NCT02247375已完成1 期
A Double-blind, Randomized, Three Parallel Group Placebo-controlled Study to Investigate Pharmacokinetics, Effect on Expression of CD11b/CD18 (Mac-1), as Well as Safety and Efficacy of Two Oral Doses of BIIL 284 BS (Dosage: 25 mg Daily, 150 mg Daily) in Patients With Rheumatoid Arthritis Over Two Weeks
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
- 26
- 主要终点
- Changes from baseline in Mac-1 expression
研究概览
简要总结
Safety, pharmacokinetics, pharmacodynamics [CD11b/CD18 (Mac-1) expression] and efficacy.
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female from 18 to 65 years of age
- •Patients suffering from active rheumatoid arthritis as defined by the ARA criteria revised 1987
- •-- At least 4 of the following 7 criteria must have been present:
- •morning stiffness in and around the joints lasting at least 1 hour before maximal improvement for at least 6 weeks
- •arthritis (soft tissue thickening or fluid - not bony overgrowth alone) of at least 3 joint areas for at least 6 weeks
- •arthritis of hand joints (at least one area swollen in a wrist, metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joint) for at least 6 weeks
- •symmetric arthritis (observed by a physician) with simultaneous involvement of the joints on both sides of the body for at least 6 weeks
- •rheumatoid nodules (observed by a physician) over bony prominences or extensor surfaces or in juxta-articular regions
- •serum rheumatoid factor positive
- •x-ray changes typical of rheumatoid arthritis (erosions or unequivocal bony decalcification localised in or most marked adjacent to the involved joints)
- •Patient belonging to the RA functional class I, II or III
- •Patient's written informed consent
排除标准
- •Pregnancy (to be excluded by pregnancy test) or breast feeding
- •Women of childbearing potential not using adequate contraception
- •Treatment with methotrexate in the previous month or intended use during the trial period
- •Treatment with slow acting antirheumatic drugs (SAARDs)/disease-modifying antirheumatic drugs (DMARDs) other than parenteral gold, D-penicillamine, sulfasalazine, chloroquine / hydroxychloroquine corticosteroid during the last 2 months prior to study entry
- •Treatment with more than one SAARD/DMARD and/or corticosteroid during the last 2 months prior to study entry
- •Change in treatment with SAARDs/DMARDs during the last 2 months prior to study entry or intended change during the trial duration
- •Change in treatment with corticosteroids during the last month prior to study entry or intended change during the trial duration
- •Systemic treatment with corticosteroids at a dose higher than 10 mg/day or 0.2 mg/kg/day (prednisone equivalent), respectively (whichever is lower) during the last month prior to study entry or their intended use during the trial treatment period
- •Change in treatment with non-steroidal anti-inflammatory drugs (NSAIDs) during the last month prior to study entry or intended change during the trial duration
- •Treatment with EnbrelTM (etanercept) or experimental therapies during the last 3 months prior to study entry
- •Synovectomy and/or surgical treatment for RA in the previous month or during the trial
- •Clinical evidence of known severe cardiovascular, hepatic, renal, respiratory, metabolic, haematological, immunological, gastro-intestinal, hormonal or mental disorders
- •Any other rheumatological or non-rheumatological disease that could interfere with the evaluation of efficacy and safety
- •Patients with active malignant disease
- •Patients with chronic or acute infections during the previous month
- •Patients with abnormal, clinically relevant laboratory values not related to RA
- •Participation in another clinical trial during this study or during the previous month
- •Previous participation in this trial (i.e. having been allocated a randomized treatment number)
- •Patient unable to comply with the protocol
- •Patient with known drug abuse
- •Patient with known alcohol abuse
研究组 & 干预措施
Low dose of BIIL 284 BS
Experimental
干预措施: Low dose of BIIL 284 BS tablets (Drug)
High dose of BIIL 284 BS
Experimental
干预措施: High dose of BIIL 284 BS tablets (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Changes from baseline in Mac-1 expression
时间窗: Pre-dose, up to day 14 after start of treatment
Plasma concentrations of BIIL 284 BS, BIIL 260 BS, BIIL 315 ZW and BIIL 304 ZW
时间窗: Pre-dose, up to day 14 after start of treatment
Maximum concentration of the analyte in plasma (Cmax)
时间窗: Pre-dose, up to day 14 after start of treatment
Trough concentration of the analyte in plasma shortly before drug administration in a steady state dosing interval (Cpre,ss)
时间窗: Pre-dose, up to day 14 after start of treatment
Time to reach the maximum concentration of the analyte in plasma (tmax)
时间窗: Pre-dose, up to day 14 after start of treatment
Area under the concentration-time curve of the analyte in plasma (AUC)
时间窗: Pre-dose, up to day 14 after start of treatment
Number of patients with adverse events
时间窗: Up to 4 weeks
Global assessment of tolerability by the patient on a 4-point scale
时间窗: Up to 14 days after start of treatment
Global assessment of tolerability by investigator on a 4-point scale
时间窗: Up to 14 days after start of treatment
次要结局
- Changes from baseline in tender joint count (TJC)(Pre-dose, up to day 14 after start of treatment)
- Changes from baseline in swollen joint count (SJC)(Pre-dose, up to day 14 after start of treatment)
- Changes from baseline in patient's current pain level assessment by visual analogue scale (VAS)(Pre-dose, up to day 14 after start of treatment)
- Changes from baseline in patient's global assessment of disease activity by VAS(Pre-dose, up to day 14 after start of treatment)
- Global assessment of disease activity by investigator on a 5-point scale(Up to 14 days after start of treatment)
- Changes from baseline for patient's assessment of physical function(Pre-dose, up to day 14 after start of treatment)
- Changes from baseline in erythrocyte sedimentation rate (ESR)(Pre-dose, up to day 14 after start of treatment)
- Changes from baseline in C-reactive protein (CRP)(Pre-dose, up to day 14 after start of treatment)
- Changes from baseline in american college of rheumatology (ACR) 20 score(Pre-dose, up to day 14 after start of treatment)
- Changes from baseline in disease activity score (DAS)(Pre-dose, up to day 14 after start of treatment)
- Global efficacy assessment by the patient on a 4-point scale(Up to 14 days after start of treatment)
- Number of withdrawals due to adverse events(Up to 4 weeks)
- Number of patients with clinically significant findings in laboratory adverse events(Up to 4 weeks)
- Number of patients with clinically significant findings in vital signs (blood pressure, pulse rate)(Up to 4 weeks)
研究者
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