Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT03180957
Eligibility Criteria:
Inclusion Criteria:
* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years or above.
* For 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. Or for Part 2: Participants with early disease nodules who have shown or reported 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 chest x-ray 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.
Exclusion Criteria:
* For 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. Or for 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.
* For Part 1: Scheduled elective surgery or other procedures requiring general anaesthesia during the study other than the scheduled Dupuytren's surgery. Or for Part 2: Scheduled elective surgery or other procedures requiring general anaesthesia during the study
* Participant who has ever been diagnosed with cancer, is terminally ill or is inappropriate for placebo medication
* Systemic inflammatory disorder such as rheumatoid arthritis (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 coumarin anticoagulants, such as 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. Participants may receive concurrent vaccinations but must avoid the use of live vaccines for 12 weeks after their last injection.
* Part1: Have received parenteral steroid within the previous 6 weeks.
* Part 2: Participants at risk of Hepatitis B infection.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03180957
Study Brief:
Protocol Section:
NCT03180957