Moderately to severely active rheumatoid arthritis MedDRA version: 19.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
Gilead Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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), 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) 5) Have limited or no prior treatment with MTX, ie, no more than 3 doses of MTX =25 mg each in the subject’s lifetime for the treatment of RA, with the last dose at least 28 days prior to Day 1, and are an appropriate candidate for MTX therapy, as per investigator judgment 6) Females of childbearing potential (as defined in Appendix 5) 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 IEC/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 trial, and must be willing to comply with all trial visits and assessments; subjects who cannot read or understand the ICF may not be enrolled by a guardian or any other individual. 11) 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 600 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 600
Exclusion criteria
Exclusion criteria: 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) Known hypersensitivity or allergy to the MTX, its metabolites, or formulation excipients. 4) 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. 5) Receipt of an intra-articular or other injectable corticosteroid within 4 weeks prior to Day 1. 6) Use of non-steroidal anti-inflammatory drugs 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. 7) Administration of a live/attenuated vaccine within 30 days from Day 1, or planned during the study. 8) 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 are excluded as outlined in 1d. 9) Have undergone surgical treatments for RA, including synovectomy or arthroplasty in >4 joints 10) 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. 11) 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. 12) 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 13) Active autoimmune disease other than those listed above, that would interfere with assessment of study parameters or increase risk to the subject by participating in the study 14) Any known condition or contraindication as addressed in the local labeling or local clinical practice for MTX that would preclude the subject from participating in this study. 15) History of or current moderate to severe congestive heart failure (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 protocol. 16) History of malignancy within the past 5 years prior to Screening (except for adequately treated basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin or cervical carcinoma in situ with no evidence of recurrence). 17) History of lymphoproliferative disease or current lymphoproliferative disease. 18) History of gastrointestinal perforation. 19) History o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the effects of filgotinib in combination with MTX versus MTX alone for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the proportion of subjects achieving an American College of Rheumatology 20% improvement response (ACR20) at Week 24; Secondary Objective: For a complete list of the secondary objective for this trial, please refer to the study protocol (section 2). 1) To evaluate the effect of filgotinib in combination with MTX versus MTX alone: - on physical function as measured by change from Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) score at Week 24 - for the treatment of signs and symptoms of RA as measured by the proportion of subjects achieving Disease Activity Score for 28 joint count using C-reactive protein (DAS28 [CRP]) < 2.6 at Week 24 2) To evaluate the effect of filgotinib alone versus MTX alone: - for the treatment of signs and symptoms of RA as measured by the proportion of subjects achieving ACR20 at Week 24 - on physical function as measured by change from Baseline in HAQ-DI score at Week 24 - for the treatment of signs and symptoms of RA as measured by the proportion of subjects achieving DAS28(CRP) <2.6 at Week 24 ;Primary end point(s): The primary endpoint is the proportion of subjects who achieve an ACR20 response at Week 24.;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The key secondary endpoints are: - Change from Baseline in the HAQ-DI score at Week 24 - The proportion of subjects who achieve DAS28 (CRP)<2.6 at Week 24 - Change from Baseline in mTSS at Week 24 ; Timepoint(s) of evaluation of this end point: Week 24 ? | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czech Republic, France, Germany, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Malaysia, Mexico, New Zealand, Peru, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Trials Mailbox
Gilead Sciences International Ltd.
Outcome results
None listed