KCT0006755招募中未知
Multicenter, Prospective Clinical Trial for Optimizing TNFi dose Adjustment in AS patients with Stable Disease Activity
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 448
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 65(Year)（—）
- 性别
- All
入选标准
- •Subjects enrolled in the study must meet all of the following inclusion criteria:
- •Aged between 18 and 65
- •Documented diagnosis of Ankylosing spondylitis (AS) and meet the modified New York classification criteria for AS
- •Subjects maintaining stable disease (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] < 4) with standard-dose subcutaneous tumor necrosis factor inhibitor (TNFi) treatment during previous 6 months from the screening
- •Ankylosing Spondylitis Disease Activity Score (ASDAS) < 2.1 at screening (Week -4) and baseline (Week 0)
- •In subjects treated with methotrexate or sulfasalazine, the dose should be maintained (methotrexate= 25mg/day, sulfasalazine = 3 g/day) during previous 4 weeks before screening
- •In subjects treated with systemic glucocorticoids, the dose should be less than 10mg/day of predinisolone or equivalent during at least 2 weeks from the screening
- •Subjects with stable dose of concomitant NSAID (including Cox2 inhibitors) during the 2 weeks from the randomization
排除标准
- •Subjects will be excluded from participating in the study if they meet any of the following criteria:
- •Exposure to more than 1 TNFi
- •History of hypersensitivity reaction to any TNFis
- •Subjects with concomitant fibromyalgia, as determined by the investigator
- •Subjects who have received any TNFis with reduced dosage
- •Presence of total spinal ankylosis (‘Bamboo spine’)
- •Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study
- •Subjects with a history of malignancies and lymphoproliferative disorder including lymphoma within 5 years (Basal cell carcinoma treated within previous 3 months and showing no evidence of recurrence, actinic keratosis, and treated cervical/colon carcinoma in situ were allowed.)
- •Subjects with current or history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac or neurological disease, as determined by the investigator
- •Subjects with significant laboratory abnormalities included but not limited to:
- •1) AST/ALT > 3.0 X ULN
- •2) White blood cell (WBC) < 3000/µL and/or absolute neutrophil count (ANC) < 1500/µL
- •3) Platelet count <100,000/µL and/or hemoglobin level <8.5 g/dL
- •4) Serum creatinine = 1.5 X ULN
- •Subjected with any high-potency opioids (ex. methadone, hydromorphone, morphine, oxycodone, oxymorphone, fentanyl, levorphanol, buprenorphine, meperidine)
- •Subjects with current acute or chronic viral hepatitis B or C or with human immunodeficiency virus (HIV) infection
- •Subjects planning to receive any live attenuated vaccinations after screening
- •Subjects has history of chronic alcohol abuse or drug abuse within 6 months from screening
- •Subjects concomitantly treated with systemic glucocorticoid (>10mg/day of prednisolone or equivalent doses)
- •Subjects with any other condition that, in the Investigator’s judgment, would make the subject unsuitable for inclusion in the study
- •18) Patients who are contraindicated in administration of clinical investigational drugs
- •-Patients with hypersensitivity to drugs
- •-Patients at risk of sepsis or sepsis
- •- Infections, including chronic or localized infections, severe infections, opportunistic infections, including tuberculosis
- •patient with
- •- Congestive heart failure (New York Heart Association Grade III or IV status)
研究者
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