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 @ 3:00 PM
Ignite Modification Date:
2025-12-24 @ 3:00 PM
NCT ID:
NCT00696059
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of rheumatoid arthritis according to the American College of Rheumatology 1987 criteria
* Moderate or severely active RA, defined as a DAS28(CRP)\> 3.2
* Moderate radiographic structural joint damage, defined as Larsen grade 2-3, in ≥ 2 wrist and/or MCP joints
* No previous biological therapy
* Clinical indication for biological therapy, according to the treating physician
* Treatment with methotrexate and folic acid for at least 4 weeks prior to inclusion
* No history of tuberculosis, and no signs of tuberculosis at chest radiograph or Mantoux test.
* No contra-indications for TNF-alpha antagonist treatment
* Co-operability of the patient, including that the patient is willing and able to comply with the treatment and scheduled follow-up visits and examinations
* Oral and signed informed consent by the patient
Exclusion Criteria:
* Acute infection, and known chronic viral infection such as HIV or hepatitis B and C
* Other DMARDs than methotrexate within last 4 weeks before inclusion
* Intramuscular or intraarticular glucocorticoids within last 4 weeks before inclusion
* Oral treatment with prednisolone \>10 mg per day
* Malignant lymphoma and other malignant disease
* Other serious concomitant diseases (uncontrolled/severe kidney, liver, haematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological or cerebral disease (including demyelinating disease))
* Pregnancy and lactation. Patients must use safe anti-conception during the treatment.
* Development of SLE-like disease. Occurrence of positive ANA and/or anti-DNA antibodies without clinical symptoms is not considered a contra-indication.
* Contra-indications for MRI
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT00696059
Study Brief:
Protocol Section:
NCT00696059