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).
Clinics
Greater Manchester and South Staffordshire
Therapy Area
Crohn’s Disease
Gender and Age
Males and Females aged 18 - 75
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
- Male or female aged 18 to 75 inclusive
- Confirmed diagnosis of Crohn’s disease for at least 3 months
- Inadequate response, loss of response or intolerance to at least one treatment for Crohn’s disease. (Further conditions will apply)
- Active Crohn’s disease
- Experiencing diarrhoea or soft/liquid stools
- Experiencing abdominal pain
Key Exclusion Criteria
- Intolerance to taking oral medication
- Fear of needles
- Presence of a stoma, gastric or ileoanal pouch, previous proctocolectomy or total colectomy
- Diagnosis of alternative forms of colitis (Infectious, inflammatory, ulcerative colitis, indeterminate, toxic, malignant etc.)
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
Introduction
The collection and analysis of the most confidential and personal information about people is of fundamental importance for conducting medical research. MAC Clinical Research understands that in order for individuals to share their most sensitive personal 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 (collectively “MAC,” “We,” “Us,” or “Our”), is committed to ensuring that We handle all individual information in a responsible and careful manner and in accordance with applicable data privacy and confidentiality laws in the UK and other countries.
This Privacy Policy (“Policy“) outlines and describes Our commitment as an organisation to the individuals whose data We manage, the key types of personal data We collect, process and how that information may be used or disclosed. The Policy explains in general terms how We strive to comply with data privacy laws, including without limitation the UK General Data Protection and the Data Protection Act 2018, EU General Data Protection Regulation, and any subsequent amendments to this regulation or local law equivalent that is later adopted, and any applicable local law (“Law(s)”) and the privacy and confidentiality requirements of ICH Good Clinical Practice.
Who Are We?
MAC is a leading global Contract Research Organisation with a network of clinical research centres in multiple countries. MAC provides patient engagement and recruitment services and conducts ethically approved clinical research and medical trials for pharmaceutical and biotechnology companies, medical device companies and other contract research organisations (“Sponsor” and/or “Client”). MAC also provides healthcare and professional consultancy services for its Clients.
Please read the following carefully to understand Our views and practices regarding personal data information and how We will treat it.
Types of Personal Information Managed by MAC
In our capacity as a Contract Research Organisation providing services for Sponsors, we host and analyse significant quantities of health data relating to clinical trial participants and individuals who have volunteered to be on a clinical trial and are assessed for eligibility to enter a clinical trial. MAC also collects, processes, and manages personal information about its employees, Clients and other service providers, during the course of its business operations. MAC also processes contact information provided by members of the public via its website.
MAC may be the data processor or the controller for different types of personal data, and the legal basis for this processing may differ for each activity, the specific arrangements for each type of personal information we process is described in detail below:
1. Clinical Trial Participant Information
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 of humans.
MAC collects, gathers and manages personal data from individuals who have expressed their interest in a MAC clinical trial and have provided their consent to their participation to be on a clinical trial and/or to be considered for a clinical trial. We only use personal data for the purposes We have collected the information for.
Personal data, including sensitive personal data, is collected and processed to match prospective participants to the eligibility requirements of relevant clinical trials, and to conduct and deliver clinical trials and analyse their results. This data may include personal information such as contact details, date of birth, gender, race, ethnicity, physical or mental disability, sex (including pregnancy, and related medical conditions), genetic information (including familial genetic information), and GP Surgery details, health information including current health status, health behaviours and medical history information obtained from the individual, or their GP or other method of collecting information in a local country (for example: NHS England) that identifies the participant, such as their passport or other identifying documents, photographs; and clinical trial data which includes the individuals eligibility to enter the clinical trial and any treatments administered, clinical tests, observations and assessments (including samples such as blood and genetic tests) collected during the clinical trial and any follow-up period.
We do not use automated individual decision-making when processing medical records, but we do use search tools to identify registered individuals who may be suitable for further assessment. Eligibility is always verified by a qualified healthcare professional prior to participation in any clinical trial.
MAC is the controller or processor of this data and has a legitimate interest in processing and retaining this information in accordance with applicable Laws and/or regulations, even if the individual does not enter the trial or withdraws from the trial after enrolment. Sponsor and regulatory representatives may audit or inspect MAC’s data for quality and safety purposes which may include personal data belonging to the clinical trial participant. However, this activity is strictly controlled, and these representatives are not permitted to remove any identifiable participant data from MAC.
MAC engages a range of specialist third-party service providers to deliver clinical trial activities, and to process personal data on its behalf including monitoring whether potential participants were previously on a clinical trial. All processors are required to put in place appropriate safeguards to ensure the protection of personal data. They are subject to contractual restrictions on the processing of this data which reflect their legal and contractual obligations under UK and EU GDPR and/or applicable local Law relating to personal data.
We may also process information for individuals who have consented to being considered for participation in future clinical trials. MAC is the data controller of this information and processes this data under the legal basis of MACs legitimate interest in offering clinical trial recruitment services.
MAC shares the data collected during a clinical trial with the clinical trial Sponsor. This information is pseudonymised, which means that the personal data which could be used to identify the individual is removed and replaced with a special code prior to it being shared. Only MAC can use this code to link the pseudonymised data back to the individual. The Sponsor controls this pseudonymised data and is legally obliged to process and retain it in accordance with applicable Laws and/or regulations.
During the initial and on-going communications with the potential clinical trial participant and successful clinical trial participant We record all calls for training and monitoring purposes.
2. Industry Professional Information
MAC will liaise with its customers and/or Clients, 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 control personal data including 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.
3. Employee and Human Resource Data
We collect and control personal information from applicants pursuing employment with MAC and MAC employees for its legitimate business-related purposes. Such professional or employment-related data includes private contact details, professional qualifications and previous employment history, DBS and professional disbarment checks to assist with the personnel recruitment, staff performance, payroll, security, safety of Our premises and tax purposes. MAC processes similar information relating to consultants, contractors and other third parties that We engage to deliver products or services.
4. Website Visitors Information
Generally anyone can visit the MAC website without revealing who they are and without disclosing any of their personal information. However, MAC collects names and contact details volunteered by visitors to Our company website when making an online enquiry via the site. This includes enquiries, for example by industry professionals regarding information about company services, or when members of the public are interested in volunteering to a clinical trial or applying for a job vacancy with the company. MAC may collect various data via cookie-based technologies, linked to virtual identities allocated to visitors when they access Our websites, such as browsing history, device ID, search history, IP address (Internet Protocol address), information on the visitors’ interaction with a website, device geolocation, application type and version, or advertisements placed and ad interactions. 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. MAC is the data controller of this information and processes it for legitimate business-related purposes in engaging with members of the public in the delivery of clinical research services, employment opportunities and business development.
5. Commercial Information:
MAC will collect and use commercial information such as records of products or services purchased or obtained, or correspondence received. MAC will also collect information for one or more of the following purposes: to fulfil or meet the reason for which the information is provided, including to process payments and other financial transactions; to provide information, products or services that are requested from Us; to provide electronic messages consisting of alerts, reminders, event registrations and other notices concerning Our products or services, appointments, events or news that may be of interest; to improve Our website and present its contents to visitors to the site; for testing, research, analysis and product or services’ development.
Internal and External Disclosures of Personal Information
Personal information is only shared on a “need to know” basis within MAC and its affiliates and subsidiaries and with relevant third parties (such as agents, contractors) to deliver stated legitimate business purposes and legal obligations. Any access to personal information contained within databases and binders is carefully restricted and only viewable by appropriate MAC staff for legitimate purposes. MAC does not trade or sell personal information.
Under some circumstances, MAC may be required by law enforcement agency, court, regulator, government authority, or judicial authorities or other third party to disclose certain personal information as part of investigations or for litigation purposes. Or, where We believe such disclosure is necessary to comply with a legal or regulatory obligation, or otherwise to protect Our rights or the rights of any third party, including to identify or locate anyone for the prevention or detection of crime or the apprehension or prosecution of offenders. In such circumstances we expressly disclaim any liability from any claims resulting from such disclosures and from any actions taken as a consequence of investigations by either Us or law enforcement authorities.
MAC may disclose and transfer personal information to a third party in connection with the sale, assignment, or other transfer of Our business to which the information relates.
Any companies who work as third party contractors or agents for MAC are required to sign “data processing agreements” as a processor and/or confidentiality agreements whereby they commit to only process personal information consistent with contracted purposes and to ensure organisational and technical security safeguards for the data are in place prior to any processing of personal data.
We also share aggregate, non-personal information about website usage with affiliated and unaffiliated third parties.
We may, for example, provide visitors information to agents, contractors, or partners for hosting Our databases, for data processing services, or so that they can mail information to that visitor if requested.
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 personal 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. However, in certain cases where the law allows processing of personal data, in particular where the intended processing of the personal 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, for example, where gaining consent from a person will involve a disproportionate effort. MAC will also use and disclose personal information without consent where required by law and judicial order to disclose information.
MAC will collect all necessary informed consents of clinical trial participants on behalf of Clients, according to good clinical practice, Laws on confidentiality and data privacy regulations and Laws in the country where the consent is provided. MAC’s interests are in conducting ethically approved clinical trials and following good clinical practice to the highest medical and scientific standards.
Data Quality, Integrity and Retention of Records
Data quality and accuracy is essential in ensuring the safety and integrity of clinical trials and the reliability of the scientific knowledge they generate. MAC employs a number of specialists to ensure that data processing standards comply with all legal requirements. Our privacy notices provide individuals with straight-forward information on how to check, update and correct their information. MAC retains personal information in accordance with contractual and regulatory requirements which may vary in different countries and/or across clinical trials.
We will retain this information for as long as necessary for the uses set out in this Policy and for a period permitted under applicable law, including as necessary to comply with our legal obligations, resolve disputes, enforce our legal agreements and policies, and protect Our property. We will also retain usage data for internal analysis purposes. Usage data is generally retained for a shorter period of time, except when this data is used to strengthen the security or to improve the functionality of the website, or We are legally obligated to retain this data for longer time periods. If you ask us to delete your information before this time, we may not be able to do so for technical, regulatory, or contractual constraints.
If you agree to take part in one of our clinical trials, we will provide detailed information regarding retention periods prior to your enrolment.
Your Rights
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. Where no overriding legal obligation or legitimate interest prevails to individuals requests, MAC will endeavour to allow the following informational rights under this Policy as a matter of good practice, these may include:
- to allow access to copies of personal information;
- to correct personal information where inaccurate;
- to erase personal information;
- to object to Our use of personal information;
- to restrict Our use of personal information;
- to withdraw a previously provided consent to processing of personal information;
- to receive personal information in a usable electronic format and transmit it to a third party (right to data portability); and
- to lodge a complaint with local data protection authority if one exists in the country where the personal data was collected.
Information collected about individuals who are assessed for eligibility or enrolled in a clinical trial is subject to overriding legal obligations to ensure the safety and integrity of the trial. This means that some informational rights are restricted in these circumstances, including the individual’s right to access the personal data we hold about them, to the correction of their personal data when incorrect, out of date or incomplete, to withdraw consent or object to further processing of their personal data, to request deletion of personal data we hold about them, to restrict aspects of data processing, or to request transmission of personal data in a common digital format (e.g. pdf) to the themselves or another organisation.
Participants enrolled in a clinical trial should discuss any concern with their Principal Investigator, who will be able to identify the participant and progress their request accordingly. Principal Investigators contact details are provided in the clinical trial specific information leaflet, or they can be contacted via the MAC clinical trial site. Contact details for MAC clinical trial sites are available at the following web address: https://researchforyou.co.uk/clinical-trial-centre-locations/.
If you wish to exercise any of these rights, please contact our Data Protection Officer using the details shown in the section titled “Inquiries, Complaints and Requests to Exercise Rights” below.
Information Security
MAC maintains wide-ranging information security policies to apply technical and organisational security measures appropriate to the risk to the personal information We process. This is to ensure We protect sensitive and personal information that participants provide to Us (particularly sensitive clinical data), against unauthorized access or loss. MAC’s security breach policy provides a procedural response for managing any breach of personal information, including making necessary notifications to individuals or governmental authorities.
Depending on which country personal data is collected or received from will decide which servers are used to store personal data. In the UK MAC stores information on its own servers or on third-party servers (which may be in a different country) and personal data is transferred and stored in accordance with applicable Laws. All data stored are downloaded by MAC personnel. MAC uses commercial measures to ensure that your data is kept safe and treated in accordance with this Policy and applicable data protection and privacy Laws.
Worldwide Transfer of Personal Information: Personal information may be transferred to, stored, and processed in a country other than the one in which it was provided, including the U.S. (i.e., a ‘Recipient’ country). MAC will use mechanisms for any such transfer as required under applicable Law. If you have questions concerning the transfer of your information, please contact Us using the contact details set out below.
Considerations When Online
The pages on MAC’s websites may contain links to external websites, i.e. outside of the company. These external websites are not controlled, maintained, or endorsed by MAC and may contain different information and/or different privacy policies from those of Our company. This Policy does not apply to linked websites outside the MAC organisation. MAC recommends that visitors review the privacy policy of each individually linked website before submitting any personal information. We do not accept any responsibility or liability for external/other websites’ privacy policies.
Our web pages also use cookies. A cookie is a data file that is placed by a website operator on the hard drive of a visitor to their website. MAC, and third parties with whom We work, may place cookies with the following functions on the computers of visitors to MAC websites: to allow the site to deliver the service requested by the visitor; to remember repeat visitors; to improve the user experience of the site; to allow the company to perform site analytics; and to serve and help tailor Our marketing messages on our websites and elsewhere on the internet, based on the visitor’s previous browsing activity.
The web browser and cookie settings on your electronic devices can be tailored to manage your online relationship with MAC. At this time, We do not respond to “do not track” signals, however most web browsers will allow users to choose which cookies can be placed on their electronic device and to delete or disable cookies. Visitors should be aware that disabling cookies may prevent them from using certain features on MAC websites. For more information, please see Our Cookie Policy.
The safety and security of information also depends on the individual providing the personal information:
If any individual chooses or are given a user identification code, password, or any other information as part of Our security procedures for one of the registration-only sections of the website, the individual is responsible for maintaining the confidentiality of their password and username for the website and the individual is responsible for all activities that are carried out under them. We will not be liable where the individual’s password or username is used by someone else. MAC requires that the individual must notify Us immediately, at the contact information provided below, of any unauthorised use of the individuals password or username as soon as they become aware of such unauthorised use. We have the right to disable any user identification code or password, whether chosen by the individual or allocated by Us, at any time to safeguard the individuals account and data. Please be aware that while We take appropriate steps to safeguard the security of personal information, the transmission of information over the Internet is not completely secure and therefore the individual that discloses personal information does this at their own risk.
Children’s Online Privacy Protection
This website is not intended for, or designed to attract, individuals under the age of 18. 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. If you are a parent or guardian and you are aware that your child has provided Us with personal information, please contact Us.
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 Clinical Research Finance Limited, Kaman Court, 1 Faraday Way, Blackpool, Lancashire, FY2 0JH, United Kingdom, (“DPO”).
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: 21st May 2024). Changes and additions to this Policy are effective from the date on which they are posted. Please review the privacy Policy from time to time to check whether We have made any changes to the way in which We use personal information. You may request previous versions of the Privacy Policy from the DPO.
We reserve the right to take any appropriate legal action, including referral to law enforcement, for any illegal or unauthorised use of this website. We also reserve the right take any action to prevent the unauthorised use of Our intellectual property.
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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