A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076.

CB Pharma S.A.0 个研究点目标入组 132 人开始时间: 2010年1月5日最近更新: 2013年1月21日

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: 132

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

性别: All

入选标准

•1. Subjects must have either failed to achieve remission in study C87076 at Week 20 and/or Week 24 (CDAI > 2.8), which is confirmed at Week 24 or must have achieved remission at Week 20, which was confirmed at Week 24, flared up between Week 24 and Week 52 and completed the entire C87076 study through Week 52.
•2. Subjects must have complied with the protocol requirements during their participation in study C87076.
•3. Female subjects of childbearing potential must have a negative urine pregnancy test at the Entry visit and must continue to have negative urine pregnancy tests administered every 8 weeks immediately before certolizumab pegol administration. Female subjects must be either postmenopausal for at least one year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral / parenteral / implantable hormonal contraceptives, intrauterine device or barrier and spermicide). Abstinence only is not an acceptable method. Subjects must agree to use adequate contraception during the study and for 12 weeks after the last dose of certolizumab pegol.
•4. Subjects must be able to understand the information provided to them and to give written Informed Consent for C87080.
•5. Subjects must be able and willing to comply with the requirements of the study protocol.
•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 must not have a diagnosis of any other inflammatory arthritis.
•2. Subjects must not have a secondary, non–inflammatory type of arthritis that in the Investigator’s opinion is symptomatic enough to interfere with evaluation of the effect of study drug on the subject’s primary diagnosis of RA.
•3. Subjects must not have a history of an infected joint prosthesis at any time with that prosthesis still in situ.
•4. Female subjects who are breast feeding, pregnant, or plan to become pregnant during the trial or for three months following last dose of study drug.
•5. Subjects with a history of chronic infection (more than 4 episodes requiring antibiotics/antivirals during the preceding year), recent serious or life–threatening infection during C87076 participation (including herpes zoster), or any current sign or symptom that may indicate an infection.
•6. Subjects with active tuberculosis.
•7. Subjects at a high risk of infection.
•8. Subjects with a history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time
•9. Subjects with known concurrent acute or chronic viral hepatitis B or C.
•10. Subjects with known human immunodeficiency virus (HIV) infection.
•11. Subjects receiving any vaccination (live or attenuated) during their participation in C87076 study (however, influenza and pneumococcal vaccines are allowed).
•12. 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).
•13. Subjects with a history of blood dyscrasias.
•14. Subjects 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
•15. Subjects with class III or IV congestive heart failure. New York Heart Association (NYHA) 1964.
•16. Subjects with a history of, or suspected, demyelinating disease of the central nervous system.
•17. Subjects with a history of an adverse reaction to PEG or a protein medicinal product.
•18. Subjects with any other condition which in the Investigator’s judgment would make the subject unsuitable for inclusion in the study.

研究者

发起方

CB Pharma S.A.

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