An open-label, international, multi-center, phase II, extension trial investigating long-term efficacy and safety of repeated treatment courses of ofatumumab, a fully human monoclonal anti-CD20 antibody, in adult patients with active rheumatoid arthritis who previously received ofatumumab or placebo in Trial Hx-CD20-403 - Long-term efficacy and safety of repeated ofatumumab courses in RA patients who were in Hx-CD20-403

GlaxoSmithKline Research & Development Ltd0 个研究点目标入组 0 人开始时间: 2007年10月16日最近更新: 2019年6月30日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: GlaxoSmithKline Research & Development Ltd

研究概览入排标准研究者记录与标识符相似试验

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

入选标准

•1)Previously received ofatumumab or placebo in Trial Hx-CD20-403
•2)Applicable only to patients on methotrexate therapy at time of screening:
•Treatment with a stable dose of methotrexate (7.5 – 25 mg/week, p.o., i.m., and/or s.c.) = 4 weeks prior to visit 2 and
•Treatment with methotrexate = 12 weeks prior to Visit 2, with possible interruption of treatment of maximum two weeks in total, in the period 5-12 weeks from baseline.
•3)Applicable only to patients on oral corticosteroids therapy at time of screening:
•Treatment with a stable dose of oral corticosteroids (= 10 mg/day prednisolone or equivalent) = 4 weeks prior to visit 2
•4)Active disease at the time of screening as defined as:
•= 3 swollen joints (of 28 joints assessed) and
•= 3 tender joints (of 28 joints assessed) and
•DAS28=3.2 (based on ESR)
•To accommodate for fluctuations in joint swelling, tenderness and ESR the following will be allowed:
•The joint swelling count, tenderness count, and ESR may be repeated once during the 14 day period from the screening visit to the baseline visit (Visit 2), to meet requirements for inclusion criterion 4. All three assessments should be reassessed regardless of which of the three assessments fails inclusion criterion 4. If one of the three criteria after the reassessment still do not fulfill inclusion criterion 4, Visit 1 may be repeated several times within the recruitment period.
•The swollen and tender joints should be reassessed at baseline (Visit 2). Where possible, joint count reassessment should be performed at the baseline visit (Visit 2); if this is not possible it can be performed = 3 days prior to Visit 2. If the patient does not have = 3 swollen and tender joints at Visit 2, this visit may be repeated once within the following 4 week period.
•If joint counts at the repeated Visit 2 (if applicable) are still not meeting eligibility criterion no. 4, then Visit 1 and Visit 2 may be repeated several times within the recruitment period.
•5)Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out.
•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) yes
•F.1.3.1 Number of subjects for this age range

排除标准

•1)Use of DMARDs other than methotrexate < 4 weeks prior to Visit 2. Specifically for leflunomide treatment: use of leflunomide < 12 weeks prior to Visit 2, unless the patient has completed peroral cholestyramine treatment for washout, according to locally accepted clinical practices.
•2)Exposure to other cell depleting therapy, including investigational compounds (e.g. anti-CD11a, anti-CD19, anti-CD20, anti-CD22, anti-BLyS/BAFF, anti-CD3, anti-CD4, anti-CD5, CAMPATH) < 6 months prior to Visit 2.
•3)Exposure to etanercept or anakinra < 4 weeks, infliximab or adalimumab < 8 weeks, or abatacept < 12 weeks prior to Visit 2
•4)Received any of the following treatments < 4 weeks prior to Visit 2:
•Anti-cancer therapy (e.g. alkylating agents, anti-metabolites, purine analogues, monoclonal antibodies)
•Oral corticosteroids > 10 mg prednisolone per day or equivalent
•Intra-articular, i.m. or i.v. corticosteorids
•Live/attenuated vaccinations
•Cyclosporine
•Azathioprine
•Penicillamine
•Mycophenolate Mufetil
•5)Exposure to cyclophosphamide, nitrogen mustard, chlorambucil or other alkylating agents < 5 years prior to screening
•6)Exposure to gold therapy <12 weeks prior to Visit 2
•7)Exposure to i.v. immunogammaglobulins < 24 weeks prior to Visit 2
•8)Active autoimmune disease (other than RA and RA-associated secondary diseases) requiring immunosuppressive therapy
•9)Diagnosis of fibromyalgia or other chronic pain syndrome requiring daily narcotic treatment
•10)History of infected joint prosthesis within five years before Visit 1 and infected native joints within one year before Visit 1
•11)Past or current malignancy, except for:
•Cervical carcinoma Stage 1B or less
•Non-invasive basal cell and squamous cell skin carcinoma
•Malignant melanoma with a complete response of a duration of > 10 years
•Other cancer diagnoses with a complete response of a duration of > 5 years
•12)Chronic or ongoing active infectious disease requiring systemic treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active hepatitis B and C
•13)Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months from Visit 1, congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities
•14)Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease
•15)History of significant cerebrovascular disease
•16)Known or suspected HIV positive
•17)A circulating IgG level 18)Screening laboratory values:
•-Hemoglobin < 6.2 mmol/L (9.9 g/dL)
•- Neutrophils < 2 x 109/ L
•- Platelets < 100 x 109/ L
•-CD4 (or CD4/CD8 ratio) < LLN

研究者

发起方

GlaxoSmithKline Research & Development Ltd

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