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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04049448
Other study ID # ABX464-302
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 24, 2019
Est. completion date January 23, 2023

Study information

Verified date January 2023
Source Abivax S.A.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 23, 2023
Est. primary completion date April 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 76 Years
Eligibility 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-TNFa naïve patients or DAS-28-CRP = 3,2 for patients previously treated by anti-TNFa. Exclusion Criteria: - Any condition, which in the opinion of the investigator, could compromise the patient's safety or adherence to the study protocol

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ABX464
All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 2 years (104 weeks).

Locations

Country Name City State
Belgium Cliniques Universitaires Saint-Luc Bruxelles
Belgium UZ Gent Gent
Belgium UZ Leuven Leuven
Belgium ZNA Jan Palfijn Merksem
Czechia Fakultni Tomayerova nemocnice Praha
Czechia Revmatologicky ustav Praha
France CHU de Brest - Hôpital Cavale Blanche Brest
France CHD Vendée La Roche-sur-Yon
France CHU DE MONTPELLIER - Hôpital Lapeyronie Montpellier
France GHR Mulhouse Sud-Alsace Mulhouse
France CHU de Nice - Hôpital Pasteur Nice
France CHR d'Orléans Orléans
France APHP - Hôpital Salpétrière Paris
France CHU de Tours - Hôpital Trousseau Tours
Hungary Complex Medical Centre - Déli Klinika Budapest
Hungary CRU Hungary Ltd. Miskolc
Hungary CMed Rehabilitációs és Diagnosztikai Központ Székesfehérvár
Poland ClinicMed Daniluk, Nowak Sp. J. Bialystok
Poland Pratia MCM Kraków
Poland Zespól Poradni Specjalistycznych REUMED Lublin
Poland NZOZ Lecznica MAK-MED S.C. Nadarzyn
Poland Medyczne Centrum Hetmanska Poznan
Poland National Institute of Geriatrics Warszawa
Poland RHEUMA MEDICUS Zaklad Opieki Zdrowotnej Warszawa

Sponsors (1)

Lead Sponsor Collaborator
Abivax S.A.

Countries where clinical trial is conducted

Belgium,  Czechia,  France,  Hungary,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of treatment-emergent adverse events in the ABX464 treated Patients, categorized by severity Incidence of adverse events emerging during the treatment through study completion (average of 104 weeks)
Secondary Proportion of patients achieving Low Disease Activity (LDA) Low Disease Activity (LDA) is defined as DAS28-ESR <=3.2 Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104
Secondary Proportion of patients achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean remission The ACR/EULAR boolean-based remission is a validated criteria based on: Tender/painful Joint Count (28), Swollen Joint Count (28), C-Reactive Protein, patient global assessment of disease, All = 1 Week 4, Week 12, Week24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104
Secondary Proportion of patients achieving Simplified Disease Activity Score (SDAI) remission The SDAI remission is considered achieved if the SDAI score = 3.3 Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104
Secondary Proportion of patients achieving Clinical Disease Activity (CDAI) remission The CDAI remission is considered achieved if the CDAI score = 2.8 Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104
Secondary Proportion of patients achieving ACR20/50/70 response The categorical American College of Rheumatology 20% or 50% or 70% (ACR20/50/70) response is a validated index of rheumatoid arthritis disease activity, defined by the number of patients who achieved at least 20% or 50% or 70% improvement in the ACR response. Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104
Secondary Proportion of patients achieving categorical Disease Activity Scores (DAS) (measured on 28 joints) - C-Reactive Protein (DAS28-CRP) response Proportion of patients achieving categorical Disease Activity Score (DAS) DAS28-C-Reactive Protein (CRP) [DAS28-CRP] response will be measured as moderate/good European League Against Rheumatism (EULAR) response Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104
Secondary Time to onset of the Low Disease Activity (LDA) remission time when DAS28-ESR <=3.2 up to 104 weeks
Secondary Time to onset of the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean remission The ACR/EULAR remission is a validated criteria based on: Tender/painful Joint Count (28), Swollen Joint Count (28), C-Reactive Protein, patient global assessment of disease, All = 1.
Time to onset will be when this criteria will be = 1
up to 104 weeks
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