EUCTR2007-004687-47-SE进行中（未招募）不适用
A Phase 3, Multicenter, Randomized, Double-blind Study Comparing the Safety and Efficacy of ABT-874 to Methotrexate in Subjects with Moderate to Severe Chronic Plaque Psoriasis.
Abbott GmbH & Co. K.G.0 个研究点目标入组 317 人开始时间: 2007年12月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 317
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. Males and females 18 years of age and over.
- •2. Clinical diagnosis of psoriasis for at least 6 months as determined by subject
- •interview of his/her medical history and confirmation of diagnosis through
- •physical examination by the Principal Investigator.
- •3. Stable plaque psoriasis for at least 2 months before Screening and at Baseline
- •(Week 0) visits as determined by subject interview of his/her medical history.
- •4. Moderate to severe plaque psoriasis defined by = 10% Body Surface Area (BSA)
- •involvement at the Baseline (Week 0) visit.
- •5. PGA of at least moderate disease (defined as PGA = 3) at the Baseline (Week 0)
- •6. PASI score of = 12 at the Baseline (Week 0) visit.
- •7. Subject is a candidate for systemic therapy or phototherapy and has active psoriasis despite treatment with topical agents.
- •8. Women are eligible to participate in the study if they meet one of the following
- •? Women of childbearing potential must undergo monthly pregnancy testing
- •during the study and agree to use two of the following methods of
- •contraception throughout the study and for 6 months after the last dose of study
- •? Oral contraceptives;
- •? Transdermal contraceptives;
- •? Injectable or implantable methods;
- •? Intrauterine devices; and
- •? Barrier methods (diaphragm with spermicide, condom with spermicide).
- •Subjects using oral or parenteral forms of contraceptives must have been
- •practicing birth control for at least three months prior to study drug
- •administration.
- •? Women who are postmenopausal (for at least one year), sterile, or
- •hysterectomized;
- •? Women who have undergone tubal ligation will be required to undergo
- •monthly pregnancy testing during the duration of the study and agree to use a
- •second form of contraception which includes:
- •? Oral contraceptives;
- •? Transdermal contraceptives;
- •? Injectable or implantable methods;
- •? Intrauterine devices; and
- •? Barrier methods (diaphragm with spermicide, or condom with
- •spermicide).
- •9. Sexually active male subjects (including males who have had a vasectomy) are
- •able to participate in the study if they use effective contraception (i.e. condoms
- •with spermicide) during the study and 6 months after study completion.
- •10. Subject is judged to be in good general health as determined by the Principal
- •Investigator based upon the results of medical history, laboratory profile, physical
- •examination, chest X-ray (CXR), and 12-lead electrocardiogram (ECG) performed
- •at Screening.
- •11. Able and willing to give written informed consent and to comply with the
- •requirements of this 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. Previous exposure to systemic anti-IL-12 therapy, including ABT-874.
- •2. Subject has previous exposure to MTX.
- •3. Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis,
- •medication-induced or medication-exacerbated psoriasis, or new onset guttate
- •4. Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or
- •viral) that may interfere with evaluation of psoriasis.
- •5. History of an allergic reaction or significant sensitivity to constituents of study
- •drug (See Section 5.5.2 of the study protocol).
- •6. Cannot discontinue topical therapies for the treatment of psoriasis such as
- •corticosteroids, vitamin D analogs, or retinoids at least 2 weeks prior to the
- •Baseline (Week 0) visit and during the study. Subjects are allowed to use:
- •? Shampoos that contain no corticosteroid;
- •? Bland (without beta or alpha hydroxy acids) emollients;
- •? Low potency (Class VI or Class VII) topical corticosteroids on the palms,
- •soles, face, inframammary area, and groin only. See Appendix O for a listing
- •of examples of Class VI or VII topical corticosteroids.
- •7. Cannot avoid UVB phototherapy for at least 2 weeks prior to the Baseline
- •(Week 0) visit and during the study.
- •8. Cannot avoid PUVA phototherapy for at least 4 weeks prior to the Baseline
- •(Week 0) visit and during the study.
- •9. Cannot discontinue systemic therapies for the treatment of psoriasis, or systemic
- •therapies known to improve psoriasis, during the study. See study protocol for further details.
- •10. Subject is taking or requires oral or injectable corticosteroids during the study.
- •Inhaled corticosteroids for stable medical conditions are allowed.
- •11. Poorly controlled medical condition, such as uncontrolled diabetes with
- •documented history of recurrent infections, unstable ischemic heart disease,
- •congestive heart failure, recent cerebrovascular accidents and any other condition,
- •which, in the opinion of the Investigator or Medical Monitor, would put the subject at risk by
- •participation in the study.
- •12. Subject has a history of clinically significant hematologic (e.g. severe anemia,
- •leukopenia, thrombocytopenia), renal or liver disease (e.g. fibrosis, cirrhosis,
- •hepatitis).
- •13. Subject has infection or risk factors for severe infections, for example:
- •? Excessive immunosuppression or other factors associated with it, including
- •human immunodeficiency virus infection;
- •? Severe, recurrent, or persistent infections such as Hepatitis B or C;
- •? Active tuberculous disease;
- •? Evidence of latent tuberculosis (TB) infection demonstrated by Purified
- •Protein Derivative (PPD) = 5 mm of induration and/or chest X-ray (CXR)
- •findings suggestive of latent TB; EXCEPT if prophylactic treatment, as
- •recommended by local guidelines, is initiated prior to administration of study
- •drug or there is documentation that the subject has received prophylactic
- •treatment for TB previously, see Appendix D of the study protocol (US Center for Disease Control [CDC] Treatment Recommendations for Positive PPD Tuberculosis
- •Information - Treatment of Latent TB Infection);
- •? Any other significant infection requiring hospitalization or intravenous (IV)
- •antibiotics in the month prior to Screening;
- •? Infection requiring treatment with antibiotics in the two weeks prior to
- •? Subject has received vaccination with Bacille Calmette-Guerin (BCG) within
- •12 months prior to Screening;
- •? Subject has received vaccination with a live viral agent one month prior to
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