EUCTR2008-007510-30-HU进行中（未招募）不适用
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE THE SAFETY, EFFICACY, PHARMACOKINETICS AND PHARMACODYNAMICS OF 12 WEEKS OF TREATMENT WITH ARRY-371797 IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS AND INADEQUATE RESPONSE TO CONVENTIONAL THERAPY
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 126
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. Has provided written informed consent and is willing to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures;
- •2. Is at least 18 years of age;
- •3. Diagnosed with ankylosing spondylitis according to the Modified New York Criteria (1984);
- •4. Total Back Pain Score measured by 10-point numerical rating scale (NRS) = 4 at Screening and at Baseline;
- •5. Clinically active axial disease characterized by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score = 4 at Screening and at Baseline despite concurrent treatment with conventional therapy (e.g., NSAIDs, glucocorticoids or DMARDs);
- •6. Inadequate response to at least 2 weeks of continuous treatment with NSAIDs, or unable to receive = 2 full weeks of continuous treatment with NSAIDs because of intolerance;
- •7.If previously treated with a biological agent must NOT have failed due to lack of efficacy, and has completed the following washouts (calculated from first dose of Study Drug):
- •a. Within 4 weeks of first dose of Study Drug: etanercept (Enbrel®), anakinra (Kineret®);
- •b. Within 8 weeks of first dose of Study Drug: infliximab (Remicade®), adalimumab (Humira®);
- •8. Has completed a 4-week washout period (calculated from first dose of Study Drug), if treated with any of the following therapies:
- •a. Any experimental therapy (within or outside a clinical trial setting);
- •b. Intramuscular or intravenous corticosteroids;
- •c. Other—herbal medications; immunization with any live virus vaccination (e.g., FluMist®).
- •9. Patients may continue on stable background therapy for AS (doses should be stable for at least 4 weeks prior to the first dose of Study Drug) only if it is included in the following list:
- •a. Non-investigational NSAIDs and/or COX-2 inhibitors;
- •b. DMARDs—methotrexate (= 25 mg/week), sulfasalazine (= 3 gm/day), leflunomide (= 20 mg/day);
- •c. Hydroxychloroquine (= 400 mg/day);
- •d. Low-dose oral corticosteroids (= 10 mg prednisone or equivalent per day);
- •e. Opioid analgesics (= 30 mg oral morphine or equivalent per day);
- •f. Acetaminophen (paracetamol) = 4000 mg/day (4 g/day);
- •g. Aspirin if taken for non-arthritic reasons (= 325 mg/day).
- •10. If female participant, has met either criterion a” or b” below:
- •a. Is of non-childbearing potential (amenorrheic for at least 2 years, or had a hysterectomy and/or bilateral oophorectomy at least 8 weeks prior to screening);
- •All other female patients (including those with tubal ligation) will be considered of childbearing potential.
- •b. Is of childbearing potential and willing to use the acceptable methods of contraception and abide by the timelines of each method.
- •11. If male participant, must be willing to use the acceptable methods of contraception and abide by the timelines.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Diagnosis of any other active or uncontrolled inflammatory or non-inflammatory articular disease that may interfere with disease activity assessments;
- •2. Previously treated with IV immunoglobulins within 6 months of first dose of Study Drug;
- •3. History of:
- •a. Significant renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological or dermatological disease;
- •b. Significant cardiac disease, myocardial infarction within 6 months of screening, unstable angina, congestive heart failure (New York Heart Association [NYHA] Class III-IV), known arrhythmias of ventricular etiology, unexplained syncope or syncope/seizures related to arrhythmia;
- •c. Serious infection (defined as requiring parenteral antibiotics or hospitalization) within 6 months of first dose of Study Drug;
- •d. Active tuberculosis or history of tuberculosis without documented curative treatment and/or positive tuberculin reaction to PPD (Purified Protein Derivative) without known vaccination with the Bacillus Calmette - Guerin vaccine (BCG). Prior history of BCG with positive reaction to PPD will require follow-up negative chest X-ray;
- •e. Significant trauma or major surgery within 8 weeks of first dose of Study Drug;
- •f. Alcohol abuse with less than 12 months of sobriety, or any drug abuse within 3 years of first dose of Study Drug;
- •g. Cancer unless in complete curative remission for = 5 years, excluding patients with adequately treated or excised nonmetastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ;
- •h. Participation in another clinical trial within 4 weeks of Screening.
- •4. Presenting with any of the following:
- •a. Severe psychological illness or any condition which will interfere with the patient’s ability to understand and/or comply with the requirements of the study;
- •b. Any condition possibly affecting oral drug absorption (e.g., gastrectomy, malabsorption, Crohn’s disease or clinically significant diabetic gastroenteropathy);
- •c. A documented body temperature = 37.5°C (99.5 °F) at Screening and Baseline (e.g., pre-dose on Day 1);
- •d. An infection with human immunodeficiency virus (HIV) or hepatitis B or C;
- •e. Any clinically significant active infection including herpes lesions;
- •f. A confirmed mean of the screening triplicate QTc interval > 450 ms by Fridericia’s formula as calculated by the site.
- •g. Total fusion of the spine
- •5. Evidence of organ dysfunction or hematopoietic disorder based on any of the following assessments at Screening:
- •a. Hgb = 10 g/dL or Hct = 32%;
- •b. Absolute WBC count = 3.0 × 109/L (3000/mm3);
- •c. Neutrophil count = 1.2 × 109/L (1200/mm3);
- •d. Platelet count = 100 × 109/L (100,000/mm3);
- •e. AST (aspartate aminotransaminase) or ALT (alanine aminotransaminase) = 1.2 × upper limit of normal (ULN);
- •f. Total bilirubin = 1.5 × ULN;
- •g. Alkaline phosphatase = 1.5 × ULN;
- •h. Albumin = 3.5 g/dL (35 g/L);
- •i. Serum creatinine = 1.2 × ULN;
- •j. Thyroid-stimulating hormone (TSH) = 1.2 × ULN unless clinically euthyroid and receiving a stable dose of thryroxine.
- •6. Patients requiring prohibited concomitant medications including moderate or strong CYP3A inhibitors, CYP3A inducers and Biologic Response Modifiers (BRMs) while on study;
- •7. Pregnant or breastfeeding patients.
研究者
相似试验
进行中（未招募）
不适用
A Study of the Safety and Efficacy of Subcutaneous Administration of Cinryze with Recombinant Human Hyaluronidase for the Prevention of HAE AttacksEUCTR2012-000083-24-SEShire ViroPharma Incorporated47
进行中（未招募）
不适用
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE THE SAFETY, EFFICACY, PHARMACOKINETICS AND PHARMACODYNAMICS OF 12 WEEKS OF TREATMENT WITH ARRY-371797 IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS AND INADEQUATE RESPONSE TO CONVENTIONAL THERAPYANKYLOSING SPONDYLITISMedDRA version: 9.1Level: LLTClassification code 10002556Term: Ankylosing spondylitisEUCTR2008-007510-30-PLArray BioPharma Inc.168
进行中（未招募）
不适用
A Study of the Safety and Efficacy of Subcutaneous Administration of Cinryze with Recombinant Human Hyaluronidase for the Prevention of HAE AttacksAngioedema.MedDRA version: 14.1Level: PTClassification code 10019860Term: Hereditary angioedemaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2012-000083-24-DEViroPharma Incorporated47
进行中（未招募）
不适用
A Study of the Safety and Efficacy of Subcutaneous Administration of Cinryze with Recombinant Human Hyaluronidase for the Prevention of HAE AttacksAngioedema.MedDRA version: 14.1Level: PTClassification code 10019860Term: Hereditary angioedemaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2012-000083-24-HUViroPharma Incorporated30
进行中（未招募）
1 期
A Study of the Safety and Efficacy of Subcutaneous Administration of Cinryze with Recombinant Human Hyaluronidase for the Prevention of HAE AttacksAngioedema.MedDRA version: 14.1Level: PTClassification code 10019860Term: Hereditary angioedemaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2012-000083-24-ESViroPharma Incorporated47