Follow-up Phase 2a study of ABX464 in moderate to severe active Rheumatoid Arthritis patients.

Phase 1

• Conditions: Rheumatoid Arthritis; MedDRA version: 23.1Level: LLTClassification code 10003268Term: Arthritis rheumatoidSystem Organ Class: 100000004859; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2019-001578-27-HU
• Lead Sponsor: Abivax

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-02
• Last Update Posted: 9 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified