NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Study Evaluating the Long-Term Safety and Efficacy of ABX464 in Patients With Moderate to Severe Rheumatoid Arthritis

CompletedPhase 2

Sponsor: Abivax S.A.

Conditions: Rheumatoid Arthritis

Interventions: ABX464

Countries: Belgium, France, Hungary, Poland

A phase 2a open-label study to evaluate the long-term safety and efficacy of ABX464 50mg as maintenance therapy in patients with moderate to severe rheumatoid arthritis.

Eligibility overview

Sex: ALL

Age: 18 Years to 76 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (14)

Brussels, Belgium
Ghent, Belgium
Brest, France
Montpellier, France
Orléans, France
Budapest, Hungary
Miskolc, Hungary
Székesfehérvár, Hungary
Bialystok, Poland
Krakow, Poland
Lublin, Poland
Nadarzyn, Poland
Poznan, Poland
Warsaw, Poland