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Study on Peripheral Spondyloarthritis: Comparing Methotrexate Disodium and Golimumab for Early Remission in Adult Patients

Fast replyRegistered drugNo placebo

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What is this trial about?

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

This clinical trial is focused on studying a condition called , which is a type of arthritis that affects the joints, particularly in the lower limbs. The study is exploring two different treatment strategies to manage this condition. One strategy involves using conventional synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) like and/or sulphasalazine. The other strategy introduces a biological treatment early on, using a Tumor Necrosis Factor inhibitor (TNFi) called , which is a type of protein that helps reduce inflammation.

The purpose of the study is to compare these two treatment approaches to see which one is more effective in achieving remission, which means reducing or eliminating the symptoms of the disease. Participants in the study will receive either the csDMARDs or the TNFi treatment. Some participants may also receive a placebo, which is a substance with no active medication, to help researchers understand the effects of the actual treatments better. The study will last for a period of up to 36 weeks, during which participants will be monitored regularly to assess their response to the treatment.

Throughout the study, researchers will evaluate various aspects of the participants' health, including joint pain and swelling, overall disease activity, and any side effects experienced. The goal is to determine which treatment strategy is more effective in helping patients achieve a state of remission, where their symptoms are significantly reduced or absent. This research aims to provide valuable insights into the best ways to manage Peripheral Spondyloarthritis and improve the quality of life for those affected by this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of peripheral spondyloarthritis and ensuring symptoms have been present for 12 months or less.
The assessment also involves evaluating the current level of disease activity using a numerical rating scale.
Step 2
Treatment group assignment
Participants are randomly assigned to one of two treatment strategies: the csDMARD Step-Up strategy or the TNFi Induction strategy.
The csDMARD Step-Up strategy involves starting with conventional synthetic disease-modifying drugs, such as methotrexate.
The TNFi Induction strategy involves starting treatment with a biological drug called golimumab.
Step 3
Medication administration
For those in the csDMARD Step-Up group, methotrexate is administered orally in tablet form.
Participants in the TNFi Induction group receive golimumab through subcutaneous injection using a pre-filled pen or syringe.
Step 4
Monitoring and assessments
Regular monitoring is conducted to assess the effectiveness of the treatment. This includes clinical assessments and patient-reported outcomes.
Assessments occur at baseline, week 12, and week 24, with additional monitoring for those continuing treatment until week 36.
Step 5
Evaluation of clinical remission
The primary goal is to determine the proportion of patients achieving clinical remission.
Secondary evaluations include sustained remission, improvement in joint counts, and changes in inflammatory markers.
Step 6
Completion of trial
The trial concludes with a final assessment to evaluate the overall outcomes and any adverse events experienced during the study.
The estimated end date for the trial is May 31, 2025.

Who can join the trial?

6 criteria

Participants must be between 18 and 65 years old.
Participants must have been diagnosed with **peripheral spondyloarthritis** by their doctor. This is a type of arthritis that affects the joints, especially in the arms and legs.
Participants must meet the **ASAS classification criteria** for peripheral spondyloarthritis. This means they must have current arthritis (which is swelling and pain in the joints, usually in the legs), or current **enthesitis** (which is pain where tendons or ligaments attach to the bone, but not along the spine, hips, or chest), or current **dactylitis** (which is swelling of the fingers or toes) plus at least one feature of spondyloarthritis.
Participants must have started having symptoms of peripheral spondyloarthritis within the last 12 months before the screening visit.
Participants must have active disease at the screening visit. This is defined by a **Patient Global Assessment of Disease Activity** score of 4 or higher and a **Patient Global Assessment of Pain** score of 4 or higher. At the start of the study, patients will be checked to make sure they are not in spontaneous remission, which means their symptoms have not gone away on their own.
If participants have symptoms of **axial spondyloarthritis** (which affects the spine), the symptoms in the arms and legs must be the main symptoms at the start of the study, based on the doctor's judgment.

Who cannot join the trial?

3 criteria

Patients who have a different condition than Peripheral Spondyloarthritis cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are part of a vulnerable population cannot participate.

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Verified sites

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

Verified
Algemeen Stedelijk Ziekenhuis Campus Aalst
Aalst, Belgium
Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium
Responsive
Universitair Ziekenhuis Gent
Gent, Belgium

Trial locations

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Investigated drugs

Methotrexate
is a medication used to treat certain types of arthritis by slowing down the immune system and reducing inflammation. It is part of a group of drugs known as conventional synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs).
Sulphasalazine
is another csDMARD used to treat arthritis. It helps to reduce pain and swelling in the joints by affecting the immune system.
Golimumab
is a biological DMARD (bDMARD) that works by blocking a protein called Tumor Necrosis Factor (TNF), which is involved in inflammation. It is used in the trial as part of an early treatment strategy to induce remission in patients with arthritis.

What is already known about the treatment

Golimumab – Golimumab is administered as an injection under the skin. It is currently used in medicine to treat conditions like peripheral spondyloarthritis, and it is well-documented in medical literature as a biological disease-modifying anti-rheumatic drug (bDMARD). The main therapeutic indication for golimumab is to reduce inflammation and halt disease progression in autoimmune conditions. At the molecular level, golimumab works by blocking tumor necrosis factor-alpha (TNF-alpha), a substance in the body that causes inflammation. It is classified pharmacologically as a TNF inhibitor.

Investigated diseases

Peripheral Spondyloarthritis – Peripheral Spondyloarthritis is a type of inflammatory arthritis that primarily affects the joints in the arms and legs, as well as the sites where tendons and ligaments attach to bones. It is characterized by pain, swelling, and stiffness in the affected areas. The disease can also cause inflammation in other parts of the body, such as the eyes and skin. Over time, the inflammation can lead to joint damage and reduced mobility. The progression of symptoms can vary, with periods of increased activity and remission.