Rheumatoid Arthritis MedDRA version: 23.1 Level: LLT Classification code 10003268 Term: Arthritis rheumatoid System Organ Class: 100000004859
Conditions
Sponsors
Abivax
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A patient will be eligible to participate in this study if ALL the following criteria are met: - Patients previously enrolled in the ABX464-301 clinical study who have completed the ABX464-301 study; - Patients are able and willing to comply with study visits and procedures as per protocol; - Patients should understand, sign and date the written voluntary informed consent form at the enrolment visit prior to any protocol-specific procedures are performed; - Females and males receiving the study treatment and their partners must agree to use a highly effective contraceptive method during the study and for 6 months after end of study or early termination. Contraception should be in place at least 2 weeks prior to study participation. Women must be surgically sterile or if of childbearing potential must use a highly effective contraceptive method. Women of childbearing potential (WOCBP) will enter the study after confirmed menstrual period and a negative pregnancy test. Highly effective methods of contraception include true abstinence, intrauterine device (IUD) or hormonal contraception aiming at inhibition of ovulation, intrauterine hormone releasing system, bilateral tubal ligation, vasectomized partner. True abstinence is defined when this is in line with the preferred and usual lifestyle of the patient. In each case of delayed menstrual period (over one month between menstruations) confirmation of absence of pregnancy is required. This recommendation also applies to WOCBP with infrequent or irregular menstrual cycle. Female and male patients must not be planning pregnancy and male patients should use condom and must not donate sperm during the trial and for 6 months post completion of their participation in the trial. 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. - Patients able and willing to continue the study treatment and who are compliant with study visits and procedures and who signed the update of the written voluntary informed consent form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: The following criteria should be checked at the time of screening. If ANY exclusion criterion applies, the patient will not be included in the study: - 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 |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the long-term safety of ABX464 given at 50mg once daily in patients with moderate to severe active Rheumatoid Arthritis.;Secondary Objective: - To evaluate the long-term effects of ABX464 on Low Disease Activity (LDA) or remission (DAS28-ESR remission, ACR/EULAR remission, SDAI and CDAI remission); - To evaluate the long-term effects of ABX464 on disease activity scores (DAS28 scores, simplified disease activity score [SDAI] and clinical disease activity score [CDAI]). - To evaluate the long-term effects of ABX464 on the Patient Reported Outcomes (PRO), Healthy Assessment Questionnaire Disability Index (HAQ-DI) and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue; - To evaluate the long-term effects of ABX464 on the American College of Rheumatology (ACR) 20/50/70 response and each of its components and the European League Against Rheumatism (EULAR) response (based on DAS28-CRP response). - To evaluate the expression of miR-124 in total blood (determined by qPCR) at Week 52 and 104. Echocardiography: - To evaluate the effect of ABX464 in cardiac function as assessed through echocardiograms.;Primary end point(s): Primary safety endpoint - Incidence of treatment-emergent adverse events in the ABX464 treated Patients, categorized by severity ;Timepoint(s) of evaluation of this end point: Up to 104 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Main efficacy Endpoint: - Proportion of patients achieving DAS28-ESR remission (DAS28 ESR 15% (e.g., -22% to -18%) - Number of subjects with an absolute reduction of LVER > 10% to EF >50% with a relative fall in GLS of > 15% - Number of subjects with an absolute reduction of LVEF <10% to ED <50% - Changes of other echocardiographic parameters as described in a standard protocol, including 2- and 3-dimensional volumes, RV size and systolic function and valve function.;Timepoint(s) of evaluation of this end point: See E.5.2 for Timepoint(s) of evaluation of this end point | — |
Countries
Hungary
Contacts
Public ContactVP Clinical Operations
Abivax
Outcome results
None listed