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Evaluating Safety and Effectiveness of Combining Biologic Medications for Patients with Rheumatoid Arthritis and Psoriatic Arthritis ## Human: Give a detailed summary of a clinical trial for patients: 1.

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What is this trial about?

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

This study aims to test the effectiveness of combining biologic drugs for treating Rheumatoid Arthritis and Psoriatic Arthritis. These are immune-mediated inflammatory diseases (IMIDs) that cause joint pain, stiffness, and damage. The research focuses on combining Tumor Necrosis Factor inhibitors (TNFis) with IL-6 inhibitors, which are medications that target specific proteins involved in inflammation. The purpose is to determine if this combination can help more patients achieve disease remission than current standard treatments.

During the study, participants with active arthritis who are currently using TNF inhibitors will receive a combination therapy approach. The research will monitor how well this combination works to reduce disease activity and inflammation in the joints. The main goal is to see if patients can achieve remission, which means having very low or no disease activity after 24 weeks of treatment.

The study will also collect information about the safety and tolerability of combining these medications. This approach using multiple medications together is being investigated as a potential way to improve outcomes for patients whose arthritis symptoms aren't adequately controlled with current therapies.

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
Enrollment and Initial Assessment
After joining the study, you will be assessed to confirm you have active arthritis. For Rheumatoid Arthritis (RA), this means having a DAS28 score greater than 3.2. For Psoriatic Arthritis (PsA), this means having a Disease Activity in Psoriatic Arthritis (DAPSA) score greater than 14.
You must already be on treatment with an approved TNF inhibitor (a type of medication that reduces inflammation) to participate in this trial.
Step 2
Treatment Assignment
You will continue your current TNF inhibitor medication and begin additional treatment with tocilizumab (Tyenne).
The tocilizumab will be given as a 162 mg injection using a pre-filled pen. Your healthcare provider will explain how to administer this medication.
Step 3
Treatment Period
You will follow this combination therapy (your current TNF inhibitor plus tocilizumab) for 24 weeks (approximately 6 months).
Throughout this period, you will have regular appointments to monitor how your disease is responding to treatment and to check for any side effects.
Step 4
Assessment of Treatment Effectiveness
At week 24, your disease activity will be assessed to determine if you have achieved remission.
For Rheumatoid Arthritis patients, remission is defined as having a Clinical Disease Activity Index (CDAI) score of 2.8 or less.
For Psoriatic Arthritis patients, remission is defined as having a DAPSA score of less than 4.
Step 5
Study Completion
After the 24-week treatment period and final assessment, your participation in the clinical trial will be complete.
The study is expected to run until February 28, 2026, though your individual participation will last 24 weeks from your start date.

Who can join the trial?

6 criteria

You must be at least 18 years old (no upper age limit)
You must have either Rheumatoid Arthritis (RA) or Psoriatic Arthritis (PsA) diagnosed according to standard medical criteria
You must currently be receiving treatment with TNF inhibitors (a type of medication that reduces inflammation in your joints)
You must have active arthritis as shown by:
- For Rheumatoid Arthritis: a DAS28 score greater than 3.2 (this is a measurement of disease activity)
- For Psoriatic Arthritis: a DAPSA score greater than 14 (this is a different measurement of disease activity specific to psoriatic arthritis)
- You must be willing to sign an informed consent form to participate in the study

Who cannot join the trial?

12 criteria

Having other types of inflammatory arthritis besides psoriatic arthritis or rheumatoid arthritis
Previous treatment with any biologic therapy (medications that target specific parts of the immune system)
Having active tuberculosis (TB) infection
Having a history of malignancy (cancer) within the past 5 years, except for successfully treated skin cancers
Having hepatitis B or C infection
Having a significant heart condition or uncontrolled high blood pressure
Being pregnant or breastfeeding
Having serious infections requiring hospitalization or intravenous antibiotics within the past 6 months
Having a compromised immune system due to HIV or other conditions
Having a history of allergic reactions to similar medications
Participation in other clinical trials within the past 30 days
Having severe kidney or liver problems

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hospital Universitario Hermanos Trias y Pujol. Institut Catalá d'Oncología (ICO)
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Badalona, Spain
Hospital Vall d’Hebron
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Barcelona, Spain

Trial locations

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Investigated drugs

Methotrexate
Methotrexate is a medication that works by reducing inflammation in the body. It is commonly used to treat autoimmune conditions such as rheumatoid arthritis and psoriatic arthritis. It helps to slow down the immune system's attack on healthy tissues.
Rituximab
Rituximab is a type of medication called a biologic therapy. It works by targeting specific cells in the immune system called B cells, which are involved in inflammation. By reducing these cells, rituximab can help decrease inflammation and improve symptoms in autoimmune diseases.
Etanercept
Etanercept is a biologic medication that blocks a protein in the body called tumor necrosis factor (TNF), which contributes to inflammation. By blocking TNF, etanercept helps reduce inflammation, pain, and swelling in conditions like rheumatoid arthritis and psoriatic arthritis.
Adalimumab
Adalimumab is a biologic medication that also targets the TNF protein to reduce inflammation. It helps improve joint pain, swelling, and physical function in people with immune-mediated inflammatory diseases such as rheumatoid arthritis and psoriatic arthritis.

Tocilizumab

What is already known about the treatment

Secukinumab
An injectable medication administered subcutaneously that is FDA-approved for treating psoriatic arthritis and other related conditions. Secukinumab works by targeting and blocking interleukin-17A, a protein involved in inflammation, thereby reducing joint pain, swelling, and slowing disease progression. It belongs to the class of biologic disease-modifying antirheumatic drugs (bDMARDs) and is specifically classified as an interleukin inhibitor. Clinical studies have shown secukinumab to be effective in achieving disease remission in patients with psoriatic arthritis, improving both skin symptoms and joint function.
Methotrexate
An oral or injectable medication that is widely used as a first-line treatment for rheumatoid arthritis and psoriatic arthritis. Methotrexate works by inhibiting the enzyme dihydrofolate reductase, which reduces cell proliferation and inflammation in the immune system. It belongs to the class of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and is classified as an antimetabolite. Studies have consistently shown methotrexate to be effective in reducing disease activity in inflammatory arthritis, often used as monotherapy or in combination with biologics to enhance treatment outcomes.

Investigated diseases

Psoriatic Arthritis
A chronic inflammatory disease that occurs in some people with psoriasis, affecting joints and the points where tendons and ligaments connect to bones. It typically causes pain, stiffness, and swelling in the affected joints. Psoriatic arthritis can affect any joint in the body and may develop slowly with mild symptoms, or appear suddenly and severely. The disease often progresses in a pattern where symptoms flare up and then subside. Over time, psoriatic arthritis can lead to joint damage and reduced mobility if inflammation persists.
Rheumatoid Arthritis
A chronic autoimmune disorder where the immune system mistakenly attacks the body's own tissues, primarily affecting the lining of joints. It causes painful swelling that can eventually result in bone erosion and joint deformity. The inflammation associated with rheumatoid arthritis can also damage other parts of the body. Rheumatoid arthritis typically affects joints symmetrically, meaning if one hand is affected, the other likely will be too. The disease usually progresses from smaller joints in fingers and toes to larger joints like wrists, knees, ankles, and shoulders.