All studies
Active not recruitingPHASE3INTERVENTIONAL

Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib Compared to Subcutaneous Adalimumab in Adult Participants With Moderate to Severe Rheumatoid Arthritis

This study is for adults with moderate to severe Rheumatoid Arthritis (RA) who haven't responded well to a previous treatment. We're comparing two approved medicines: upadacitinib, which is a pill, and adalimumab, which is an injection. The main goal is to see how safe and effective each medicine is in managing RA symptoms like pain, stiffness, and swelling. Patients will be randomly assigned to receive one of these treatments, and neither they nor their doctors will know which one they're getting. We'll be closely monitoring for any side effects and how much the disease activity changes. This research helps us find better ways to treat RA.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
AbbVie
Enrolment target
487
Start
15 Jun 2023
Estimated completion
01 Jul 2026

What is this study about?

This study is looking at two different medicines for adults who have Rheumatoid Arthritis (RA). RA is a long-term condition that causes pain, stiffness, and swelling in joints. These can make it hard to move and do everyday things. The medicines being studied are called upadacitinib and adalimumab, both of which are already approved for treating RA. Upadacitinib is a tablet you take by mouth, while adalimumab is given as an injection under the skin.

The main aim of this study is to compare these two treatments. We want to understand how effective each one is at reducing RA symptoms and whether they cause any side effects. This is really important because it helps doctors and patients make informed choices about which treatment might be best. Improving our understanding of these medicines can lead to better care for people living with RA.

About 480 adults with RA will take part in this study across many locations worldwide. You'll be randomly assigned to receive either upadacitinib or adalimumab, like flipping a coin, so there's an equal chance of getting either. Neither you nor your study doctor will know which treatment you are receiving, which helps make sure the results are fair and unbiased.

Key takeaways

  • Compares two existing RA medicines: upadacitinib (pill) and adalimumab (injection).
  • For adults with moderate to severe RA who haven't responded to a previous treatment.
  • Participants are randomly assigned to one of the two treatment groups.
  • Neither you nor your doctor will know which medicine you're taking.
  • Involves regular clinic visits and close monitoring for side effects.
  • You can stop participating in the study at any time.

Who may be eligible?

To join this study, you need to be an adult with Rheumatoid Arthritis (RA) that was diagnosed at least three months ago. Your RA should be moderate to severe, meaning you still have joint pain and swelling. You also need to have tried another RA medicine called a TNF inhibitor in the past, but it either didn't work well enough, or you couldn't tolerate it. You should also be taking a stable dose of methotrexate for at least three months, along with folic acid supplements.

There are also some reasons why you might not be able to join. For example, if you have another type of inflammatory joint condition besides RA, or if you've already taken certain other RA medicines called JAK inhibitors, you won't be eligible. The study team will check all these details carefully with 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.

  1. Are you an adult (18 years or older)?
  2. Have you been diagnosed with Rheumatoid Arthritis for at least 3 months?
  3. Do you still have active RA symptoms (e.g., joint pain and swelling)?
  4. Have you tried a 'TNF inhibitor' medicine for RA before, but it didn't work well or you couldn't take it?
  5. Are you currently taking methotrexate steadily, along with folic acid supplements?
  6. Have you NOT taken medicines like JAK inhibitors in the past?
Answer every question to see your result.

What does participation involve?

If you join this study, it's important to know what to expect. You'll be taking either a daily upadacitinib pill (and a 'dummy' injection every other week) or having an adalimumab injection every other week (and a 'dummy' pill every day). These 'dummy' treatments look just like the real medicine but contain no active drug. This helps keep the study fair, as neither you nor the doctors will know which actual treatment you're getting.

You'll need to attend regular visits at a hospital or clinic. During these visits, the study team will carry out medical checks to see how you're doing and if the medicine is helping. They'll also monitor you closely for any side effects. You'll likely fill out questionnaires about how you're feeling. The study involves two main periods, and after the first period, if you're doing well, you'll continue with the same assigned treatment. You'll then have follow-up visits for about 30 to 70 days after your last dose.

Potential risks and benefits

Taking part in any medical study has potential benefits and potential risks. A possible benefit of joining this study is that you might receive an active RA treatment that could improve your symptoms. You'll also be closely monitored by a medical team, which can be reassuring. On the other hand, there might be more hospital visits and tests than your usual care, which can be time-consuming. Like all medicines, both upadacitinib and adalimumab can have side effects, and some might be serious. It’s important to remember that you can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (218)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • AZ Arthritis and Rheumotology Research, PLLC - Flagstaff /ID# 253431
    Verified postcode
    Flagstaff, United States
  • Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 255018
    Verified postcode
    Glendale, United States
  • Sun Valley Arthritis Center Ltd. /ID# 254654
    Verified postcode
    Peoria, United States
  • Arizona Arthritis & Rheumatology Associates - East Bell Road /ID# 253432
    Verified postcode
    Phoenix, United States
  • Arizona Arthritis & Rheumatology Associates - East Bell Road /ID# 255021
    Verified postcode
    Phoenix, United States
  • Arizona Arthritis & Rheumatology Associates - Tucson /ID# 255017
    Verified postcode
    Tucson, United States
  • Arthritis and Rheumatism Associates /ID# 254013
    Verified postcode
    Jonesboro, United States
  • Providence - St. Jude Medical Center /ID# 252690
    Verified postcode
    Fullerton, United States
  • Newport Huntington Medical Group /ID# 252687
    Verified postcode
    Huntington Beach, United States
  • Purushotham & Akther Kotha MD, Inc /ID# 252704
    Verified postcode
    La Mesa, United States
  • Valerius Medical Group & Research Center of Greater Long Beach, Inc /ID# 252692
    Verified postcode
    Los Alamitos, United States
  • Rheumatology Center of San Diego /ID# 255038
    Verified postcode
    San Diego, United States

Common questions

What is Rheumatoid Arthritis (RA)?

RA is a long-lasting condition where your body's immune system attacks your own joints, causing pain, swelling, and stiffness.

What's the difference between upadacitinib and adalimumab?

Upadacitinib is a pill you take daily, while adalimumab is an injection you give yourself every other week.

Why don't I know which medicine I'm getting?

This helps make the results fairer and more accurate, as knowing could affect how you or the doctors observe your symptoms.

How long will I be in the study?

The study involves two periods of treatment, followed by checks about 30 to 70 days after your last dose.

Can I leave the study at any time?

Yes, you have the right to withdraw from the study at any point, and it won't affect your future medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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