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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04049448
• Other study ID #: ABX464-302
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

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