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 @ 12:05 PM
Ignite Modification Date:
2025-12-24 @ 12:05 PM
NCT ID:
NCT02878161
Eligibility Criteria:
Inclusion Criteria:
* signed the consents voluntarily
* age between 18-75 years old
* patients were meet the American College of Rheumatology(ACR)
* European League Against Rheumatism(EULAR) 2009 diagnostic criteria (total scores beyond 6)
* for severe RA patients DAS28-CRP≥5.1
* The participants receiving Infliximab plus Methotrexate will be invited to enroll the study.
* The participants receiving Etanercept plus Methotrexate will be invited to enroll the study.
* The participants receiving Adalimumab plus Methotrexate will be invited to enroll the study.
Exclusion Criteria:
* The patient have the disease history or the disease of cardiovascular, respiratory system, liver, gastrointestinal tract, endocrine, hematology, neurology or psychiatric disturbance, and investigator believe that there are some risks for patients with these disease history or disease when use study drugs, or these disease history or disease will disturb the interpret of data
* Patients with cancer in situ or exist the possibility of cancer malignancies
* Basically or completely loss of mobility, lack self-care ability, such as rely on a wheelchair or bed-ridden .
* Experimental examination display any of the following:
Aspartate aminotransferase or alanine aminotransferase\>1.5 times of the upper limit of the normal value Total bilirubin\>1.5 times of the upper limit of the normal value Total white blood cells \<2500 cells/L absolute neutrophil count \<1200 cells/L lymphocyte count \<750 cells/L platelet\<100000/L
* Patients with symptomatic herpes simplex
* Latent tuberculosis signal (PPD+++ OR T-SPOT\>5 )
* Positive result of the hepatitis B virus (HBV):
HBsAg + Or HBeAg + Or HBeAg + Or HBcAb + Or HBV DNA +
* hepatitis C virus(HCV)+ or HCV RNA +
* HIV infection or HIV+
* 1 months before join the group, from a clinical point of view,patients have a serious infection caused by the virus, bacteria, fungi, or parasites
* Pregnancy 、 location 、prepare for conceive in one years or there is risk to impregnate their partners
* Patients received any biological therapies for 6 months, or participated any other clinical trials of new drugs
* A history of drug allergy
* A history of heavy drink
* vaccinate the live vaccine recently
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02878161
Study Brief:
Protocol Section:
NCT02878161