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Can early TNF blockers stop arthritis drugs for good?

NCT ID NCT04435288

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests whether starting a strong TNF inhibitor (golimumab) early in peripheral spondyloarthritis can help patients reach drug-free remission, compared to the usual step-up approach with milder drugs. 90 adults with recent-onset disease will be randomly assigned to one of two strategies. The goal is to see if early, temporary treatment can reset the immune system and allow patients to stop all medications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
golimumab (a TNF inhibitor)
What this could lead to
If successful, this could show that early, temporary use of a TNF inhibitor can lead to drug-free remission in some patients with peripheral spondyloarthritis.
What could go wrong
This is a relatively small phase 3 trial (90 participants) and remission may not be sustained long-term. The treatment also carries risks like increased infection and allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

90 people

The number who actually took part.

Started

Aug 2020

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: SPARTACUS Phase A: "Remission-Induction Phase" A subject will be eligible for study participation if all of the following criteria are met: * Subjects must be able and willing to provide written informed consent and comply with the requirements of this study protocol. * Subjects must be between 18 and 65 years of age. * Subjects must have been diagnosed with peripheral spondyloarthritis by the treating rheumatologist. * Subjects must meet the ASAS classification criteria for peripheral spondyloarthritis: subjects must have current arthritis (asymmetric or predominantly in the lower limbs) or current enthesitis (except for enthesitis only along the spine, sacroiliac joints and/or chest wall) or current dactylitis plus at least 1 of the following SpA features: * Anterior uveitis confirmed by an ophthalmologist (past or present) * Crohn's disease or ulcerative colitis diagnosed by a gastroenterologist (past or present). * Evidence of preceding infection (acute diarrhea or non-gonococcal urethritis or cervicitis 1 month before arthritis). * Psoriasis diagnosed by a dermatologist (past or present). * HLA B27 positivity * Sacroiliitis by imaging defined as bilateral grade 2-4 or unilateral grade 3-4 sacroiliitis on plain radiographs, according to the modified New York criteria or active sacroiliitis on MRI according to the ASAS consensus definition (ref of addendum). * Subjects must have had onset of peripheral SpA symptoms ≤12 months prior to the screening visit. * Subjects must have active disease at screening defined by Patient Global Assessment of Disease Activity Numerical Rating Scale (NRS) ≥ 4 and Patient Global Assessment of Pain NRS ≥ 4. At the baseline visit patients will be clinically evaluated to exclude spontaneous clinical remission. * In subjects with concurrent axial SpA symptoms, the peripheral SpA symptoms must be the predominant symptoms at study entry based on the Investigator's clinical judgment. * Subjects must have a negative PPD test (or equivalent) and chest radiography (anteroposterior and lateral view) at screening. If the subject has a positive PPD test (or equivalent), has had a past ulcerative reaction following PPD placement and/or a chest radiography consistent with prior TB exposure, the subject must initiate, or have documented completion of a course of anti-TB therapy. * Women of childbearing potential or men capable of fathering children must be using adequate birth control measures during the study and for 3 months after receiving the last administration of study agent. * Subject is judged to be in good health as determined by the principal investigator based upon the results of medical history, physical examination, laboratory profile, and chest x-ray (CXR) performed during screening. * Subjects must be able and willing to self-administer SC injections or have a qualified person available to administer SC injections. SPARTACUS Phase B: "Drug-Free Remission Phase" A subject will be eligible for phase B of the study if all of the following criteria are met: * Subjects must have participated in SPARTACUS Phase A. * Subjects must have reached a status of sustained clinical remission (defined as absence of clinical arthritis, enthesitis and dactylitis at 2 consecutive 'major' visits with an interval of 12 weeks). Exclusion Criteria: * Medical history of inflammatory arthritis of a different etiology than peripheral spondyloarthritis (e.g. rheumatoid arthritis, systemic lupus erythematosus, gout, …). * Prior adequate treatment with methotrexate and/or sulphasalazine. * Prior exposure to any biologic therapy with a potential therapeutic impact on SpA. * Treatment with any investigational drug of chemical or biological nature within a minimum of 30 days or 5 half-lives of the drug (whichever is longer) prior to the Baseline Visit. * Subject is taking or has taken prohibited medications as outlined in Table 1 without meeting the mandatory washout period(s) relative to the baseline visit. * Infection(s) requiring treatment with intravenous (iv) anti-infective agents within 30 days prior to the Baseline visit or oral anti-infectives within 14 days prior to the baseline Visit. * Have a known hypersensitivity to human immunoglobulin proteins or other components of golimumab. * History of central nervous system (CNS) demyelinating disease or neurologic symptoms suggestive of CNS demyelinating disease. * History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection, Hepatitis C infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active TB. * (History of) chronic heart failure, including medically controlled, asymptomatic CHF. * History of malignancy (including lymphoma and leukemia) other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix. * Have received any live virus or bacterial vaccination within 3 months prior to the first administration of study agent; patients who are expected to receive such vaccinations during the trial, or within 3 months after the last administration of study agent. * Positive serum pregnancy test at screening. * Female subjects who are breast-feeding. * Clinically significant abnormal screening laboratory results as evaluated by the Investigator. * Positive anti-cyclic citrullinated peptide (anti-CCP) antibody at screening if the titers are crossing 3 times the upper limit of normal. * Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study. * Subject with current symptoms of fibromyalgia that would confound evaluation of the patient.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • ASZ Aalst

    Aalst, 9300, Belgium

  • AZ Maria Middelares

    Ghent, 9000, Belgium

  • AZ Sint-Jan

    Bruges, 8000, Belgium

  • UZ Ghent

    Ghent, 9000, Belgium

  • UZ Leuven Gasthuisberg

    Leuven, 3000, Belgium

  • ZNA Jan Palfijn

    Merksem, 2170, Belgium