Rheumatoid Arthritis
Conditions
Sponsors
GlaxoSmithKline K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Participants with rheumatoid arthritis who are aged >=18 years at the time of signing informed consent, who have completed one of the qualifying GSK3196165 clinical studies and who, in the opinion of the investigator, may benefit from treatment with GSK3196165. -Body weight >=40 kilograms (kg). Other inclusion criteria specified protocol may also be followed.
Exclusion criteria
Exclusion criteria: -Had study intervention permanently discontinued at any time during a qualifying study. -Were temporarily discontinued from study intervention at the time of the final study visit of a qualifying study and, in the opinion of the investigator, participation in the extension study poses an unacceptable risk for the participant's participation. Other exclusion criteria specified protocol may also be followed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety -Incidence of adverse events (AEs) , serious adverse events (SAEs) and adverse events of special interests (AESI) [ Time Frame: Up to 4 years ] -Change from Baseline in platelet count, neutrophils lymphocytes, monocytes, eosinophils, and basophils (Giga cells per liter [giga cells/L]) [ Time Frame: Baseline (Day 1) and up to 4 years ] -Proportion of participants with National Cancer Institute-Common terminology criteria for adverse events (NCI-CTCAE) more than or equal to (>=)Grade 3 hematological/clinical chemistry abnormalities [ Time Frame: Up to 4 years ] | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy -Proportion of participants achieving Clinical disease activity index (CDAI) total score less than or equal to (<=10) (CDAI Low disease activity [LDA]) at Week 24 [ Time Frame: Week 24 ] -Proportion of participants achieving CDAI total score <=10 (CDAI LDA) at Week 48 and every 48 weeks thereafter [ Time Frame: Week 48 and every 48 weeks thereafter, up to 4 years ] -Proportion of participants achieving CDAI total score <=2.8 (CDAI Remission) at Week 24 [ Time Frame: Week 24 ] -Proportion of participants achieving CDAI total score <=2.8 (CDAI Remission) at Week 48 and every 48 weeks thereafter [ Time Frame: Week 48 and every 48 weeks thereafter, up to 4 years ] -Proportion of participants achieving Disease Activity Score using 28 joint count (DAS28)-C-reactive protein (CRP) <2.6 (DAS28-CRP Remission) at Week 24 [ Time Frame: Week 24 ] -Proportion of participants achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 48 and every 48 weeks thereafter [ Time Frame: Week 48 and every 48 weeks thereafter, up to 4 years ] -Proportion of participants with DAS28- Erythrocyte sedimentation rate (ESR)<2.6 (DAS28-ESR Remission) at Week 24 [ Time Frame: Week 24 ] -Proportion of participants with DAS28-ESR<2.6 (DAS28-ESR Remission) at Week 48 and every 48 weeks thereafter [ Time Frame: Week 48 and every 48 weeks thereafter, up to 4 years ] -Proportion of participants achieving American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) remission (Boolean and simplified disease activity index [SDAI]) at Week 24 [ Time Frame: Week 24 ] -Proportion of participants achieving ACR and EULAR remission (Boolean and SDAI) at Week 48 and every 48 weeks thereafter [ Time Frame: Week 48 and every 48 weeks thereafter, up to 4 years ] -Absolute values of CDAI total score at Week 24 [ Time Frame: Week 24 ] -Absolute values of CDAI total score at Week 48 and every 48 weeks thereafter [ Time Frame: Week 48 and every 48 weeks thereafter, up to 4 years ] -Absolute | — |
Countries
Argentina, Australia, Belgium, Bulgaria, Canada, China, Colombia, Czechia, Estonia, Germany, Hungary, India, Korea, Latvia, Lithuania, Malaysia, Mexico, Poland, Russian Federation, Serbia, South Africa, Spain, Thailand, Ukraine, United Kingdom, United States
Contacts
Public ContactYasutoshi Okawa
GlaxoSmithKline K.K.
Outcome results
None listed