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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABX464 50mg + methotrexate | Experimental | Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks + methotrexate |
|
| ABX464 100mg + methotrexate | Experimental | Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks + methotrexate |
|
| Placebo + methotrexate | Placebo Comparator | Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABX464 50mg | Drug | ABX464 is a new anti-inflammatory drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of Patients Achieving ACR20/50/70 Response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul GINESTE, PharmD | Abivax S.A. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques Universitaires Saint-Luc | Brussels | Belgium | ||||
| UZ Gent |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35641124 | Derived | Daien C, Krogulec M, Gineste P, Steens JM, Desroys du Roure L, Biguenet S, Scherrer D, Santo J, Ehrlich H, Durez P. Safety and efficacy of the miR-124 upregulator ABX464 (obefazimod, 50 and 100 mg per day) in patients with active rheumatoid arthritis and inadequate response to methotrexate and/or anti-TNFalpha therapy: a placebo-controlled phase II study. Ann Rheum Dis. 2022 Jul 12;81(8):1076-1084. doi: 10.1136/annrheumdis-2022-222228. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ABX464 50mg + Methotrexate | Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks + methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 24, 2019 | Feb 3, 2022 |
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| Matching Placebo | Drug | placebo matching with ABX464 |
|
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| ABX464 100mg | Drug | ABX464 is a new anti-inflammatory drug |
|
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| Methotrexate | Drug | MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study |
|
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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) | Change from baseline in C-reactive protein (CRP) at Week 12 | Week 12 |
| 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 |
| 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 √ (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) | 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 | 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) | 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) | 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) | 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) | 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 | 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 | 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 | 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) | 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) | 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 | 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) | 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) | 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) | 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 |
| Ghent |
| Belgium |
| UZ Leuven | Leuven | Belgium |
| ZNA Jan Palfijn | Merksem | Belgium |
| Fakultni Tomayerova nemocnice | Prague | Czechia |
| Revmatologicky ustav | Prague | Czechia |
| 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 | France |
| Complex Medical Centre - Déli Klinika | Budapest | Hungary |
| CRU Hungary Ltd. | Miskolc | Hungary |
| CMed Rehabilitációs és Diagnosztikai Központ | Székesfehérvár | Hungary |
| ClinicMed Daniluk, Nowak Sp. J. | Bialystok | Poland |
| Pratia MCM | Krakow | Poland |
| Zespół Poradni Specjalistycznych REUMED | Lublin | Poland |
| NZOZ Lecznica MAK-MED S.C. | Nadarzyn | Poland |
| Medyczne Centrum Hetmańska | Poznan | Poland |
| National Institute of Geriatrics | Warsaw | Poland |
| RHEUMA MEDICUS Zakład Opieki Zdrowotnej | Warsaw | Poland |
| FG001 |
| ABX464 100mg + Methotrexate |
Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks + methotrexate 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 |
| FG002 | Placebo + Methotrexate | Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ABX464 50mg + Methotrexate | Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks + methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study |
| BG001 | ABX464 100mg + Methotrexate | Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks + methotrexate 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 |
| BG002 | Placebo + Methotrexate | Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | through study completion, an average of 15 weeks |
|
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| |||||||||||||||||||||||||||||||||
| 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. | Intent to treat population | Posted | Count of Participants | Participants | 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. | Intent to Treat Population | Posted | Count of Participants | Participants | Week 12 |
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| Secondary | Change From Baseline in C-reactive Protein (CRP) | Change from baseline in C-reactive protein (CRP) at Week 12 | Intent to Treat | Posted | Mean | Standard Deviation | mg/L | Week 12 |
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| 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 | Intent to Treat population | Posted | Count of Participants | Participants | Week 12 |
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| 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 √ (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. | Intent to Treat population | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
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| Secondary | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) | Change from baseline in erythrocyte sedimentation rate (ESR) at Week 12 | Intent to Treat population | Posted | Mean | Standard Deviation | mm/h | 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 | Intent to Treat population | Posted | Count of Participants | Participants | Week 12 |
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| 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 √ (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 | Intent to Treat | Posted | Mean | Standard Deviation | mm/h | 12 weeks |
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| 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 | Intent to Treat population | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
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| 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 | Intent to Treat population | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
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| 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 | Intent to Treat population | Posted | Count of Participants | Participants | Week 12 |
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| 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 | Intent to Treat population | Posted | Count of Participants | Participants | Week 12 |
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| 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 | Intent to Treat population | Posted | Count of Participants | Participants | Week 12 |
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| 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 | Intent to Treat population | Posted | Count of Participants | Participants | 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 | intent to treat | Posted | Mean | Standard Deviation | joints | 12 weeks |
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| 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 | Intent to treat | Posted | Mean | Standard Deviation | joints | 12 weeks |
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| 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 | Intent to Treat | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
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| 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 | Intent to Treat | Posted | Mean | Standard Deviation | units on a scale | 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 | Intent to treat | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
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| 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 | Intent to Treat | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
15 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ABX464 50mg + Methotrexate | Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks + methotrexate ABX464 50mg: ABX464 is a new anti-inflammatory drug Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study | 0 | 21 | 0 | 21 | 15 | 21 |
| EG001 | ABX464 100mg + Methotrexate | Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks + methotrexate 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 | 0 | 19 | 1 | 19 | 17 | 19 |
| EG002 | Placebo + Methotrexate | Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study | 0 | 20 | 1 | 20 | 5 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment | atrial fibrillation reactive to hypokalemia secondary to diarrhea in the context of study drug treatment |
| |
| Covid-19 | Infections and infestations | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
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| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
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| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Clinical Operations | Abivax | 01 53 83 08 41 | paul.gineste@abivax.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 10, 2020 | Feb 3, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000623073 | ABX464 |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| OG002 |
| Placebo + Methotrexate |
Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study |
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| OG002 | Placebo + Methotrexate | Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study |
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| OG002 |
| Placebo + Methotrexate |
Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study |
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| Placebo + Methotrexate |
Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study |
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Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks
+ methotrexate
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
| OG002 | Placebo + Methotrexate | Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate Matching Placebo: placebo matching with ABX464 Methotrexate: MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study |
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