EUCTR2010-019871-31-DE进行中（未招募）不适用
A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid Arthritis
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,250
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. Patient is a male or female = 18 years of age on the day of signing informed consent.
- •2. Patient understands the study procedures, the alternative treatments available, the risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
- •3. Patient is able to read, understand and complete study questionnaires, including
- •questions requiring a visual analog scale (VAS) response.
- •4. Female patients of reproductive potential must demonstrate a serum ß-hCG level
- •consistent with a nongravid state at the prestudy visit and agree to remain abstinent, use oral, barrier, intramuscular, or implanted contraceptives from the prestudy Visit 1 until 28 days after the last dose of study medication. Women who are postmenopausal or have had a hysterectomy or bilateral tubal ligation or bilateral oophorectomy are exempt from this requirement. (Postmenopausal is defined as no menses for the previous 1 year).
- •Note: Serum FSH sample will be obtained only from women with cessation of menses within 1 year prior to Visit 1. If a patient’s Visit 1 FSH result is not within the postmenopausal range (as defined by the central laboratory), serum ß-hCG must be tested. The patient must demonstrate a serum ß-hCG level consistent with a nongravid state at the screening to continue in the study.
- •5. Patient is willing to limit alcohol intake to 2 drinks or equivalent per day for the duration of the study and follow-up period (one drink is defined as 2 oz. of hard alcohol, 5 oz. of wine, or 12 oz. of beer) and avoid unaccustomed physical activity (e.g., weight lifting) for the duration of the study.
- •6. Excepting RA, patient is judged to be in otherwise general good health based on
- •medical history, physical examination, and routine laboratory tests.
- •7. Patient has satisfied (for RA diagnosis) at least 4 of 7 ARA 1987 revised criteria for
- •the diagnosis of RA.
- •8. Patient is ACR Functional Class I, II, or III.
- •9. Patient has had a diagnosis of RA made at least 6 months prior to study start and was = 16 years of age when diagnosed.
- •10. Patient global assessment of disease activity (VAS of 100 mm) at Visit 1 is less than 80 mm.
- •11. Patient has a history of positive therapeutic benefit with NSAIDs and has taken an NSAID on a regular basis and at a therapeutic dose level (see Appendix 6.1) prior to study enrollment ( basis is defined as greater than 20 of the previous 30
- •days, including 7 of the last 10 days).
- •12. If patient is currently using anti-rheumatic therapy othen than NSAIDs, patient's approved nonstudy antirheumatic therapy has been at stable dosing relative to Visit 2 for the required time periods listed below AND is not anticipated to undergo a change during the study. Similarly, patients must not have discontinued such therapy within the timeframe given below.
- •Abatacept: 3 months; Adalimumab: 3 months; Anakinra: 2 months; Antimalarials: 6 weeks; Azathioprine: 3 months; Certolizumab pegol: 3 months; Cyclosporin A: 3 months; d-Penicillamine: 3 months; Etanercept: 3 months; Gold salts (oral or injectable): 3 months; Golimumab: 3 months; Infliximab: 3 months; Leflunomide: 3 months; Methotrexate: 2 months; Sulfasalazine: 6 weeks; Tocilizumab: 3 months;
- •Note: Treatment with rituximab or epratuzumab is not allowed within 6 months
- •prior to enrollment. Note: The use of other locally approved RA medications will be considered on a case-by-case basis and require prior discussion with the SPONSOR (or its delegates)
排除标准
- •Previous or Concurrent Diseases
- •1. Patient is legally incompetent (e.g., a minor or mentally incapacitated), or has active psychosis, or significant emotional problems at the time of the study which in the view of the investigator are sufficient to interfere with the conduct of the study.
- •2. Patient has a concurrent medical/arthritic disease that could confound or interfere with evaluation of efficacy including, but not limited to: inflammatory arthritis (e.g., systemic lupus erythematosus, spondyloarthropathy, polymyalgia rheumatica), recent acute attacks of gout or pseudogout, Paget’s disease affecting the study joint, a history of septic arthritis or intra-articular fracture of the study joint, osteochondritis desiccans or osteonecrosis of the study joint, Wilson’s disease, hemachromomatosis,
- •ochronosis, or primary osteochondromatosis and inflammatory muscle diseases (e.g. polymyositis, dermatomyositis). Note: Rheumatoid subjects with secondary Sjoegren's syndrome are allowed to participate in the study.
- •3. Patient has a history of gastric or biliary surgery (including gastric bypass surgery) or small intestine surgery that causes clinical malabsorption. Note: Patients who have had gastric banding or patients with cholecystectomy not resulting in malabsorbtion are allowed to participate.
- •4. Patient has an active peptic (gastric or duodenal) ulcer or history of inflammatory bowel disease.
- •5. Patient has a confirmed medical diagnosis of ischemic heart disease, cerebrovascular disease, or peripheral artery occlusive disease. In countries in which the use of selective COX-2 inhibitors has not been contraindicated in patients with these conditions, patients can otherwise participate (with the exception of those patients who have undergone coronary artery bypass graft surgery, angioplasty, or had a cerebrovascular accident or transient ischemic attack within the past 6 months).
- •6. Patient has class II-IV congestive heart failure (See Appendix 6.5).
- •7. Patient has uncontrolled hypertension (systolic >160 mm Hg or diastolic > 90 mm Hg) at Visit 1 or Visit 2. Investigators are encouraged to maximize blood pressure control according to local guidelines. Note: Local product labeling should be followed. In countries where the use of etoricoxib is contraindicated in patients with blood pressure values that are persistently elevated above 140/90 mm Hg, this definition of uncontrolled hypertension should be used. Note: Patients may be rescreened one time if blood pressure at Visit 1 is outside of the ranges listed above; patients must be excluded if blood pressure at Visit 2 is outside of the ranges listed above.
- •8. Patient has a history of neoplastic disease; Exceptions: (1) patients with adequately treated basal cell carcinoma or carcinoma in situ of the cervix may participate; (2) patients with other malignancies which have been successfully treated = 5 years prior to screening, where in the judgment of both the investigator and treating physician, appropriate follow-up has revealed no evidence of recurrence from the time of treatment through the time of screening. However, patients with a history of leukemia, lymphoma, malignant melanoma, and myeloproliferative disease are ineligible for the study regardless of the time since treatment, and in such cases, no exceptions will apply.
- •9. Patient is allergic to, or has a history of a significant clinical or laboratory adverse experience associated with etoricoxib; has hypersensitivity (e.
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