EUCTR2010-019926-15-CZ进行中（未招募）不适用
A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY, TO COMPARE THE EFFICACY AND SAFETY OF TWO DOSES OF APREMILAST (CC-10004) IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 210
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
- •General Subject Population:
- •1. Male or female, must be age = 18 years at the time of consent.
- •2. Must understand and voluntarily sign an informed consent form prior to any study related assessments/procedures are conducted.
- •3. Must be able to adhere to the study visit schedule and other protocol requirements. Disease Specific Parameters:
- •4. Must have a documented diagnosis of RA (1987 ACR Criteria, Appendix A) with onset of signs/symptoms of disease = 4 months of duration from randomization.
- •5. Must be receiving treatment on an outpatient basis.
- •6. Must have active disease despite current methotrexate treatment as defined below:
- •= 6 swollen joints (66 swollen joint count) at randomization (Visit 2) AND
- •= 6 tender joints (68 tender joint count) at randomization (Visit 2)
- •7. Must meet at least one of the four lab requirements below:
- •- hsCRP = 10 mg/L
- •- ESR > 28 mm after the first 1 hour
- •- Positive for RF
- •- Positive for anti-CCP antibodies
- •8. For subjects participating in the MRI assessment:
- •-Must have RA joint involvement, as assessed by swollen joint counts in: 1) at least
- •two MCP swollen joints on the same hand, or 2) at least one swollen MCP joint and
- •swollen wrist on the same hand.
- •Current Treatment:
- •9. Must have been treated with methotrexate for at least 4 months prior to randomization, and must be on stable dose between 7.5 and 25 mg/week (oral or parenteral) for at least 4 weeks prior to randomization. Subjects will be required to maintain their stable dose through Week 52 of the study. Oral folate (folic acid) supplementation is required with a minimum dose of 5 mg/week, or instead leucovorin may be used up to 10 mg/week orally.
- •10. NSAIDs and pain medications are allowed, however, must be on stable regimen for at least 7 days prior to randomization and through Week 52 of the study.
- •11. Oral corticosteroids (if taken) are allowed, however, must be on stable dose of prednisone = 10 mg/day or equivalent for at least 28 days prior to randomization and through Week 52 of the study.
- •Laboratory Measures:
- •12. Must meet the following laboratory criteria at screening:
- •- White blood cell count = 3000/mm3 (= 3.0 x 109/L) and < 14,000/mm3 (< 14 x
- •- Platelet count = 100,000/µL (= 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). If initial test
- •shows ALT or AST > 2 times the ULN, one repeat test is allowed during the
- •screening period.
- •- Total bilirubin = 2 mg/dL (= 34 µmol/L). If initial test result is > 2 mg/dL, one repeat
- •test is allowed during the screening period.
- •- Hemoglobin = 9 g/dL (= 5.6 mmol/L)
- •- Hemoglobin A1c = 9.0%
- •- Negative for hepatitis B surface antigen
- •- Negative for hepatitis C antibody
- •Contraception Requirement:
- •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 IP and for at least 28 days after taking the last dose of IP with either: 1) one highly effective form (non-oral hormonal, intrauterine device [IUD], tubal ligation, vasectomized partner); or 2) an or
排除标准
- •Disease Specific Requirements:
- •1. Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization.
- •2. Rheumatic autoimmune disease other than RA, including systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis or significant systemic involvement secondary to RA (eg, vasculitis, pulmonary fibrosis or Felty syndrome). Sjögren syndrome secondary to RA is allowable.
- •3. Functional Class IV as defined by the ACR Classification of Functional Status in
- •Rheumatoid Arthritis (Appendix B).
- •4. Prior history of, or current, inflammatory joint disease other than RA (eg, gout, reactive arthritis, psoriatic arthritis, ankylosing spondylitis, Lyme disease).
- •Previous and Current Medications/Therapy:
- •5. Receiving treatment with DMARDs (other than MTX), including biologic DMARDs.
- •Previous use is only allowed after adequate washout prior to randomization.
- •6. Inadequate response to treatment with an anti-TNF agent. Patients who terminated previous anti-TNF treatment due to cost or safety reason, such as discomfort with the subcutaneous injections, may participate in this study after adequate washout.
- •7. Treatment with any investigational agent within four weeks (or five half-lives of the investigational drug, whichever is longer) of screening.
- •8. Previous treatment with any cell depleting therapies, including investigational agents (eg, CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19 and anti-CD20).
- •9. Treatment with intravenous gamma globulin, plasmapheresis or Prosorba® column within 6 months of baseline.
- •10. Intra-articular or parenteral corticosteroids are not allowed within 6 weeks prior to randomization.
- •11. Any previous treatment with alkylating agents such as cyclophosphamide or
- •chlorambucil, or with total lymphoid irradiation.
- •General Health:
- •12. Pregnant women or nursing (breast feeding) mothers.
- •13. Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including severe or very severe chronic obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus as defined by HbA1c > 9.0%) or gastrointestinal (GI) disease.
- •14. Uncontrolled disease states, such as asthma, psoriasis or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids.
- •15. Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (including but not limited to tuberculosis and atypical mycobacterial disease, Hepatitis B and C, and herpes zoster, but excluding onychomycosis) or any major episode of infection requiring hospitalization or treatment with IV or oral antibiotics within 4 weeks of screening.
- •16. History of positive Human Immunodeficiency Virus (HIV), or congenital or acquired
- •immunodeficiency (eg, Common Variable Immunodeficiency Disease).
- •17. History of malignancy, including solid tumors and hematologic malignancies (except basal cell carcinoma of the skin that has been excised and cured).
- •18. History of alcohol, drug or chemical abuse within the 6 months prior to screening.
- •19. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- •20. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
- •21. Any condition that i
研究者
相似试验
进行中（未招募）
1 期
A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, COMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF TIGECYCLINE VERSUS IMIPENEM/CILASTATIN FOR THE TREATMENT OF SUBJECTS WITH HOSPITAL-ACQUIRED PNEUMONIAHospital-Acquired Pneumonia (HAP) including Ventilator-Associated Pneumonia (VAP)MedDRA version: 9.1Level: PTClassification code 10035664Term: PneumoniaEUCTR2008-000412-33-FRWyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development210
进行中（未招募）
1 期
A phase 2, multicenter, randomized, double-blind, controlled with placebo, to obtaine efficacy , safety and tolerability information for TAK-935 as an adjuntive therapy in pediatric patinets ((aged =2 and =17 years) with developmental and/or epileptic encephlopathies (Dravet syndrome and Lennox Gastaut)Epileptic Encephalitis: Dravet and Lennox Gastuat syndrome (LGS)EUCTR2018-002484-25-PTTakeda Development Center Americas, Inc.141
进行中（未招募）
不适用
A multicenter, randomized, double-blind, placebo-controlled study in parallel groups on the efficacy and safety of apremilast in patients with erosive arthritis of finger jointsErosive osteoarthritis of the hand (EHOA)MedDRA version: 14.1Level: LLTClassification code 10019115Term: Hand osteoarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2008-005365-61-DEMed. Fakultaet der Friedrich-Alexander Universitaet Erlangen-Nuernberg
进行中（未招募）
不适用
A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney diseaseAutosomal Dominant Polycystic Kidney Disease (ADPKD)MedDRA version: 14.1Level: LLTClassification code 10036046Term: Polycystic kidney, autosomal dominantSystem Organ Class: 100000004850EUCTR2010-023017-65-SEPfizer Inc., 235 East 42nd Street, New York, NY 10017190
进行中（未招募）
不适用
A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, COMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF TIGECYCLINE VERSUS IMIPENEM/CILASTATIN FOR THE TREATMENT OF SUBJECTS WITH HOSPITAL-ACQUIRED PNEUMONIAEUCTR2008-000412-33-LVWyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development210