New pill shows promise for long-term rheumatoid arthritis control
NCT ID NCT04049448
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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40 people
The number who actually took part.
- Started
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Oct 2019
- Finished
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Jan 2023
- Lead sponsor
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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
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18 to 76 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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CHR d'Orléans
Orléans, France
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CHU DE MONTPELLIER - Hôpital Lapeyronie
Montpellier, France
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CHU de Brest - Hôpital Cavale Blanche
Brest, France
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CMed Rehabilitációs és Diagnosztikai Központ
Székesfehérvár, Hungary
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CRU Hungary Ltd.
Miskolc, Hungary
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ClinicMed Daniluk, Nowak Sp. J.
Bialystok, Poland
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Cliniques Universitaires Saint-Luc
Brussels, Belgium
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Complex Medical Centre - Déli Klinika
Budapest, Hungary
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Medyczne Centrum Hetmańska
Poznan, Poland
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NZOZ Lecznica MAK-MED S.C.
Nadarzyn, Poland
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National Institute of Geriatrics
Warsaw, Poland
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Pratia MCM
Krakow, Poland
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UZ Gent
Ghent, Belgium
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Zespół Poradni Specjalistycznych REUMED
Lublin, Poland
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Other studies related to the condition(s) this trial covers.
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