Request for participation in STUDY

NOR-SPRINT

This is a request for you to participate in a research project that involves testing a new treatment strategy for psoriatic arthritis. The main goal of the study is to investigate whether treatment that is guided by both regular clinical examination (including blood tests) and the imaging examinations MRI and ultrasound provides better control of disease activity than adjusting treatment based on clinical examination. You are being asked because you are being followed at a rheumatology department that is participating in the study and because your doctor believes that you should start with a disease-modifying drug.

What does the study involve?

You will be followed up for 2 years after inclusion in the study. All patients are followed regularly with clinical examinations and blood tests, a total of 12 visits over the course of 2 years. All are examined with MRI and X-ray at baseline, 1 and 2 years. Half of those who participate in the study will be selected to receive follow-up with ultrasound at each examination, for the other half this examination will be performed 3 times (baseline, 1 year and 2 years). All patients are treated with medications that are approved and in common use in Norway and in accordance with European recommendations. In half of the patients, the results from MRI and ultrasound examinations are also used to choose the first treatment, and to determine changes in treatment during the follow-up. If you do not want to participate in the study, you will be followed according to the usual procedure in the department where you are being followed up.

In the project, we will also collect and record information about you. We will record findings from clinical examination and blood tests. You will also be asked to complete questionnaires about your health, including questions about yourself and your background that may be of importance to psoriatic arthritis. Clinical information will be recorded in your electronic hospital record in the usual way and relevant information from your hospital patient record will be used in the study.

Possible advantages AND disadvantages

If you choose to participate in the study, you will receive closer follow-up than is routine at most rheumatology departments today, and the follow-up will ensure good quality and standardized assessment of treatment effect and side effects. This will give your therapist a good starting point for deciding whether your treatment is effective. If you end up in the patient group where treatment is also determined by findings on ultrasound and MRI, you may be able to escalate treatment more quickly. This may entail a slightly increased risk of side effects but may also lead to faster and better treatment of the disease. The disadvantage of participating in the study is primarily that the follow-up leads to somewhat increased time consumption, as more extensive examinations will be performed than usual. There is no particular risk with the examinations in the study.

Voluntary participation and possibility to withdraw consent

Participation in the study is voluntary. If you wish to participate, please sign the consent form on the last page. You may withdraw from the study at any time and without giving any reason, without any consequences for your further treatment.

If you agree to participate in the study, you have the right to access the information that has been registered about you. You also have the right to have any errors in the information we have registered corrected. You also have the right to access the security measures when processing the information. If you withdraw from the study, no more information or material will be collected from you, and if you specifically request it, the information collected will be deleted. The right to demand destruction, deletion or disclosure does not apply if the material or information has been anonymized or published. This access may also be limited if the information has been included in analyses performed, or if the material has been processed.

If you later wish to withdraw or have questions about the study, you can contact study personnel at the center where you are being monitored.

HERE YOU WILL FIND THE CONTACT INFORMATION FOR YOUR LOCAL STUDY CENTER IN THE CONSENT YOU RECEIVE AT THE HOSPITAL

What happens to the samples and INFORMATION about you?

The samples taken from you, and the information recorded about you, will only be used as described in the purpose of the study.

All information and samples will be processed without name and social security number or other directly identifiable information. A code links you to your information and samples through a name list. The list that can link your name to the code will only be kept at the hospital and only personnel responsible for the study will have access to it.

In addition, information necessary for analyses of adverse events, medical events and health economic calculations may be obtained from the following sources: 1) The FD-Trygd longitudinal database from Statistics Norway 2) The Norwegian Patient Register 3) The Municipal Patient and User Register (IPLOS) 4) The KUHR database 5) The Prescription Register 6) The Cause of Death Register 7) The Cancer Register 8) The National Cardiovascular Register 9) The Infectious Diseases Reporting System (MSIS). In all relevant links mentioned above, data will be de-identified. The information will be deleted 5 years after the final report for the study has been written and no later than 1.1.2041. We would like to have the opportunity to contact you again later for follow-up studies and ask for your permission to do so.

Publication of results is a necessary part of the research process. All publication must be done in a way that individual participants cannot be recognized, but we are obliged to inform you that we cannot rule out the possibility that this may happen.

GENETIC TESTING

Blood samples will be taken for freezing which can later be used for DNA research. Only genetic factors relevant to psoriatic arthritis will be investigated, and permission will be sought from the Regional Ethics Committee before the research is carried out. The research will only be done at a group level, and you will not receive individual feedback on the results. If you do not want genetic research to be carried out on your blood samples, you can opt out of this at the end of this form.

Approval

The Regional Committee for Medical and Health Research Ethics has reviewed the study and has given prior approval [Insert case number at REK (20xx/yyyy)]

According to the new Personal Data Act, the controller of your personal data, Diakonhjemmet Hospital and project manager, Siri Lillegraven, have an independent responsibility to ensure that the processing of your information has a lawful basis. We process the information based on the EU General Data Protection Regulation, Articles 6 a and 9 no. 2 a and your consent.

You have the right to complain about the processing of your information to the Norwegian Data Protection Authority.

Contact information

HERE YOU WILL FIND THE CONTACT INFORMATION FOR YOUR LOCAL STUDY CENTER IN THE CONSENT YOU RECEIVE AT THE HOSPITAL

Further information about the study can be found in Chapter A – detailed explanation of what the study entails.

Further information about biobanking, privacy, finances and insurance can be found in Chapter B – Privacy, biobanking, finances and insurance.

Consent form follows after Chapter B.  – Signed by the person who agrees to participate in the study. The person who has informed about the study can confirm that the information has been provided.

The consent form has been removed in this version published online.

Chapter A - detailed explanation of what the study entails

Background information about the study

Modern treatment strategies for arthritis involve close follow-up and that the treatment is directed towards a predetermined treatment goal. The treatment is adapted to the disease activity, so that it is escalated at high disease activity until the patient achieves remission – that is, a state without or with minimal symptoms and signs of inflammation. This concept is well developed for rheumatoid arthritis and has shown very good results. Psoriatic arthritis is a disease with great variation in disease expression and it can be difficult to assess disease activity with a regular clinical examination. The study aims to investigate whether one gets better results from treatment if the doctor has information from MRI and ultrasound in addition to a regular clinical examination.

Overview of study visits, surveys and expected time spent

All included patients will be examined at the start of the study, once per month for the first 4 months, then every 2 months until 12 months and every 4 months thereafter. Some will need further examinations, e.g. when changing treatment.

The expected time depends on what is done at each study visit. As a general rule, you should expect about 1 hour for blood sampling, filling out questionnaires and a clinical examination. There will be an extended visit annually, which will include time for imaging examinations, which will take about 10 minutes for X-ray examinations, about 60 minutes for MRI examinations and about 30 minutes for ultrasound. Participants who are followed by ultrasound at each examination will have about 30 minutes more examination time at the other examination times as well. Participants in this study will, to the greatest extent possible, be followed up by the same team of nurses and doctors at all study visits. Below is an overview of what happens at each examination time.

*Performed at each examination in half of patients

Advantages, disadvantages and potential side effects

The advantages and disadvantages of participating in the study are described in the first part of the consent form. All the preparations included in the study are approved and have marketing authorization in Norway. If you choose not to participate in the study, your further treatment will be determined by your treating physician. In total, approximately 200 patients will be included in the study, distributed across 10-12 study centers.

Possible consequences of new knowledge

If new information becomes available during the study period and is of a nature that may affect your participation in the study, you will be informed of this as soon as possible. You will also be informed of decisions or situations that may lead to the study ending sooner than planned as soon as possible.

Chapter B - Privacy, biobanking, finance and insurance

What information about you is collected?

Information recorded about you is age, gender, height, weight, education, occupational status, possible risk factors, use of medications, any side effects, other illnesses, results from clinical examinations and health information questionnaires, results from imaging examinations and results from blood and urine tests.

In addition, information necessary for analyses of side effects and health economic calculations can be obtained from the following sources: 1) The FD-Trygd historical database from Statistics Norway. This database contains information on social assistance, movements in the social security system and the labor market, diagnoses, and other relevant background information. 2) Administrative and medical information related to the use of specialist health services from the Norwegian Patient Register. 3) The Municipal Patient and User Register (IPLOS) database, which contains data on municipal nursing and care services. 4) The KUHR database, which contains information on work capacity and consumption of health services 5) The Prescription Register, which contains information on prescription of medicines 6) The Cause of Death Register, which contains information on deaths such as cause, time and place 7) The Cancer Register, which contains information on all cases of cancer 8) The National Heart and Vascular Register, which contains information on people with cardiovascular disease 9) The Notification System for Infectious Diseases (MSIS), which contains information on a number of notifiable infectious diseases, such as tuberculosis.

Clinical information will be recorded in the electronic hospital record as usual. In addition, the information will be recorded electronically in a research data storage program for later analysis. Relevant information from the hospital patient record will also be used in the study.

Representatives from Diakonhjemmet Hospital and regulatory authorities in Norway and abroad may be given access to study information and be given access to relevant parts of your medical record. The purpose will be to check that the study information matches the corresponding information in your medical record and thus that the study information is valid and can be used in research. Anyone who has access to information about you is bound by confidentiality.

What happens to samples taken from you?  

Blood samples taken from you will be stored in a research biobank affiliated with Diakonhjemmet Hospital. Professor Espen Haavardsholm, head of the Department of Research and Innovation at Diakonhjemmet Hospital, is responsible for the biobank. The biobank is planned to last until September 15, 2035. After this, the material will be destroyed/deleted according to internal guidelines. The biological material can only be used after approval from the Regional Committee for Medical and Health Research Ethics (REK). The biobank will cease at the end of the study.

COLLABORATION WITH OTHER RESEARCH GROUPS IN DENMARK AND ABROAD

In some cases, it may be appropriate to analyze collected samples and data in collaboration with other research groups in Norway and abroad. In such cases, the data will be de-identified, i.e. without name, personal identification number or other directly identifiable information. This applies to all collected data and samples, including genetic analyses. By participating in the study, you agree that information collected in the study may be transferred abroad as part of research collaboration and publication in line with the purpose of the study. Diakonhjemmet Hospital is responsible for ensuring that the transfer of information is in accordance with Norwegian law and the EU's data protection legislation (GDPR). The code that links you to your personally identifiable information will not be disclosed.

Financing

The study and the biobank are funded by Diakonhjemmet Hospital through research funds from the South-Eastern Health Service and the Research Council. The project manager and others working on the project have no financial gain associated with the project. The clinical examination is part of the normal activities of the departments, and blood tests, imaging diagnostics and clinical examinations that are considered appropriate for your medical condition will usually be carried out regardless of whether you participate in the study or not. The same applies to the drug treatment. You will therefore pay the usual deductibles, but you will not pay for any additional examinations that are not part of normal clinical practice and are carried out under the auspices of the study. This will especially apply to X-rays and MRI examinations.

Insurance

You are insured in accordance with the Patient Injuries Compensation Act.

Information about the outcome of the study

The results of the study will be presented in international journals and at international congresses. After the results of the study are published, all participants will be sent a summary with information about the results of the study. In addition, a popular scientific presentation of the results will be presented in national patient journals.

IN THE ORIGINAL VERSION, THERE IS A SIGNATURE PAGE THAT HAS BEEN REMOVED FOR ONLINE PUBLICATION