EUCTR2006-004834-33-BE进行中（未招募）不适用
A Phase II, Randomised, Double-blind, International, Multicentre, Placebo-controlled, Dose-ranging, Parallel-group Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 when Added to Stable Methotrexate in Patients with Moderate or Severe Active Rheumatoid Arthritis - Robust
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- OxyPharma AB
- 入组人数
- 224
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. = 18 years old
- •2. Diagnosed with RA based on the ARA 1987 revised criteria
- •at least 16 weeks prior to study enrolment, Day 0 (Appendix B)
- •3. Have an ACR global functional status class of 1 to 3
- •(Appendix C)
- •4. Have active disease, defined as the presence of 6 swollen
- •joints and 6 tender joints in a 44 joint examination
- •5. Have a CRP level at screening of = 1.5 mg/dL
- •6. Have been taking oral or parenteral methotrexate (15 mg
- •weekly or above), have been using methotrexate for at least
- •16 weeks (up to Day 0 of study), and have been on a stable dose
- •for at least 8 weeks, up to Day 0. (Subjects using 10 to 15 mg
- •methotrexate may be considered for inclusion if an unacceptable
- •toxicity was recorded when higher doses were used.)
- •7. Stable optional RA medication:
- •- Folic acid supplementation if already in use
- •- Nonsteroidal anti-inflammatory drugs (NSAIDs)
- •including cyclooxengase-2 (Cox-2) inhibitors – doses
- •must be stable for 4 weeks prior to dosing with study
- •drug and consistent with labelling recommendations
- •- Acetylsalicylic acid is allowed in low doses as
- •cardiovascular prophylaxis
- •- Oral glucocorticoids, daily doses of up to 10 mg (incl.) of
- •prednisolone or equivalent for 4 weeks prior to study
- •enrolment (Day 0)
- •- Painkillers (acetaminophen, Tramadol and similar, alone
- •or in combinations) usage as per routine instructions will
- •be allowed, except for 24 hours before rheumatology
- •evaluations
- •8. Are using adequate forms of birth control - defined as 2
- •methods of birth control (eg, contraceptives and single-barrier
- •methods). Birth control is not necessary in subjects who have
- •been postmenopausal for > 1 year or who are surgically sterile
- •(including hysterectomy)
- •9. Subjects must be able to give informed consent after reading
- •and understanding the subject information sheet, are willing to
- •comply with all study procedures including completing all
- •questionnaires.
- •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. Arthritis onset prior to 16 years old
- •2. Any of the following infections:
- •- Known or acute infection that may affect CRP levels
- •- Active tuberculosis
- •- Known chronic infection with human immunodeficiency
- •virus (HIV), hepatitis C virus (HCV) or hepatitis B virus
- •(HBV) including positive serology
- •3. Ongoing systemic inflammatory condition which may
- •interfere with the results of clinical or laboratory tests planned in
- •the study (eg, systemic lupus erythematosus or any other systemic
- •rheumatic disease other than RA)
- •4. Any clinically significant concurrent medical condition
- •resulting in the following abnormal laboratory values:
- •aspartate aminotransferase (AST) = 2× the upper
- •limit of normal (ULN)
- •alanine aminotransferase (ALT) = 2× ULN
- •Alkaline phosphatase = 2.5 × ULN
- •Total bilirubin > ULN
- •Serum creatinine > 1.5 × ULN
- •Urea > 1.5 × ULN
- •Significant proteinuria (2+ on urinary dipstick test)
- •- Haematology
- •Haemoglobin < 9 g/dL
- •Leukocytes < 3.5 × 10exp6/dL
- •Absolute neutrophil count (ANC) < 1.5 × 10exp9/L
- •Platelets < 100 × 10exp6/L
- •5. Present or previous malignancies, except cured squamous or
- •basal skin cell carcinoma
- •6. Have uncontrolled diabetes mellitus
- •7. Have any medical condition, which in the judgment of the
- •Investigator, will put the subject at an unacceptable risk by
- •participating in the study
- •8. Require one or several of the following medications:
- •- Narcotics (except for Tramadol) or any drug for
- •treatment of RA other than NSAIDs, Cox-2 inhibitors,
- •acetaminophen/paracetamol for pain and arthritis control,
- •or aspirin (except for cardiovascular prophylaxis)
- •- Current or previous use of anti-inflammatory or immunemodulatory
- •therapy for treatment of RA (e.g., anti-IL-1
- •and anti-B-cell treatment)
- •- Current or previous use of DMARDs (e.g.
- •sulphasalazine, antimalarials, etc.), except methotrexate,
- •within 4 months prior to study enrolment (Day 0)
- •- Anti-tumour necrosis factor [anti-TNF] 2 months prior to
- •study enrolment (Day 0)
- •- Intra-articular, intramuscular, or intravenous
- •glucocorticoids within 4 weeks prior to study enrolment
- •9. Participation in an investigational study within the last 30
- •days or expects to be treated with an investigational product
- •during this study period.
- 另有 8 项未显示
研究者
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