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:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-26 @ 11:09 AM
NCT ID:
NCT00396812
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of RA, as defined by fulfilling at least four of seven American College of Rheumatology (ACR) criteria
* Positive for rheumatoid factor (RF) and/or anticyclic citrullinated peptide (CCP)
* The presence of arthritis symptoms for more than 6 weeks but less than 1 year
* Active RA, as defined by at least four swollen joints, at least four tender joints, and either an erythrocyte sedimentation rate (ESR) of greater than 30 mm/hr OR C-reactive protein level greater than 1.0 mg/dL (normal less than 0.4)
* Willing to adhere to the study requirements
* Willing to use acceptable effective forms of contraception
Exclusion Criteria:
* Allergy to methotrexate (MTX)
* Previous exposure to anti-CD20 monoclonal antibody (mAb) or other type(s) of mAb therapy
* Previous disease-modifying anti-rheumatic drugs (DMARD) therapy
* Previous use of a biologic agent
* Currently taking daily oral steroid doses of greater than 7.5 milligrams (mg)
* Receipt of intra-articular injections within 4 weeks prior to study entry
* Current peptic ulcer disease (PUD)
* Unwilling to stop drinking alcohol (ETOH)
* History of alcohol or substance abuse
* Active infection, or chronic or persistent infection that might worsen with immunosuppressive treatment (e.g., Human Immunodeficiency Virus \[HIV\], hepatitis B virus \[HBV\], hepatitis C virus \[HCV\], tuberculosis \[TB\])
* Interstitial lung disease observed by chest x-ray \[chest radiograph\]
* Known coronary artery disease or significant cardiac arrhythmias or severe congestive heart failure (New York Heart Association \[NYHA\] classes III or IV)
* Definitive diagnosis of another autoimmune rheumatologic disease (e.g., systemic lupus erythematosus \[SLE\], scleroderma, primary Sjögren's syndrome, primary vasculitis)
* History of immunoglobulin E (IgE)-mediated or non-IgE-mediated hypersensitivity or known anaphylaxis to mouse proteins
* History of cancer. Exception: participants with previous resected basal or squamous cell carcinoma, treated cervical dysplasia, or treated in situ Grade I cervical cancer within 5 years prior to study entry are not excluded from study eligibility
* History of positive purified protein derivative (PPD) test (i.e., positive tuberculosis \[TB\] test) without treatment for TB infection or chemoprophylaxis for TB exposure
* History of inflamed pancreas
* Live vaccine within 3 months of study entry
* Certain abnormal laboratory values
* Require certain medications
* Any psychiatric disorder that would prevent a participant from providing informed consent
* Any condition or treatment (including biologic therapies) that, in the opinion of the investigator, may place the participant at unacceptable risk during the study
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00396812
Study Brief:
Protocol Section:
NCT00396812