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 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT02477059
Eligibility Criteria:
Inclusion Criteria:
* Age: 40-85
* Hand OA according to the ACR criteria (with recent X-rays of the hands - less than 6 months )
* Symptomatic hand OA lasting more than 3 months (DIP or PIP) despite analgesics and NSAIDs
* OA affecting more than three finger joints (DIP or PIP) (Kellgren and Lawrence equal or more than 2)
* Pain intensity superior to 40 (VAS 0-100 mm) in the last 24 hours
* Not breastfeeding throughout the study and for 150 days after the last infusion
* Negative pregnancy test or effective contraception for women of childbearing age throughout the study and for 150 days after the last infusion or postmenopausal or surgically sterile
* Written informed consent
* Affiliated to health system
Exclusion Criteria:
* Patients having already been treated with an anti-TNF alpha within 6 months
* Patients having already been treated with an Interleukin-6-Receptor Inhibitor
* Hand OA secondary to inflammatory rheumatism
* Existence of painful syndrome of upper limbs likely to interfere with the monitoring of pain (cervicobrachial neuralgia, incapacitating carpal tunnel syndrome, joint disorders of the elbow or shoulder)
* Inflammatory rheumatism
* Psoriasis
* Contraindications to Interleukin-6-Receptor Inhibitor
* Contraindications to acetaminophen
* Anticoagulant (oral) or treatment with heparin at a curative dose
* Surgery scheduled within 6 months following recruitment
* Local injection of a corticosteroid in a symptomatic finger joint during the previous month
* Local injection of hyaluronic acid in a symptomatic finger joint during the prior 6 months
* Treatment with a slow-acting anti-osteoarthritis agent initiated within the previous 3 months
* Treatment with methotrexate, hydrochloroquine, sulfasalazine, colchicine within the last month
* History of symptomatics sigmoiditis or intestinal ulceration
* Oral corticosteroid within 3 days for hydrocortisone or cortisone, within 8 days for prednisone, prednisolone, methylprednisolone or triamcinolone, and within 12 days for betamethasone or dexamethasone
* Psychiatric illness
* Antidepressants initiated or modified within previous month
* Non-controlled diabetes "mellitus"
* Known viral hepatitis B or C, HIV infection
* Current infectious (active or latent tuberculosis)
* Excessive drinking
* Participation in another search
* Lidocain plasters on digital joint within two months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
85 Years
Study:
NCT02477059
Study Brief:
Protocol Section:
NCT02477059