Table 6. RIDD trial eligibility criteria.
| Inclusion criteria | |
|---|---|
| * | Tissue response RCT: DD affecting the fingers resulting in flexion deformities of ≥30° at the MCP
and/or the PIP joint, with impaired hand function and awaiting surgery OR Early DD RCT: Participants with early DD nodules shown or reported to progress in the previous 6 months, with flexion deformities of ≤30° at the metacarpophalangeal and/or at the proximal interphalangeal joint, i.e. total flexion deformity of up to 60° |
| * | Nodule distinct and identifiable |
| * | Adequate contraception during the study for women of child bearing potential or their male
partners |
| * | Aged 18 years or above |
| * | Able and willing to comply with all study requirements |
| * | Willing to allow their general practitioner to be notified of study participation |
| * | Sufficient language fluency for informed consent and to complete questionnaires |
| Exclusion criteria | |
| * | Previous fasciectomy, dermofasciectomy, needle fasciotomy, collagenase injection, steroid
injection to treat DD in the digit concerned, or previous radiotherapy to the hand concerned |
| * | Pregnant, lactating or planning pregnancy within 5 months after last injection |
| * | Significant renal or hepatic impairment |
| * | Scheduled procedures requiring general anaesthesia during the study, other than planned
Dupuytren’s surgery (Tissue response RCT only) |
| * | Ever been diagnosed with cancer, is terminally ill or is inappropriate for placebo medication |
| * | Systemic inflammatory disorder such as rheumatoid arthritis 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 a 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. Participants in the Early DD RCT must not be at risk of hepatitis B
infection |
| * | Known to have an infection or history of repeated infections |
| * | History of Tuberculosis (TB) |
| * | Multiple Sclerosis (MS) or other demyelinating diseases |
| * | History of local injection site reactions |
| * | Needle phobia |
| * | Moderate or severe heart failure |
| * | Being treated with coumarin anticoagulants, such as warfarin (Tissue response RCT only) |
| * | Known lung fibrosis |
| * | 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 |
| * | Received parenteral steroids within the previous 6 weeks |
| * | Participants with known allergy to tetracaine or allergy to either lidocaine or prilocaine will not
receive Ametop or EMLA cream anaesthetic, respectively |