ISRCTN27786905已完成2 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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 181
研究概览
简要总结
2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29983350 part one results 2022 Results article in https://doi.org/10.1016/S2665-9913(22)00093-5 (added 03/05/2022) 2017 Protocol article in https://pubmed.ncbi.nlm.nih.gov/29218326/ (added 11/08/2022) 2022 Results article in https://doi.org/10.1302/2633-1462.311.BJO-2022-0103.R2 Cost-effectiveness (added 03/01/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria (as of 14/02/2018):
- •1. Aged 18 years or above
- •2. Participant is willing and able to give informed consent for participation in the study
- •3. Diagnosed with Dupuytren’s disease affecting the fingers resulting in flexion deformities of greater than 30° at the metacarpophalangeal joint and or the proximal interphalangeal joint with impaired hand function and awaiting surgery
- •4. The Dupuytren’s disease nodule to be treated must be distinct and identifiable
- •5. 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).
- •6. Participant results from safety screening tests within normal ranges within 8 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.
- •7. Able (in the Investigators opinion) and willing to comply with all study requirement
- •8. Willing to allow his or her general practitioner to be notified of participation in the study
- •9. Sufficient language fluency to ensure informed consent is obtained and to complete the questionnaires pertaining to hand function
- •1. Aged 18 years or above
- •2. Participant is willing and able to give informed consent for participation in the study
- •3. Patients with early Dupuytren’s disease nodules who also show progression of the disease in the previous 6 months with flexion deformities of their fingers of less than 30° at the metacarpophalangeal and/or at the proximal interphalangeal joint, i.e. total flexion deformity of up to 60°
- •4. The Dupuytren’s disease nodule to be treated must be distinct and identifiable.
- •5. 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).
- •6. 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
排除标准
- •Current participant exclusion criteria (as of 03/08/2018):
- •1. Participant has previously had fasciectomy, dermofasciectomy, needle fasciotomy, collagenase injection, steroid injection or radiotherapy to treat Dupuytren’s disease in the digit concerned
- •2. Female participant who is pregnant, lactating or planning pregnancy during the course of the study and for 5 months following last injection
- •3. Male participant who is planning a pregnancy during the course of the study and for 5 months following last injection
- •4. Significant renal or hepatic impairment
- •6. Scheduled elective surgery or other procedures requiring general anaesthesia during the study other than the scheduled Dupuytren’s surgery
- •7. Participant who has ever been diagnosed with cancer, is terminally ill or is inappropriate for placebo medication
- •8. Systemic inflammatory disorder such as rheumatoid arthritis or inflammatory bowel disease
- •9. 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
- •10. Participated in another research study involving an investigational medicinal product in the past 12 weeks
- •11. Known allergy to any anti-TNF agent
- •12. Have HIV or hepatitis B or C
- •13. Known to have an infection or history of repeated infections
- •14. History of Tuberculosis (TB)
- •15. Have Multiple Sclerosis (MS) or other demyelinating disease
- •16. History of local injection site reactions
- •17. Needle phobia
- •18. Have moderate or severe heart failure
- •19. Being treated with coumarin anticoagulants, such as warfarin
- •20. Have known lung fibrosis (thickening of lung tissue)
- •21. Being treated with concomitant biologic DMARDS
- •22. Have received a live vaccine within the previous 4 weeks. Participants may receive concurrent vaccinations but must avoid the use of live vaccines for 12 weeks after their last injection.
- •23. Have received parenteral steroid within the previous 6 weeks
- •24. Participants with epilepsy or a known allergy to tetracaine may take part in the study but will not receive Ametop gel as a local anaesthetic. Participants with a known allergy to lidocaine or prilocaine will not receive lidocaine/prilocaine cream/EMLA cream as a local anaesthetic.
- •1. Participant has previously had fasciectomy, dermofasciectomy, needle fasciotomy, collagenase injection to the digit to be treated or steroid injection to treat Dupuytren’s disease in the hand concerned
- •2. Female participant who is pregnant, lactating or planning pregnancy during the course of the study and for 5 months following last injection
- •3. Male participant who is planning a pregnancy during the course of the study and for 5 months following last injection
- •4. Significant renal or hepatic impairment
- •5. Scheduled elective surgery or other procedures requiring general anaesthesia during the study
- •6. Particip
研究者
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