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 @ 9:54 PM
Ignite Modification Date:
2025-12-24 @ 9:54 PM
NCT ID:
NCT01004432
Eligibility Criteria:
Inclusion Criteria:
* Have inadequate RA disease control prior to the first administration of study agent despite treatment with etanercept (Enbrel) + methotrexate or adalimumab (Humira) + methotrexate (MTX)
* Must have received a stable dose of MTX greater than or equal to (\>=) 7.5 milligram (mg) per week to less than or equal to (\<=) 25 mg per week for at least 4 consecutive weeks prior to the first screening visit and must plan to maintain that dose throughout the study
* Participants must have received etanercept or adalimumab in combination with MTX for a minimum of 3 months prior to the first visit
* Negative tuberculosis (TB) test
* Are capable of providing informed consent, which must be obtained prior to any study-related procedures
Exclusion Criteria:
* Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, or are frequently in contact with individuals who carry active TB infection
* Have inflammatory diseases other than RA, including but not limited to psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, primary Sjogren's or Lyme disease
* Have demonstrated a discernible improvement in disease activity between screening and prior to the first golimumab injection at Week 0
* Have any known malignancy or have a history of malignancy within the previous 5 years (with the exception of a nonmelanoma skin cancer that has been treated with no evidence of recurrence)
* Have a history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01004432
Study Brief:
Protocol Section:
NCT01004432