CTRI/2020/12/029972尚未招募3 期
A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis. - contRAst-X
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. 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.
- •2. Body weight equal to or more than 40 kg
- •3. Male or female participants are eligible to participate as long as they meet the contraceptive eligibility criteria
- •4. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
- •5. For participants on MTX: must be willing to continue treatment with oral folic acid (at least 5 mg/week) or equivalent while receiving MTX (mandatory co-medication for MTX treatment).
排除标准
- •1. Had study intervention permanently discontinued at any time during a qualifying study except any participant with a new diagnosis of latent 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 WHO or national guidelines prior to re-commencing therapy and complete the remainder of anti-TB treatment while on study.
- •2. 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
- •o Are currently undertaking or willing to complete at least 4 weeks of anti-TB therapy off study treatment, as per WHO or national guidelines prior to recommencing study treatment and agree to complete the remainder of anti- TB treatment while in the study
- •o Had documented evidence of satisfactory anti-TB treatment as per WHO or national guidelines following review by a physician specialising in TB on entry to a qualifying study.
- •3. Current or previous active Mycobacterium tuberculosis (TB) regardless of treatment.
- •4. 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 patientâ??s participation.
- •5. 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.
- •6. 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.
- •7. 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 patientâ??s participation.
研究者
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