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 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
NCT ID:
NCT03703934
Eligibility Criteria:
Inclusion criteria Hand-OA
* Patients (above 18 years) with Hand-OA according to the American Collage of Rheumatology (ACR) criteria (1990)
* Hand-OA of the phenotype: Nodal, Non-erosive.
* Ability and willingness to give written informed consent and to meet the requirements of the study protocol.
* VAS pain during the last 24 hours 30mm or more
* Negative pregnancy test (serum HCG) prior to trial start (for women of childbearing potential) and the use of contraception throughout the study period and for 3 months after conclusion of the study period for males and females of childbearing potential. The forms of contraception include: intrauterine device (IUD) and hormonal contraceptives (contraceptive pill, implant, patch or injection or vaginal ring). Sterile and non-fertile participants do not have to use contraception. Sterile or non-fertile is defined as having undergone surgical sterilization (vasectomy / bilateral tubectomy, hysterectomy or bilateral oophorectomy) or post-menopausal status, defined as absence of menstrual period for at least 12 months prior to enrollment.
Inclusion criteria PsA
* Patients (over 18 years) with PsA according to the Clarification Criteria for Psoriatic Arthritis (CASPAR) criteria (2006)
* Ability and willingness to give written informed consent and to meet the requirements of the study protocol.
* VAS pain during the last 24 hours 30mm or more
* Negative pregnancy test (serum human chorionic gonadotropin (HCG)) prior to trial start and the use of contraception throughout the study period and for 1 month after conclusion of the study period for women of childbearing potential. The forms of contraception include: intrauterine device (IUD) and hormonal contraceptives (contraceptive pill, implant, patch or injection or vaginal ring). Sterile and non-fertile participants do not have to use contraception. Sterile or non-fertile is defined as having undergone surgical sterilization (vasectomy / bilateral tubectomy, hysterectomy or bilateral oophorectomy) or post-menopausal status, defined as absence of menstrual period for at least 12 months prior to enrollment.
Inclusion criteria healthy controls
* Men and women age over18 years
* Ability and willingness to give written informed consent and to meet the requirements of the study protocol.
Exclusion Criteria:
* Other known inflammatory rheumatic disease (i.e. rheumatoid arthritis, gout) \*
* Erosive Hand-OA (One or more erosive joints on plain x-ray)
* Isolated Hand-OA of the first metacarpal joint or this joint as the most painful\*
* Other known pain condition (i.e. fibromyalgia, Carpel tunnel syndrome, polyneuropathy)
* Other known disease where exacerbations need to be treated with systemic corticosteroids (i.e. certain types of inflammatory bowl disease) or patients who have received systemic corticosteroid treatment during the last 3 months.
* Planning pregnancy, pregnant or breastfeeding. (Fertile women will be tested for pregnancy)
* Planned major surgery or recent major surgery (last 8weeks)
* Verified malignant disease
* History of epilepsy or severe cramps
* History of serious cardiovascular pathology
* Lacking ability to corporate with the research staff.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03703934
Study Brief:
Protocol Section:
NCT03703934