Health Condition 1: M058- Other rheumatoid arthritis with rheumatoid factor Health Condition 2: null- Patients with Rheumatoid Arthritis
Conditions
Interventions
Intervention1: Open Label Filgotinib 200mg, Open Label Filgotinib 100 mg: Open Label Filgotinib 200 mg group: Open Label filgotinib 200 mg QD.
Open Label Filgotinib 100 mg group: Open Label filgotinib
Sponsors
Alfasigma SpA
Klinera Corporation India
Eligibility
Inclusion criteria
Inclusion criteria: 1.Able and willing to sign the informed consent as approved by the IRB/IEC. Written consent must be provided before initiating any Day -1 evaluations for this study. Subjects must have read and understood the 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. 2. Male or female subjects who may benefit from filgotinib as judged by the investigator AND who completed a Gilead sponsored filgotinib parent study for RA as outlined below: a) Subjects who completed GS-US-417-0301, GS-US-417-0302, GS-US-417-0303 or GS-US-417-3910 on study drug OR b) Subjects who completed GS-US-417-0302 on standard of care therapy due to RA non-responder status OR c) Subjects who completed GS-US-417-3910 on standard of care therapy due to semen-related stopping criteria 3. Females of childbearing potential must have a negative pregnancy test at Day -1 and must agree to continued monthly pregnancy testing during the study 4. Lactating female subjects must agree to discontinue nursing at Day -1 for the duration of the study 5. Male 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, during the study and through 35 days (female) or 90 days (male) after their last dose of study drug. 6. Subjects receiving protocol permitted RA medications 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. Note: Subjects on MTX during their parent study will have their MTX dose discontinued at the time of Day -1 and be evaluated for resuming of MTX treatment after 4 weeks of study drug treatment on the LTE study. 7. Subjects, who meet study drug interruption criteria (as outlined in Section 3.5.1) at Day -1, are eligible to enter into the LTE, but should not start study drug until deemed medically appropriate. Study drug should be reinitiated as outlined in Section 3.5.1.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following are not to be enrolled in this study. 1) An autoimmune or inflammatory joint disease other than RA, which would put the subject at risk by participating in the study or would interfere with study assessments/data interpretation, per judgment of the investigator; (Sjogren’s syndrome or stable thyroiditis is permitted). 2) Known hypersensitivity to the study drug, its metabolites or formulation excipients. 3) Any medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) which would put the subject at risk by participating in the study or would interfere with study assessments/data interpretation, per judgment of the investigator; 4) Administration of a live/ attenuated vaccine within 30 days prior to Day -1 5) Currently on any therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes zoster, and atypical mycobacteria) 6) History of disseminated/complicated herpes zoster infection (multi-dermatomal involvement, ophthalmic zoster, central nervous system involvement or postherpetic neuralgia) 7) Any condition or circumstances 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 8) Use of prohibited medication as outlined in Section 5.4 9) Subjects who meet discontinuation criteria as outlined in outlined in Section 3.5.2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the long-term safety and tolerability of filgotinib in subjects who have completed one of the parent studies of filgotinib in RATimepoint: 6 years | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the long-term safety and tolerability of filgotinib in subjects who have completed one of the parent studies of filgotinib in RATimepoint: 6 years | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czech Republic, France, Germany, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Peru, Poland, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom
Contacts
Public ContactRajeev Singh
Klinera Corporation India
Outcome results
None listed