Table 4. Table of Early DD RCT objectives and outcome measures.

	Objectives	Outcome measures
Primary Objective	To determine if injection with adalimumab is superior to placebo injection of normal saline in controlling disease progression.	Hardness of selected nodule.
Secondary Objectives	1. To compare the development of Dupuytren’s nodules and associated cord, flexion deformities of the fingers and impairment of hand function for participants on each treatment. 2. Monitor for adverse events.	1.1. Ultrasound imaging of nodule size. 1.2. Range of motion of the affected digit. 1.3. Grip strength. 1.4. Participant Reported Outcomes: Michigan Hand Outcomes Questionnaire (MHQ) Participant identified activity most restricted by DD scored on a scale of 1–10. 1.5. Clinical assessment of the hand. 2.1. Adverse event assessment comparing active and placebo groups using visual inspection of injection site and laboratory reports. 2.2. Progression to surgery of the digit being assessed.
Tertiary Objectives	3. To assess if early DD injection therapy represents good value for money compared to current clinical care. 4. Monitor circulating levels of adalimumab and antibodies to adalimumab in the blood	3. Analysis of health care resource utilisation data and EQ-5D-5L data to estimate cost and utilities from participants on each treatment. 4. Analysis of blood sample.