Crohn’s disease - Moderate to severe
You may be reimbursed for any reasonable expenses incurred including travel and £89 for your time attending the site for each colonoscopy
About This clinical research study
MAC Clinical Research is currently conducting a clinical study to test a new investigational medication for Crohn’s disease (CD). CD is a chronic inflammatory disease where parts of the digestive system become inflamed, it is characterised by periods of remission and relapse, or ‘flare-ups’. Symptoms include diarrhoea or soft/liquid stools, stomachache/cramps, blood in your poo, tiredness and weight loss.
The investigational medication, BMS-986165, has been developed as a variation of a protein in our bodies known as tyrosine kinase 2 (TYK-2). Previous studies have shown that BMS-986165 may help to control the part of the immune system responsible for CD. The purpose of this clinical study is to further assess the safety and effectiveness of BMS-986165 compared to placebo in participants with moderate to severe Crohn’s disease. Administration is by tablet, taken orally, twice a day (morning and evening).
Eligible participants may enter a 12-week Induction period where they will have a 3 in 4 chance (75%) of receiving BMS-986165, the investigational medication, and a 1 in 4 chance (25%) chance of receiving the placebo (a ‘dummy drug’). Following week 12; if you respond to the treatment you may continue to receive the same study treatment. If you experience a loss of response, you may be offered to switch to open label treatment, where you will receive the investigational medication (no possibility for placebo).
If you contact us, it does not mean you have to decide at that point whether to participate.
If you do decide to participate you are free to withdraw at any time.
If you choose to participate you may be involved in the clinical study’s 5 phases, for a duration of up to 112 weeks (just over 2 years) which may include up to 25 outpatient visits.
At the end of the Open Label treatment period, you may also be eligible to continue receiving BMS-986165 during a separate Long Term Extension (LTE) study, this can be discussed later in the study and there will be no obligation to participate.
Reimbursement: You may be reimbursed for any reasonable expenses incurred including travel and £89 for your time attending the site for each colonoscopy
Key Inclusion Criteria
Key Exclusion Criteria
Other eligibility criteria will apply. Please contact MAC for more information.
If you are eligible you will receive a comprehensive health screen. Your GP will be fully informed of your participation and provided with any information relevant to your healthcare.
ABOUT CLINICAL RESEARCH STUDIES
Clinical research studies are performed as a way of bringing about progress in medicine and research. Clinical research studies make it possible to scientifically assess the properties of a drug, to demonstrate the effectiveness and safety of a treatment or a medical device, or to learn more about a disease and methods to diagnose and monitor it.
If the study is successful, it may be an important step towards developing a promising new treatment.
MAC Clinical Research is conducting a trial to evaluate a potential new treatment for Crohn’s Disease.
If you would like more information, please fill in the form below and we will be in touch…
Alternatively, please call our recruitment team on freephone 0800 633 5507.
Data Privacy Statement
The collection and analysis of the most confidential information about people is of fundamental importance for conducting medical research. MAC Research understands that in order for individuals to share their most sensitive information with us, we must have a culture of trust and that we will store data following safe data management practices.
MAC Research Limited (together with its affiliates and subsidiary companies “MAC,” “we,” “us,” and “our”) is committed to ensuring that we handle all individual information in a responsible and careful manner and in accordance with data privacy and confidentiality laws.
Who Are We?
MAC is a leading European clinical research organisation with a network of clinical research centres. MAC provides patient engagement and recruitment services and conducts full scope ethically approved clinical research and medical trials for pharmaceutical companies (“Sponsor”), medical device companies and clinical research organisations. MAC also provides healthcare and consultancy services.
As an employer and clinical research organisation we act as Data Controller over individual personal data and healthcare information. When conducting clinical trials MAC will be regarded as the Data Controller and the Sponsor will be regarded as a Data Processor and participants should consider our respective roles in processing the personal data. For example, with regard to coded clinical trial data provided to Sponsor, MAC is the Data Controller and the Sponsor is a Data Processor of the personal data. Importantly, both act in accordance with the applicable data protection law. Under some particular circumstances, where MAC is involved jointly in determining purpose and/or means of processing data, MAC may be regarded as Joint Controller of Clinical Trials Data.
MAC has internal policies, procedures and training programs designed to support compliance with the above laws and this Policy. All our policies, procedures and training programs are reviewed on a regular basis and overseen by our legal team and senior executives.
Types of Personal Information Managed by MAC Research
Clinical and Medical Information
In our capacity as a clinical research organisation providing services for Sponsors, our clinical research sites collect, host and analyse significant quantities of health data and bio-medical samples relating to clinical trial participants. This is because it is necessary to establish the identity of participants accurately and to ensure they are participating in clinical trials that are appropriate for them. MAC is regarded as the Data Controller and the clinical trial Sponsors are considered to be a Data Processor in the terms established by Regulation. However, under some particular circumstances, where MAC is involved jointly in determining purpose and/or means of processing data, MAC may be regarded as Joint Controller of Clinical Trials Data. To adhere to good clinical practice and to ensure the privacy of clinical trial participants is maintained, identification numbers (i.e. not names) are applied to specific clinical trial documentation and any samples taken during the course of clinical trials.
Clinical Trial Participant Engagement and Recruitment Information
MAC gathers and manages personal and demographic contact details, date of birth, supporting personal information and data relating to health, medical indications and relevant areas of research from individuals who have expressed their interest in clinical trial participation. We also gain appropriate consents from participants to retain information and access medical records. MAC uses this information to correctly identify participants and access medical health records via a participant’s doctor or NHS Digital. MAC considers all of this information to match prospective participants against relevant future clinical trials and to conduct study recruitment analyses. We do not use automated individual decision-making when processing medical records but do use search tools when matching participants for studies. MAC does this because participant safety is of paramount importance when conducting clinical trials. Therefore, matching participants accurately against the participation eligibility criteria of a clinical trial protocol, forms a vital part of the clinical research process. This is important because the objective of all clinical trials is to determine the safety and efficacy of the new medication or device under investigation. The integrity of a clinical trial relies on the accurate delivery of the clinical trial protocol and these stringent measures ensure that new medications once approved by regulatory authorities for use by humans, can ultimately be used to benefit health and social care.
Industry Professional Information
MAC will liaise with employees, consultants, contractors and other third parties employed or engaged by our clients, when conducting our clinical trials and research activities. MAC will record and use the names, contact details and other professional information on these individuals for legitimate business-related purposes, including project and financial administration. This information may be used (including email addresses), to provide background on MAC’s services for our clients.
Employee and Human Resource Data
We collect personal information from applicants pursuing employment with MAC, including private contact details, professional qualifications and previous employment history to assist with the personnel recruitment process. MAC carries out a range of background inspections on applicants, including DBS and professional disbarment checks. Consistent with the operation of a business, MAC systems collect information on employed staff for human resource, performance, payroll and tax purposes. MAC processes similar information relating to consultants, contractors and other third parties that we engage to deliver products or services.
MAC collects named information about visitors to our company websites when there is a request volunteered from an individual. This includes requests, for example by clients regarding information about company services, or when medical professionals are interested in contributing to a clinical trial or where job applicants are applying for a vacancy. MAC may collect various data via cookie-based technologies, linked to virtual identities allocated to visitors when they access our websites. This information is used for website analytics and for first party marketing. These virtual identities are sometimes connected with real world identities of visitors when they submit named details. This enables MAC to personalise marketing messages to make them relevant to those visitors.
Internal and External Disclosures of Personal Information
Personal information is only shared on a “need to know” basis within MAC and its affiliates and with relevant third parties to deliver stated legitimate business purposes. Any access to personal information contained within databases and binders is carefully restricted and only viewable by appropriate staff for legitimate purposes. MAC does not trade or sell personal information.
Under some circumstances, MAC may be required by law enforcement or judicial authorities to disclose certain personal information as part of investigations or for litigation purposes. MAC may disclose personal information to a buyer or other successor in the event of a merger, divestiture, restructuring, reorganisation, dissolution or other sale or transfer of MAC or cases or all of its assets.
Any companies who work as vendors for MAC are required to sign “processor” and/or confidentiality agreements whereby they commit to only process personal information consistent with contracted purposes and take organisational and technical security safeguards for the data.
Notice of Data Use and Consent
MAC will provide notice to individuals using clear and conspicuous language at the point of data collection, about how their information will be used and disclosed. We will make clear what choices are available in relation to how individual data is managed and what rights there are under data privacy law or under this Policy and who to contact with any questions or complaints. MAC’s privacy notices are tailored according to specific data collection circumstances. In providing such notice, MAC meets its obligations to be transparent and fair with individuals as is required by General Data Protection Regulation. Dependent on the medium, notice may be given in person, by email, post, telephone, or by posting on our website.
In accordance with data privacy law and good practice, MAC will seek consent of individuals to collect, use and disclose their data consistent with the relevant privacy notice. In certain cases where law allows, particularly where gaining consent will involve a disproportionate effort, where intended processing of the data is in MAC’s or our clients’ legitimate interests and the privacy risks are low, MAC will proceed to process personal information absent of consent. MAC will also use and disclose personal information without consent where required by law and judicial order. MAC will collect all necessary informed consents of clinical trial participant on behalf of clients, according to good clinical practice, laws on confidentiality and data privacy regulations. MAC’s interests are in conducting ethically approved clinical trials and following good clinical practice to the highest medical and scientific standards. In order to facilitate the safe delivery of clinical trials and to enable the development of new medications for health and social care, it is of vital importance that MAC has personal and demographic information that will enable participants to be correctly identified. Furthermore, is also critical that additional personal information including medical history, medical conditions and medications are recorded to ensure that participants meet the medical criteria to deliver the clinical trial objectives and most importantly in consideration of participant safety.
Data Quality, Integrity and Retention of Records
Data quality and accuracy is essential in clinical trials and MAC understands the vital importance of this. The accuracy of data relating to clinical trial participants is critical for the integrity clinical research, particularly where bio-medical samples are concerned. MAC employs an in-house quality assurance department to ensure that standards are commensurate with all legal requirements. Our privacy notices provide individuals with a straight-forward way of updating and validating information and enabling error corrections. MAC retains personal information for up to 15 years, in accordance with contractual, legal and regulatory requirements. We will retain your information for as long as necessary for the uses set out in this Policy or while there is a legitimate business reason for doing so. If you ask us to delete your information before this time, we may not be able to do so for technical, legal, regulatory or contractual constraints.
In accordance with data privacy laws and contractual commitments, MAC ensures that individuals can exercise all relevant informational rights with respect to their personal information processed by the organisation, including but not limited to the right of access and correction, to withdraw consent at any time, object to data processing, request data deletion, restrict aspects of data processing, prevent direct marketing and request transmission of personal data in a common digital format (e.g. pdf) to the themselves or another organisation.
In all other respects, where no overriding interest prevails, MAC will endeavour to allow the following informational rights under this Policy as a matter of good practice:
- to allow access to copies of personal information within a reasonable timeframe;
- to correct personal information where inaccurate; and
- to withdraw a previously provided consent to processing of personal information.
Participants enrolled in clinical trials run by MAC’s clients must contact the principal investigator at their MAC research centre, who will be able to identify the participant and progress their request accordingly. The contact details for MAC research centres are available at the following web address: https://researchforyou.co.uk/clinical-trial-centre-locations/
Considerations When Online
Children’s Online Privacy Protection
MAC does not collect information through our websites from individuals who are known to be under the age of 13, and no part of our online presence is directed to anyone less than 13 years.
Inquiries, Complaints and Requests to Exercise Rights
Communications, queries, requests to exercise informational rights (e.g., access to data) or complaints can be addressed for the attention of the Data Protection Officer, MAC Research, Kaman Court, 1 Faraday Way, Blackpool, Lancashire, FY2 0JH, United Kingdom.
Within UK individuals have the right in law to complain about how their information is managed to a supervisory authority that is responsible for regulating compliance with the Regulation. The following URL links to the relevant authority https://ico.org.uk/make-a-complaint/your-personal-information-concerns/
Legal Status of Policy and Policy Changes
This Policy is not a contract, and it does not create any legal rights or obligations. MAC reserves the right to modify or amend this Policy and may do so according to new or amended legislation. The updated Policy will be posted on https://www.macplc.com/mac-privacy-policy and https://researchforyou.co.uk/privacy-policy/ (Last Updated: 7 October, 2020).
Frequently Asked Questions
Crohn’s disease is a lifelong condition that causes inflammation in the digestive system, and is one of the two main forms of inflammatory bowel disease (IBD), the second being ulcerative colitis. It is often characterised by periods of remission and relapse, or “flare ups”, however, some may experience constant symptoms. Severity of symptoms will vary but those commonly experienced are stomach pains/cramps, diarrhoea, often containing blood, mucus or pus, fatigue and weight loss. Those diagnosed with Crohn’s disease tend to have symptoms on and off for life, the correct treatments can control, but not cure, the condition.
Medical treatments for Crohn’s disease aim to decrease the severity and frequency of “flare-ups”. Options will vary from patient to patient, depending on the severity and frequency of their symptoms, and may involve short or long-term treatment using conventional or advanced therapies, and sometimes a combination of all. Medications used to treat the symptoms of Crohn’s disease include: Aminosalicylates (5-ASAs), Corticosteroids (steroids), Immunosuppressants, and advanced therapies such as biologics, janus kinase (JAK) inhibitors or Sphingosine-1-phosphate receptor 1 (S1PR1) inhibitors.
Currently there is no cure, Crohn’s disease tends to be a progressive condition, meaning symptoms will get worse without treatment. Medical treatments aim to decrease the severity and frequency of “flare-ups”. Treatments also help to improve the long-term prognosis of Crohn’s disease by limiting complications, such as colorectal cancer, deep vein thrombosis, or other complications. Whilst living with Crohn’s disease can be difficult at times, there is no reason why patients cannot enjoy a normal life if their symptoms are well controlled with the right treatment.
Volunteers are vital for the success of clinical trials, to help test new medicines and find better treatments for the future for medical conditions such as Crohn’s disease. Taking part in a clinical trial offers an opportunity to be a part of the development of treatments and help future sufferers of Crohn’s disease. Clinical trials test the safety and efficacy of new medicines and may involve potential risks, it is, therefore, crucial that you fully understand what is involved in the clinical trial before agreeing to take part. Volunteers for clinical trials are always screened to assess their suitability for the trial and will be fully informed of the risks associated with the trial during this screening process.
All clinical trials must be reviewed and authorised by various governing bodies and committees before they can go ahead to minimise any risks. The Medicines and Healthcare products Regulatory Agency (MHRA) ensures that medicines meet applicable standards of safety, quality and efficacy, meaning a trial must be thought to be safe before it is approved. The Health Research Authority (HRA) is responsible for research ethics committees across the UK. Independent research ethics committees work to protect the interests and rights of volunteers who take part in the trial, adding another layer of protection to the process.
If you have a diagnosis of Crohn’s disease that has been confirmed by colonoscopy and/or a gastroenterologist and are aged 18 or above, you may be eligible to take part. Age ranges and length of diagnosis will vary between clinical trials and other eligibility criteria will apply.
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