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
Verified date | January 2023 |
Source | Abivax S.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Abivax S.A. |
Belgium, Czechia, France, Hungary, Poland,
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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