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:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2025-12-26 @ 12:19 PM
NCT ID:
NCT02243800
Eligibility Criteria:
Inclusion Criteria:
\- Patients with RA (ACR 1987) not in remission (DAS28\> 2.6) in whom no change in treatment is considered by the investigator for at least 3 months, DMARD stable RA for at least 3 months and lack of infiltration in the last 2 months
\- Serum 25-OH vitamin D \<30 ng / ml
Exclusion Criteria:
* Arthritis resulting in class IV functional disability (according to the ACR criteria)
* Hypercalcemia (serum calcium\> 2.6 mmol/L) and/or known hypercalciuria (calcium excretion\> 4 mg / kg / day), history of renal colic, thiazideic therapy.
* Known hypersensitivity to vitamin D
* Patient refused to sign the consent form, pregnant or nursing women, patients minor, major patients under protection of the Act
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02243800
Study Brief:
Protocol Section:
NCT02243800