Phase
Condition
Rheumatoid Arthritis
Bone Diseases
Joint Injuries
Treatment
Filgotinib Maleate
Clinical Study ID
Ages > 19 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants who voluntarily provided written consent to participate in this study
Male or female, aged greater than or equal to (>=) 19 years at the time of writteninformed consent
Participants diagnosed with rheumatoid arthritis according to the 2010 ACR/ EuropeanLeague Against Rheumatism (EULAR) classification criteria and who have an ACRfunctional class of I to III
Participants who meet the following criteria are eligible for the specifiedtreatment protocol; those who have been treated with two or more type types (including MTX) of Disease-Modifying Antirheumatic Drugs (DMARDs) for at least 6months (at least 3 months each) but have experienced insufficient therapeuticeffects or have had to discontinue treatment due to adverse events of thesemedications (However, in cases where MTX is contraindicated due to conditions suchas liver disease or renal failure, the participant must have been treated with atleast two types of DMARDs, excluding MTX).
- Furthermore, in participants over 65 years of age, those at high risk ofcardiovascular diseases, and those with a potential risk of malignancy, thisprotocol applies if they have not adequately responded to or toleratedconventional therapies, including Tumor Necrosis Factor (TNF) inhibitors orother biologic agents. Eligibility is confirmed if one of the followingcriteria is met:
- DAS28 score exceeding 5.1.
- DAS28 score between 3.2 and 5.1, with diagnostic imaging showingprogression of joint damage.
Exclusion
Exclusion Criteria:
Participants with hypersensitivity reactions to the active ingredient or othercomponents of the investigational product
Participants with serious infections (for example [e.g.], sepsis) or activeinfections including localized infections
Participants with active tuberculosis (TB)
Participants with severe hepatic impairment (e.g., Child-Pugh C)
Participants with end-stage renal disease (<creatinine clearance [CrCl] 15milliliters per minute [mL/min])
Participants with absolute neutrophil count (ANC) <1*10^9 cells per liter (/L)
Participants with absolute lymphocyte count (ALC) <0.5*10^9 cells/L
Participants with hemoglobin <8 grams per deciliter (g/dL)
Pregnant or lactating women
Women of childbearing potential who are not willing to consent to using effectivecontraception
Participants with rare hereditary problems of galactose intolerance, total lactasedeficiency or glucose-galactose malabsorption should not take this medicinal product
Participants who received Janus kinase (JAK) inhibitors for the treatment ofrheumatoid arthritis
Participants who have participated in other clinical studies for investigationalproduct/medical device within 4 weeks prior to screening
Participants in whom the administration of Jyseleca Tablet is contraindicatedaccording to the product label approved in Korea or based on certain medicalconditions that have been identified in previous clinical studies
Participants for whom follow-up deems impossible
Study Design
Connect with a study center
Eisai site #11
Anyang-si,
Korea, Republic ofActive - Recruiting
Eisai site #01
Busan,
Korea, Republic ofActive - Recruiting
Eisai site #09
Daegu,
Korea, Republic ofActive - Recruiting
Eisai site #12
Daegu,
Korea, Republic ofActive - Recruiting
Eisai site #06
Daejeon,
Korea, Republic ofActive - Recruiting
Eisai site #15
Guri-si,
Korea, Republic ofActive - Recruiting
Eisai site #02
Gwangju,
Korea, Republic ofActive - Recruiting
Eisai site #13
Incheon,
Korea, Republic ofActive - Recruiting
Eisai site #03
Seoul,
Korea, Republic ofActive - Recruiting
Eisai site #04
Seoul,
Korea, Republic ofActive - Recruiting
Eisai site #05
Seoul,
Korea, Republic ofActive - Recruiting
Eisai site #07
Seoul,
Korea, Republic ofActive - Recruiting
Eisai site #08
Seoul,
Korea, Republic ofActive - Recruiting
Eisai site #10
Seoul,
Korea, Republic ofActive - Recruiting
Eisai site #14
Seoul,
Korea, Republic ofActive - Recruiting
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