The MK7240-013 Study is evaluating the safety of an investigational study medicine and how well it may work in resolving or improving r-axSpA symptoms compared with a placebo.

Before you agree to participate, the study team will review all aspects of the research study with you. If you decide to take part, you will be given a document called an Informed Consent FormInformed Consent form (IC)A document that provides information about the purpose of the study, possible risks and benefits, and the participant's rights and responsibilities. Signing the consent form means that the person agrees to participate in the research; A document used to explain the details of a study (clinical trial) that provides, in writing, the clinical research study’s purpose, assessmentsAssessmentA test; A measurement, procedures, potential benefits and risks, and precautions. You will have the opportunity to ask questions and decide if participating is right for you.

The study team respects and protects your privacy and will not share your information, except as required by law, and will store your personal information with codes that do not identify you. The Informed Consent Form (completed by you prior to participation) will provide more information about how your privacy will be maintained.

Your participation in the clinical research study is entirely voluntaryVoluntaryTo choose to participate; to do something by choice; to participate because a person wants to; to participate without being forced or made to and you may withdraw for any reason, at any time. If you do decide to withdraw early, you will be asked to notify the study team before doing so. You will be asked to return to the study site at least once to complete a final visit and return any unused drug.

No, you will receive the study medicine at no cost. You will also get all study-related medical tests at no cost.

No, your doctor does not have to give permission for you to participate. However, either you or the study doctor, with your permission, may contact your personal doctor to discuss your participation before you begin and keep your doctor up-to-date about your progress.

A research study, also known as a clinical trial, tries to answer questions about how medicines work in the people who take them. Researchers run studies to test whether an investigational study medicine is safeSafe / SafetyAn assessment of the likelihood of causing an undesired effect and effective. These studies may help doctors find new ways to help prevent, detect, or treat health problems.

ParticipantParticipantPerson; people in a clinical trial. safety is the priority. There are rules in place to help protect the rights, safety, and well-being of people who volunteer for research studies. These rules are put in place to make sure research studies follow strict scientific and ethical guidelines.

Before a research study can begin, a review board or ethics committee must review the research study. In the United States, this group is called an IRB or Institutional Review BoardInstitutional Review Board (IRB)(In US): A team of people who review studies to protect the rights and welfare of study participants; A group formally designated and responsible for reviewing study proposals, monitoring studies involving people and protecting the rights and welfare of study participants. An IRB is made up of doctors, scientists, and other members of the community.

Only people who meet all eligibility criteriaEligibility criteriaA set of requirements (characteristics) used to determine whether a person can enroll in a study [clinical trial]; the reasons a person can be included in, or excluded from a study; used to make sure that a study includes the right participants to help answer the research questions [For example, a study may be looking to include only people of a certain age or with a certain health condition. When all participants meet the same eligibility criteria, it is more likely that results of the study are caused by the intervention being tested and not by other factors or by chance]; See also Inclusion Criteria, Exclusion Criteria for a clinical research study may take part. The study team at the site you select will review your medical history and current medical status against the eligibility criteria. They will determine if you are eligible to participate. You may also be asked to provide information from your medical records to help the study team determine whether you may be eligible.

An investigational study medicine is a drug that hasn’t yet been approved for use in the general public. In order for it to be approved, the investigational study medicine must be tested in research studies to see if it is safe and effective for treating the target disease in certain groups of people.

The investigational study medicine in the MK7240-013 Study is being tested to see how well it may work in resolving or improving symptoms compared with a placebo in people with r-axSpA.

An autoinjector device delivers an injection just under the skin in your thigh, abdomen, or upper arm. You will be trained to use this device to give an injection to yourself. If you prefer, a family member or caregiver can be trained to give you the injections. Or you can have a member of the study team give you the injections at the study clinic.

A placebo is a material that looks like the investigational study medicine but does not contain any active medication. Researchers use a placebo to see if the investigational study works better or is safer than taking nothing.

Everyone participating in this study will get the investigational study medicine at some point during the study. Participants will be put into different groups to receive different doses of the investigational study medicine or a placebo for the first 4 months of the treatment phase of the study.

Participants, the study doctor, and the study team will not know which group each participant is placed in until all participants have completed their first 4 months of treatment.

In case of a health emergency, the study doctor can find out which medicine was given. After 4 months, all participants in the study will receive the investigational study medicine.

You may have the option to join a long-term extension period that could last up to 21 months. During the extension period, all participants get the investigational study medicine by injection.

If you are eligible and choose to participate, the study staff will be available to answer any questions you may have.

Understanding research studies is important when making a decision about joining one. To see more Frequently Asked Questions, click on the link below.

If you are eligible and choose to participate, the study staff will be available to answer any questions you may have.

Understanding research studies is important when making a decision about joining one. To see more Frequently Asked Questions, click on the link below.