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

niversity of Oxford0 sites181 target enrollmentNovember 18, 2015

ConditionsDupuytren's disease of the hand Skin and Connective Tissue Diseases Dupuytren's disease

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Dupuytren's disease of the hand
Sponsor: niversity of Oxford
Enrollment: 181
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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)

Registry

who.int

Start Date

November 18, 2015

End Date

June 30, 2021

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

niversity of Oxford

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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