A Clinical Trial to look at the Safety, Tolerability and Efficacy of the Drug Product GS-9876 on patients with Rheumatoid Arthritis who are also being treated with Methotrexate.
- Conditions
- Rheumatoid ArthritisMedDRA version: 19.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2016-001496-75-CZ
- Lead Sponsor
- Gilead Sciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
1) Male or female subjects who are between 18 and 75 years of age, inclusive, on the day of signing informed consent
2) Have a diagnosis of RA as defined by the 2010 American College of Rheumatology - European League Against Rheumatism Collaborative Initiative Classification Criteria for Rheumatoid Arthritis (Appendix 6)
3) Active RA disease as defined by: a TJC of = 6 (out of 68), an SJC of = 6 (out of 66) at Screening and Day 1
4) Inadequate response to treatment with oral or parenteral MTX 7.5 to 25 mg/week continuously for at least 12 weeks, with at least 6 weeks at a stable dose (defined as no change in prescription) prior to the first dose of study drug
5) Subjects must be receiving a folic or folinic acid supplementation at a stable dose. Subjects who are not taking folic or folinic acid at Screening should be initiated on an adequate dose of folic acid (>5 mg/week total dose or as per local practice) or equivalent and maintained
throughout the study.
6) Use of oral corticosteroids of no more than 10 mg prednisone or its equivalent per day is allowed if the dose is stable (defined as no change in prescription) for at least 28 days prior to the first dose of study drug
7) NSAIDs or other analgesics (including aspirin = 100 mg daily) are allowed if doses are stable (defined as no change in prescription) for at least 14 days prior to the first dose of study drug; PRN use for other indications is allowed.
8) No evidence of active or latent TB as demonstrated by a negative QuantiFERON® TB-Gold In-Tube test at Screening. Tests with inconclusive results may be repeated one time. If an inconclusive test is repeated and is returned with inconclusive results a second time, the subject will be excluded from the study. Any prior history of active or latent TB (regardless of treatment) is exclusionary.
9) Able and willing to sign the informed consent as approved by the IRB/IEC. Written consent must be provided before initiating any Screening evaluations. Subjects must have read and understood the informed consent form (ICF), must fully understand the requirements of the study, and must be willing to comply with all study visits and assessments.
10) A negative serum pregnancy test is required for female subjects of childbearing potential, as defined in Appendix 5
11) Lactating females must agree to discontinue nursing before the study drug is administered and for the duration of the study.
12) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Appendix 5.
13) Male subject agrees to refrain from sperm donation throughout the study period and for at least 90 days following their last dose of study drug.
14) Female subject agrees to refrain from egg donation/harvest throughout the study period and for at least 35 days after their last dose of study drug.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
1) Prior treatment with B-cell depleting agents, unless more than 6 months prior to the first dose of study drug and documented return of CD19+ cells at Screening
2) Prior treatment with any SYK inhibitor
3) Concurrent treatment at Screening with any other csDMARD other than MTX and/or HCQ
4) Concurrent treatment at Screening with any bDMARD
5) QT interval corrected for heart rate using the Fridericia formula (QTcF) > 450 msec determined by the average of values at the Screening visit
6) History of any major bleeding event defined as Grade 3 severity and above within the last year or personal or family history of bleeding disorder
OR
Current use of chronic anticoagulant, not including daily aspirin for cardiac prophylaxis
7) Treatment with moderate or strong CYP3A inducers or inhibitors within 2 weeks prior to the first dose of study drug
8) Joint injections within 4 weeks prior to the first dose of study drug
9) Known hypersensitivity or allergy to GS-9876, filgotinib or MTX, and their metabolites, or their formulation excipients
10) Administration of a live or attenuated vaccine within 30 days of Screening or planned for during the study.
11) Participation in any investigational drug/device clinical study within 4 weeks or 5 half-lives prior to Screening, whichever is longer. Exposure to investigational biologics should be discussed with the sponsor.
12) Have a diagnosis of any generalized musculoskeletal disorder that would interfere with study procedures or assessments per the discretion of the investigator.
13) History of or current moderate to severe congestive heart failure, or within the last 6 months prior to Screening: a cerebrovascular accident, myocardial infarction, unstable angina, unstable arrhythmia or any other cardiovascular condition which, in the opinion of the investigator, would put the subject at risk by participating in the study.
14) History of malignancy within the past 5 years prior to Screening.
15) History of lymphoproliferative disease or possible current lymphoproliferative disease
16) History of organ or bone marrow transplant.
17) Positive serology at Screening for human immunodeficiency virus 1 or 2, hepatitis B virus or hepatitis C virus or any history of infectious hepatitis from any cause with the exception of hepatitis A.
18) History of opportunistic infection or immunodeficiency syndrome which would put the subject at risk, as per investigator judgment.
19) Known active infection of any kind (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with intravenous (IV) or oral anti-infectives within 4 weeks of Screening.
20) History of symptomatic herpes zoster or herpes simplex infection within 12 weeks prior to Screening or history of disseminated/complicated herpes zoster infection (multi-dermatomal involvement, ophthalmic zoster, central nervous system involvement or postherpetic neuralgia).
21) History of an infected joint prosthesis or other implanted device with the prosthesis or device still in situ.
22) History within the previous 2 years prior to Screening or current drug or alcohol abuse, or heavy tobacco use, per the investigator judgment.
23) Any condition or circumstances (such as fibromyalgia or others) which in the opinion of the investigator or sponsor may make a subject unlikely or unable to complete the study or comply with study procedures and requirements.
24) Have any chronic, uncontrolled
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method