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 @ 3:54 AM
Ignite Modification Date:
2025-12-25 @ 3:54 AM
NCT ID:
NCT01198002
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Rheumatoid Arthritis (RA) of more than 6 months and less than 15 years
* Regular use of methotrexate (MTX) in the past 12 weeks, with the dose being stable during the past 8 weeks
* At least 8 tender and swollen joints
* At least one erosion of a hand or foot joint observed on an X-ray
* An abnormally high C-reactive protein (CRP) level or erythrocyte sedimentation rate (ESR)
* Positive for rheumatoid factor (RF) or anti-cyclic citrullinated peptide (CCP) antibody
* Woman must not be pregnant, breastfeeding, or become pregnant during the study
Exclusion Criteria:
* Use of unstable doses of non-steroidal anti-inflammatory drugs (NSAIDS) in the past 6 weeks
* Steroid injection or intravenous (iv) infusion in the last 6 weeks
* Use of more than 10 milligrams/day (mg/day) of oral steroids in the last 6 weeks
* History of an inadequate response to a biologic disease-modifying anti-rheumatic drug (DMARD)
* History of a serious reaction to other biological DMARDs
* History of the use of rituximab or other B cell therapy
* Use of DMARDS other than MTX, hydroxychloroquine, or sulfasalazine within the last 8 weeks
* Use of leflunomide within the last 12 weeks (unless cholestyramine was used to speed up the elimination of leflunomide)
* Surgery on a joint or other major surgery less than 2 months ago, or plans to have joint surgery or major surgery during the study
* Active fibromyalgia, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, or other systemic inflammatory condition except RA
* Cervical cancer or squamous skin cancer within the past 3 years, or other cancer within the past 5 years
* Received a live vaccine received within the past 12 weeks (for example, vaccines for measles, mumps, rubella, and chicken pox, and nasal-spray flu vaccines)
* Hepatitis or human immunodeficiency virus (HIV)
* A serious bacterial infection (for example, pneumonia or cellulitis) within 3 months or a serious bone or joint infection within 6 months
* Symptoms of herpes zoster or herpes simplex within the last month
* Active or latent tuberculosis (TB)
* Current symptoms of a serious disorder or illness
* Use of an investigational drug within the last month
* History of the use of rituximab, any other B cell targeted biotherapy, or denosumab
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01198002
Study Brief:
Protocol Section:
NCT01198002