NL-OMON47596已完成3 期
A 52-week, multicenter study to assess the time course of response to secukinumab on joint inflammation using Power Doppler ultrasonography in patients with active psoriatic arthritis - Ultimate study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational invasive
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Provide written, signed and dated informed consent before any study
- •assessment is performed.
- •2. Male or female patients at least 18 years of age.
- •3. Diagnosis of PsA as per CASPAR criteria with active PsA for at least 6
- •months and a TJC >= 3 of 78 and SJC >= 3 of 76 at Baseline.
- •4. Patients must have a total synovitis PDUS score >= 2 and inflammation related
- •to PD signal >= 2 for at least 2 (affected joints as observed via PDUS) of 48
- •joints at the Screening visit and at the Baseline visit (before injection).
- •5. At least 1 clinically-involved enthesitis site at Screening and at the
- •Baseline visit (before injection) defined by SPARCC index different from 0.
- •6. Rheumatoid factor and anti-cyclic citrullinated peptide (anti-CCP) negative
- •at Screening.
- •7.Patients with PsA who are taking NSAIDs should be on a stable dose for at
- •least 2 weeks prior to enrollment and remain on a stable dose throughout the
- •24-week study period.
- •8.Patients with PsA who are taking steroids must have received steroids at
- •least 3 months prior to the Baseline visit and be on a stable dose of <= 10 mg
- •equivalent prednisone for at least 4 weeks prior to Baseline visit and remain
- •on a stable dose throughout the 24 week study period unless tolerance issues.
- •9.Patients with PsA who are taking MTX or DMARDs must have received them at
- •least 3 months prior to Baseline visit and be on a stable dose of <= 25 mg/week
- •of MTX or stable standard doses of other DMARD(s) (according to the
- •Investigator*s judgment) for at least 4 weeks prior to the Baseline visit and
- •remain on a stable dose throughout the 24-week study period.
排除标准
- •1. Chest X-ray or chest MRI with evidence of ongoing infectious or malignant
- •process obtained within 3 months prior to Screening and evaluated by a
- •qualified physician.
- •2. Previous exposure to secukinumab or other biologic drug directly targeting
- •interleukin 17 (IL-17) or IL-17 receptor.
- •3. Patients taking high-potency opioid analgesics (e.g. methadone,
- •hydromorphone, morphine).
- •4. Use of any investigational drug and/or devices within 4 weeks before
- •randomization or a period of 5 half-lives of the investigational drug,
- •whichever is longer.
- •5. Any change in the dose of oral corticosteroids in the last 4 weeks prior to
- •the Baseline visit or use of i.v. intramuscular or intra-articular
- •corticosteroid during the last 4 weeks prior to the enrollment visit.
- •6. Patients who have previously been treated with TNFa inhibitors
- •(investigational or approved).
- •7. History of hypersensitivity to the study drug or its excipients or to drugs
- •of similar classes.
- •8. Previous treatment with any cell-depleting therapies including but not
- •limited to anti CD20 investigational agents (e.g. CAMPATH, anti-CD4, anti-CD5,
- •anti-CD3, anti CD19).
- •9. Prohibited psoriasis treatments/medications with topical corticosteroids in
- •the last 4 weeks prior to randomization
- •10. Pregnant or nursing (lactating) women
- •11. Women of child-bearing potential, defined as all women physiologically
- •capable of becoming pregnant, unless they are using effective methods of
- •contraception during the entire study or longer if required by locally approved
- •prescribing information (e.g. 20 weeks in EU)
- •12. Active ongoing inflammatory diseases other than PsA that might confound the
- •evaluation of the benefit of secukinumab therapy.
- •13. Underlying metabolic, hematologic, renal, hepatic, pulmonary, neurologic,
- •endocrine, cardiac, infectious or gastrointestinal conditions which in the
- •opinion of the Investigator immunocompromise the patient and/or place the
- •patient at unacceptable risk for participation in an immunomodulatory therapy.
- •14. Significant medical problems or diseases, including but not limited to the
- •following: uncontrolled hypertension (>= 160/95 mmHg), congestive heart failure
- •(New York Heart Association status of class III or IV), and uncontrolled
- •diabetes (as per investigator's judgement).
- •15. History of clinically significant liver disease or liver injury as
- •indicated by abnormal liver function tests (LFT) such as aspartate
- •aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase,
- •or serum bilirubin.
- •16. History of renal trauma, glomerulonephritis, or patients with 1 kidney
- •only, or a serum creatinine level exceeding 1.5 mg/dL (132.6 µmol/L).
- •17. Screening total white blood cell (WBC) count <3 000/µL, or platelets <100
- •000/µL or neutrophils <1 500/µL or hemoglobin <8.5 g/dL (85 g/L).
- •18. Active systemic infections during the last 2 weeks (exception: common cold)
- •prior to randomization.
- •19. History of ongoing, chronic or recurrent infectious disease or evidence of
- •tuberculosis infection as defined by either a positive purified protein
- •derivative (PPD) skin test (the size of induration will be measured after 48-72
- 另有 2 项未显示
研究者
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