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:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-25 @ 5:06 AM
NCT ID:
NCT04755127
Eligibility Criteria:
Inclusion criteria In order to be eligible to participate in this study, a subject must meet all of the following criteria:
* Male and female patients with age ≥ 18 years
* Subjects able and willing to give written informed consent (or legally acceptable representative or impartial witness when applicable) and is available for entire study
* Patients meet the criteria of either group below:
Group 1. Inclusion criteria RA patients:
* Patients that are diagnosed with RA according to the revised 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Rheumatoid Arthritis Classification Criteria (table 1)
* Patients are experiencing an exacerbation defined as an increase in DAS28 \> 1.2 or \> 0.6 if DAS28 ≥ 3.2 compared to last DAS28 measurement (maximum six months before)
* The exacerbation is refractory to systemic cDMARDs for at least three months, defined as 'no response' according to the EULAR response criteria (table 2)
* Wrist arthritis, that is diagnosed clinically, is the predominant symptom
Group 2. Inclusion criteria PsA patients:
* Patients that are diagnosed with PsA according to the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria (table 3)
* Patients are experiencing an exacerbation defined as an increase in DAS28 \> 1.2 or \> 0.6 if DAS28 ≥ 3.2 compared to last DAS28 measurement (maximum six months before)
* The exacerbation is refractory to systemic cDMARDs for at least three months, defined as 'no response' according to the EULAR response criteria (table 2)
* Wrist arthritis, that is diagnosed clinically, is the predominant symptom
Exclusion criteria A potential subject who meets any of the following criteria will be excluded from participation in this study:
* Previous or current treatment with biological (b) DMARDs
* Current inflammatory joint disease other than RA or PsA (e.g. gout, reactive arthritis, Lyme disease)
* Subjects who are pregnant or intend to become pregnant during the study
* Intra-articular corticosteroids injection in the wrist in the last 6 months
* Previous wrist surgery
* Severe osteoarthritis with malformations of the wrist
* Congenital abnormalities of wrist function or motion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04755127
Study Brief:
Protocol Section:
NCT04755127