Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03813199
Other study ID # ABX464-301
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date July 4, 2019
Est. completion date April 27, 2021

Study information

Verified date May 2022
Source Abivax S.A.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This Phase IIa study aims at investigating the safety and tolerability of 2 dose-levels of ABX464 administered daily in combination with methotrexate (MTX) in patients with moderate to severe active Rheumatoid Arthritis (RA) who had an inadequate response to MTX or/and to one or more anti- tumor necrosis factor alpha (TNFα) therapies.


Description:

This is a randomized, double-blind, placebo-controlled, multicenter study. The study will consist of 3 phases: a screening phase, a treatment phase, and a follow-up phase. Approximately 60 participants with active Rheumatoid Arthritis will be randomly assigned to receive placebo, 50mg ABX464 or 100mg ABX464 during the treatment phase. The maximum period of active treatment will be 12 weeks. The maximum duration of study participation will be 17 weeks. Participant safety will be monitored throughout the study. In addition, several experimental and clinical endpoints will be assessed to obtain information on preliminary efficacy.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date April 27, 2021
Est. primary completion date April 27, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Patient with a confirmed and documented diagnosis of adult-onset rheumatoid arthritis, for at least 12 weeks, according to the revised 2010 American College of Rheumatology- European League Against Rheumatism (ACR-EULAR) classification criteria, including at least one positive criteria among the following: Rheumatoid Factor (RF), Anti-Citrullinated Peptide Antibody (ACPA) or bone erosion; - Swollen joint count (SJC) of = 4 (28-joint count) and tender joint count (TJC) =4 (28-joint count) at screening; - Patient with a moderate to severe disease activity score Disease Activity Score (28 joints) C-Reactive Protein [DAS28 CRP] = 3.2 and C-reactive Protein (CRP) = 5 mg/L (= 4.76 nmol)/L) at screening; - Patient who had an inadequate response (IR), or failed either methotrexate (MTX) or/and anti- Tumor Necrosis Factor alpha (TNFa) therapy (both administered for at least 12 weeks before IR) or were intolerant to anti- TNFa therapy. Exclusion Criteria: - Patient with a known positive anti-double stranded deoxyribonucleic acid (DNA [anti-dsDNA]) and confirmed diagnosis of systemic lupus erythematosus (SLE); - Patient with known active infections at screening such as CytoMegaloVirus (CMV), herpes virus and/or recent infectious hospitalization; - Acute, chronic or history of clinically relevant pulmonary, cardiovascular, hepatic, pancreatic or renal functional abnormality, encephalopathy, neuropathy or unstable Central Nervous System (CNS) pathology such as seizure disorder, angina or cardiac arrhythmias, active malignancy or any other clinically significant medical problems as determined by physical examination and/or laboratory screening tests and/or medical history; - Acute, chronic or history of immunodeficiency or other autoimmune disease; - Patient previously treated with any non-anti-TNF biological Disease-Modifying AntiRheumatic Drugs (bDMARDs), and targeted DMARDs (tDMARDS) prior to baseline.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ABX464 50mg
ABX464 is a new anti-inflammatory drug
Matching Placebo
placebo matching with ABX464
ABX464 100mg
ABX464 is a new anti-inflammatory drug
Methotrexate
MTX = 10 mg/week will be given at previous dose regimen kept stable throughout the study

Locations

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 - 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

Sponsors (1)

Lead Sponsor Collaborator
Abivax S.A.

Countries where clinical trial is conducted

Belgium,  Czechia,  France,  Hungary,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Treatment-emergent Adverse Events in the ABX464 Treated Patients Versus Placebo TEAE definition is undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment through study completion, an average of 15 weeks
Secondary Number of Patients Achieving ACR20 Response The categorical American College of Rheumatology 20% (ACR20) response is a validated index of rheumatoid arthritis disease activity, defined by the number of patients who achieved at least 20% improvement in the ACR response. at Week 12
Secondary Number of Patients Achieving ACR20/50/70 Response Number of patients who achieved at least 20%, 50% or 70% improvement in the American College of Rheumatology (ACR) response. Week 12
Secondary Change From Baseline in C-reactive Protein (CRP) Change from baseline in C-reactive protein (CRP) at Week 12 Week 12
Secondary Number of Patients Achieving DAS28-CRP Response Number 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 12
Secondary Change From Baseline in Disease Activity Scores (DAS-CRP) (28 Joints) [DAS28] The DAS28 is a validated index of rheumatoid arthritis disease activity. The DAS28 assessment include 28 tender and swollen joint counts (TJC and SJC), acute phase reactant (CRP ), and patient's global assessment of disease activity (PtGA).
DAS28-CRP = 0.56 v (TJC28) + 0.28 v (SJC28) + 0.36 Ln [CRP(mg/L)+1] + 0.014 PtGA(VAS100mm) + 0.96 Score scale range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Week 12
Secondary Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Change from baseline in erythrocyte sedimentation rate (ESR) at Week 12 Week 12
Secondary Number of Patients Achieving Disease Activity Score (DAS) DAS28-Erythrocyte Sedimentation Rate (ESR) [DAS28-ESR] Remission Number of patients achieving Disease Activity Score (DAS) DAS28-Erythrocyte Sedimentation Rate (ESR) [DAS28-ESR]remission, which is defined as DAS2-ESR < 2.6 Week 12
Secondary Change From Baseline in Disease Activtiy Score (DAS)28-Erythrocyte Sedimentation Rate (ESR) The DAS28 is a validated index of rheumatoid arthritis disease activity. The DAS28 assessment include 28 tender and swollen joint counts (TJC and SJC), acute phase reactant (ESR), and patient's global assessment of disease activity (PtGA).
DAS28-ESR = 0.56 v (TJC28) + 0.28 v (SJC28) + 0.70 Ln [ESR(mm/h)] + 0.014 PtGA(VAS100mm) Score scale range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
change from baseline at weeks 12: the bigger negative score shows a bigger improvment
12 weeks
Secondary Change From Baseline in Simplified Disease Activity Index Score (SDAI) SDAI is a validated index of rheumatoid arthritis disease activity. The SDAI calculation is based on 28 tender and swollen joint counts, C-Reactive Protein (CRP), patient's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PrGA).
SDAI score= tender28 + swollen28 + CRP + (PtGA/10) + (PrGA/10). A moderate activity is defined by a SDAI score >11 to 26 included. A high activity is defined by a SDAI score >26. Change from Baseline: the higher negative number shows a bigger improvment
Week 12
Secondary Change From Baseline in Clinical Disease Activity Index Score (CDAI) CDAI is a validated index of rheumatoid arthritis disease activity. The CDAI calculation is based on 28 tender and swollen joint counts, patient's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PrGA).
CDAI score= tender28 + swollen28 + (PtGA/10) + (PrGA/10). A moderate activity is defined by a CDAI score >10 to 22 included. A high activity is defined by a CDAI score >22. Change from Baseline: the higher negative number shows a bigger improvment
Week 12
Secondary Number of Patients Achieving Low Disease Activity (LDA) Number of patients achieving a Low Disease Activity (LDA) which is defined as DAS28-ESR <=3.2 Week 12
Secondary Number of Patients Achieving Simplified Disease Activity Score (SDAI) Remission Number of patients achieving Simplified Disease Activity Score (SDAI) remission, which is considered achieved if the SDAI score = 3.3 Week 12
Secondary Number of Patients Achieving Clinical Disease Activity (CDAI) Remission Number of patients achieving Clinical Disease Activity (CDAI) remission, which is considered achieved if the CDAI score = 2.8 Week 12
Secondary Number 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 12
Secondary Change From Baseline in Tender/Painful Joint Count (TJC28) Change from Baseline in Tender/painful joint count based on 28-joint assessment (TJC28) at Week 12 TJC28 score range from 0 to 28 Change from Baseline: the higher the negative number is, the better improvment is 12 weeks
Secondary Change From Baseline in Swollen Joint Count (SJC) Change from Baseline in Swollen joint count based on 28-joint assessment (SJC28) at Week 12 SJC28 score range from 0 to 28 Change from Baseline: the higher the negative number is, the better improvment is 12 weeks
Secondary Change From Baseline in Pain Visual Analog Scale Change from Baseline in Pain Visual Analog Scale (Pain-VAS) at week 12 The VAS range from 0 to 10 cm (the higher, the more painful) A bigger negative change from baseline shows a bigger improvment 12 weeks
Secondary Change From Baseline in Patient Global Assessment of Disease (PtGA) Change from Baseline in Patient Global Assessment of Disease (PtGA) . This is a patient's self assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity The change from baseline: a bigger negative number shows a bigger improvment 12 weeks
Secondary Change From Baseline in Investigator Global Assessment of Disease (PrGA) Change from Baseline in Investigator global assessment of disease (PrGA): investigator's assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity The change from baseline: the higher negative number shows a better improvement 12 weeks
Secondary Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Change from Baseline in Health Assessment questionnaire disability index (HAQ-DI) at Week 12 There are 8 sections in this questionnaire: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section, i.e. if one question is scored 1 and another 2, then the score for the section is 2. In addition, if an aide or device is used or if help is required from another individual, then the minimum score for that section is 2.
The 8 scores of the 8 sections are summed and divided by the number of section answered.
This gives a score range from 0 to 3 (the bigger the worst activity). The change from Baseline: the bigger negative number shows a bigger improvment
12 weeks
See also
  Status Clinical Trial Phase
Completed NCT04226131 - MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics N/A
Completed NCT04171414 - A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis Phase 3
Completed NCT02833350 - Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA) Phase 2
Completed NCT04255134 - Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN) Phase 4
Recruiting NCT05615246 - Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
Completed NCT03248518 - Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases N/A
Completed NCT03514355 - MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms N/A
Recruiting NCT06005220 - SBD121, a Synbiotic Medical Food for RA Management N/A
Recruiting NCT05451615 - Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis Phase 3
Completed NCT05054920 - Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis N/A
Completed NCT02037737 - Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting N/A
Recruiting NCT04079374 - Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel Phase 3
Completed NCT02504268 - Effects of Abatacept in Patients With Early Rheumatoid Arthritis Phase 3
Recruiting NCT05496855 - Remote Care in People With Rheumatoid Arthritis N/A
Completed NCT05051943 - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Recruiting NCT06103773 - A Study of Single and Multiple Oral Doses of TollB-001 Phase 1
Recruiting NCT06031415 - Study of GS-0272 in Participants With Rheumatoid Arthritis Phase 1
Completed NCT05999266 - The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
Recruiting NCT05302934 - Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
Recruiting NCT04169100 - Novel Form of Acquired Long QT Syndrome Phase 4