Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
- Conditions
- Moderately to severely active rheumatoid arthritisMedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2016-000568-41-BG
- Lead Sponsor
- Gilead Sciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 1650
For a complete list of study inclusion criteria, please refer to study protocol (sections 4.2):
1) Male or female subjects who are =18 years of age, on the day of signing informed consent.
2) Have a diagnosis of RA (2010 ACR/EULAR criteria for RA), and are ACR functional class I-III .
3) Have =6 swollen joints (from a SJC66) and =6 tender joints (from a TJC68) at both Screening and Day 1 (need not be the same joints).
4) Must meet at least one of the Screening parameters defined in the protocol (section 4.2) regarding the number of joint erosions and serum CRP
5) Ongoing treatment with a stable dose of MTX as described in the protocol (section 4.2)
6) Females of childbearing potential must have a negative pregnancy test at screening and Day 1
7) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception.
8) Lactating female subjects must agree to discontinue nursing from Screening through the end of their study participation.
9) Meet one of the tuberculosis (TB) Screening criteria described in the protocol (section 4.2)
10) Able and willing to sign the informed consent as approved by the Independent Ethics Committee (IEC)/Institutional Review Board (IRB). 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; subjects who cannot read or
understand the ICF may not be enrolled by a guardian or any other individual.
11) Able and willing to perform subcutaneous self-injections or have a caregiver able, willing and available to administer the injections.
12) Subjects receiving non-prohibited medication for any reason should be on a stable dose (defined as no change in prescription) within 7 days or 5 half-lives (whichever is longer) prior to the first administration of study drug on Day 1.
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 825
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 825
For a complete list of study exclusion criteria, please refer to study protocol (Sections 4.3):
1) Prior treatments for RA as defined in Section 4.3 of the protocol
2) Known hypersensitivity or allergy to the study drug(s), its metabolites, or formulation excipients.
3) Oral steroids at a dose >10 mg/day of prednisone (or equivalent) or a prescription for oral steroids which has changed within 4 weeks of Day 1.
4) Receipt of an intra-articular or parenteral corticosteroid injection within 4 weeks prior to Day 1.
5) Use of nonsteroidal anti-inflammatory drugs (NSAIDs) which have not been at a stable dose (defined as no change in prescription) for at least 2 weeks prior to Day 1. NOTE: subjects are permitted to take acetylsalicylic acid at a dose of =325mg daily for cardiac prophylaxis, or occasional NSAIDs for non-RA indications (eg, headache).
6) Administration of a live/attenuated vaccine within 30 days prior to Day 1, or planned during the study.
7) Participation in any clinical study of an investigational drug/device within 4 weeks or 5 half-lives prior to Screening, whichever is longer. Exposure to investigational biologics should be discussed with the Sponsor.
8) Have undergone surgical treatments for RA, including synovectomy or arthroplasty in >4 joints
9) Have any chronic, uncontrolled medical condition, which would put the subject at increased risk during study participation, such as uncontrolled: diabetes, hypertension, morbid obesity, thyroid, adrenal, pulmonary, hepatic, renal, neurologic or psychiatric disease, or other disease
of concern, as per judgment of investigator 10) Have a history of major surgery (requiring regional block or general anesthesia) within the last 3 months prior to Screening or planned major surgery during the study.
11) Have a moderately to severely active, generalized musculoskeletal disorder that would interfere with assessment of study parameters or increase risk to the subject by participating in the study.
12) Active autoimmune disease that would interfere with assessment of study parameters or increase risk to the subject by participating in the study.
13) History of or current moderate to severe congestive heart failure (New York Heart Association [NYHA] class III or IV), or within the last 6 months, a cerebrovascular accident, myocardial infarction, unstable angina, unstable arrhythmia, new or significant ECG finding at Screening, or any other cardiovascular condition which, in the opinion of the investigator, would put the subject at risk by participation in the study.
14) History of malignancy within the past 5 years prior to Screening
15) History of lymphoproliferative disease or current lymphoproliferative disease
16) History of gastrointestinal perforation.
17) History of organ or bone marrow transplant.
18) Positive serology for human immunodeficiency virus (HIV) 1 or 2.
19) Evidence of active Hepatitis C Virus (HCV) infection.
20) Evidence of active Hepatitis B Virus (HBV) infection.
21) History of opportunistic infection, or immunodeficiency syndrome, which would put the subject at risk, as per investigator judgmen
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