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 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT00837434
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of RA\*
* Disease duration as defined from the onset of symptoms of at least 3 months prior to study entry
* Active RA with DAS28 \> 4.4, clinically requiring the addition of anti-TNF therapy
* Stable dose of MTX between 7.5 mg and 25 mg weekly for at least 8 weeks prior to study entry
* Able and willing to self-administer subcutaneous injections or have available qualified person(s) or caregiver to administer subcutaneous injections
* For females, agree to use accepted methods of contraception during the duration of the study and for 150 days after study completion\*. \*More information on these criterion can be found in the protocol.
Exclusion Criteria:
* Positive PPD test - a tuberculosis (TB) skin test: (\> 5 mm induration regardless of prior Bacille Calmette-Guerin \[BCG\] vaccine administration) without evidence of ongoing treatment for at least 30 days or completed treatment
* History of positive PPD or chest x-ray findings indicative of prior TB infection, without documentation of either treatment for TB infection or chemoprophylaxis for TB exposure
* Prednisone dose \> 10 mg/day (or equivalent dose of another corticosteroid) within 30 days prior to study entry
* Definitive diagnosis of another autoimmune disease that may require immunosuppression for treatment\*
* Concomitant use of DMARDSs (e.g., disease-modifying antirheumatic drugs)\*
* Any immunosuppressive therapy other than MTX, NSAIDs, or corticosteroids\*
* Current or previous use of any biologic agent
* Presence of open leg ulcers
* Chronic or persistent infection that might be worsened by immunosuppressive treatment\*
* Active infection or severe infections requiring hospitalization or treatment with intravenous (IV) antibiotics, IV antivirals, or IV antifungals within 30 days prior to study entry
* Received oral antibiotics, antivirals, or antifungals within 14 days prior to study entry
* Certain abnormal laboratory values\*
* Any medical condition that, in the opinion of the investigator, would interfere with the study
* History of malignancy other than treated localized carcinoma in situ of the cervix or adequately treated non-metastatic squamous or basal cell skin carcinoma within 10 years prior to study entry
* Any Investigational agent within the earlier of 4 weeks or 5 half-lives prior to study entry
* History of drug or alcohol abuse within 6 months prior to study entry
* Known allergy or hypersensitivity to study products
* Inability or unwillingness to follow the protocol
* Any condition or treatment that, in the opinion of the investigator, places the participant at an unacceptable risk
* Pregnant or breastfeeding \*More information on these criterion are in the protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00837434
Study Brief:
Protocol Section:
NCT00837434