NCT01199809已完成1 期
A Multi-center, Randomized, Observer-blinded, Multiple-Ascending-Dose, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5310074 Following Multiple Intravenous Administrations in Subjects With Psoriatic Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 主要终点
- Safety: Incidence of adverse events
研究概览
简要总结
This randomized, double-blind. placebo-controlled study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of RO5310074 in patients with psoriatic arthritis who have or have had an inadequate response to oral disease-modifying antirheumatic drugs (DMARDs) or non-steroidal anti-rheumatic drugs (NSAIDs). Patients will be randomized in cohorts to receive either 6 intravenous doses of RO5310074 or placebo. Anticipated time on study treatment is 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, 18 - 75 years of age
- •Diagnosis of Psoriatic Arthritis (Moll and Wright or CASPAR criteria) of >/= 6 months duration
- •Have >/= 3 swollen and >/= 3 tender joints
- •Inadequate response to a current or previous oral DMARD or NSAID therapy
- •Current oral DMARDs must be at stable dose for the appropriate duration (e.g. 14 days for sulfasalazine and 28 days for methotrexate or oral steroids)
- •NSAIDs up to maximum recommended dose are permitted if at stable dose for at least 14 days prior to first dose of study drug, but not more than one NSAID simultaneously (except for low-dose aspirin for cardioprotection)
- •Body mass index (BMI) 18 - 42 kg/m2 inclusive
排除标准
- •Previous prolonged treatment with a biologic DMARD; use of biologic DMARD within 3 months or 5 times its elimination half-live (whichever is longer) prior to first dose of study drug
- •Previous use of B-cell depleting biologic DMARDs
- •Any previous treatment with alkylating agents such a cyclophosphamide or chlorambucil or with total lymphoid irradiation
- •History of or current inflammatory joint disease other than psoriatic arthritis; Gout or pseudogout that is current or has been active within the past 6 months
- •Positive for hepatitis B, hepatitis C or HIV infection
- •Any acquired or congenital immune deficiency or history of disease known to cause significant alteration in immunologic function
- •Acute clinically significant infection in the 6 weeks prior to administration of study drug, history or presence of chronic infection, or history of recurrent infection as an adult
研究组 & 干预措施
1
Experimental
干预措施: RO5310074 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety: Incidence of adverse events
时间窗: 25 weeks
次要结局
- Pharmacodynamics (anti-drug-antibodies)(25 weeks)
- Pharmacokinetics (Cmax, t1/2, AUC, Vss, CL)(12 weeks)
研究者
相似试验
已完成
1 期
A Study of RO5095932 in Patients With Type 2 Diabetes MellitusDiabetes Mellitus Type 2NCT00961909Hoffmann-La Roche122
撤回
2 期
A Study of RO5036505 in Patients With Moderate to Severe AsthmaAsthmaNCT00967590Hoffmann-La Roche
已完成
1 期
A Study of RO5428029 in Healthy Volunteers and Patients With Chronic Hepatitis CHepatitis C, Chronic, Healthy VolunteerNCT01371162Hoffmann-La Roche42
已完成
1 期
A Study of RO5024048 in Japanese and Caucasian Healthy VolunteersHealthy VolunteerNCT01152671Hoffmann-La Roche97
已完成
1 期
A Study of RO4989991 in Patients With Allergic RhinitisAsthmaNCT01152619Hoffmann-La Roche24