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:
NCT01793259
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent
* Age between 18 and 75 years
* Rheumatoid arthritis according to the American College of Rheumatology (ACR) criteria 1987 or ACR/European Liga Against Rheumatology (EULAR)2010
* Disease activity score (DAS) 28 \> 2.6
Main Exclusion Criteria:
* Prior or other current subcutaneous treatment with self-injection
* Prior or concomitant treatment with biologics
* Contraindications to MTX treatment
* History or diagnosis of a dermatological disease at the injection site
* Women with child-bearing potential who do not use a highly effective method of contraception or men who have a partner with child-bearing potential and do not use a contraception during the study and at least 6 months thereafter.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01793259
Study Brief:
Protocol Section:
NCT01793259