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 @ 2:46 PM
Ignite Modification Date:
2025-12-24 @ 2:46 PM
NCT ID:
NCT01590459
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects, between 18 and 80 years of age (inclusive)
* All subjects must have been diagnosed with RA
* Must have a swollen joint count of ≥6 out of 66 joints and tender joint count of ≥6 out of 68 joints
* Baseline CRP level must be above the upper limit of normal
* All subjects must have been receiving stable MTX coadministered with folic or folinic acid (at least 5 mg/week)
* Subjects may remain on 1 nonsteroidal anti-inflammatory medication during the study (aspirin ≤ 325 mg/day is allowed).
* Subjects must not have received prior treatment with a JAK inhibitor
* Subjects who are on an additional nonbiologic DMARD (e.g., sulfasalazine) must be willing to discontinue that DMARD after signing consent, except for hydroxychloroquine
* Subjects may have received previous therapy with a single TNF inhibitor (e.g., etanercept, adalimumab, infliximab, golimumab, certolizumab pegol)
* Females must have a negative pregnancy test prior to study dosing
* Sexually active subjects and their partners must agree to contraceptive requirements
Exclusion Criteria:
* History or presence of a clinically significant medical disorder other than RA that, in the opinion of the investigator and medical monitor, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
* Subjects with inflammatory, rheumatological disorders other than RA
* Pregnant or nursing female subjects
* Subjects who have a female partner who is pregnant, nursing, or planning to become pregnant
* Subjects who have planned major surgery (e.g., joint replacement) or procedures during the study
* History of drug abuse or positive drug screen
* History of alcohol abuse or excessive alcohol consumption
* History of tuberculosis (TB) infection of any kind (pulmonary or extrapulmonary, active or latent), regardless of history of anti-TB treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01590459
Study Brief:
Protocol Section:
NCT01590459