Active not recruitingPHASE3INTERVENTIONAL

A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate

This study is for adults with moderate to severe rheumatoid arthritis whose current methotrexate treatment isn't working well enough. It aims to see how effective and safe a new drug called upadacitinib is, compared to a dummy pill (placebo) and another well-known medicine, adalimumab. Participants will receive one of these treatments, and researchers will monitor their joint pain, swelling, and overall arthritis progression over a year, and then for up to five more years. The goal is to find better ways to manage rheumatoid arthritis and improve patients' lives, especially when initial treatments aren't fully effective.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AbbVie

Enrolment target

1,629

Start

01 Dec 2015

Estimated completion

30 Sep 2027

Rheumatoid Arthritis

What is this study about?

This research study is looking into new ways to help adults living with rheumatoid arthritis (RA). RA is a condition where your body's immune system mistakenly attacks your joints, causing pain, swelling, and stiffness. Many people take a medicine called methotrexate to help manage their RA. However, sometimes methotrexate alone isn't enough to control the symptoms.

That's where this study comes in. It's comparing a new medicine, upadacitinib, to a dummy pill (called a placebo) and also to a widely used RA medicine called adalimumab. The main goal is to figure out if upadacitinib is better at reducing RA symptoms and slowing down joint damage, and to check if it's safe to use. Researchers hope to find more effective treatment options for people who haven't found enough relief from traditional medicines like methotrexate.

During the study, participants will be carefully monitored to see how their arthritis responds to the treatment they receive. This will involve checking things like how many tender or swollen joints they have, and also looking at X-ray scans to see if joint damage is being prevented. The study is designed to be fair, so participants are randomly assigned to a treatment group, and neither they nor their doctors will know which treatment they are receiving until later. This helps ensure the results are unbiased and reliable.

Key takeaways

This study compares a new RA drug (upadacitinib) with a placebo and an existing drug (adalimumab).
It's for adults with moderate to severe rheumatoid arthritis whose methotrexate isn't fully effective.
The study aims to check the new drug's safety and how well it reduces pain, swelling, and joint damage.
Participants will receive one of the three treatments and have regular check-ups.
It's a 'double-blind' study, meaning neither you nor your doctor will know which treatment you receive initially.
The study could last up to five years, helping researchers find better RA treatments.

Who may be eligible?

To join this study, you need to be an adult (at least 18 years old) and have been diagnosed with rheumatoid arthritis for at least three months. You must also be taking methotrexate, and have been on a steady dose for at least a month, but it shouldn't be fully controlling your RA symptoms. This means you would still have a certain number of swollen and tender joints.

The study is looking for people whose RA has already caused some noticeable changes, like bone erosions on X-rays. You generally shouldn't have taken certain types of RA medications called 'JAK inhibitors' before. Also, if you've previously taken adalimumab or if your doctor thinks you haven't responded well to another type of strong RA medicine, you might not be able to join. However, a small number of people who have only tried one other strong RA medicine for a short time might still be considered.

Basically, the study is for adults with active rheumatoid arthritis who are already taking methotrexate but need more help to manage their condition, and who haven't tried certain strong RA medications in the past.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with rheumatoid arthritis for at least 3 months?
Are you currently taking methotrexate, but your RA symptoms are still active?
Have you *not* taken certain types of strong RA medicines called 'JAK inhibitors' before?
Have you *not* previously taken adalimumab, or had a poor response to a strong biologic medicine?
Do you still have a certain number of tender and swollen joints, showing active RA?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll first be assessed to make sure the study is right for you. The study will last for a total of up to five years, with an initial 48-week (about 11-month) main treatment period.

During the first 48 weeks, you'll be randomly assigned to one of three groups: you might receive the new medicine (upadacitinib), the existing medicine (adalimumab), or a dummy pill (placebo). You won't know which one you're getting, and neither will your doctor, which helps keep the study fair. All treatments are given as daily tablets or injections every other week.

You'll have regular visits to the clinic for check-ups, where doctors will monitor your joints, take blood samples, and perform X-rays to see how your arthritis is progressing. If your symptoms don't improve enough while on the dummy pill or adalimumab, you might be switched to upadacitinib. Similarly, if you're on upadacitinib and not improving, you might be switched to adalimumab. After the first 48 weeks, if you complete the main part of the study, you could continue onto a long-term extension period for up to five years, continuing the treatment you finished on, as long as it's helping.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. A potential benefit of this study is that you might receive access to a new treatment (upadacitinib) that could improve your rheumatoid arthritis symptoms more effectively than your current treatment or previous medicines. You will also receive careful medical monitoring throughout the study. However, there's no guarantee that the treatment you receive will work for you, and it's possible you could experience side effects or no improvement in your condition. As with any medication, there are risks associated with the study drugs, which will be fully explained by the study team. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (370)

Achieve Clinical Research, LLC /ID# 143136
Birmingham, United States
AZ Arthritis and Rheum Assoc /ID# 143130
Mesa, United States
SunValley Arthritis Center, Lt /ID# 143123
Peoria, United States
Elite Clinical Studies, LLC /ID# 144881
Phoenix, United States
AZ Arthritis and Rheum Researc /ID# 143080
Phoenix, United States
AZ Arthritis and Rheum Researc /ID# 143121
Phoenix, United States
AZ Arthritis & Rheuma Research /ID# 143131
Phoenix, United States
Arizona Research Center, Inc. /ID# 144877
Phoenix, United States
AZ Arthritis & Rheum Research /ID# 156093
Sun City, United States
University of Arizona Cancer Center - North Campus /ID# 143114
Tucson, United States
Osteoporosis Medical Center /ID# 153935
Beverly Hills, United States
T. Joseph Raoof, MD, Inc. /ID# 144884
Encino, United States

+358 more sites — see the official record for the full list.

Common questions

What is upadacitinib?

Upadacitinib is a new medicine being tested for rheumatoid arthritis. It works in a different way to reduce inflammation and relieve symptoms.

What is a placebo?

A placebo is a 'dummy pill' that looks exactly like the actual medicine but contains no active drug. It helps researchers compare how well the real medicine works.

How long will the study last?

The main part of the study lasts 48 weeks (about 11 months), but some participants may continue in a longer phase for up to 5 years.

Will I have to stop my methotrexate?

No, you will continue taking your stable dose of methotrexate throughout the study.

What does 'double-blind' mean?

It means that neither you nor your study doctor will know whether you are receiving the new medicine, the existing medicine, or the placebo. This helps ensure the study results are fair and unbiased.