EUCTR2009-016068-35-AT进行中（未招募）不适用
A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIG
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
- •I 01. Patients with active AS based on the Modified New York criteria for ankylosing
- •spondylitis.
- •I 02. Patients must had an adequate trial of at least 2 different NSAIDs taking for at least 2 weeks in each case and on a stable dose for =2 weeks or be intolerant to NSAIDs.
- •I 03. Active disease must be present for =3 months and be present at screening and at baseline as defined:
- •- Bath AS Disease Activity Index (BASDAI) score of =4 (NRS 0-10);
- •- Total back pain score =4 (NRS 0-10).
- •I 04. Patients treated with corticosteroid must be on a stable dose for >2 weeks prior to baseline.
- •I 05. Patients treated with DMARDs: hydroxychloroquine, sulfasalazine and MTX must be on a stable dose =12 weeks.
- •I 06. Patients must give informed consent prior to any procedure related to the study.
- •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
- •E01 Male and female patients age <18 of age or =75 years.
- •E02 Weight <50 kg for man or <45 Kg for women or >110 kg for both man or women.
- •E03 BASDAI score <4 (NRS 0-10) at screening and baseline.
- •E04 Total Back Pain score <4 (NRS 0-10) at screening and baseline.
- •E05 Patients with complete fusion of the spine.
- •E06 Patient who has previously participated in any clinical trial of SAR153191.
- •E07Participation in any clinical research study evaluating another investigational drug or therapy within 60 days or at least 5 half-lives, whichever is longer, of the
- •investigational drug, prior to the Screening Visit.
- •E08 Have a history or presence of significant other concomitant illness according to the investigator’s judgment.
- •E09 Conditions/situations such as:
- •- Patients with short life expectancy;
- •- Patients with conditions/concomitant diseases making them non-evaluable for the
- •primary efficacy endpoint;
- •- Requirement for concomitant treatment that could bias primary evaluation;
- •- Impossibility to meet specific protocol requirements;
- •- Patient is the Investigator or any sub-Investigator, research assistant, pharmacist,
- •study coordinator, other staff or relative thereof directly involved in the conduct of
- •- Uncooperative or any condition that could make the patient potentially
- •non-compliant with study procedures.
- •E10 Starting treatment with NSAIDs <4 weeks prior to screening or change current
- •treatment or dose for =2 weeks prior to baseline.
- •E11 Treatment with oral prednisone or equivalent corticosteroids >10 mg/day within
- •6 weeks prior to screening.
- •E12 Use of intramuscular or intra-articular corticosteroids within the last 4 weeks before screening.
- •E13 Patients who had previously been treated or are currently treated with Disease
- •Modifying Anti-Rheumatic Drugs or with cyclosporine, azathioprine, or DMARDs
- •other than methotrexate, sulfasalazine and hydroxychloroquine; and must be on stable dose for =12 weeks; and not to exceed the following dose:
- •- Methotrexate >25 mg/week;
- •- Hydroxychloroquine >400 mg/day;
- •- Sulfasalazine >3 gr/day.
- •E14 Past history of non response to any anti-TNFs treatment or non response to any other biological treatment for AS.
- •E15 Any past or current treatment with anti-TNFs agents or any biological agent within 3 months from screening.
- •E16 Pregnant or breast-feeding women.
- •E17 For women of childbearing potential, unwillingness to utilize adequate contraception or not become pregnant during full course of the study.
- •E18 History of alcohol or drug abuse within the 5 years prior to the Screening Visit.
- •E19 Any subject who has had surgery within 4 weeks prior to the Screening Visit or with planned elective surgery.
- •E20 History of malignancy other than effectively treated carcinoma in-situ of the cervix, or adequately treated, non-metastatic squamous or basal cell carcinoma of the skin within five years prior to Screening Visit. History of lymphoproliferative disease or possible current lymphoproliferative disease.
- •E21 Patients with latent or active tuberculosis.
- •E22 Patients with history of Listeriosis or tuberculosis (unless documented that it was adequately treated) (see Section 10.2).
- •E23 Fever (=38°C) or persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the Screening Visit, or history of frequent recurrent infections unacceptable per investigator judgment.
- •E24 Unhealed infected skin ulcers.
- •E25 Received administration of any
研究者
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