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 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT01163318
Eligibility Criteria:
Inclusion criteria:
1. Participants who received adalimumab in accordance with its indications for treatment and dosage regimens.
2. Participants who used adalimumab continuously.
3. Participants without current or past history of malignant tumors.
4. Participants evaluated for Disease Activity Score 28 - 4 Erythrocyte Sedimentation Rate (DAS28-4ESR).
5. Participants evaluated by Health Assessment Questionnaire (HAQ) or Modified Health Assessment Questionnaire (MHAQ) prior to the initiation of adalimumab treatment in the all-case PMOS.
Exclusion criteria:
1. Contraindications according to the package insert.
2. Participants with serious infections.
3. Participants with tuberculosis.
4. Participants with a history of hypersensitivity to any ingredient of adalimumab.
5. Participants with demyelinating disease or a history of demyelinating disease.
6. Participants with congestive cardiac failure.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT01163318
Study Brief:
Protocol Section:
NCT01163318