A Multi-centre Long-term Extension Study to Assess the Safety and Efficacy of GSK3196165 in the Treatment of Rheumatoid Arthritis
A Multi-centre Long-term Extension Study to Assess the Safety and Efficacy of GSK3196165 in the Treatment of Rheumatoid Arthritis
RA is a chronic, systemic inflammatory autoimmune disease which requires treatment for a long time period, hence it is important to study the long-term safety and efficacy of the continuous treatment with GSK3196165 over several years. This is a Phase 3, multicenter, parallel group treatment and long-term extension study primarily to assess safety with efficacy assessment as a secondary objective. Adult participants with RA who have completed the treatment phase of a qualifying GSK3196165 clinical studies (Phase 3 studies contRAst 1 (201790: NCT03980483), contRAst 2 (201791: NCT03970837) and contRAst 3 (202018: NCT04134728) and who, in investigator's judgement will benefit from extended treatment with GSK3196165 will be included in this study (contRAst X [209564: NCT04333147]). Participants will continue to receive the same background conventional synthetic disease modifying anti-rheumatic drug(s) [csDMARD(s)] treatment as they received in their qualifying study. Eligible participants will be enrolled to receive weekly GSK3196165 90 milligrams (mg) or 150 mg by subcutaneous (SC) injection. The anticipated study duration is approximately 4 years which will enable participants to receive treatment with GSK3196165 until it is expected to become commercially available. Approximately 3000 participants from the qualifying studies will participate in this long-term extension study
Inclusion Criteria:
Exclusion Criteria:
Had study intervention permanently discontinued at any time during a qualifying study except any participant with a new diagnosis of latent Mycobacterium tuberculosis (TB) at the end of study assessment in a qualifying study and currently undertaking or willing to complete at least 4 weeks of anti-TB treatment off study treatment, per world health organization (WHO) or national guidelines prior to re-commencing therapy and complete the remainder of anti-TB treatment while on study.
Evidence of latent TB (as documented by a positive QuantiFERON-TB Gold plus test or T-SPOT.TB test, no findings on medical history or clinical examination consistent with active TB, and a normal chest radiograph) except for participants that
Current or previous active TB regardless of treatment.
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.
A new cancer or malignancy except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated and considered cured by the investigator.
Have developed any lymphoproliferative disorder during a qualifying study, such as Epstein Barr Virus (EBV) related lymphoproliferative disorder, or signs and symptoms suggestive of current lymphatic disease.
Have significant uncontrolled cardiovascular, cerebrovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neuropsychiatric disorders, or abnormal laboratory values that developed during a qualifying study that, in the opinion of the investigator, poses an unacceptable risk for the participant's participation.
Participants who are expected to be non-compliant with restrictions on medications and vaccinations prior to the study, during the study or during the 8-week safety follow-up of the study.
Participants who are currently participating in any interventional clinical study other than a qualifying GSK3196165 clinical study.
Abnormal chest radiograph within the last 12 weeks judged by the investigator as clinically-significant.
Pregnant or lactating, or women planning to become pregnant or initiating breastfeeding.
History of sensitivity to any of the study treatments, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
Ciudad Autonoma Buenos Aires, Buenos Aires C1046AAQ, Argentina
Ciudad Autonoma Buenos Aires, Buenos Aires C1114ABH, Argentina
Ciudad Autonoma Buenos Aires, Buenos Aires C1417, Argentina
Ciudad Autonoma Buenos Aires, Buenos Aires C1430EGF, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires 1426, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires C1128AAF, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires C1431FWO, Argentina
La Palta, Buenos Aires B1900AXI, Argentina
Ciudad Autonoma Buenos Aires, C1015ABO, Argentina
Nueva Cordoba, X5000AVE, Argentina
Praha 4 Nusle, 140 00, Czechia
Hokkaido, 053-8567, Japan
Hokkaido, 060-0001, Japan
Hokkaido, 060-8648, Japan
Hokkaido, 063-0811, Japan
Hokkaido, 085-0032, Japan
Mexico City, Durango 06700, Mexico
Cheonan-si, 31151, South Korea
Suwon-si, Gyeonggi-do, 16499, South Korea
Santiago de Compostela. La Coruña., 15706, Spain
Rajathevee, 10400, Thailand
Zaporizhzia, 69065, Ukraine