EUCTR2007-000828-40-AT进行中（未招募）不适用
A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis. - C87076
CB Pharma S.A.0 个研究点目标入组 170 人开始时间: 2008年3月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 170
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. Patients must be at least 18 years old at the screening visit.
- •2. Female patients must be either postmenopausal for at least one year, surgically
- •incapable of childbearing, or effectively practicing an acceptable method of
- •contraception (i.e. either oral/parenteral/implantable hormonal contraceptives,
- •intrauterine device or barrier and spermicide). Abstinence only is not an acceptable
- •method. Patients must agree to use adequate contraception during the study and for 12 weeks after the last dose of certolizumab pegol.
- •3. Patients must have a diagnosis of adult–onset RA (of at least six months duration but not longer than ten years) as defined by the 1987 American College of Rheumatology classification criteria.
- •4. Patients must have moderate to low disease activity as defined by all of the following:
- •CDAI > 6 and = 16 at Screening and Baseline
- •= 2 tender joints (28 joint count) at Screening and Baseline
- •= 2 swollen joints (28 joint count) at Screening and Baseline
- •fulfilling 1 of the following 2 criteria during the screening period:
- •=28 mm/hour ESR (Westergren), or
- •CRP >10 mg/L
- •5. Patients must have received combination or mono DMARD therapy ((i.e., Sulfasalazine = 3mg/day; Leflunomide = 20mg/day; Hydroxychloroquine =400mg/day; MTX = 25mg/week) for at least six months prior to the Baseline visit.
- •The dose and route of administration of the DMARD therapy must have been stable
- •for at least 2 months prior to the baseline visit.
- •6. Patients must be able to understand the information provided to them and to give
- •written Informed Consent.
- •7. Patients must be able and willing to comply with the requirements of the study
- •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. Patients must not have a diagnosis of any other inflammatory arthritis (e.g., psoriatic arthritis,ankylosing spondylitis or connective tissue disease).
- •2. Patients must not have a secondary, non–inflammatory type of arthritis (e.g.
- •osteoarthritis or fibromyalgia) that in the Investigator’s opinion is symptomatic
- •enough to interfere with evaluation of the effect of study drug on the patient’s primary diagnosis of RA.
- •3. Patients must not have a history of an infected joint prosthesis at any time with that prosthesis still in situ.
- •4. Patients must be free of prohibited medication as detailed in the respective table in the protocol.
- •5. Patients must not have received any previous biological therapy for RA.
- •6. Patients must not have received any experimental non–biological therapy, within or outside a clinical trial in the three months prior to Baseline visit.
- •7. Female patients who are breast feeding, pregnant, or plan to become pregnant during the trial or for three months following last dose of study drug.
- •8. Patients with a history of chronic infection (more than 4 episodes requiring
- •antibiotics/antivirals during the preceding year), recent serious or life–threatening
- •infection within 6 months (including herpes zoster), or any current sign or symptom
- •that may indicate an infection.
- •9. Patients with active TB (or history of active TB) or positive chest X–ray for TB or
- •positive (defined as induration of = 5mm) PPD skin test or patients having close
- •contact with an individual with active TB. Patients having a PPD skin test greater or
- •equal to 5 mm can enter the study, provided that active TB is excluded and provided
- •that they are adequately treated for latent tuberculosis (e.g., isonicotinic acid hydrazide [INH therapy] for 9 months [with vitamin B6]) and provided that treatment is initiated at least 1 month prior to first administration of certolizumab pegol.
- •10. Patients at a high risk of infection (e.g. leg ulcers, indwelling urinary catheter and
- •persistent or recurrent chest infections and patients who are permanently bed ridden or wheelchair bound).
- •11. Patients with a history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time.
- •12. Patients with known concurrent acute or chronic viral hepatitis B or C.
- •13. Patients with known human immunodeficiency virus (HIV) infection.
- •14. Patients receiving any vaccination (live or attenuated) within eight weeks prior to
- •Baseline. (However, influenza and pneumococcal vaccines are allowed)
- •15. Concurrent malignancy or a history of malignancy (other than carcinoma of the cervix or basal cell carcinoma successfully treated more than five years prior to screening).
- •16. Patients with a history of blood dyscrasias.
- •17. Patients with a current or recent history, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease.
- •18. Patients with class III or IV congestive heart failure. New York Heart Association
- •(NYHA) 1964.
- •19. Patients with a history of, or suspected, demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis).
- •20. Patients with a history of an adverse reaction to PEG or a protein medicinal product.
- •21. Patients with any other condition (i.e. clinically significant laboratory values) which in the Investigator’s judgment would make the patient u
研究者
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