EUCTR2007-004878-31-HU进行中（未招募）不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 264
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) 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 2A or
- •- Treatment with methotrexate = 12 weeks prior to Visit 2A, 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 2A
- •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)
- •a) To accommodate for fluctuations in joint swelling and tenderness, and ESR, these assessments may be repeated once during the 14 day period from the screening visit to the baseline visit (Visit 2A), to meet requirements for inclusion criterion 4.
- •b) The swollen and tender joints should be reassessed at baseline (Visit 2A). 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 2A. If the patient does not have = 3 swollen and tender joints at Visit 2A, this visit may be repeated once within the following 4 week period.
- •c) If joint counts at the repeated Visit 2A (if applicable) are still not meeting eligibility criterion no. 4, then Visit 1 and Visit 2A may be repeated at a later time 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 MTX <4 weeks prior to Visit 2A. Use of leflunomide <12 weeks prior to Visit 2A, unless peroral cholestyramine washout treatment completed according to local practice
- •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 2A
- •3) Exposure to etanercept or anakinra <4 weeks, infliximab or adalimumab <8 weeks, or abatacept <12 weeks prior to Visit 2A
- •4) Received any of the following treatments < 4 weeks prior to Visit 2A:
- •Anti-cancer therapy (e.g. alkylating agents, anti-metabolites, purine analogues, monoclonal antibodies)
- •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 2A
- •7) Exposure to i.v. immunogammaglobulins <24 weeks prior to Visit 2A
- •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 <5 years before Visit 1 and infected native joints <1 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 complete response of duration of >10 years
- •-Other cancer diagnoses with 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, TB and active hepatitis B and C
- •Note i) Subjects with screening chest X-ray suggestive of TB without documented adequate TB treatment will be excluded: ii) Screening for latent TB infection using intradermal injection of tuberculin should be conducted according to local guidelines. Subjects with a positive skin tuberculin test should be excluded if investigator judges patient at risk of latent TB infection
- •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 <5.5 mmol/L (9.9 g/dL)
- •Neutrophils <2 x 109/ L
- •Platelets <100 x 109/ L
- •CD4 (or CD4/CD8 ratio) < LLN
- •S-ALAT >3 times ULN
- •S-ALP >two times ULN
- •S-AST >1.5 x ULN
- •S-creatinine >133 µmol/L (1.5 mg/dL)
- •19) Positive serology for hepatitis B (HB) defined as:
- •- Positive test for HBsAg and/or
- •- Positive test for anti-HBc and anti-HBs
- •Patients with documented vaccination against Hepatitis B (primary and secondary immunization and booster) will be considered negative
- •20) Positive plasma or white cell JC virus (JCV) PCR (either compartment)
- •21) Known hypersensitivity to compone
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