EUCTR2004-000145-38-CZ进行中（未招募）1 期
A Phase 2, Double-blind, Placebo-controlled, Randomized, Dose-ranging Study of Multiple Subcutaneous Injections of Human Monoclonal Antibody to IL-12p40 (CNTO 1275) in Subjects with Relapsing-remitting Multiple Sclerosis.
Centocor B.V.0 个研究点目标入组 0 人开始时间: 2004年9月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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. Be >/= 18 and 2. Have a definite diagnosis of RRMS according to the 2001 Guidelines from the
- •International Panel on the Diagnosis of MS (McDonald at al, 2001).
- •3. Have a Kurtzke’s EDSS Scale score of 0 to 6.5 (described in Appendix B of the
- •4. Have a history of at least 1 of the following:
- •* A minimum of 2 relapses of MS within the previous 2 years but not within the
- •1-month period prior to screening.
- •* A relapse of MS within the previous 6 months but not within the 1-month period
- •prior to screening.
- •5. Women of childbearing potential and men must be using adequate birth control
- •measures (eg, abstinence, oral contraceptives, intrauterine device [IUD], barrier
- •method with spermicide, or surgical sterilization) during the study and must agree
- •to continue such precautions for 1 year after receiving the last injection(s) of
- •study agent. Women of childbearing potential must test negative for pregnancy at
- •6. Are considered eligible according to county–specific TB screening guidelines for
- •latent TB defined in Section 4.3. of the protocol.
- •7. Are capable of providing written informed consent, which must be obtained prior
- •to any study-related procedures.
- •8. Are able to adhere to the study visit schedule and understand and comply with
- •other protocol requirements.
- •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. Have a CNS disease (eg, CNS lymphoma, systemic lupus erythematous) that could
- •affect the interpretation of the functional disability scale scores.
- •2. Have significant bulbar involvement of MS or other neurologic deficits or history
- •that would, in the judgment of the investigator, place the subject at significant risk
- •of infectious complications.
- •3. Have a decubitus ulcer.
- •4. Have an indwelling foley catheter.
- •5. Have received any immunomodulating therapies (eg, interferon) within the
- •3-month period prior to screening.
- •6. Have received glatiramer acetate within the 3-month period prior to screening.
- •7. Have ever received cladribine or any chemotherapeutic agents (eg, mitoxantrone).
- •8. Have received systemic corticosteroids within the 1-month period prior to
- •9. Have received any previous treatment with CNTO 1275 or any other
- •investigational agent for the treatment of MS that is known to target IL-12 or
- •10. Have received treatment in a clinical study within 3 months prior to screening or
- •within 5 half-lives (if known) of an investigational agent, whichever is longer.
- •The Sponsor may grant inclusion approval on an individual basis if it is
- •determined unlikely that the investigational agent would have an effect on MRI
- •lesions during the screening or treatment period.
- •11. Are pregnant, nursing, or planning pregnancy (both men and women) within 1
- •year after the last study agent injection(s).
- •12. Have a history of a previous immediate hypersensitivity response including
- •anaphylaxis or a severe allergic reaction to monoclonal antibodies.
- •13. Have a chest x-ray at screening or within 2 months prior to screening that shows
- •evidence of malignancy, infection, or any abnormalities suggestive of TB as
- •described in Section 4.3.2. of the protocol.
- •14. Have laboratory evidence of any of the following:
- •* Hemoglobin < 8.0 gm/dL
- •* WBC count < 3.0 x 1,000,000,000 cells/L
- •* Neutrophil count < 1.5 x 1,000,000,000 cells/L
- •* Platelet count < 100 x 1,000,000,000 cells/L
- •* Serum transaminase levels > 1.5 times the upper limit of normal for the clinical
- •* Serum creatinine levels > twice the upper limit of the normal reference
- •rangefor the clinical laboratory, unless calculated creatinine clearance is
- •> 30mL/min.
- •15. Have a serious infection (eg, hepatitis, pneumonia or pyelonephritis), a chronic
- •or serious recurring infection, hospitalization for infection, or treatment with IV
- •antibiotics for infection within 2 months prior to screening. Less serious
- •infections (eg, acute upper respiratory tract infection or uncomplicated urinary
- •tract infection) need not be considered exclusions at the discretion of the
- •investigator.
- •16. Have or have had opportunistic infections (eg, cytomegalovirus [CMV],
- •Pneumocystis carinii, histoplasmosis or any mycobacterial infection other than
- •TB) within 6 months prior to randomization.
- •17. Have a known or suspected diagnosis of asthma.
- •18. Have documented current or past infection with hepatitis B or C.
- •19. Have documented human immunodeficiency virus (HIV) infection.
- •20. Have presence of a transplanted organ (with the exception of a corneal
- •transplant performed > 3 months prior to randomization).
- •21. Have a known malignancy or history of malignancy within the previous 5 years
- 另有 1 项未显示
研究者
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