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 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT01878318
Eligibility Criteria:
Inclusion Criteria:
* Adult patients, \>/= 18 years of age
* Diagnosis of rheumatoid arthritis according to ACR/EULAR classification (2010) of \>/= 6 months duration
* Active moderate to severe rheumatoid arthritis (DAS \>/= 3.2)
* Swollen joint count (SJC) \>/= 6, tender joint count \>/= 8
* Synovitis in the dominant hand
* Inadequate response to stable dose of a non-biological DMARD for at least 3 months
* Oral corticosteroids must have been on stable dose for at least 25 out of 28 days before first dose of study drug
* Patient on outpatient treatment
Exclusion Criteria:
* Major surgery (including joint surgery) in the 8 weeks prior to screening, or planned major surgery within 6 months of randomization
* Rheumatic autoimmune disease other than rheumatoid arthritis
* American College of Rheumatology (ACR) functional class IV
* History of or current inflammatory joint disease other than rheumatoid arthritis
* Previous inadequate response to a biologic DMARD; prior biologic therapy for no longer than 1 month is allowed if discontinued for reasons of tolerability at least 6 months prior to study recruitment
* Intra-articular or parenteral corticosteroids within 6 weeks prior to study start
* Inadequate hematologic, renal or liver function
* Positive for hepatitis B, hepatitis C or HIV infection
* Pregnant or lactating women
* History of severe allergic reactions or anaphylaxis to human, humanized or mural monoclonal antibodies
* Current infections or history of recurrent infections
* History of or currently active primary or acquired immunodeficiency
* Active tuberculosis requiring treatment in the previous 3 years
* Body weight \> 150 kg
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01878318
Study Brief:
Protocol Section:
NCT01878318