Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment

Phase 1

• Conditions: Moderately to severely active rheumatoid arthritis; MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2016-000570-37-GB
• Lead Sponsor: Gilead Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-17
• Study Completion: 2019-05-08
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1252

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

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 of organ or bone marrow transplant.
20) Positive serology for human immunodeficiency virus (HIV) 1 or 2.
21) Evidence of active Hepatitis C Virus (HCV) infection.
22) Evidence of active Hepatitis B Virus (HBV) infection.
23) History of opportunistic infection or immunodeficiency syndrome which

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified