Clinical trial NCT04049448: Study Evaluating the Long-Term Safety and Efficacy of ABX464 in Patients With Moderate to Severe Rheumatoid Arthritis
Official title: A Follow-up Phase 2a Open-label Study to Evaluate the Long-term Safety and Efficacy Profile of ABX464 in Patients With Moderate to Severe Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: moderate to severe Rheumatoid Arthritis
Lead sponsor: Abivax S.A.
Sponsor class: INDUSTRY
First posted: 2019-08-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label, follow-up study
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This Phase 2a open-label study aims at investigating the long-term safety and efficacy of an oral dose of ABX464 in patients who have been previously enrolled in the ABX464-301 clinical study and who are willing to continue their treatment.

All patients will receive ABX464 given at 50mg o.d. irrespectively of their previous treatment received in the ABX464-301 study (i.e. ABX464 or Placebo).

The enrolment in this follow-up study will be based on the willingness of the subject to carry on his/her participation and also based on investigator's judgement.

Patients will be treated with ABX464 for a period of 52 weeks. If they achieve a clinical response on Week 52 (defined as DAS28-CRP ≤ 2,6 for anti-TNFα naïve patients or DAS-28-CRP ≤ 3,2 for patients previously treated by anti-TNFα), they will be eligible to continue treatment for up to 104 weeks.Patients will be followed up at week , week 2 and then, on a monthly basis the first year (up to W52), and quaterly the second year (up to W104).

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

Primary outcomes:
measure: Incidence of treatment-emergent adverse events in the ABX464 treated Patients, categorized by severity
timeFrame: through study completion (average of 104 weeks)
Secondary outcomes:
measure: Proportion of patients achieving Low Disease Activity (LDA)
timeFrame: Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104
measure: Proportion of patients achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean remission
timeFrame: Week 4, Week 12, Week24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104
measure: Proportion of patients achieving Simplified Disease Activity Score (SDAI) remission
timeFrame: Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104
measure: Proportion of patients achieving Clinical Disease Activity (CDAI) remission
timeFrame: Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104
measure: Proportion of patients achieving ACR20/50/70 response
timeFrame: Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104
measure: Proportion of patients achieving categorical Disease Activity Scores (DAS) (measured on 28 joints) - C-Reactive Protein (DAS28-CRP) response
timeFrame: Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104
measure: Time to onset of the Low Disease Activity (LDA) remission
timeFrame: up to 104 weeks
measure: Time to onset of the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean remission
timeFrame: up to 104 weeks
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven
city: Merksem
country: Belgium
facility: ZNA Jan Palfijn
city: Praha
country: Czechia
facility: Fakultni Tomayerova nemocnice
city: Praha
country: Czechia
facility: Revmatologicky ustav
city: Brest
country: France
facility: CHU de Brest - Hôpital Cavale Blanche
city: La Roche-sur-Yon
country: France
facility: CHD Vendée
city: Montpellier
country: France
facility: CHU DE MONTPELLIER - Hôpital Lapeyronie
city: Mulhouse
country: France
facility: GHR Mulhouse Sud-Alsace
city: Nice
country: France
facility: CHU de Nice - Hôpital Pasteur
city: Orléans
country: France
facility: CHR d'Orléans
city: Paris
country: France
facility: APHP - Hôpital Salpétrière
city: Tours
country: France
facility: CHU de Tours - Hôpital Trousseau
city: Budapest
country: Hungary
facility: Complex Medical Centre - Déli Klinika
city: Miskolc
country: Hungary
facility: CRU Hungary Ltd.
city: Székesfehérvár
country: Hungary
facility: CMed Rehabilitációs és Diagnosztikai Központ
city: Białystok
country: Poland
facility: ClinicMed Daniluk, Nowak Sp. J.
city: Kraków
country: Poland
facility: Pratia MCM
city: Lublin
country: Poland
facility: Zespół Poradni Specjalistycznych REUMED
city: Nadarzyn
country: Poland
facility: NZOZ Lecznica MAK-MED S.C.
city: Poznań
country: Poland
facility: Medyczne Centrum Hetmańska
city: Warszawa
country: Poland
facility: National Institute of Geriatrics
city: Warszawa
country: Poland
facility: RHEUMA MEDICUS Zakład Opieki Zdrowotnej
Study officials:
affiliation: Abivax S.A.
name: Paul GINESTE, PharmD
role: STUDY_DIRECTOR
References: