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 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT04576403
Eligibility Criteria:
Inclusion Criteria:
1. HOA with fulfillment of the ACR criteria:
a. Hand pain, aching or stiffness on most days the previous 4 weeks
And at least 3 of the following features:
* Hard tissue enlargement of ≥2 of the 10 selected joints\*
* Hard tissue enlargement of ≥2 of the 10 DIP joints
* Fewer than 3 swollen metacarpophalangeal (MCP) joints
* Deformity of at least 1 of 10 selected joints\* \*The 10 selected joints are the second and third DIP, the second and third PIP, and the first carpometacarpal joints of both hands.
2. AUSCAN Function ≥ 40 aggregated points (0-100 scale)
3. Willing and able to participate in all study visits
4. Able to understand and read Danish.
Exclusion Criteria:
1. Other diseases affecting the joints of the hand (Rheumatoid arthritis, Psoriatic arthritis, ect.)
2. Widespread or generalized pain syndrome (e.g. fibromyalgia)
3. Steroid injections in the finger joints within the last month
4. Other condition that in the opinion of the investigator makes the participant unsuitable for participation.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04576403
Study Brief:
Protocol Section:
NCT04576403