EUCTR2012-003876-38-HU进行中（未招募）1 期
A randomized, double- blind, controlled, parallel-group, multicenter study to assess the safety and immunogenicity of transitioning to GP2013 or re-treatment with Rituxan® or MabThera® in patients with active rheumatoid arthritis, previously treated with Rituxan® or MabThera® - ASSIST-RT
Hexal AG (a Sandoz company)0 个研究点目标入组 100 人开始时间: 2015年5月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or non-pregnant, non-lactating female patients at least 18 years of age at screening, who give written informed consent before any assessment is performed.
- •2. Patients must have the diagnosis of RA (according to American College of Rheumatology 2010 criteria).
- •3. Patients must have received at least one full treatment course of rituximab for the therapy of RA (i.e. 2 complete i. v. infusions of 1000 mg of Rituxan® in the USA or MabThera® in the EU) six to eighteen months prior to randomization.
- •4. Patients must be eligible for the subsequent treatment course with Rituxan® or MabThera® according to the clinical judgment of the Investigator.
- •5. Patients must be on a stable dose of methotrexate (MTX) (7.5 to 25 mg per week) for at least 4 weeks prior to randomization. If patients receive a combination of DMARDs (MTX + hydroxychloroquine or MTX+ chloroquine or MTX+ sulfasalazine) these DMARDs must be also on a stable dose for at least 4 weeks prior to randomization.
- •6. Patients must be on a stable dose of folic acid or folinic acid (= 5 mg per week) for at least 4 weeks prior to randomization.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. RA of functional status class IV classified according to the ACR 1991 revised criteria.
- •2. Systemic manifestation of RA, with the exception of Sjögren’s syndrome.
- •3. Use of any other investigational drugs within 30 days prior to screening (or within 5 half-lives or until the expected PD effect has returned to baseline, whichever is longer).
- •4. Requiring treatment with any biological medicinal product during the study other than the study medication.
- •5. Treatment with any biologics for any indication since the start of last treatment with either Rituxan®/MabThera®.
- •6. History of severe hypersensitivity to either Rituxan®/MabThera® or any of its excipients, requiring drug discontinuation.
- •7. Any contraindication to Rituxan®/MabThera® or MTX.
- •8. Therapy with any DMARDs (including tofacitinib) other than MTX or combination of MTX with hydroxychloroquine or MTX with chloroquine or MTX with sulfasalazine within 4 weeks prior to randomization. In case of leflunomide it has to be discontinued 8 weeks prior to randomization (if a cholestyramine washout is performed, leflunomide has to be discontinued 4 weeks prior to randomization).
- •9. Previous treatment with any cell depleting therapies, including investigational agents.
- •10. Current treatment or need for treatment with any prohibited medications.
- •11. Any serious illness or uncontrolled medical condition, including but not limited to severe infections, significant hepatic or renal disease, uncontrolled hypertension (defined as =160/95), congestive heart failure (NYHA class III or IV), or other severe, uncontrolled cardiac disease.
- •12. Any medical condition which, in the investigator’s opinion, would preclude the patient from completing all protocol requirements.
- •13. Any of the following laboratory values at screening: WBC < 3000/µL; Platelets < 100.000/µL; Neutrophils < 1.500/µL; Hemoglobin < 85 g/L; aspartate aminotransferase (AST) > 3 × ULN (upper limit of normal); alanine aminotransferase (ALT) > 3 × ULN; gamma-glutamyl transferase (GGT) > 3 × ULN; alkaline phosphatase (AP) > 3 × ULN; glomerular filtration rate (GFR) < 60 mL/min/1.73m2 (GFR calculated as per 4-variable MDRD formula); immunoglobulin G (IgG) and/or IgM and/or IgA below LLN.
- •14. Positive serology to hepatitis C infection.
- •15. Positive serology to hepatitis B infection.
- •15a. In case a patient is HBsAg negative but positive for hepatitis B core antibody [anti-HBc], this patient can only be included after consultation with a hepatitis expert to clarify the potential risk of Hepatitis B reactivation, required Hepatitis B monitoring and antiviral therapy.
- •16. History of serious recurrent or chronic infectious disease (excluding fungal infections of the nail beds) or active systemic infection within 2 weeks prior to screening or during the screening period, except for common cold.
- •17. Severely immunocompromised state, including but not limited to Felty’s syndrome and known (HIV) infection.
- •18. Any malignancy prior to screening, with exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer, or non-invasive malign colon polyps that have been removed with no evidence of recurrence.
- •19. Active tuberculosis. If a QuantiFERON®- Tuberculosis (TB) Gold test at screening is positive, further work-up, according to local guidelines/practices needs to be performed to conclusively establish that that the patient has no evidence of active tuberc
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