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临床试验/NL-OMON48290
NL-OMON48290撤回4 期

A phase 4, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with early, oligoarticular psoriatic arthritis despite initial stable treatment with either non-steroidal anti-inflammatory drugs (NSAIDs) and/or <=1 conventional synthetic disease-modifying antirheumatic drugs (DMARD). - Celgene CC-10004-PSA-013

Celgene Corporation0 个研究点目标入组 10 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
4 期
状态
撤回
入组人数
10
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

Trial never started

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99（—）

入选标准

  • •1. 1. Subject is a male or female, >= 18 years at time of consent.
  • •2. Subjects must understand and voluntarily sign an informed consent document
  • •prior to any study related assessments/procedures being conducted.
  • •3. Subject is willing and able to adhere to the study visit schedule and other
  • •protocol requirements.
  • •4. Subject must have a documented diagnosis of PsA (by any criteria) of >= 3
  • •months but <= 24 months duration at the time of the Screening Visit.
  • •5. Subject meets the CASPAR (Appendix B) criteria for PsA at the Screening
  • •6. Subject must have a total number of swollen joints greater than 1 and equal
  • •or less than 4 (> 1 but < 4 swollen joints) at the Screening Visit and
  • •confirmed prior to randomization at the Baseline Visit.
  • •7. Subject must have a total number of tender joints greater than 1 and equal
  • •or less than 4 (> 1 but < 4 tender joints) at Screening and confirmed prior to
  • •randomization at the Baseline Visit.
  • •8. Subjects taking oral glucocorticosteroids must be on a stable dose of
  • •prednisone <= 10 mg/day or equivalent for at least 4 weeks prior to the Baseline
  • •Visit (Section 8.1).
  • •9. For all regions, the local Regulatory Label for treatment with apremilast
  • •must be followed. For example, subjects in the EU must have had inadequate
  • •response or intolerance to a prior csDMARD.
  • •10. Subjects taking 1 protocol-allowed csDMARD (methotrexate [MTX] or
  • •sulfasalazine [SSZ]) may enter the study provided that the duration of
  • •treatment is <=6 months prior to the Baseline Visit and treatment is taken at a
  • •stable dose for at least 3 months prior to the Baseline Visit. See Permitted
  • •Medications (Section 8.1) for details describing dose criteria.
  • •11. Subjects exposed to MTX or SSZ and stopped treatment due to intolerance or
  • •due to safety reasons may enter the study provided that treatment was stopped
  • •within at least 4 days of the Baseline Visit.
  • •12. Subjects taking NSAIDs may enter the study provided that the dose is stable
  • •for at least 2 weeks prior to the Baseline Visit. Subjects may discontinue
  • •NSAIDs at any time up to and including the Baseline Visit, prior to study
  • •randomization.
  • •13. Females of childbearing potential (FCBP*) must have a negative pregnancy
  • •test at Screening and the Baseline Visit. While on investigational product and
  • •for at least 28 days after taking the last dose of investigational product,
  • •FCBP who engage in activity in which conception is possible must use one of the
  • •approved contraceptive** options described below:
  • •Option 1: Any one of the following highly effective methods: hormonal
  • •contraception (oral, injection, implant, transdermal patch, vaginal ring);
  • •intrauterine device (IUD); tubal ligation; or partner*s vasectomy;
  • •Option 2: Male or female condom (latex condom or non-latex condom NOT made out
  • •of natural [animal] membrane [for example, polyurethane]); PLUS one additional
  • •barrier method: (a) diaphragm with spermicide; (b) cervical cap with
  • •spermicide; or (c) contraceptive sponge with spermicide.
  • •NOTE: Option 2 may not be acceptable as a highly effective contraception option
  • •in all countries per local guidelines/regulations.
  • •*A female of childbearing potential is defined as a sexually mature female who:
  • •1) has not undergone a hysterectomy (the surgical removal of the uterus) or
  • •bilateral oophorectomy (the surgical remo

排除标准

  • •1.1. Prior use of >1 cs DMARD.
  • •2. Prior exposure to a JAK-inhibitor, including tyk2 inhibitors and/or a
  • •biologic DMARD.
  • •3. Use of intra-articular (IA) or intra muscular (IM) glucocorticoid injection
  • •within 8 weeks before the Baseline Visit.
  • •4. Use of leflunomide within 12 weeks of randomization. Subjects who stopped
  • •leflunomide and completed 11 days of treatment with cholestyramine (8 g, 3 x
  • •daily) prior to the Baseline Visit may enter the study.
  • •5. Prior use of cyclosporine.
  • •6. Prior treatment with apremilast, or participation in a clinical study,
  • •involving apremilast.
  • •7. Use of any investigational drug within 4 weeks of the Baseline Visit, or 5
  • •pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
  • •8. History of clinically significant or uncontrolled disease (as determined by
  • •the Investigator), which places the subject at unacceptable risk if he/she were
  • •to participate in the study.
  • •9. Any condition, including the presence of laboratory abnormalities, which
  • •places the subject at unacceptable risk if he/she were to participate in the
  • •study. Subjects with a creatinine clearance level less than 30 mL/min
  • •(estimated by the Cockcroft-Gault equation) will be considered to have severe
  • •renal impairment and will be excluded from the study.
  • •10. Prior history of suicide attempt at any time in the subject's lifetime
  • •prior to signing the informed consent, or major psychiatric illness requiring
  • •hospitalization within the last 3 years prior to signing the informed consent.
  • •11. Pregnant or breast feeding.
  • •12. Active substance abuse or a history of substance abuse within 6 months
  • •prior to Screening.
  • •13. History of allergy or hypersensitivity to any component of the
  • •investigational product.
  • •14. History of positive human immunodeficiency virus (HIV), or congenital or
  • •acquired immunodeficiency (eg, Common Variable Immunodeficiency Disease).
  • •15. Active tuberculosis or a history of incompletely treated tuberculosis.
  • •16. Bacterial infections requiring treatment with oral or injectable
  • •antibiotics, or significant viral or fungal infections, within 4 weeks of
  • •Screening. Any treatment for such infections must have been completed and the
  • •infection cured, at least 4 weeks prior to Screening and no new or recurrent
  • •infections prior to the Baseline Visit.
  • •17. Malignancy or history of malignancy or myeloproliferative or
  • •lymphoproliferative disease within the past 3 years, except for treated (ie,
  • •cured) basal cell or squamous cell in situ skin carcinomas.
  • •18. Major surgery (including joint surgery) within 8 weeks prior to the
  • •Screening Visit or planned major surgery within 6 months following the Baseline
  • •19. Rheumatic autoimmune disease other than PsA, including, but not limited to:
  • •systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD),
  • •scleroderma, polymyositis, or fibromyalgia.
  • •20. Prior history of or current inflammatory joint disease other than PsA (eg,
  • •gout, reactive arthritis, rheumatoid arthritis [RA], ankylosing spondylitis,
  • •Lyme disease), which confounds the ability to interpret data from the study.
  • •21. Erythrodermic, guttate, or generalized pustular psoriasis at randomization.

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