预约演示
更新于：2026-08-06
Certolizumab Pegol
培塞利珠单抗
更新于：2026-08-06
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2008-04-22), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、优先审评 (中国) |
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结构/序列
Sequence Code 7540H
来源: *****
Sequence Code 99012L
来源: *****
关联
135
项与 培塞利珠单抗 相关的临床试验CTIS2026-525221-21-01
Optimising Arthritis Strategies in Elderly patients (≥70 years) with rheumatoid arthritis in sustained low disease activity (the OASE study): A Prospective Target Trial Emulation Study Evaluating Tapering of Disease-Modifying Anti-Rheumatic Drugs vs. Usual Care Based on Patient Preference
NCT07352566
Utilization of a Cutaneous Therapy In Situ Microdevice
CTIS2026-525316-33-00
DISCO-RA:DIScontinuation of COncomitant disease modifying anti-rheumatic drugs (DMARDs) in rheumatoid arthritis patients also using TNF inhibitors - a randomized long-term non-inferiority strategy trial
100 项与 培塞利珠单抗 相关的临床结果
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100 项与 培塞利珠单抗 相关的转化医学
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100 项与 培塞利珠单抗 相关的专利（医药）
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1,416
项与 培塞利珠单抗 相关的文献（医药）2026-12-01MOLECULAR BIOLOGY REPORTS
The effect of hesperidin on trigeminal nerve damage in an NTG-induced migraine model: the role of the TRPV1 channel
Article
作者: Çınar, Ramazan ; Ahlatcı, Adem ; Bayir, Mehmet Hafit ; Yıldızhan, Kenan ; Keleş, Ömer Faruk
BACKGROUND:
Migraine is a common neurovascular disease associated with trigeminovascular activation and neurogenic inflammation. The transient receptor potential vanilloid-1 (TRPV1) channel plays a central role in nociceptive signalling, while hesperidin (HES), a citrus flavonoid, is known for its antioxidant and neuroprotective properties. This study evaluated the protective effects of HES on TRPV1-mediated pathways in the trigeminal nerve (TGN) in a nitroglycerin (NTG)-induced migraine model.
METHODS:
C57BL/6j mice were randomly assigned to control, NTG, HES + NTG, capsazepine (CPZ) + NTG, and HES + CPZ + NTG groups. Migraine-like pain was induced with NTG (10 mg/kg, i.p.), while HES (200 mg/kg, gavage, 3 days) and CPZ (1 mg/kg, i.p.) were administered as treatments. Behavioral nociceptive assays (tail withdrawal, paw withdrawal, hot plate tests) were performed. The TGN was removed after the mice were killed sacrificed under anesthesia. Substance P, CGRP, BDNF, GSH, MDA, IL-1β, TNF-α, caspase-3, caspase-9, and TRPV1 levels in the TGN were analyzed by an ELISA kit. TRPV1 channel expression was measured in the TGN by western blot analysis. Also, TGN were evaluated histopathologically.
RESULTS:
NTG significantly induced hyperalgesia, oxidative stress, inflammatory cytokine release, apoptotic activation, and increased TRPV1. HES and CZP treatment significantly attenuated these changes, prolonging nociceptive thresholds, restoring antioxidant defences, suppressing neuropeptides, down-regulating TRPV1, and preserving neuronal morphology.
CONCLUSIONS:
HES treatment and TRPV1 channel inhibition offer a potential therapeutic opportunity for preventive and therapeutic strategies in the treatment of migraine.
2026-10-01JOINT BONE SPINE
Certolizumab inhibits radiographic progression in patients with early rheumatoid arthritis and high rheumatoid factor levels: A pooled, post-hoc analysis of the phase 3 C-EARLY and C-OPERA trials
Article
作者: Huizinga, Thomas ; Mikuls, Ted R ; Robinson, William H ; Curtis, Jeffrey R ; Lopez-Medina, Clementina ; Mahoney, Paul ; Tanaka, Yoshiya ; Smolen, Josef S ; Taylor, Peter C ; Takeuchi, Tsutomu ; Ufuktepe, Baran ; Lauwerys, Bernard ; Burmester, Gerd
OBJECTIVE:
To assess radiographic progression in patients with early rheumatoid arthritis (RA) and poor prognostic factors treated with certolizumab pegol (CZP)+methotrexate (MTX) versus placebo (PBO)+MTX, stratified by rheumatoid factor (RF) level.
METHODS:
In a pooled, post-hoc analysis of phase 3 randomized trials (C-EARLY [NCT01519791] and C-OPERA [NCT01451203], patients were stratified by baseline RF level (low: <200 IU/mL; high: ≥200IU/mL). Change from baseline (Δ) in modified Total Sharp Score (mTSS) and components, predicted risk of RP, and disease activity are reported up to Week (Wk)52.
RESULTS:
Eight hundred and thirteen CZP+MTX-randomized (low RF: n=571; high RF: n=242) and 367 PBO+MTX-randomized (low RF: n=242; high RF: n=125) patients were included. Baseline characteristics were similar between treatments; however, patients with high RF had more severe disease. The proportion of patients with clinically meaningful radiographic worsening (ΔmTSS >5) at Wk24 was more comparable between patients with high and low RF levels randomized to CZP+MTX (low RF: 1.0% vs high RF: 0.0%) and was numerically lower than with PBO+MTX (2.8% vs 6.5%) and this pattern was maintained through Wk52. Clinical outcomes were generally favorable with PBO+MTX, but better with CZP+MTX.
CONCLUSION:
In MTX-naïve patients with early RA, radiographic progression was more similar between CZP+MTX-treated patients with high and low RF levels, and consistently numerically lower, than PBO+MTX-treated patients. Irrespective of RF level, CZP+MTX better attenuated than MTX alone and was associated with more favorable clinical outcomes. Our findings suggest that RF level does not adversely influence radiographic response to CZP+MTX.
2026-07-01DIABETES-METABOLISM RESEARCH AND REVIEWS
Tissue and Serum Concentrations of Time‐Dependent Antibiotics in Infected Diabetic Foot Ulcers by Bolus or Continuous Administration: The Randomised DFIATIM Trial
Article
作者: Polák, Jan ; Beca, Pavol ; Fejfarová, Vladimíra ; Jarošíková, Radka ; Tůma, Petr ; Němcová, Andrea ; Sojáková, Dominika ; Wosková, Veronika ; Skružná, Markéta ; Mekadim, Chahrazed ; Modos, Istvan ; Antalová, Simona ; Dubský, Michal ; Mrázek, Jakub ; Mareš, Jan
ABSTRACT:
Aims:
The clinical effectiveness of antibiotic (ATB) therapy in patients with infected diabetic foot ulcers (iDFUs) depends on achieving sufficient ATB concentrations in both serum and peripheral tissues. This study evaluated the availability and bactericidal activity of the time‐dependent ATBs—ceftazidime (CTZ) and amoxicillin/clavulanate (AMC) in serum and peripheral tissues by comparing bolus versus continuous administration.
Methods:
Sixty patients with iDFUs were randomised into four subgroups according to ATB and administration method: CTZ bolus (CTZ
bolus
), CTZ continuous infusion (CTZ
continuous
), AMC bolus (AMC
bolus
), and AMC continuous infusion (AMC
continuous
). Once steady‐state concentrations were reached, microdialysis was used to assess ATB levels in tissue adjacent to the ulcer. Serum and tissue samples were collected over a 6‐h period. Bactericidal activity was assessed by peak concentrations (Cmax), area under the curve (AUC), and the proportion of time free drug concentrations remained above the minimum inhibitory concentration (fT > MIC). Target thresholds were fT > MIC ≥ 60% for CTZ and ≥ 50% for AMC.
Results:
All patients achieved serum fT > MIC targets for CTZ and AMC in 100% of AMC
bolus
and 89% of AMC
continuous
. In tissue, target attainment was 60% (CTZ
bolus
), 73% (CTZ
continuous
), 79% (AMC
bolus
), and 83% (AMC
continuous
). Bolus administration led to rapid serum peaks (5 min) and delayed tissue peaks (30–60 min), with subsequent declines. Continuous infusion produced gradual concentration increases over time.
Conclusions:
While all patients achieved serum fT > MIC targets for CTZ and AMC (100% for AMC
bolus
and 89% for AMC
continuous
), target attainment in tissue was substantially lower. These findings suggest that although serum pharmacodynamic targets are reliably achieved, tissue exposure remains suboptimal.
100 项与 培塞利珠单抗 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 红皮病性银屑病 | 日本 | 2019-12-20 | |
| 寻常性银屑病 | 日本 | 2019-12-20 | |
| 脓疱型银屑病 | 日本 | 2019-12-20 | |
| 非放射性轴性脊柱关节炎 | 澳大利亚 | 2010-01-20 | |
| 斑块状银屑病 | 澳大利亚 | 2010-01-20 | |
| 强直性脊柱炎 | 欧盟 | 2009-10-01 | |
| 强直性脊柱炎 | 冰岛 | 2009-10-01 | |
| 强直性脊柱炎 | 列支敦士登 | 2009-10-01 | |
| 强直性脊柱炎 | 挪威 | 2009-10-01 | |
| 银屑病关节炎 | 欧盟 | 2009-10-01 | |
| 银屑病关节炎 | 冰岛 | 2009-10-01 | |
| 银屑病关节炎 | 列支敦士登 | 2009-10-01 | |
| 银屑病关节炎 | 挪威 | 2009-10-01 | |
| 中轴性脊柱关节炎 | 欧盟 | 2009-10-01 | |
| 中轴性脊柱关节炎 | 冰岛 | 2009-10-01 | |
| 中轴性脊柱关节炎 | 列支敦士登 | 2009-10-01 | |
| 中轴性脊柱关节炎 | 挪威 | 2009-10-01 | |
| 类风湿关节炎 | 美国 | 2009-05-13 | |
| 克罗恩病 | 美国 | 2008-04-22 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 银屑病 | 临床3期 | 比利时 | 2022-01-30 | |
| 活动性中度克罗恩病 | 临床3期 | 美国 | 2017-11-03 | |
| 泛发性脓疱型银屑病 | 临床3期 | 日本 | 2017-02-21 | |
| 间质性膀胱炎 | 临床3期 | 美国 | 2015-12-15 | |
| 炎症 | 临床3期 | 美国 | 2015-09-01 | |
| 炎症 | 临床3期 | 澳大利亚 | 2015-09-01 | |
| 炎症 | 临床3期 | 保加利亚 | 2015-09-01 | |
| 炎症 | 临床3期 | 加拿大 | 2015-09-01 | |
| 炎症 | 临床3期 | 捷克 | 2015-09-01 | |
| 炎症 | 临床3期 | 匈牙利 | 2015-09-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
N/A | 1,167 | 鏇製衊繭選鏇鹽廠鹹積(選廠鑰夢蓋鏇夢壓簾範) = 積鏇糧蓋衊壓淵繭衊艱 鑰窪製淵獵範範鏇繭簾 (膚醖簾鏇廠繭襯鑰醖壓 ) 更多 | 积极 | 2026-06-11 | |||
(PsA) | 鏇製衊繭選鏇鹽廠鹹積(選廠鑰夢蓋鏇夢壓簾範) = 壓膚繭簾鹹衊衊簾獵壓 鑰窪製淵獵範範鏇繭簾 (膚醖簾鏇廠繭襯鑰醖壓 ) 更多 | ||||||
临床3期 | 795 | Active conventional treatment | 鑰鹹顧壓鹽繭夢獵鬱醖(鑰範鏇壓範鏇蓋淵選觸) = 鏇衊憲願鏇壓簾鬱遞壓 夢範構繭餘蓋醖艱獵鬱 (獵網積夢夢襯艱繭衊願 ) | 积极 | 2026-04-01 | ||
Certolizumab pegol + methotrexate | 鑰鹹顧壓鹽繭夢獵鬱醖(鑰範鏇壓範鏇蓋淵選觸) = 鏇廠願醖衊選遞顧網獵 夢範構繭餘蓋醖艱獵鬱 (獵網積夢夢襯艱繭衊願 ) | ||||||
临床2期 | 50 | Certolizumab Pegolht heparin + (lupus anticoagulant + antiphospholipid syndrome) | 蓋獵壓觸淵構壓選遞鏇(鏇鑰鏇夢淵簾夢簾鏇襯) = 範鹽膚範蓋構膚廠襯鹽 餘艱餘網獵獵鑰獵鹽鏇 (顧簾憲簾夢衊顧繭鬱鏇, 8.6 ~ 31.4) 更多 | 积极 | 2025-10-24 | ||
N/A | 252 | 遞構顧蓋製窪網衊齋憲(憲繭壓窪廠膚糧糧築醖) = 鹹蓋膚鏇糧繭窪獵鏇積 獵鹹窪夢網遞膚廠網憲 (鬱網製顧襯鏇蓋觸糧鹹, 1.29) 更多 | 积极 | 2025-10-24 | |||
JAK Inhibitors (Tofacitinib/Baricitinib/Upadacitinib/Filgotinib) | 遞構顧蓋製窪網衊齋憲(憲繭壓窪廠膚糧糧築醖) = 壓夢窪窪鹹製艱積鑰鏇 獵鹹窪夢網遞膚廠網憲 (鬱網製顧襯鏇蓋觸糧鹹, 1.38) 更多 | ||||||
N/A | - | 624 | Methotrexate combined with other csDMARDs/corticosteroids or steroids alone | 糧顧鹽壓壓衊窪簾選鬱(觸繭餘願鑰遞廠廠膚壓) = 齋網衊窪蓋範蓋壓積觸 齋夢憲顧網膚鹹襯鏇簾 (鬱觸鹹積構簾網窪淵範 ) 更多 | 积极 | 2025-10-24 | |
N/A | 84 | 憲獵遞繭願夢鑰鏇選襯(願構願網膚憲築鑰蓋觸) = AEs were broadly similar between the two groups, and no SAEs were reported. 窪艱壓鏇齋鬱糧鏇鬱餘 (膚窪淵廠壓選醖餘醖積 ) 更多 | 非劣 | 2025-06-11 | |||
临床2期 | 51 | Certolizumab pegol+LMWH+LDA | 繭壓醖廠獵膚夢願廠鏇(鹽構觸獵觸選觸鹹廠築) = 鏇鏇獵醖範廠鬱範鹹淵 構範夢範選衊夢網夢鹹 (壓繭糧範齋繭鏇餘製蓋 ) | 积极 | 2025-06-11 | ||
N/A | 3,072 | 膚顧艱範鑰範壓餘餘鹹(艱鑰鏇顧鏇壓艱鬱衊壓) = concomitant use of thiopurines was associated with higher odds of NMSC (odds ratio: 2.30 [95% CI: 1.09, 4.89]) 餘壓遞觸顧築顧願艱蓋 (鏇窪鹹築簾鏇觸網顧範 ) 更多 | 积极 | 2024-12-30 | |||
Corticosteroids | |||||||
临床3期 | 1,180 | Certolizumab pegol+methotrexate | 艱鏇餘憲鬱選鑰簾廠繭(觸積廠膚窪鏇糧構簾齋) = 鏇願顧餘鬱壓鹽鹹簾範 鹹鏇糧繭襯鬱繭鹹觸範 (願襯顧繭鏇憲選壓網製, 2.63) 更多 | 积极 | 2024-11-10 | ||
Placebo+methotrexate | 艱鏇餘憲鬱選鑰簾廠繭(觸積廠膚窪鏇糧構簾齋) = 鹽壓願艱膚膚製鏇積構 鹹鏇糧繭襯鬱繭鹹觸範 (願襯顧繭鏇憲選壓網製, 3.43) 更多 | ||||||
临床3期 | 930 | 鏇廠夢觸鏇遞壓簾鏇願(壓繭選淵衊構齋選築襯) = 衊餘築製衊願構鬱醖簾 廠願廠鏇鹹鹽窪構構壓 (鬱築顧蓋製鬱膚糧醖製 ) 更多 | 积极 | 2024-11-10 | |||
Placebo | 鏇廠夢觸鏇遞壓簾鏇願(壓繭選淵衊構齋選築襯) = 選壓鹹製範繭構糧獵糧 廠願廠鏇鹹鹽窪構構壓 (鬱築顧蓋製鬱膚糧醖製 ) 更多 |
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