Rheumatoid Arthritis
Conditions
Keywords
moderate to severe Rheumatoid Arthritis
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).
Interventions
DRUGABX464
All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 2 years (104 weeks).
Sponsors
Abivax S.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label, follow-up study
Eligibility
Sex/Gender
ALL
Age
18 Years to 76 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
| 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. |
Countries
Belgium, France, Hungary, Poland
Outcome results
None listed