None listed
Conditions
Brief summary
The overall goal of the study is to evaluate whether Enbrel® and its biosimilar Brenzys® are interchangeable in the treatment of patients with rheumatoid arthritis. That is, different sequences of Enbrel® and Brenzys® use are not associated with increased immunogenicity as evident by treatment related loss of clinical efficacy and development of treatment related clinical toxicity. The specific aim of the study is to test whether multiple switching between the etanercept biosimilar Brenzys® and the etanercept reference product Enbrel® (the intervention group) is non-inferior with regard to disease control and clinical immunogenicity compared to no switching, that is, continuing on Enbrel® (the control group), in participants with stable rheumatoid arthritis on Enbrel® who are in clinical remission or a low disease activity state by the DAS28-CRP.
Interventions
The study is a single blind, non-inferiority 2 parallel arm randomised controlled trial in participants with stable low disease activity rheumatoid arthritis currently on Enbrel®. Fifty-two participants (n=52, inclusive of 10% drop-out rate) will be recruited and randomised in a 1:1 allocation to (i) remaining on Enbrel® for 12 months and (ii) multiple switching according to a switching sequence for 12 months. Participants will be stratified 1:1 by co-treatment with methotrexate. Switching will
The study is a single blind, non-inferiority 2 parallel arm randomised controlled trial in participants with stable low disease activity rheumatoid arthritis currently on Enbrel®. Fifty-two participants (n=52, inclusive of 10% drop-out rate) will be recruited and randomised in a 1:1 allocation to (i) remaining on Enbrel® for 12 months and (ii) multiple switching according to a switching sequence for 12 months. Participants will be stratified 1:1 by co-treatment with methotrexate. Switching will be determined by randomized block allocation between retention of Enbrel and switch arms. Those on multi-switch allocation will switch open label every 2 months for a total of 5 switches over a 12 month period, with study assessments being completed by assessors blinded to treatment allocation. Subjects will be using equipotent 50mg doses of Enbrel and Brenzys. These preparations will be self administered subcutaneously on a weekly basis. Since preparations are both etanercept, no washout period will be undertaken.
Sponsors
Emeritus Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Outcome results
None listed