NCT04230213已完成3 期
A RANDOMIZED COMPARATIVE STUDY ASSESSING THE SWITCHING BETWEEN PF-06410293 AND HUMIRA (REGISTERED) IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 455
- 试验地点
- 72
- 主要终点
- Maximum Observed Serum Concentration (Cmax) of Adalimumab
研究概览
简要总结
The study will assess the impact of pharmacokinetics (PK), safety and immunogenicity after switches between PF-06410293 and adalimumab and with continuous dosing with adalimumab in combination with methotrexate in subjects with moderately to severely active rheumatoid arthritis.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of RA based on 2010 ACR/EULAR for RA for at least a 4 month duration.
- •Moderately to severely active RA based on local standard of care.
排除标准
- •Evidence of untreated or inadequately treated latent or active TB.
研究组 & 干预措施
Treatment Arm 1
Experimental
Subcutaneous (SC) injection given every other week
干预措施: PF-06410293 (Drug)
Treatment Arm 1
Experimental
Subcutaneous (SC) injection given every other week
干预措施: adalimumab (Drug)
Treatment Arm 2
Active Comparator
SC injection given every other week
干预措施: adalimumab (Drug)
结局指标
主要结局
Maximum Observed Serum Concentration (Cmax) of Adalimumab
时间窗: Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30)
Cmax refers to maximum observed serum concentration of drug. The geometric coefficient of variation is expressed in percentage.
Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau) of Adalimumab
时间窗: Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30)
Area under the serum concentration curve from time 0 to end of dosing interval (tau), where dosing interval was once every two weeks. The geometric coefficient of variation is expressed in percentage.
次要结局
- Time to Reach Cmax (Tmax) of Adalimumab(Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30))
- Apparent Clearance (CL/F) of Serum Adalimumab(Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30))
- Pre-dose Serum Concentration During Multiple Dosing (Ctrough) of Adalimumab(Pre-dose on Day 1, 71,113, 155, 169, 183, 197 and 211)
- Mean NAb Titers(Week 10, 16, 22, 24, 26, 28, 30, 32)
- Average Serum Concentration (Cav) of Adalimumab(Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30))
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Treatment Related TEAEs: TP1(Day 1 up to maximum of 10 Weeks)
- Number of Participants With TEAEs, Serious TEAEs and Treatment Related TEAEs: TP2 and Beyond(Post randomization up to maximum of 4 weeks after last dose (maximum of 26 weeks))
- Number of Participants With Grade 3 or Higher TEAEs: TP1(Day 1 up to maximum of 10 Weeks)
- Number of Participants With Grade 3 or Higher TEAEs: TP2 and Beyond(Post randomization up to maximum of 4 weeks after last dose (maximum of 26 weeks))
- Number of Participants Who Discontinued Treatment and Study Due to TEAEs: TP1(Day 1 up to maximum of 10 Weeks)
- Number of Participants Who Discontinued Treatment and Study Due to TEAEs: TP2 and Beyond(Post randomization up to maximum of 4 weeks after last dose (maximum of 26 weeks))
- Number of Participants With TEAEs of Special Interest: TP2 and Beyond(Post randomization up to maximum of 4 weeks after last dose (maximum of 26 weeks))
- Number of Participants With Potential Immunogenic AEs to Study Treatment: TP2 and Beyond Among Anti-drug Antibody (ADA) Positive Participants During TP1(TP2 and Beyond: Week 16, 22, 24, 26, 28, 30, 32)
- Number of Participants With Potential Immunogenic AEs to Study Treatment: TP2 and Beyond Among ADA Negative Participants During TP1(TP2 and Beyond: Week 16, 22, 24, 26, 28, 30, 32)
- Number of Participants With TEAEs and Serious TEAEs Related to COVID-19: TP1(Day 1 up to maximum of 10 Weeks)
- Number of Participants With TEAEs and Serious TEAEs Related to COVID-19: TP2 and Beyond(Post randomization up to maximum of 4 weeks after last dose (maximum of 26 weeks))
- Number of Participants Who Discontinued Treatment and Study Due to TEAEs Related to COVID-19: TP1(Day 1 up to maximum of 10 Weeks)
- Number of Participants Who Discontinued Treatment and Study Due to TEAEs Related to COVID-19: TP2 and Beyond(Post randomization up to maximum of 4 weeks after last dose (maximum of 26 weeks))
- Number of Participants With Laboratory Abnormalities: TP1(Day 1 up to maximum of 10 Weeks)
- Number of Participants With Laboratory Abnormalities: TP2 and Beyond(Post randomization up to end of study treatment (maximum of 22 weeks))
- Number of Participants With Hematology Results by Maximum Common Toxicity Criteria (CTC) Grade: TP2 and Beyond(Post randomization up to end of study treatment (maximum of 22 weeks))
- Number of Participants With Chemistry Results by Maximum CTC Grade: TP2 and Beyond(Post randomization up to end of study treatment (maximum of 22 weeks))
- Number of Participants With Laboratory Results Based on Evaluation of Drug-Induced Serious Hepatotoxicity (eDISH) Analysis: TP2 and Beyond(Post randomization up to end of study treatment (maximum of 22 weeks))
- Baseline, Absolute Week 32 Values for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Change From Baseline in SBP, DBP at Week 32 (EOT/ ET)(Baseline and Week 32 (end of treatment [EOT]/early termination [ET]))
- Baseline, Absolute Week 32 Values for Pulse Rate and Change From Baseline in Pulse Rate at Week 32 (EOT/ET)(Baseline and Week 32 (EOT/ET))
- Baseline, Absolute Week 32 Values for Temperature and Change From Baseline in Temperature at Week 32 (EOT/ET)(Baseline and Week 32 (EOT/ET))
- Baseline, Absolute Week 32 Values for Respiratory Rate and Change From Baseline in Respiratory Rate at Week 32 (EOT/ET)(Baseline and Week 32 (EOT/ET))
- Number of Participants Who Were Anti-Drug Antibodies (ADA) Positive and Neutralizing Antibodies (NAb) Positive(Week 10, 16, 22, 24, 26, 28, 32)
- Mean ADA Titers(Week 10, 16, 22, 24, 26, 28, 30, 32)
研究者
研究点 (72)
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