Study Evaluating the Long-Term Safety and Efficacy of ABX464 in Patients With Moderate to Severe Rheumatoid Arthritis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ABX464 50 mg All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 2 years (104 weeks) |
Drug: ABX464
All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 2 years (104 weeks).
|
Outcome Measures
Primary Outcome Measures
- Incidence of treatment-emergent adverse events in the ABX464 treated Patients, categorized by severity [through study completion (average of 104 weeks)]
Incidence of adverse events emerging during the treatment
Secondary Outcome Measures
- Proportion of patients achieving Low Disease Activity (LDA) [Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104]
Low Disease Activity (LDA) is defined as DAS28-ESR <=3.2
- Proportion of patients achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean remission [Week 4, Week 12, Week24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104]
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
- Proportion of patients achieving Simplified Disease Activity Score (SDAI) remission [Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104]
The SDAI remission is considered achieved if the SDAI score ≤ 3.3
- Proportion of patients achieving Clinical Disease Activity (CDAI) remission [Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104]
The CDAI remission is considered achieved if the CDAI score ≤ 2.8
- Proportion of patients achieving ACR20/50/70 response [Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104]
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.
- Proportion of patients achieving categorical Disease Activity Scores (DAS) (measured on 28 joints) - C-Reactive Protein (DAS28-CRP) response [Week 4, Week 12, Week 24, Week36, Week 52, Week 65, Week 78, Week 91 and Week 104]
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
- Time to onset of the Low Disease Activity (LDA) remission [up to 104 weeks]
time when DAS28-ESR <=3.2
- Time to onset of the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean remission [up to 104 weeks]
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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cliniques Universitaires Saint-Luc | Bruxelles | Belgium | ||
| 2 | UZ Gent | Gent | Belgium | ||
| 3 | UZ Leuven | Leuven | Belgium | ||
| 4 | ZNA Jan Palfijn | Merksem | Belgium | ||
| 5 | Fakultni Tomayerova nemocnice | Praha | Czechia | ||
| 6 | Revmatologicky ustav | Praha | Czechia | ||
| 7 | CHU de Brest - Hôpital Cavale Blanche | Brest | France | ||
| 8 | CHD Vendée | La Roche-sur-Yon | France | ||
| 9 | CHU DE MONTPELLIER - Hôpital Lapeyronie | Montpellier | France | ||
| 10 | GHR Mulhouse Sud-Alsace | Mulhouse | France | ||
| 11 | CHU de Nice - Hôpital Pasteur | Nice | France | ||
| 12 | CHR d'Orléans | Orléans | France | ||
| 13 | APHP - Hôpital Salpétrière | Paris | France | ||
| 14 | CHU de Tours - Hôpital Trousseau | Tours | France | ||
| 15 | Complex Medical Centre - Déli Klinika | Budapest | Hungary | ||
| 16 | CRU Hungary Ltd. | Miskolc | Hungary | ||
| 17 | CMed Rehabilitációs és Diagnosztikai Központ | Székesfehérvár | Hungary | ||
| 18 | ClinicMed Daniluk, Nowak Sp. J. | Białystok | Poland | ||
| 19 | Pratia MCM | Kraków | Poland | ||
| 20 | Zespół Poradni Specjalistycznych REUMED | Lublin | Poland | ||
| 21 | NZOZ Lecznica MAK-MED S.C. | Nadarzyn | Poland | ||
| 22 | Medyczne Centrum Hetmańska | Poznań | Poland | ||
| 23 | National Institute of Geriatrics | Warszawa | Poland | ||
| 24 | RHEUMA MEDICUS Zakład Opieki Zdrowotnej | Warszawa | Poland |
Sponsors and Collaborators
- Abivax S.A.
Investigators
- Study Director: Paul GINESTE, PharmD, Abivax S.A.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ABX464-302