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Study on the Effects of Baricitinib in Early-Stage Rheumatoid Arthritis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The purpose of this study is to evaluate the effect of a drug called Baricitinib on people who are in the early stage of a condition known as rheumatoid arthritis. Rheumatoid arthritis is a condition that causes pain and swelling in the joints. The study is focused on individuals who have not yet developed full-blown arthritis but may show early signs through tests like ultrasound or are at genetic risk.

In this study, some participants will receive Baricitinib, which is taken as a pill, while others will receive a placebo, a substance that looks like the medication but does not contain any active ingredients. The treatment will be given for a period of up to 24 weeks. Researchers want to see if Baricitinib can help delay or prevent the development of full arthritis symptoms compared to those who receive a placebo.

Participants will be monitored for changes in joint pain, swelling, and overall joint function. The study also looks at the safety of Baricitinib and checks for any side effects. Tests will be conducted to track the health of the participants' joints over time, as well as any changes in specific antibodies that often appear in early rheumatoid arthritis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, absence of arthritis in a joint count, and presence of certain autoantibodies.
Participants must be between 18 and 64 years old and meet specific genetic and imaging criteria.
Step 2
Medication administration
Participants receive either Baricitinib or a placebo. The medication is taken orally.
The purpose is to evaluate the effect of JAK inhibition with Baricitinib in the early stage of joint inflammation.
Step 3
Monitoring and assessments
Participants are monitored for the development of arthritis at week 24 and week 48.
Assessments include ultrasound evaluations to check for signs of synovitis or tenosynovitis, and changes in anti-CCP antibody levels.
Step 4
Safety and function evaluations
Safety is assessed through monitoring of any adverse events.
Hand function is evaluated using subjective and objective tests, such as the SACRAH and the Moberg pick-up test.
Step 5
Completion of the study
The study is expected to conclude by September 2026.
The primary endpoint is the number of participants developing arthritis by week 48.

Who can join the trial?

6 criteria

Patients must be female or male and between 18 and 64 years old.
Patients should not have arthritis in a specific count of 76/78 joints.
Patients must have at least one signal detected by ultrasound in the tendons of the hand or feet.
Patients need to have two different autoantibodies. One must be anti-CCP antibodies. Other options include antibodies like citrullinated vimentin or citrullinated fibrinogen.
Patients must have a specific genetic marker known as HLA status that increases the risk for rheumatoid arthritis.
Female patients must not be pregnant or breastfeeding.

Who cannot join the trial?

4 criteria

Individuals who are not in the early stage of rheumatoid arthritis cannot participate.
People who are not within the specified age range for the study are excluded.
Participants who do not meet the gender requirements for the study are not eligible.
Individuals considered part of a vulnerable population, which means they might need special protection, are excluded.

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Verified sites

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Universitaetsklinikum Erlangen AöR
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Erlangen, Germany

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Investigated drugs

Baricitinib is a medication being studied for its potential to help in the early stages of arthritis. It works by inhibiting certain enzymes known as Janus kinases (JAK), which play a role in the inflammation process. By blocking these enzymes, baricitinib may reduce inflammation and slow down the progression of arthritis.

Baricitinib

What is already known about the treatment

Baricitinib – Baricitinib is administered orally in tablet form. It is currently being studied in clinical trials for its potential use in the preclinical phase of rheumatoid arthritis. The main therapeutic indication is to prevent the progression of arthritis by targeting early disease stages. At the molecular level, baricitinib works by inhibiting Janus kinase (JAK) enzymes, which play a key role in the inflammatory process. It is classified as a JAK inhibitor, a type of medication that interferes with the signaling pathways involved in inflammation.

Investigated diseases

Rheumatoid Arthritis – Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints. It typically begins with inflammation in the synovial membrane, leading to swelling and pain. Over time, this inflammation can cause damage to the cartilage and bone within the joint. The disease often starts in smaller joints, such as those in the fingers and toes, and can progress to larger joints like the knees and shoulders. Symptoms may include joint stiffness, particularly in the morning or after periods of inactivity, and can lead to joint deformity if not managed. The preclinical phase refers to the period before the full onset of symptoms, where early signs of inflammation may be present but not yet causing significant joint damage.