- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03813199
Study of Two Doses of ABX464 in Participants With Moderate to Severe Rheumatoid Arthritis
Phase IIa Randomized, Double Blind, Placebo Controlled, Multiple Dose Study on ABX464 in Combination With Methotrexate (MTX), in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have Inadequate Response to MTX or/and to Anti-Tnfα, or Intolerance to Anti-Tnfα
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Bruxelles, Belgium
- Cliniques Universitaires Saint-Luc
-
Gent, Belgium
- UZ Gent
-
Leuven, Belgium
- UZ Leuven
-
Merksem, Belgium
- ZNA Jan Palfijn
-
-
-
-
-
Praha, Czechia
- Fakultni Tomayerova nemocnice
-
Praha, Czechia
- Revmatologicky ustav
-
-
-
-
-
Brest, France
- CHU de Brest - Hôpital Cavale Blanche
-
La Roche-sur-Yon, France
- CHD Vendée
-
Montpellier, France
- CHU de Montpellier - Lapeyronie
-
Mulhouse, France
- GHR Mulhouse Sud-Alsace
-
Nice, France
- CHU de Nice - Hopital Pasteur
-
Orléans, France
- CHR d'Orléans
-
Paris, France
- APHP - Hôpital Salpétrière
-
Tours, France
- CHU DE TOURS - Hopital Trousseau
-
-
-
-
-
Budapest, Hungary
- Complex Medical Centre - Déli Klinika
-
Miskolc, Hungary
- CRU Hungary Ltd.
-
Székesfehérvár, Hungary
- CMed Rehabilitacios es Diagnosztikai Kozpont
-
-
-
-
-
Białystok, Poland
- ClinicMed Daniluk, Nowak Sp. J.
-
Kraków, Poland
- Pratia MCM
-
Lublin, Poland
- Zespół Poradni Specjalistycznych REUMED
-
Nadarzyn, Poland
- NZOZ Lecznica MAK-MED s.c.
-
Poznań, Poland
- Medyczne Centrum Hetmańska
-
Warszawa, Poland
- National Institute of Geriatrics
-
Warszawa, Poland
- Rheuma Medicus Zakład Opieki Zdrowotnej
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 (TNFα) therapy (both administered for at least 12 weeks before IR) or were intolerant to anti- TNFα 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ABX464 50mg + methotrexate
Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks + methotrexate |
ABX464 is a new anti-inflammatory drug
Other Names:
placebo matching with ABX464
Other Names:
MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Other Names:
|
Experimental: ABX464 100mg + methotrexate
Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks + methotrexate |
MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Other Names:
ABX464 is a new anti-inflammatory drug
Other Names:
|
Placebo Comparator: Placebo + methotrexate
Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate |
placebo matching with ABX464
Other Names:
MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Treatment-emergent Adverse Events in the ABX464 Treated Patients Versus Placebo
Time Frame: through study completion, an average of 15 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients Achieving ACR20 Response
Time Frame: at Week 12
|
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
|
Number of Patients Achieving ACR20/50/70 Response
Time Frame: Week 12
|
Number of patients who achieved at least 20%, 50% or 70% improvement in the American College of Rheumatology (ACR) response.
|
Week 12
|
Change From Baseline in C-reactive Protein (CRP)
Time Frame: Week 12
|
Change from baseline in C-reactive protein (CRP) at Week 12
|
Week 12
|
Number of Patients Achieving DAS28-CRP Response
Time Frame: Week 12
|
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
|
Change From Baseline in Disease Activity Scores (DAS-CRP) (28 Joints) [DAS28]
Time Frame: Week 12
|
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 √ (TJC28) + 0.28 √ (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
|
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Time Frame: Week 12
|
Change from baseline in erythrocyte sedimentation rate (ESR) at Week 12
|
Week 12
|
Number of Patients Achieving Disease Activity Score (DAS) DAS28-Erythrocyte Sedimentation Rate (ESR) [DAS28-ESR] Remission
Time Frame: Week 12
|
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
|
Change From Baseline in Disease Activtiy Score (DAS)28-Erythrocyte Sedimentation Rate (ESR)
Time Frame: 12 weeks
|
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 √ (TJC28) + 0.28 √ (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
|
Change From Baseline in Simplified Disease Activity Index Score (SDAI)
Time Frame: Week 12
|
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
|
Change From Baseline in Clinical Disease Activity Index Score (CDAI)
Time Frame: Week 12
|
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
|
Number of Patients Achieving Low Disease Activity (LDA)
Time Frame: Week 12
|
Number of patients achieving a Low Disease Activity (LDA) which is defined as DAS28-ESR <=3.2
|
Week 12
|
Number of Patients Achieving Simplified Disease Activity Score (SDAI) Remission
Time Frame: Week 12
|
Number of patients achieving Simplified Disease Activity Score (SDAI) remission, which is considered achieved if the SDAI score ≤ 3.3
|
Week 12
|
Number of Patients Achieving Clinical Disease Activity (CDAI) Remission
Time Frame: Week 12
|
Number of patients achieving Clinical Disease Activity (CDAI) remission, which is considered achieved if the CDAI score ≤ 2.8
|
Week 12
|
Number of Patients Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission
Time Frame: Week 12
|
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
|
Change From Baseline in Tender/Painful Joint Count (TJC28)
Time Frame: 12 weeks
|
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
|
Change From Baseline in Swollen Joint Count (SJC)
Time Frame: 12 weeks
|
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
|
Change From Baseline in Pain Visual Analog Scale
Time Frame: 12 weeks
|
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
|
Change From Baseline in Patient Global Assessment of Disease (PtGA)
Time Frame: 12 weeks
|
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
|
Change From Baseline in Investigator Global Assessment of Disease (PrGA)
Time Frame: 12 weeks
|
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
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Time Frame: 12 weeks
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Arthritis, Rheumatoid
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Methotrexate
Other Study ID Numbers
- ABX464-301
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rheumatoid Arthritis
-
Janssen Research & Development, LLCWithdrawnActive Rheumatoid Arthritis; Rheumatoid Arthritis
-
Centocor, Inc.CompletedRheumatoid Arthritis, Juvenile
-
AmgenTerminated
-
Children's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedJuvenile Rheumatoid ArthritisUnited States
-
AmgenImmunex CorporationCompletedJuvenile Rheumatoid Arthritis
-
National Institute of Arthritis and Musculoskeletal...Children's Hospital Medical Center, CincinnatiCompleted
-
University of PittsburghNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedRheumatoid Arthritis | Juvenile Rheumatoid ArthritisUnited States
-
University of Missouri-ColumbiaCompletedJuvenile Rheumatoid ArthritisUnited States
-
Assistance Publique - Hôpitaux de ParisSociete Francaise de RhumatologieRecruiting
-
Amsterdam UMC, location VUmcEuropean CommissionCompletedRheumatoId ArthritisNetherlands, Germany, Portugal, Italy, Hungary, Romania, Slovakia
Clinical Trials on ABX464 50mg
-
Abivax S.A.CompletedHIV Infections | Health VolunteersSpain
-
Abivax S.A.CompletedUlcerative ColitisBelgium, Poland, Spain, France, Germany, Italy, Slovenia, Canada, Belarus, Hungary, Czechia, Austria, United Kingdom, Serbia, Slovakia, Ukraine, United States
-
Abivax S.A.TerminatedCOVID-19Spain, Belgium, United Kingdom, Germany, France, Brazil, Italy, Mexico
-
Abivax S.A.Completed
-
Abivax S.A.Active, not recruitingUlcerative ColitisBelgium, Poland, Czechia, Hungary
-
Abivax S.A.Orion Corporation, Orion PharmaActive, not recruitingUlcerative ColitisBelgium
-
Abivax S.A.Active, not recruitingUlcerative ColitisPoland, Spain, France, Germany, Italy, Slovenia, Belgium, Canada, Belarus, Hungary, Czechia, Austria, United Kingdom, Serbia, Slovakia, Ukraine
-
Abivax S.A.RecruitingUlcerative ColitisUnited States, Belgium, Korea, Republic of, Australia, Austria, Italy, Spain, China, Israel, Bosnia and Herzegovina, Croatia, Czechia, Japan, Mexico, Netherlands, Romania, Turkey, United Kingdom, Canada, New Zealand, Hungary, India, Franc... and more
-
Abivax S.A.CompletedRheumatoid ArthritisBelgium, France, Czechia, Hungary, Poland