Efficacy and safety of a novel synergistic drug candidate, CRx-102, in hand osteoarthritis.
Efficacy and safety of a novel synergistic drug candidate, CRx-102, in hand osteoarthritis.
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DOI：
10.1136/ard.2007.074401
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发表时间：
2008-07
影响因子：
27.4
通讯作者：
Lessem J
中科院分区：
文献类型：
--
作者：
Kvien TK;Fjeld E;Slatkowsky-Christensen B;Nichols M;Zhang Y;Prøven A;Mikkelsen K;Palm Ø;Borisy AA;Lessem J
新的协同候选药物CRX-102由潘生丁和小剂量强的松龙组成，正在临床开发中，用于治疗免疫性炎症性疾病。本临床研究的目的是考察CRX-102治疗手部骨关节炎(HOA)的疗效和安全性。这项研究是在挪威的四个中心以盲法、随机、安慰剂对照的方式进行的。资格标准包括年龄30-70岁，至少一个关节肿胀和压痛，X线片Kellgren-Lawrence(K-L)评分2或以上，以及澳大利亚/加拿大骨关节炎手指数视觉模拟疼痛评分至少30 mm疼痛。主要终点是在AUSCAN疼痛分量表上从基线到第42天的疼痛减轻。给出了根据基线调整的最小二乘(LS)均值差的双边p值。83名HOA患者的平均年龄为60岁，其中93%为女性。在治疗人群的意图方面，CRX-102在42天的AUSCAN疼痛变化(LS平均−14.2vs−4.0)和临床相关的次要终点(关节疼痛VAS(−18.6vs−6.3)，患者全球VAS(−15.9vs−4.2))方面在统计学上优于安慰剂。研究期间最常见的不良反应是头痛(CRX-102组为52%，安慰剂组为15%)。与安慰剂相比，新的协同候选药物CRX-102在HOA中通过统计减少疼痛而证明了有效性，并且总体耐受性良好。
The novel synergistic drug candidate CRx-102 comprises dipyridamole and low dose prednisolone and is in clinical development for the treatment of immunoinflammatory diseases. The purpose of this clinical study was to examine the efficacy and safety of CRx-102 in patients with hand osteoarthritis (HOA). The study was conducted as a blinded, randomised, placebo-controlled trial at four centres in Norway. Eligibility criteria included being of age 30–70 years, at least one swollen and tender joint, a Kellgren–Lawrence (K–L) score of 2 or higher on radiographs, and a score of at least 30 mm pain on the Australian/Canadian Osteoarthritis Hand Index (AUSCAN) visual analogue pain scale (VAS). The primary endpoint was a reduction in pain from baseline to day 42 on the AUSCAN pain subscale. Two-sided p values for the differences in least squares (LS) means adjusted for baseline are presented. The mean age of the 83 patients with HOA was 60 years and 93% were females. CRx-102 was statistically superior to placebo at 42 days for changes in AUSCAN pain (LS mean −14.2 vs −4.0) and for clinically relevant secondary endpoints (joint pain VAS (−18.6 vs −6.3), patient global VAS (−15.9 vs −4.2)) in the intention to treat population. The most frequently reported adverse event during the study was headache (52% in CRx-102 vs 15% in the placebo group). The novel synergistic drug candidate CRx-102 demonstrated efficacy by statistically reducing pain compared to placebo in HOA and was generally well tolerated.
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影响因子：
--
作者：
ALTMAN, R;ALARCON, G;WOLFE, F
通讯作者：
WOLFE, F
影响因子：
27.4
作者：
Jordan, KM;Arden, NK;Dougados, M
通讯作者：
Dougados, M
影响因子：
--
作者：
OLIVERIA, SA;FELSON, DT;WALKER, AM
通讯作者：
WALKER, AM
影响因子：
4
作者：
Forrest, Caroline M.;Stoy, Nicholas;Darlington, L. Gail
通讯作者：
Darlington, L. Gail
影响因子：
120.1
作者：
Keith, CT;Borisy, AA;Stockwell, BR
通讯作者：
Stockwell, BR