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New pill shows promise for long-term rheumatoid arthritis control

NCT ID NCT04049448

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study looked at the long-term safety and effectiveness of a daily pill called ABX464 in 40 adults with moderate to severe rheumatoid arthritis. Participants had already completed 12 weeks of treatment in an earlier study. The goal was to see if ABX464 can help keep the disease under control over many months. The study focused on tracking side effects and measuring how well the drug maintained low disease activity.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

40 people

The number who actually took part.

Started

Oct 2019

Finished

Jan 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 76 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: * Patients previously enrolled in the ABX464-301 clinical study who have completed the initial 12 weeks of treatment period; Criteria that should be met by patients at week 52 to be eligible for 52 additional weeks of study treatment: ▪ Patients should be in clinical response. Clinical response is defined as: DAS28-CRP ≤ 2,6 for anti-TNFα naïve patients or DAS-28-CRP ≤ 3,2 for patients previously treated by anti-TNFα. Exclusion Criteria: * Any condition, which in the opinion of the investigator, could compromise the patient's safety or adherence to the study protocol

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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

  • CHR d'Orléans

    Orléans, France

  • CHU DE MONTPELLIER - Hôpital Lapeyronie

    Montpellier, France

  • CHU de Brest - Hôpital Cavale Blanche

    Brest, France

  • CMed Rehabilitációs és Diagnosztikai Központ

    Székesfehérvár, Hungary

  • CRU Hungary Ltd.

    Miskolc, Hungary

  • ClinicMed Daniluk, Nowak Sp. J.

    Bialystok, Poland

  • Cliniques Universitaires Saint-Luc

    Brussels, Belgium

  • Complex Medical Centre - Déli Klinika

    Budapest, Hungary

  • Medyczne Centrum Hetmańska

    Poznan, Poland

  • NZOZ Lecznica MAK-MED S.C.

    Nadarzyn, Poland

  • National Institute of Geriatrics

    Warsaw, Poland

  • Pratia MCM

    Krakow, Poland

  • UZ Gent

    Ghent, Belgium

  • Zespół Poradni Specjalistycznych REUMED

    Lublin, Poland

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