An Assessor-blind, randomised, parallel non-inferiority trial to compare multiple switching of Brenzys® (etanercept biosimilar) and Enbrel® (etanercept reference product) versus non-switching Enbrel® in maintaining efficacy of Enbrel® in participants with rheumatoid arthritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
研究概览
简要总结
In this trial, 52 patients with rheumatoid arthritis in remission or in low disease activity who had been treated with stable doses of Enbrel (etanercept) were randomized to either continuation of their originator compound Enbrel (23 participants) or multiple switching between a biosimilar compound (Brenzys that was alternated every two months with the originator compound Enbrel; 29 participants) and followed up over a 12 month period. The intent of the study was to assess whether multiple switching between a biosimilar compound and the originator compound would allow maintenance of a stable disease activity. In this randomized control trial, it demonstrated non-inferiority of multiple switching compared to continuation of originator drug by both intention to treat and per protocol analysis. Adverse events were similar in the two groups. Blood levels of etanercept were maintained in the 2 groups and ani-drug antibodies were seen only rarely. This was a small trial, but the power calculation suggested it was sufficient to address the question of low disease maintenance activity. The number of participants who dropped out of the trial was higher than assumed but this did not affect the assessment of non-inferiority as seen either in the per protocol (completers) analysis or the intention to treat analysis. Most dropouts occurred late in the course of the trial and it is possible that social pressures stemming from the COVID pandemic may have contributed to the high dropout rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1)Participant must be over the age of 18 years, capable of providing informed consent and agree to attend the research centre for the required study assessments.
- •2)Participants must have a diagnosis of Rheumatoid Arthritis (RA), which has been stable for at least 6-months as determined by the Investigator.
- •3)Participants must have been treated successfully with Enbrel® for at least 6-months and meet the Medicare continuation criteria.
- •4)DAS28-CRP less than or equal to 3.2 calculated prior to study enrolment. The participant’s last CRP result within the last six months can be used for this calculation.
- •5)History of a negative chest x-ray, negative Hepatitis B, C, HIV serology and Quantiferon Gold Assay prior to commencement of biologics.
- •6)Any conventional DMARDs at entry doses must be stable for a minimum of three months prior to study entry and remain stable throughout the study unless mandated by safety considerations.
- •7)At study entry the dose of Prednisone must be less than or equal to 10 mg/day, be stable for a minimum of one month prior to study entry and remain stable throughout the study unless mandated by safety considerations.
- •8)At study entry NSAID doses must be stable for a minimum of two weeks and remain stable throughout the study unless mandated by safety reasons.
- •9)Females of childbearing potential (FCBP) must have a negative pregnancy test at study entry. While taking the study product FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below:
- •Hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring);
- •Intrauterine device (IUD);
- •Tubal Ligation; or
- •Partner’s Vasectomy;
- •Barrier method i.e. male condom
- •10)Male participants who have not had a vasectomy who engage in activity in which conception is possible must use barrier contraception i.e. male condom while taking the product under study, or if their partner is FCBP, the partner can use hormonal contraception, an IUD or have had a tubal ligation.
排除标准
- •Participants will be excluded from participating in the study if they meet any of the following exclusion criteria:
- •1)Change, interruption or cessation in treatment with Enbrel® during the last 6 months due to treatment related adverse events, including recent hospitalizations.
- •2) Women who are pregnant or breast feeding or plan to become pregnant during the course of the study.
- •3) Treatment with any other investigational drug or biological drug within the previous six months.
- •4)Not willing to return for required follow-up visits or clear demonstration of likely poor compliance.
- •5)Poor compliance with current biologic or with monitoring of disease activity and toxicity.
- •6)Any medical condition including current infections that in the judgement of the investigator would prohibit the patient from participating in the study e.g. major co-morbidities, such as severe malignancies, severe diabetic mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease (NYHA class 3 or 4) and/or severe respiratory diseases.
- •7)Psychiatric or mental disorders, alcohol abuse or other substance abuse.