EUCTR2011-003678-97-BE进行中（未招募）1 期
Exploration of TNF-alpha Blockade with golimumab in the Induction of Clinical Remission in Patients with Early peripheral SpondyloArthritis (SpA) according to ASAS-criteria (‘CRESPA’).
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
入选标准
- •- Subject is = 18 years of age
- •- Subjects must meet the new ASAS classification criteria for peripheral spondyloarthritis
- •- Subjects must have had onset of peripheral SpA symptoms = 3 months prior to the screening visit
- •- Subjects must have active disease at screening and baseline, defined by Patient Global Assessment of Disease Activity VAS = 40mm and Patient Global Assessment of Pain VAS = 40mm at screening and baseline visits.
- •- In subjects with concurrent axial SpA symptoms, the peripheral SpA symptoms must be the predominant symptoms at study entry based on the Investigator’s clinical judgment.
- •- Subject has a negative PPD test (or equivalent) and Chest radiography (PA and lateral view) at screening. If the subject has a positive PPD test (or equivalent), has had a past ulcerative reaction following PPD placement and/or a Chest radiography consistent with prior TB exposure, the subject must initiate, or have documented completions of a course of anti-TB therapy.
- •- Patients must undergo screening for HBV (this includes testing for HBsAg (surface antigen), anti-HBs (surface antibody) and anti-HBc total (core antibody total).
- •- Women of childbearing potential or men capable of fathering children must be using adequate birth control measures during the study and for 6 months after receiving the last administration of study agent. Female patients of childbearing potential must test negative for pregnancy.
- •- If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or is of childbearing potential and is practicing an approved method of birth control throughout the study and for 6 months after last dose of study drug.
- •- Female subjects must agree to not donate eggs (ova, oocytes) during the study and for 6 months after last dose of study agent. Male subjects must agree to not donate sperm while in the study and for 6 months after last dose of study agent
- •- Subject is judged to be in good health as determined by the principal investigator based upon the results of medical history, laboratory profile, physical examination, chest x-ray (CXR), and a 12-lead electrocardiogram (ECG) performed during screening.
- •- Subjects must be able and willing to provide written informed consent and comply with the requirements of this study protocol.
- •- Subjects must be able and willing to self-administer sc injections or have a qualified person available to administer sc injections.
- •CRESPA-Extension’
- •Subjects will be allowed to participate in the ‘CRESPA-Extension’ part of the study if they are considered good candidates for chronic anti-TNF treatment and fulfill one of the following 2 scenarios:
- •- Patients participating in ‘CRESPA’ that experienced sustained clinical remission of arthritis/enthesitis/dactylitis on 2 consecutive major study visits, and in whom withdrawal of golimumab treatment provoked a flare of peripheral SpA during the follow-up.
- •- Patients participating in ‘CRESPA’ that experienced a major improvement at the week 48 ‘end-of-study’ visit, without however reaching clinical remission. Major improvemen
排除标准
- •- Medical history of inflammatory arthritis of a different etiology other than peripheral spondyloarthritis (e.g. rheumatoid arthritis, systemic lupus erythematosus, gout, or any arthritis with onset prior to age 16 years such as JIA).
- •- Prior exposure to any biologic therapy with a potential therapeutic impact on SpA, including anti-TNF therapy.
- •- Treatment with any investigational drug of chemical or biological nature within a minimum of 30 days or 5 half lives (whichever is longer) of the drug prior to the Baseline Visit.
- •- Infection(s) requiring treatment with intravenous (iv) anti-infectives within 30 days prior to the Baseline visit or oral anti-infectives within 14 days prior to the Baseline Visit.
- •- Have a known hypersensitivity to human immunoglobulin proteins or other components of golimumab.
- •- History of CNS demyelinating disease or neurologic symptoms suggestive of CNS demyelinating disease.
- •- History of listeriosis, histoplasmosis, chronic of active Hepatitis B infection, Hepatitis C infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active TB.
- •- Have a history of, or concurrent, CHF, including medically controlled, asymptomatic CHF.
- •- Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
- •- Have received, or are expected to receive, any live virus or bacterial vaccination within 3 months prior to the first administration of study agent, during the trial, or within 6 months after the last administration of study agent.
- •- Positive pregnancy test at screening or baseline.
- •- Female subjects who are breast-feeding or considering becoming pregnant during the study.
- •- History of clinically significant drug or alcohol abuse in the last 12 months.
- •- Clinically significant abnormal screening laboratory results as evaluated by the Investigator.
- •- Positive rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP) antibody at screening if the titers are crossing 3 times the upper limit of the normal
- •- Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
- •- Subject with diagnosis and current symptoms of fibromyalgia.
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