EUCTR2008-002631-33-DE进行中（未招募）不适用
Randomized, placebo controlled, double blind, multi-center phase II proof-of-concept study to assess the efficacy of AIN457 in patients with moderate to severe ankylosing spondylitis - A2209
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
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.Males or females, aged 18-65 at time of consent.
- •2.Patients with moderate to severe AS fulfilling the modified NY criteria for a diagnosis of AS and whose disease is not controlled on NSAIDS (on at least one NSAID over a period of at least 3 months at max. dose). Minimum disease activity for inclusion of patients will be assessed based on the ASAS core set domains: back pain & nocturnal pain score = 4 despite concurrent NSAID use, PLUS a BASDAI score = 4. Elevated CRP or ESR are not mandatory for study inclusion.
- •3.Female subjects must have negative pregnancy test results at screening and baseline.
- •WoCBP must be using simultaneously double-barrier or two acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, hormone contraception as either oral or implantable is acceptable as one form), from the time of screening to 6 months post last dose of AIN457. Women on hormone contraception should be on this regimen for at least 2 months prior to study start.
- •PM females must have had no regular menstrual bleeding for at least two (2) years prior to initial dosing. If menopause is confirmed by a plasma FSH level of > 40 IU/L at screening, or consistent with menopause per local laboratory, pregnancy test will be required at screening, baseline, before the second infusion and monthly during the study.
- •Female subjects who report surgical sterilization must have had the procedure at least six (6) months prior to initial dosing. Surgical sterilization procedures should be supported with clinical documentation.
- •If females have male partners who have undergone vasectomy, the vasectomy must have occurred more than six (6) months prior to first dosing.
- •Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- •4.Males willing to use simultaneously two acceptable methods of contraception (e.g. spermicidal gel plus condom) for entire duration of the study and at least 6 months post last dose of AIN457.
- •5.Able to communicate (details in protocol).
- •6.No evidence of liver disease or liver injury as indicated by abnormal liver function tests such as AST, ALT, ? GGT, AP, or serum bilirubin. The investigator should be guided by criteria as outlined under exclusion criteria
- •7.Patients with a history of immunization against influenza (within past 12 months) and/or history of pneumococcal vaccination will be included. If not already immunized, vaccination is allowed to be completed (during flu season only) and such patients may be included after a 3-week window post immunization. Immunizations with attenuated life virus should be postponed until after completion of the study.
- •8.History or presence of PsO or IBD will be recorded.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. WoCBP who are not willing to follow the restrictions in inclusion criteria 3, are not allowed in the study. Men
- •who are not willing to follow the restrictions in inclusion criteria 4 are not allowed in the study. Male/female
- •patients who plan to conceive during the time course of the study and
- •6 months post last infusion of AIN457 are not eligible.
- •2. Participation in any clinical trial using investigational drug within 4 weeks prior to initial dosing or five half
- •lives of the IMP, whichever is longer and for any other limitation of participation based on local regulations.
- •3. For patients who were previously treated with TNF blockers, the washout
- •periods will be required for these patients to be eligble to participate in the trial.
- •- 6-month washout period prior to baseline for alefacept.
- •- 3-month washout period prior to baseline for adalimumab and cerolizumab.
- •- 2-month washout period for baseline for etanercept or infliximab.
- •4. a) For patients who were previously treated with immunosuppressive agenst other than methotrexate (MTX),
- •sulphasalazine (SSZ) and systemic corticosteriods, a 1 month washout period prior to baseline is required.
- •Immunosuppressive agent include but are not limited to cyclosporine, mycophenolate, trocrolimus and 5-
- •aminosalicylic acid (5-ASA).
- •- Prednisone should be kept at a stable dose 4 weeks before baseline and throughout the study and not exceed
- •- MTX should be kept at a stable dose 4 weeks before baseline and throughout the study and not exceed 25mg/
- •- SSZ should be kept at a stable dose 4 weeks before baseline and throughout the study.
- •In case of previous leflunomide treatment, a wash out with oral cholestyramine might be considered as
- •an alternative wash out procedure to increase the elimination of leflunomide. Based on the notion that
- •cholestyramine reduces plasma levels of the active leflunomide metabolite by approximately 40% in 24 hours
- •and by 49% in 48 hours, cholestyramine is to be given orally at a dose of 8 g t.i.d. daily for 10 days. The patient
- •may then be dosed with study drug not earlier than 2 weeks after start of the cholestyramine wash out procedure.
- •4. b) Patients who are on NSAIDS should be kept at a stable dose 4 weeks before baseline and throughout the
- •5. Positive HIV: ELISA and Western blot test result, HBsAg or Hepatitis C test result.
- •Any active systemic infection within the past 2 weeks including a positive chest X-ray.
- •6. Current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic,
- •hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral,
- •psychiatric, chronic inflammatory diseases with the exception of psoriatic arthritis or other disease which in the
- •clinical judgment of the investigator would make the patient unsuitable for the trial.
- •7. Liver disease or liver injury as indicated by abnormal liver function tests such as SGOT (AST), SGPT (ALT),
- •?-GGT, alkaline phosphatase, or serum bilirubin. The Investigator should be guided by the criteria specified in
- •the protocol.
- •8. Subjects with active or history of clinically significant cardiac abnormalities as specified in the protocol.
- •9. History of renal trauma, glomerulonephritis, or patient with one kidney.
- •10. History of malignancy (other than basal cell carcinoma or adequately treated carcinomain-situ of the cervix).
- •11. Unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to
- •12. Conditions assoc
研究者
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