EUCTR2006-002306-64-DE进行中（未招募）不适用
Open label clinical trial with Rituximab (MabThera ®) in Ankylosing Spondylitis - Extension of open label trial: Re-Treatment of patients who have shown response to first course of Rituximab - Ritux-AS-01
Charité Universitaetsmedizin0 个研究点开始时间: 2006年10月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •- Patients 18 – 65 years of age who have moderate to severe ankylosing spondylitis.
- •- Active disease is defined as a BASDAI score of > = 4 plus a back pain score (BASDAI question 2) of >= 4 despite concurrent NSAID therapy, or intolerance to NSAIDs
- •- If on prednisone, £10 mg per day must be stable for 4 weeks prior to baseline.
- •- If on methotrexate, £ 25 mg per week must be stable for 4 weeks prior to baseline
- •- Women of child bearing potential must have a negative pregnancy urine test at study baseline and use an adequate, effective method of contraception (such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence, vasectomised partner) for a duration of 12 months after stop of rituximab therapy. Sexual active men must use an accepted method of contraception for a duration of 12 months after first administration of rituximab.
- •- Willingness and capability to give written informed consent, written consent for data protection (legal requirement in Germany: datenschutzrechtliche Einwilligung) and willingness to participate and to comply with the study
- •- Patients are eligible for a second course of rituximab if they: A) in response assessment period= week 12- week 24: have shown a response after the first administration of rituximab; response defined as reaching ASAS20 criteria (compared to screening) on at least two subsequent time points between week 12 and week 24, B) in flare assessment period (starting from week 24- 48): have a flare after they have shown response (as described above): flare defined as having a 1.5-point-worsening of the BASDAI score in comparison to the lowest BASDAI score between week 12 and week 24, and C) have completed week 24 (re-treatment 24 weeks after first administration of rituximab at the earliest)
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria
- •Exclusion criteria related to general health conditions:
- •1. Patients with other chronic inflammatory articular disease or systemic autoimmune disease, e.g. Systemic lupus erythematosus, Sjögren’s syndrome, active rheumatoid vasculitis, a history of systemic diseases associated with arthritis, chronic fatigue syndrome
- •2. Any active infection, a history of recurrent clinically significant infection, a history of recurrent bacterial infections with encapsulated organisms
- •3. Primary or secondary immunodeficiency
- •4.History of cancer with curative treatment not longer than 5 years ago except basal-cell carcinoma of the skin that had been excised
- •5. A history of pulmonary or cardiac insufficiency, or serious and/or uncontrolled diseases that are likely to interfere with the evaluation of the patient's safety and of the study outcome
- •6.Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease ( e.g. heart failure class III/IV NYHA, cardiac infarct within last 6 month), nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disorders.
- •7.Neuropathy that can interfere with quality of life and/or pain assessment.
- •8.Patients with a history of a severe psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.
- •9.History of current evidence of abuse of hard” drugs (e.g. cocaine/ heroine) or alcoholism
- •10.Known hypersensitivity to any component of the product or to murine proteins (sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, HCl).
- •11.Women lactating, pregnant, nursing or of childbearing potential with a positive pregnancy test (urine test)
- •12.Males or females of reproductive potential not willing to use effective contraception (e.g. contraceptive pill, IUD, physical barrier) for up to 12.5 months after first infusion of rituximab
- •13.History of alcohol, drug or chemical abuse within 6 month prior to screening
- •14.Lack of peripheral venous accessExclusion criteria related to medications
- •15.If on leflunomide, leflunomide must have been terminated at least 8 weeks prior to the first rituximab infusion (or = 28 days after 11 days of standard cholestyramine or activated charcoal washout).
- •16.If on TNFalpha blocking agent (infliximab, etancercept, adalimumab), the TNFa therapy must have been terminated at least 4 weeks prior to the first rituximab infusion if etanercept was used and at least 8 weeks if infliximab or adalimumab were used
- •17.Previous treatment with rituximab or intolerance to rituximab
- •18.Corticosteroids at doses exceeding 10 mg per day of prednisolone or the equivalent within the last 4 weeks prior to the first rituximab infusion
- •19.Intolerance or contraindication to drugs required for the treatment of the side effects of rituximab (e.g. paracetamol, acetaminophen, diphenhydramine, p.o. and i.v. corticosteroids, anti-emetics or H1 blockers)
- •20.Previous treatment with any investigational agent
- •21.Previous treatment with i.v. immunoglobulins
- •22.Receipt of a live vaccine within 4 weeks prior to treatment
- •23.Intra-articular or parenteral corticosteroids within 4 weeks prior to screening visitExclusion criteria related to lab findings
- •24.Haemoglobin < 8.5 g/dl
- •25.Neutrophil counts < 1.500 / µl
- •26.Platelet count < 75.000 / µl
- •27.Lower than 1 x 1000/µl lymphopenia for more than three months prior to inclusion.
- •28.Serum creatinine > 1.4 mg/dl for women or 1.6 mg/dl for men.
- •29.Aspartate
研究者
相似试验
进行中（未招募）
不适用
Pilot study to evaluate the effect of Rituximab in combination with MTX in the inhibition of progression of synovitis, bone marrow edema, and erosions evaluated by magnetic resonance imaging (MRI) in the hand of patients with rheumatoid arthritis. - NDMedDRA version: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritisRheumatoid arthritisEUCTR2007-001754-11-ITROCHE
进行中（未招募）
不适用
A Randomized Controlled Trial of Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy (IMN)MN is an autoimmune disease, suggesting that the disease may be triggered by isotype specific autoantibodies directed against podocyte enzymes and podocyte receptors that are recognized as antigens. The key role of IgG antibodies formation in the pathogenesis of IMN suggests that B cell depletion may favourably impact the evolution of the glomerular disease and reduce proteinuria. We propose this study in order to test in a randomized controlled trial the hypMedDRA version: 14.1Level: PTClassification code 10018372Term: Glomerulonephritis membranousSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2011-006115-59-ITAZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA
招募中
不适用
Clinical trial of Rituximab for desensitization or antibody mediated rejection therapy in anti-donor HLA antibody positive patientsChronic renal dysfunction or post kidney transplant recipientsJPRN-jRCTs031180323Saito Kazuhide20
进行中（未招募）
不适用
A randomized trial of Rituximab in induction therapy for living donor renal transplantation - Randomized trial of rituximab in renal transplantatioEnd stage renal diseaserenal function after renal transplantationMedDRA version: 17.0Level: PTClassification code 10038533Term: Renal transplantSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2009-017066-23-GBGuys and St Thomas Foundation Trust
进行中（未招募）
不适用
MALT-2ymphoma of the Mucosa-Associated Lymphoid Tissue (MALT)MedDRA version: 14.1Level: LLTClassification code 10060707Term: MALT lymphomaSystem Organ Class: 100000004864EUCTR2011-005818-10-ATArbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH