CTRI/2024/05/067017尚未招募2 期
A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Efficacy and Safety study of SAR441566 plus Methotrexate in Adults with Moderate-to-Severe Rheumatoid Arthritis - NI
Sanofi Healthcare India Pvt Limited (SHIPL)0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. At least 18 years old (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the informed consent.
- •2. Diagnosis of adult-onset RA classified by ACR/EULAR 2010 revised classification criteria for RA (28) of at least 3 months duration, with the onset of signs and symptoms of RA of at least 6 months duration.
- •3. Moderate-to-severely active RA, defined as:
- •-- Persistently active disease more than equal to 6 tender and more than equal to 6 swollen joints.
- •-- High sensitivity C-reactive protein more than 5 mg/L.
- •4. Participants who stopped biologic treatment due to non-response, partial response, loss of efficacy (e.g., failure to achieve or maintain remission (IGA 0, clear skin to 2, mild disease)) must have been previously treated with biologic (at labelled dose level) for at least 4 months, as confirmed by investigator judgment.
- •5. Continuous treatment with MTX for at least 12 consecutive weeks prior to randomization and with stable dose/means of administration at least 6 weeks prior to the screening visit.
- •--MTX – 10 to 25 mg/week (or per local labeling requirements for the treatment of RA if the dose range differs, eg, for Japan, a stable dose of MTX is 6 to 16 mg/week) and folic/folinic acid (as part of MTX regimen).
- •6. BMI within the range (18 - 35) kg/m2 (inclusive).
- •7. All contraceptive methods used by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- •8. Male participants Male participants are eligible to participate if they agree to the following during the study treatment period and for at least 3 months after the last administration of study IMP: - Refrain from donating or cryopreserving sperm; PLUS, either: - Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; OR - Must agree to use contraception as detailed below: A male condom and an additional highly effective contraceptive method (as described in Section 10.4), when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant.
- •9. Female participants A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:- Is a woman of nonchildbearing potential (WONCBP) as defined in the protocol; OR - Is a woman of childbearing potential (WOCBP) and agrees to use a contraceptive method that is highly effective (with a failure rate of less than 1percent per year), preferably with low user dependency (as described in Section 10.4) during the study intervention period (to be effective before starting the intervention) and for at least 3 months after the last administration of study intervention and agrees not to donate or cryopreserve eggs (ova, oocytes) for the purpose of reproduction during this period.
- •A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations%2
排除标准
- •1. Immunologic disorder other than RA, with the exception of secondary Sjogrens syndrome associated with RA, and medically controlled diabetes or thyroid disorder as per Investigators judgement.
- •2. Any condition requiring oral, intravenous, IM, or intra-articular glucocorticoid therapy.
- •3. Uncontrolled polymyalgia rheumatica or fibromyalgia
- •4. History of recurrent or recent serious infection (eg, pneumonia, septicemia) or infection(s) requiring hospitalization or treatment with IV anti-infectives (antibiotics, antivirals, antifungals, antihelminthics) within 30 days prior to D1. Infections(s) requiring oral antiinfectives (antibiotics, antivirals, antifungals, antihelminthics) within 14 days prior to D1
- •5. Known history of or suspected significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration
- •6. History of moderate-to-severe congestive heart failure (NYHA Class III or IV), recent cerebrovascular accident, or any other condition in the opinion of the Investigator that would put the participant at risk by participation in the protocol.
- •7. History of solid organ transplant.
研究者
相似试验
进行中（未招募）
不适用
A Randomized Study comparing Placebo and ASP3652 in the treatment of women with Bladder Pain Syndrome / Interstitial CystitisBladder Pain Syndrome / Interstitial CystitisMedDRA version: 14.1Level: LLTClassification code 10071166Term: Bladder pain syndromeSystem Organ Class: 10038359 - Renal and urinary disordersMedDRA version: 14.1Level: LLTClassification code 10008928Term: Chronic interstitial cystitis NOSSystem Organ Class: 10038359 - Renal and urinary disordersMedDRA version: 14.1Level: LLTClassification code 10008927Term: Chronic interstitial cystitisSystem Organ Class: 10038359 - Renal and urinary disordersMedDRA version: 14.1Level: PTClassification code 10011796Term: Cystitis interstitialSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2011-004555-39-NLAstellas Pharma Europe B.V.300
进行中（未招募）
1 期
A Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adult, and Elderly Hospitalized Participants With Influenza A InfectioEUCTR2015-003002-17-BEJanssen-Cilag International NV90
进行中（未招募）
1 期
A study to investigate how safe and able to produce an effect in the body study drug VX-150 is in patients with pain that typically begins in the feet or handPain Caused by Small Fiber NeuropathyMedDRA version: 20.0Level: PTClassification code 10033371Term: PainSystem Organ Class: 10018065 - General disorders and administration site conditionsMedDRA version: 20.1Level: PTClassification code 10073928Term: Small fibre neuropathySystem Organ Class: 10029205 - Nervous system disordersEUCTR2017-001042-10-ITVERTEX PHARMACEUTICALS INCORPORATED89
进行中（未招募）
1 期
A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter, Dose-ranging Study of Cicletanine in Subjects with Pulmonary Arterial HypertensioEUCTR2008-007455-26-BEGilead Sciences, Inc.160
进行中（未招募）
1 期
A study to investigate the effects of lumicitabine (JNJ-64041575) in hospitalized infants and children infected with Respiratory Syncytial Virus (RSV).Respiratory syncytial virus infectionEUCTR2017-001862-56-ESJanssen-Cilag International NV180