Active not recruitingPHASE3INTERVENTIONAL

Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis

This research study is looking at a medicine called tildrakizumab, which is given by injection under the skin, for people who have psoriatic arthritis. Psoriatic arthritis is a type of arthritis that can cause joint pain, swelling, and stiffness, often in people who also have psoriasis. This study is an 'open-label' continuation, meaning both you and the study team will know you are receiving the active medicine. It's for people who have already taken part in previous tildrakizumab studies (INSPIRE 1 or INSPIRE 2). The main aim is to check how safe the medicine is and how well it works over a longer period. This information helps doctors understand if tildrakizumab can be a good long-term treatment option for psoriatic arthritis.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Sun Pharmaceutical Industries Limited

Enrolment target

529

Start

30 Jun 2022

Estimated completion

01 Apr 2029

Psoriatic Arthritis

What is this study about?

This study is about a medicine called tildrakizumab, which is being investigated for psoriatic arthritis. Psoriatic arthritis is a long-term condition where your immune system mistakenly attacks your joints, causing pain, swelling, and stiffness. It can affect people who also have a skin condition called psoriasis. Tildrakizumab is given as an injection just under the skin. It works by targeting a specific part of the immune system that plays a role in both psoriasis and psoriatic arthritis.

Previous studies (called INSPIRE 1 and INSPIRE 2) have already looked at this medicine. This current study, called INSPIRE LTE (Long-Term Evaluation), is a continuation for people who successfully completed one of those earlier studies. The main goal is to gather more information on how safe tildrakizumab is and how well it continues to work over an extended period. This helps researchers understand the medicine's long-term effects and benefits, which is very important for treatments that patients might take for many years.

By taking part, you would be helping doctors and researchers learn more about how tildrakizumab helps manage psoriatic arthritis in the long run. This information is crucial for deciding if this medicine could be a valuable treatment option for more people in the future.

Key takeaways

This study is for adults with psoriatic arthritis who completed a previous tildrakizumab study.
It aims to understand the long-term safety and effectiveness of tildrakizumab.
Tildrakizumab is an injection under the skin.
You'll have regular check-ups and medical tests.
Your participation helps to advance medical knowledge about psoriatic arthritis treatments.

Who may be eligible?

This study is open to adults aged 18 or older who have psoriatic arthritis. It's specifically for people who have already taken part in one of the previous tildrakizumab studies (INSPIRE 1 or INSPIRE 2).

To join, you must have finished the previous study without having to stop treatment early for any reason. You also need to be able to understand what's involved in the study and agree to follow all the study rules and visit schedules.

There are some reasons why you wouldn't be able to join. For example, if you are pregnant, breastfeeding, or planning to become pregnant or breastfeed soon. Women who could become pregnant must agree to use effective birth control throughout the study and for a period afterwards. Also, if you've already been in this specific long-term study, you can't join again, or if the study doctor thinks it wouldn't be safe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have psoriatic arthritis?
Have you previously taken part in and successfully completed the INSPIRE 1 or INSPIRE 2 studies?
Are you able to attend all study visits and understand the study requirements?
If you are a woman who could become pregnant, are you able to use effective birth control throughout the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given the study medicine, tildrakizumab, as an injection under your skin. This is an 'open-label' study, which means both you and the doctors will know you are receiving the active medicine. You will have regular visits to the study clinic where the team will monitor your health, check your psoriatic arthritis, and record how you're feeling and any side effects. These visits will involve various assessments, which might include blood tests, physical examinations, and questionnaires about your symptoms and quality of life. The exact number and frequency of visits, as well as the total duration of your participation, will be clearly explained by the study team. You will be expected to attend all scheduled appointments and follow the study instructions carefully.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as continuing to receive the study medicine that might be helping your psoriatic arthritis symptoms. You'll also receive close medical attention and contribute to important medical research. However, there are potential risks, including side effects from the medication. Tildrakizumab, like all medicines, can have side effects, and these will be fully explained to you before you agree to join. There's also the time commitment of attending appointments. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (99)

Sunpharma site no 50
Verified postcode
Dothan, United States
Sunpharma site no 80
Verified postcode
Gilbert, United States
Sunpharma site no 65
Verified postcode
Mesa, United States
Sunpharma site no 105
Verified postcode
Phoenix, United States
Sunpharma site no. 30
Verified postcode
Covina, United States
Sunpharma site no 110
Verified postcode
Encino, United States
Sunpharma site no. 17
Verified postcode
Fountain Valley, United States
Sunpharma site no. 15
Verified postcode
Thousand Oaks, United States
Sunpharma site no 113
Verified postcode
Avon Park, United States
Sunpharma site no. 21
Verified postcode
Clearwater, United States
Sunpharma site no. 02
Verified postcode
Hialeah, United States
Sunpharma site no 71
Verified postcode
Kissimmee, United States

Common questions

What is psoriatic arthritis?

Psoriatic arthritis is a type of arthritis that causes joint pain, swelling, and stiffness, and it often occurs in people who also have psoriasis, a skin condition.

What is tildrakizumab?

Tildrakizumab is a medicine given by injection under the skin that targets a part of the immune system involved in psoriatic arthritis.

Why is this study called 'open-label'?

Open-label means that both you and the study doctors will know that you are receiving the active study medicine, tildrakizumab.

Can I join this study if I haven't been in a previous tildrakizumab study?

No, this study is specifically for people who have already completed one of the earlier tildrakizumab studies (INSPIRE 1 or INSPIRE 2).

What happens if I want to stop taking part?

You can leave the study at any time, for any reason, without it affecting your medical care.