory effects ( e. g., Pavelin, Tripterygium wilfordii, Mycophenolate mofetil, Cyclosporine, Tacrolimus, Thioazopurine, 6 - mercaptopurine, etc. ) was received within 4 weeks before the first administration ;
7 ) Any prescription drugs, non-prescription drugs, Chinese herbal medicine, food or food supplements that may affect the tested drugs were used within four weeks before the first administration, such as CYP3A4 inhibitors or inducer drugs ;
8 ) Inoculate live vaccine or attenuated live vaccine within 3 months before the first administration or inactivated vaccine within 1 month or live vaccine, attenuated live vaccine or inactivated vaccine during the planned trial.
3. History or evidence of any of the following diseases :
1 ) Patients with systemic inflammatory diseases other than RA ;
2 ) Patients with viruses, bacteria, fungi, parasites, mycoplasmas or chlamydia who needed systematic treatment within one month before screening ;
3 ) having a history of recurrent herpes zoster, disseminated herpes zoster or disseminated herpes simplex, or having a history of herpes zoster or herpes simplex within the first two months of randomization ;
4 ) having a history of lymphoproliferative disorders, or may be signs or symptoms of lymphoproliferative disorders ;
5 ) having a serious hematological system disease ( such as aplastic anemia, myelodysplastic syndrome ) or any disease that can cause hemolysis or erythrocyte instability, such as malaria, hemolytic anemia, or a researcher 's judgment that may affect the absorption, distribution, metabolism and excretion of drugs, or interfere with the evaluation of results ;
6 ) Patients with malignant tumor history ( cured and no recurrence within 5 years, such as non-melanoma in situ skin cancer, superficial bladder cancer, in situ cervical cancer and other researchers believe that can be included in the group ) ;
7 ) Patients with tuberculosis ( TB ) history or high-risk groups ( those who had been to the epidemic area within two months before administration ; tuberculosis epidemic areas refer to India, Indonesia, the Philippines and Pakistan ) ;
8 ) patients with Felty syndrome ;
9 ) Immune dysfunction, researchers believe that participating in the test may bring unacceptable risk to subjects ;
10 ) Patients with decompensated heart failure ( grade III – IV by the New York Heart Association ), unstable angina, stroke or transient ischemic attack, myocardial infarction, persistent and clinically significant arrhythmia, and undergoing coronary artery bypass grafting or percutaneous coronary intervention within the first three months of randomization ;
11 ) Patients with respiratory system, liver, kidney, digestive tract, immune, endocrine, metabolic, psychiatric and other diseases or medical histories, and judged by researchers to be likely to affect the absorption, distribution, metabolism and excretion of drugs, or interfere with the evaluation of results.
4. Any abnormality in screening that meets the following criteria and has clinical significance judged by researchers :
1 ) Hemoglobin < 8.5 g / dL ( 85.0 g / L ) ;
2 ) Total white blood cell count < 3.0 × 109 / L ;
3 ) Neutrophil count < 1.2 × 10 9 / L ;
4 ) Platelet count 1.5 or activated partial thromboplastin time ( APTT ) > normal upper limit 10s ;
5 ) ALT or AST > 2.0 times ULN ; total bilirubin ( T-BIL ) > 1.5 times ULN ;
6 ) Serum creatinine ( CREA ) > 1.5 × ULN or creatinine clearance rate ( CCLR ) < 50 mL / min ( using the standard Cockcroft-Gault formula ) ;
7 ) HbA1c > 7 % ;
8 ) Blood electrolytes ( including but not limited to calcium and phosphorus ) decrease abnormally and have clinical significance ;
9 ) The researchers believe that any clinical laboratory abnormal values that may interfere with the evaluation of the results of this study.
5. When screening, hepatitis B surface antigen positive, hepatitis C virus antibody positive, human immunodeficiency virus antibody positive or syphilis antibody positive ;
6. Patients who received any surgery within 6 months before screening ;
7. Those who lost blood or donated more than 400 mL blood or received transfusion of blood or blood components within 3 months before screening ;
8. Participated in clinical trials of any drug or medical device within 3 months prior to screening and administered ( including placebo group ) ;
9. Those with a history of drug abuse or positive urine drug screening ;
10. Those who smoke more than 5 cigarettes or equivalent cigarettes per day within three months before the first administration or who cannot quit smoking during the trial ;
11. Women drink more than7cups per week or men drink more than14cups per week ( 1cup = 150mL ( 5ounce ) wine = 360mL ( 12ounce ) beer = 45mL ( 1.5ounce ) spirits ) within28days before the first administration, or have taken any alcohol-containing products within48hours before the first administration, or have positive alcohol breath test during baseline visits, or have no prohibition during the test ;
12. Those who consumed excessive tea, coffee or caffeine-containing drinks ( more than 8 cups a day, 1 cup = 200 mL ), grapefruit ( grapefruit ) or foods or drinks rich in xanthine within 14 days before the first administration, or foods or drinks rich in xanthine ( such as chocolate, tea, coffee and coke ), grapefruit ( grapefruit ) or grapefruit and products containing grapefruit or grapefruit ( such as grapefruit juice and grapefruit juice ) cannot be stopped within 48 hours before administration and during the experiment ;
13. Those who still need or plan to engage in violent physical activities or sports during the study ;
14, ' lactation women ' or ' pregnant women ' ;
15. Patients who were unable to tolerate venipuncture, with fainting needle or blood fainting history ;
16. Researchers think it is not suitable to participate in other clinical trials.

研究实施时间：

Study execute time：

从 From 2022-02-01 00:00:00至 To 2022-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-02-22 00:00:00 至 To 2022-12-31 00:00:00

干预措施：

Interventions：

组别：

20mg剂量组

样本量：

 12

Group：

20mg dose group

Sample size：

干预措施：

单次给药研究时给予20mg，多次给药研究给予20mg，给药期28d；持续给药的初步疗效研究约 8 周

干预措施代码：

Intervention：

Single dose study was given20mg, multiple dose study was given20mg, administration period28d ; initial efficacy of continuous administration for about 8 weeks

Intervention code：

组别：

50mg剂量组

样本量：

 12

Group：

50mg dose group

Sample size：

干预措施：

单次给药研究时给予50mg，多次给药研究给予50mg，给药期28d；持续给药的初步疗效研究约 8 周

干预措施代码：

Intervention：

Single dose study was given50mg, multiple dose study was given50mg, administration period28d ; initial efficacy of continuous administration for about 8 weeks

Intervention code：

组别：

70mg剂量组

样本量：

 12

Group：

70mg dose group

Sample size：

干预措施：

单次给药研究时给予70mg，多次给药研究给予70mg，给药期28d；持续给药的初步疗效研究约 8 周

干预措施代码：

Intervention：

Single dose study was given70mg, multiple dose study was given70mg, administration period28d ; initial efficacy of continuous administration for about 8 weeks

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖南 

市(区县)：

 长沙 

Country：

China

Province：

Hu'nan

City：

Changsha

单位(医院)：

 中南大学湘雅三医院 

单位级别：

 三级甲等 

Institution
hospital：

Third Xiangya Hospital, Central South University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

血药浓度

指标类型：

主要指标

Outcome：

Plasma concentration

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

关节压痛计数

指标类型：

主要指标

Outcome：

Joint tenderness count

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

关节肿胀计数

指标类型：

主要指标

Outcome：

Joint swelling count

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 岁 years
最大 Max age 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

本试验各剂量组内采用区组随机化方法（试验组：10 例；安慰剂组：2 例），各中心竞争入组。以 SAS 软件（9.4 或以上版本）产生随机号以及随机号所对应治疗组别，每个剂量组生成一个随机表（盲底密封），一式三份，密封后分别保存在临床单位、申办单位和 PK 生物分析单位。

Randomization Procedure (please state who generates the random number sequence and by what method)：

The randomized block method was used in each dose group ( experimental group : 10 cases ; placebo group : 2 cases ), each center competed. SAS software ( version 9.4 or above ) was used to generate random numbers and the treatment groups corresponding to random numbers. Each dose group generated

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Blinding：

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

否

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

no

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

本次试验采用电子化数据管理，使用电子数据采集系统（DAS for EDC V6.0)，数据管理流程详见数据管理计划（DMP）。DMP 作为数据管理的指导性文件，由数据管理员（DM）撰写，申办单位批准，数据管理工作将根据 DMP 定义的时间、内容及方法进行。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

This experiment adopts electronic data management and electronic data acquisition system (DAS for EDC 6.0). See DATA Management Plan (DMP) for the data management process. DMP shall be written by the Data Manager (DM) and approved by the sponsor as a guiding document for data management. Data management shall be carried out according to the time, content and methods defined by DMP.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2022-02-22 03:35:39