A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of two doses of Apremilast (CC-10004) in subjects with active psoriatic arthritis

Celgene Corporation0 个研究点目标入组 495 人开始时间: 2010年12月8日最近更新: 2017年2月13日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Celgene Corporation
入组人数: 495

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. Male or female, aged = 18 years at time of consent.
•2. Must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
•3. Able to adhere to the study visit schedule and other protocol requirements.
•4. Have a documented diagnosis of PsA (by any criteria) of = 6 months’ duration.
•5. Meet the CASPAR criteria for PsA at time of screening.
•6. Have = 3 swollen AND = 3 tender joints, despite prior or current treatment with DMARDs (inadequate control by DMARDs applies to therapeutic failure, loss of insurance, intolerance, adverse effects, or other reasons for discontinuation).
•7. Be receiving treatment on an outpatient basis.
•8. If taking methotrexate, leflunomide, or sulfasalazine, must have been treated for at least 16 weeks and on a stable dose (oral or parenteral methotrexate = 25 mg/week; leflunomide = 20 mg/day; sulfasalazine = 2 g/day) for at least 4 weeks prior to screening and through Week 24 of the study. One reduction in DMARD dose will be permitted after Week 24.
•9. If taking oral corticosteroids, must be on a stable dose of prednisone = 10 mg/day or equivalent for at least 1 month prior to screening.
•10. If taking NSAIDs or narcotic analgesics, must be on stable dose for at least 2 weeks prior to screening and until they have completed the Week 24 study visit.
•11. Low potency topical corticosteroids (Appendix M or locally-available equivalent) will be allowed as background therapy for treatment of psoriasis on the face, axillae and groin in accordance with the manufacturers’ suggested usage during the course of the study. Subjects with scalp psoriasis will be permitted to use coal tar shampoo and/or salicylic acid scalp preparations on scalp lesions. A non-medicated skin emollient (eg, Eucerin cream) will also be permitted for body lesions only. Subjects must not use these treatments within 24 hours prior to the clinic visit.
•12. Meet the following laboratory criteria:
•- White blood cell count ? 3000/mm3 (= 3.0 x 109/L) and < 14,000/mm3
•(< 14 x 109/L)
•- Platelet count = 100,000/mm3 (= 100 x 109/L)
•- Serum creatinine = 1.5 mg/dL (= 132.6 µmol/L)
•- AST (SGOT) and ALT (SGPT) = 2 X upper limit of normal (ULN)
•- Total bilirubin = 2 mg/dL (= 34 µmol/L)
•- Hemoglobin = 9 g/dL (= 5.6 mmol/L)
•- Hemoglobin A1c = 9.0%
•13. Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (male latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]) while on IP and for at least 28 days after the last dose of IP.
•14. Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use contraception† while on study medication and for at least 28 days after taking the last dose of study medication with either: 1) one highly effective form (non-oral hormonal, intrauterine device [IUD], tubal ligation, vasectomized partner); or 2) an oral hormonal contraceptive PLUS one additional form of barrier contraception (male or female latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane], diaphragm with spermicide, cervical cap with spermicide, contraceptive sponge with spermicide); or 3) two forms of barrier contraception (male or female latex condom or nonlatex condom NOT made out of natural [a;
•1. Male or female, aged = 18 years at time of consent.
•2. Must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
•3. Able to adhere to the study visit schedule and other protocol requirements.
•4. Have a documented diagnosis of PsA (by any criteria) of = 6 months’ duration.
•5. Meet the CASPAR criteria for PsA at time of screening.
•6. Have = 3 swollen AND = 3 tender joints, despite prior or current treatment with DMARDs (inadequate control by DMARDs applies to therapeutic failure, loss of insurance, intolerance, adverse effects, or other reasons for discontinuation).
•7. Be receiving treatment on an outpatient basis.
•8. If taking methotrexate, leflunomide, or sulfasalazine, must have been treated for at least 16 weeks and on a stable dose (oral or parenteral methotrexate = 25 mg/week; leflunomide = 20 mg/day; sulfasalazine = 2 g/day) for at least 4 weeks prior to screening and through Week 24 of the study. One reduction in DMARD dose will be permitted after Week 24.
•9. If taking oral corticosteroids, must be on a stable dose of prednisone = 10 mg/day or equivalent for at least 1 month prior to screening.
•10. If taking NSAIDs or narcotic analgesics, must be on stable dose for at least 2 weeks prior to screening and until they have completed the Week 24 study visit.
•11. Low potency topical corticosteroids (Appendix M or locally-available equivalent) will be allowed as background therapy for treatment of psoriasis on the face, axillae and groin in accordance with the manufacturers’ suggested usage during the course of the study. Subjects with scalp psoriasis will be permitted to use coal tar shampoo and/or salicylic acid scalp preparations on scalp lesions. A non-medicated skin emollient (eg, Eucerin cream) will also be permitted for body lesions only. Subjects must not use these treatments within 24 hours prior to the clinic visit.
•12. Meet the following laboratory criteria:
•- White blood cell count ? 3000/mm3 (= 3.0 x 109/L) and < 14,000/mm3
•(< 14 x 109/L)
•- Platelet count = 100,000/mm3 (= 100 x 109/L)
•- Serum creatinine = 1.5 mg/dL (= 132.6 µmol/L)
•- AST (SGOT) and ALT (SGPT) = 2 X upper limit of normal (ULN)
•- Total bilirubin = 2 mg/dL (= 34 µmol/L)
•- Hemoglobin = 9 g/dL (= 5.6 mmol/L)
•- Hemoglobin A1c = 9.0%
•13. Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (male latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]) while on IP and for at least 28 days after the last dose of IP.
•14. Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use contraception† while on study medication and for at least 28 days after taking the last dose of study medication with either: 1) one highly effective form (non-oral hormonal, intrauterine device [IUD], tubal ligation, vasectomized partner); or 2) an oral hormonal contraceptive PLUS one additional form of barrier contraception (male or female latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane], diaphragm with spermicide, cervical cap with spermicide, contraceptive sponge with spermicide); or 3) two forms of barrier contraception (male or female latex condom or nonlatex condom NOT made out of natural [a;
•1. Male or female, aged = 18 years at time of consent.
•2. Must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
•3. Able to adhere to the study visit schedule and other protocol requirements.
•4. Have a documented diagnosis of PsA (by any criteria) of = 6 months’ duration.
•5. Meet the CASPAR criteria for PsA at time of screening.
•6. Have = 3 swollen AND = 3 tender joints, despite prior or current treatment with DMARDs (inadequate control by DMARDs applies to therapeutic failure, loss of insurance, intolerance, adverse effects, or other reasons for discontinuation).
另有 16 项未显示

排除标准

•1. History of clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease.
•2. Any condition, including the presence of laboratory abnormalities that places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
•3. Clinically significant abnormality on 12-lead ECG at Screening.
•4. Pregnant or breast feeding.
•5. History of allergy to any component of the investigational product (IP).
•6. Hepatitis B surface antigen positive at screening.
•7. Hepatitis C antibody positive at screening.
•8. AST (SGOT) and/or ALT (SGPT) > 1.5X ULN and total bilirubin > ULN or albumin
•9. History of positive Human Immunodeficiency Virus (HIV), or congenital or acquired immunodeficiency (eg, Common Variable Immunodeficiency Disease).
•10. Active tuberculosis or a history of incompletely treated tuberculosis.
•11. Clinically significant abnormality based upon chest radiograph with at least PA view (radiograph must be taken within 12 weeks prior to Screening or during the Screening visit). An additional lateral view is strongly recommended but not required.
•12. Active substance abuse or a history of substance abuse within 6 months prior to Screening.
•13. 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 at least 4 weeks prior to Screening.
•14. Malignancy or history of malignancy (except for treated [ie, cured] basal-cell or squamous cell in situ skin carcinomas and treated [ie, cured] cervical intraepithelial neoplasia [CIN] or carcinoma in situ of the cervix.
•15. Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization.
•16. Erythrodermic, guttate, or generalized pustular psoriasis at randomization.
•17. Topical therapy for psoriasis, except as noted in the Inclusion Criteria, within 2 weeks of randomization (including but not limited to topical corticosteroids, topical retinoids or vitamin D analog preparations, tacrolimus, pimecrolimus, or anthralin).
•18. Rheumatic autoimmune disease other than PsA, including systemic lupus erythematosis (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis or fibromyalgia.
•19. Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis (Appendix Q).
•20. Prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, RA, ankylosing spondylitis, Lyme disease).
•21. Use of the following systemic therapy(ies) within 4 weeks of randomization, including but not limited to cyclosporine or other calcineurin inhibitors, corticosteroids and small molecule DMARDs (except as noted in inclusion criteria), oral retinoids, mycophenolate, thioguanine, hydroxyurea, sirolimus, tacrolimus, azathioprine, fumaric acid esters.
•22. Use of phototherapy within 4 weeks of randomization (ie, UVB, PUVA).
•23. Use of adalimumab, etanercept, golimumab, infliximab, certolizumab pegol, or tocilizumab within 12 weeks of randomization.
•24. Use of alefacept or ustekinumab within 24 weeks of randomization.
•25. Previous treatment with any cell depleting therapies, including investig;
•1. History of clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease.
•2. Any condition, including the presence of laboratory abnormalities that places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
•3. Clinically significant abnormality on 12-lead ECG at Screening.
•4. Pregnant or breast feeding.
•5. History of allergy to any component of the investigational product (IP).
•6. Hepatitis B surface antigen positive at screening.
•7. Hepatitis C antibody positive at screening.
•8. AST (SGOT) and/or ALT (SGPT) > 1.5X ULN and total bilirubin > ULN or albumin
•9. History of positive Human Immunodeficiency Virus (HIV), or congenital or acquired immunodeficiency (eg, Common Variable Immunodeficiency Disease).
•10. Active tuberculosis or a history of incompletely treated tuberculosis.
•11. Clinically significant abnormality based upon chest radiograph with at least PA view (radiograph must be taken within 12 weeks prior to Screening or during the Screening visit). An additional lateral view is strongly recommended but not required.
•12. Active substance abuse or a history of substance abuse within 6 months prior to Screening.
•13. 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 at least 4 weeks prior to Screening.
•14. Malignancy or history of malignancy (except for treated [ie, cured] basal-cell or squamous cell in situ skin carcinomas and treated [ie, cured] cervical intraepithelial neoplasia [CIN] or carcinoma in situ of the cervix.
•15. Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization.
•16. Erythrodermic, guttate, or generalized pustular psoriasis at randomization.
•17. Topical therapy for psoriasis, except as noted in the Inclusion Criteria, within 2 weeks of randomization (including but not limited to topical corticosteroids, topical retinoids or vitamin D analog preparations, tacrolimus, pimecrolimus, or anthralin).
•18. Rheumatic autoimmune disease other than PsA, including systemic lupus erythematosis (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis or fibromyalgia.
•19. Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis (Appendix Q).
•20. Prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, RA, ankylosing spondylitis, Lyme disease).
•21. Use of the following systemic therapy(ies) within 4 weeks of randomization, including but not limited to cyclosporine or other calcineurin inhibitors, corticosteroids and small molecule DMARDs (except as noted in inclusion criteria), oral retinoids, mycophenolate, thioguanine, hydroxyurea, sirolimus, tacrolimus, azathioprine, fumaric acid esters.
•22. Use of phototherapy within 4 weeks of randomization (ie, UVB, PUVA).
•23. Use of adalimumab, etanercept, golimumab, infliximab, certolizumab pegol, or tocilizumab within 12 weeks of randomization.
•24. Use of alefacept or ustekinumab within 24 weeks of randomization.
•25. Previous treatment with any cell depleting therapies, including investig;
另有 25 项未显示

研究者

发起方

Celgene Corporation

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