EUCTR2008-004754-33-CZ进行中（未招募）不适用
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of BG00012 when given with Methotrexate to Subjects with Active Rheumatoid Arthritis who have had an Inadequate Response to Coventional Disease-Modifying Anti-rheumatic Drug Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
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. Must give written informed consent and any authorisations required by local law
- •2. Aged 18-75 years old inclusive at time of randomisation
- •3. Must have a diagnosis of adult, onset RA according to the 1987 Revised American Rheumatism Association Criteria for the Classification of Rheumatoid Arthritis (Section 22, Appendix A1), and be (Function Class I-III) (Section 22, Appendix A2), for at least 6 months prior to Day 0
- •4.Must have been treated with and be tolerating MTX (=7.5 mg/week to = 25 mg/week) for at least three months immediately prior to Day 0
- •5. Must have had an inadequate response to at least 1 coventional DMARD therapy (e.g. MTX, leflunomide, sulfasalazine, etc.) due to inadequate efficacy or toxicity
- •6.Must have a swollen joint count (SJC) =6 and a Tender Joint Count (TJC) =6 (66/68 joint count at screening)
- •7. Must have an elevated hsCRP = 1.5 times the upper limit of normal (ULN) or erythrocyte sedimentation rate (ESR) = 28 mm/hr at Screening
- •8.Must be willing to receive oral folate (= 5mg/week) or folinic acid (=1mg/week) for the duration of the study
- •9. All male and female subjects of child-bearing potential must practice effective contraception during the study and be willing and able to continue contraception for 1 month after their last dose of study treatment
- •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. Subjects with a history of malignant disease, including solid tumours and haematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completed excised and are considered cured)
- •2. History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
- •3. History of clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal or haematologic insufficiency, or any major disease that could affect any of the efficacy assessments, in particular, joint pain and swelling (e.g. Parkinson's Disease, cerebal palsy, diabetic neuropathy)
- •4. Known active bacterial, viral, fungal, mycobacterial, opportunistic infection or other infection (including atypical micobacterial disease, but excluding fungal infections of the nail beds) or any major episode of infection requiring hospitalisation or treatment with intravenous (IV) antibiotics within 4 weeks of Day 0
- •5. Nursing mothers, pregnant women, or women who are planning to become pregnant while in the study
- •6 Treatment with another investigational drug, investigational device, or approved therapy for investigational use within three months prior to Day 0 or within 5 half-lives of the agent, whichever is longer.
- •7. Previous treatment with anti-TNF treatment or any other non-TNF inhibitor biologic or prosorba column
- •8. Any live immunisation/vaccination within 1 month prior to dosing.
- •9. Treatment with the following concomitant medications:
- •- Any oral steroid exceeding 10 mg/day of prednisone or equivalent administered within 4 weeks prior to Day 0 or any oral steroid = 10 mg/day of prednisone or equvalent that was not administered at a stable dose for at least 4 weeks prior to Day 0
- •- Leflunomide administered within 8 weeks prior to Day 0
- •- Cyclosporin A administered within 8 weeks prior to Day 0
- •- Azathioprine or 6-MP administered within 28 days prior to Day 0
- •-Hydroxychloroquine sulfate or sulfasalazine, or any other allowed concomitant DMARDS administered at doses greater than the recommended therapeutic dose or not adminstered at a stable dose for 4 weeks prior to Day 0
- •- Any NSAIDS not administered at a stable dose for at least 2 weeks prior to Day 0
- •- Intra-articular or intramuscular corticosteroid injections given within 4 weeks prior to Day 0
- •10. Previous exposure to BG00012 or FUMADERM® for RA
- •11. Subjects who underwent any surgical procedure, including bone, joint, synovectomy within 12 weeks prior to Day 0 or who are planning unapproved ( by Biogen Idec) procedure within 16 weeks prior to Day 0
- •12. Subjects with any laboratory test result at screening visit considered clinically significant
- •13. Serum creatinine > 1.2 ULN established by the central laboratory
- •14. Any of the following abnormal urine tests at screening, confirmed by a second urinalysis 2 weeks later:
- •-proteinuria (1+ or greater)
- •- haematuria, without known etiology
- •- glycosuria, without known etiology
- •15. Positive for hepatitis C or current hepatitis B infection
- •16. Known to be postive for HIV at screening visit
- •17. Blood donation within 2 months prior to Day 0
- •18. History of drug or alcohol abuse within 1 year prior to Day 0
- •19. Current enrollment in any other study treatment or disease study
- •20.Inability to comply with study requirements
- •21. Other unspecified reasons that, in the opinion of the investigator or Biogen Idec, make the subject unsuitable for enrollment
研究者
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