NL-OMON51816招募中2 期
ANIfrolumab treatment for 24 weeks in patients with primary Sjögren*s syndrome - Efficacy and safety assessment in a randomized, double-blind, placebo-controlled phase-IIa proof-of-concept trial (ANISE-II) - ANISE-II
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
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
- 年龄范围
- 18 至 99（—）
入选标准
- •- Written informed consent.
- •- Female or male aged >= 18 years.
- •- Disease duration <= 10 years.
- •- Fulfillment of the 2016 ACR/EULAR classification criteria for primary
- •Sjögren's syndrome.
- •- ESSDAI >=5 and/or ESSPRI >=5. ESSDAI >=5 implicates a moderate to high
- •systemic disease activity and ESSPRI >=5 implicates that the patient-reported
- •symptom state is unacceptable. At least 50% of patients need to fulfil the
- •ESSDAI >=5 criterion. Inclusion of patients with low ESSDAI (<5) should be
- •discontinued when 50% have a low ESSDAI.
- •- Willingness to undergo a repeated biopsy. Baseline biopsy <=1 year before
- •inclusion and follow-up biopsy 24 weeks after start treatment.
- •- Use of reliable method of contraception for participants of reproductive
- •- Fully vaccinated against SARS-CoV-2, based on the current vaccine
- •recommendations for immunocompromised patients.
- •- Weight of >= 40 kg.
排除标准
- •- Presence of any other connective tissue disease.
- •- Positive pregnancy test at screening or breastfeeding.
- •- History of alcohol or drug abuse.
- •- History of malignancy or with a current suspicion for cancer, apart from
- •local MALT lymphoma, squamous or basal cell carcinoma of the skin treated with
- •documented success of curative therapy <=3 months prior to week 0 or cervical
- •cancer in situ treated with apparent success with curative therapy <=1 years
- •prior to week 0.
- •- Subjects with evidence (as assessed by the investigator) of active or latent
- •bacterial or viral infections at the time of potential enrollment, including
- •subjects with evidence of HIV which will be tested during screening.
- •- History of chronic or recurrent serious infections.
- •- Subjects who have received any live or attenuated vaccines within 8 weeks
- •prior to signing the ICF.
- •- Blood transfusion or receipt of blood products within 4 weeks prior to
- •signing the ICF.
- •- Underlying cardiac, pulmonary, metabolic, renal, hepatic, gastrointestinal,
- •hematological or neurological conditions, chronic or latent infectious diseases
- •or immune deficiency which places the patient at an unacceptable risk for
- •participation in this study.
- •- Preceding treatment with biological DMARDs, including abatacept, anti-TNF or
- •other monoclonal antibodies within 6 months, and rituximab within 12 months
- •from baseline.
- •- Use of high-dose prednisone, less than 2 weeks before inclusion. Stable low
- •dose (<= 10 mg) is allowed.
- •- Use of hydroxychloroquine, methotrexate, cyclophosphamide, cyclosporine,
- •azathioprine, MMF and leflunomide less than 3 months ago.
研究者
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