EUCTR2015-001780-40-GB进行中（未招募）1 期
A multi-centre, double blind, randomised, placebo-controlled, parallel group, phase II trial to determine the efficacy of intra-nodular injection of anti-TNF to control disease progression in early Dupuytren’s disease, with a dose response. - Repurposing anti-TNF for treating Dupuytren's disease
niversity of Oxford, Clinical Trials and Research Governance0 个研究点目标入组 228 人开始时间: 2015年4月30日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 228
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Participant is willing and able to give informed consent for participation in the study.
- •Male or Female, aged 18 years or above.
- •Part 1: Diagnosed with DD affecting the fingers resulting in flexion deformities of =30° at the metacarpophalangeal joint and or the proximal interphalangeal joint with impaired hand function and awaiting surgery.
- •Part 2: Patients with early disease nodules who also show progression of the disease in the previous 6 months with flexion deformities of their fingers of =30° at the metacarpophalangeal and/or at the proximal interphalangeal joint, i.e. total flexion deformity of up to 60°.
- •The DD nodule to be treated must be distinct and identifiable.
- •Female participants of child bearing potential, and male participants whose partner is of child bearing potential, must be willing to ensure that they or their partner use effective contraception throughout the treatment period and for 5 months following the last research injection. Acceptable methods of contraception include: a combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods), injectables, the combined oral contraceptive pill (at a stable dose for at least 3 months before entering the study), an intrauterine device, vasectomised partner, or true sexual abstinence (when this is in line with the preferred and usual lifestyle of the participant).
- •Participant results from safety screening tests within normal ranges within 12 weeks of enrolment, with the exception that an earlier clear CXR result may be used where this is in accordance with the time frames of local standard procedures for anti-TNF screening.
- •Able (in the Investigators opinion) and willing to comply with all study requirements.
- •Willing to allow his or her general practitioner to be notified of participation in the study.
- •Sufficient language fluency to ensure informed consent is obtained and to complete the questionnaires pertaining to hand function.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 78
排除标准
- •Part 1: Participant has previously had fasciectomy, dermofasciectomy, needle fasciotomy, collagenase injection, steroid injection or radiotherapy to treat Dupuytren’s disease in the digit concerned.
- •Part 2: Participant has previously had fasciectomy, dermofasciectomy, needle fasciotomy, collagenase injection, steroid injection to the digit to be treated or radiotherapy to treat Dupuytren’s disease in the hand concerned.
- •Female participant who is pregnant, lactating or planning pregnancy during the course of the study and for 5 months following last injection.
- •Male participant who is planning a pregnancy during the course of the study and for 5 months following last injection.
- •Significant renal or hepatic impairment.
- •Part 1. Scheduled elective surgery or other procedures requiring general anaesthesia during the study other than the scheduled Dupuytren’s surgery
- •Participant who has ever been diagnosed with cancer, is terminally ill or is inappropriate for placebo medication
- •Systemic inflammatory disorder such as RA or inflammatory bowel disease.
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study.
- •Participated in another research study involving an investigational medicinal product in the past 12 weeks.
- •Known allergy to any anti-TNF agent.
- •Have HIV or hepatitis B or C.
- •Known to have an infection or history of repeated infections.
- •History of Tuberculosis (TB).
- •Have Multiple Sclerosis (MS) or other demyelinating disease.
- •History of local injection site reactions.
- •Needle phobia.
- •Have moderate or severe heart failure.
- •Part 1: Being treated with anticoagulants, including warfarin.
- •Have known lung fibrosis (thickening of lung tissue).
- •Being treated with concomitant biologic DMARDS.
- •Have received a live vaccine within the previous 4 weeks. Patients may receive concurrent vaccinations but must avoid the use of live vaccines for 12 weeks after their last injection.
- •Part 2. Patients at risk of Hepatitis B infection.
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