Rheumatoid Arthritis
Conditions
Brief 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.
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.
Interventions
DRUGABX464 50mg
ABX464 is a new anti-inflammatory drug
DRUGMatching Placebo
placebo matching with ABX464
DRUGABX464 100mg
ABX464 is a new anti-inflammatory drug
DRUGMethotrexate
MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Sponsors
Abivax S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatment-emergent Adverse Events in the ABX464 Treated Patients Versus Placebo | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Achieving ACR20/50/70 Response | Week 12 | Number of patients who achieved at least 20%, 50% or 70% improvement in the American College of Rheumatology (ACR) response. |
| Change From Baseline in C-reactive Protein (CRP) | Week 12 | Change from baseline in C-reactive protein (CRP) at Week 12 |
| Number of Patients Achieving DAS28-CRP Response | 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 |
| Change From Baseline in Disease Activity Scores (DAS-CRP) (28 Joints) [DAS28] | 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. |
| Change From Baseline in Erythrocyte Sedimentation Rate (ESR) | Week 12 | Change from baseline in erythrocyte sedimentation rate (ESR) at Week 12 |
| Number of Patients Achieving Disease Activity Score (DAS) DAS28-Erythrocyte Sedimentation Rate (ESR) [DAS28-ESR] Remission | 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 |
| Change From Baseline in Disease Activtiy Score (DAS)28-Erythrocyte Sedimentation Rate (ESR) | 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 |
| Change From Baseline in Simplified Disease Activity Index Score (SDAI) | 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 |
| Change From Baseline in Clinical Disease Activity Index Score (CDAI) | 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 |
| Number of Patients Achieving ACR20 Response | 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. |
| Number of Patients Achieving Simplified Disease Activity Score (SDAI) Remission | Week 12 | Number of patients achieving Simplified Disease Activity Score (SDAI) remission, which is considered achieved if the SDAI score ≤ 3.3 |
| Number of Patients Achieving Clinical Disease Activity (CDAI) Remission | Week 12 | Number of patients achieving Clinical Disease Activity (CDAI) remission, which is considered achieved if the CDAI score ≤ 2.8 |
| Number of Patients Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission | 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 |
| Change From Baseline in Tender/Painful Joint Count (TJC28) | 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 |
| Change From Baseline in Swollen Joint Count (SJC) | 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 |
| Change From Baseline in Pain Visual Analog Scale | 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 |
| Change From Baseline in Patient Global Assessment of Disease (PtGA) | 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 |
| Change From Baseline in Investigator Global Assessment of Disease (PrGA) | 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 |
| Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | 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 |
| Number of Patients Achieving Low Disease Activity (LDA) | Week 12 | Number of patients achieving a Low Disease Activity (LDA) which is defined as DAS28-ESR \<=3.2 |
Countries
Belgium, Czechia, France, Hungary, Poland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 21 |
| 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 | 19 |
| 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 | 20 |
| Total | 60 |
Baseline characteristics
| Characteristic | ABX464 50mg + Methotrexate | ABX464 100mg + Methotrexate | Placebo + Methotrexate | Total |
|---|---|---|---|---|
| Age, Continuous | 57.9 years STANDARD_DEVIATION 11.4 | 54.4 years STANDARD_DEVIATION 10.6 | 58.6 years STANDARD_DEVIATION 11 | 57.0 years STANDARD_DEVIATION 11 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 15 Participants | 11 Participants | 11 Participants | 37 Participants |
| Sex: Female, Male Male | 6 Participants | 8 Participants | 9 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 19 | 0 / 20 |
| other Total, other adverse events | 15 / 21 | 17 / 19 | 5 / 20 |
| serious Total, serious adverse events | 0 / 21 | 1 / 19 | 1 / 20 |
Outcome results
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
Time frame: through study completion, an average of 15 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABX464 50mg + Methotrexate | Number of Treatment-emergent Adverse Events in the ABX464 Treated Patients Versus Placebo | 18 Participants |
| ABX464 100mg + Methotrexate | Number of Treatment-emergent Adverse Events in the ABX464 Treated Patients Versus Placebo | 18 Participants |
| Placebo + Methotrexate | Number of Treatment-emergent Adverse Events in the ABX464 Treated Patients Versus Placebo | 14 Participants |
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
Time frame: Week 12
Population: Intent to Treat population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABX464 50mg + Methotrexate | Change From Baseline in Clinical Disease Activity Index Score (CDAI) | -15.89 score on a scale | Standard Deviation 13.29 |
| ABX464 100mg + Methotrexate | Change From Baseline in Clinical Disease Activity Index Score (CDAI) | -9.99 score on a scale | Standard Deviation 15.85 |
| Placebo + Methotrexate | Change From Baseline in Clinical Disease Activity Index Score (CDAI) | -6.93 score on a scale | Standard Deviation 10.13 |
Secondary
Change From Baseline in C-reactive Protein (CRP)
Change from baseline in C-reactive protein (CRP) at Week 12
Time frame: Week 12
Population: Intent to Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABX464 50mg + Methotrexate | Change From Baseline in C-reactive Protein (CRP) | -4.31 mg/L | Standard Deviation 28.83 |
| ABX464 100mg + Methotrexate | Change From Baseline in C-reactive Protein (CRP) | 0.62 mg/L | Standard Deviation 4.89 |
| Placebo + Methotrexate | Change From Baseline in C-reactive Protein (CRP) | -0.65 mg/L | Standard Deviation 18.74 |
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.
Time frame: Week 12
Population: Intent to Treat population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABX464 50mg + Methotrexate | Change From Baseline in Disease Activity Scores (DAS-CRP) (28 Joints) [DAS28] | -1.41 score on a scale | Standard Deviation 1.45 |
| ABX464 100mg + Methotrexate | Change From Baseline in Disease Activity Scores (DAS-CRP) (28 Joints) [DAS28] | -0.72 score on a scale | Standard Deviation 1.13 |
| Placebo + Methotrexate | Change From Baseline in Disease Activity Scores (DAS-CRP) (28 Joints) [DAS28] | -0.60 score on a scale | Standard Deviation 0.98 |
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
Time frame: 12 weeks
Population: Intent to Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABX464 50mg + Methotrexate | Change From Baseline in Disease Activtiy Score (DAS)28-Erythrocyte Sedimentation Rate (ESR) | -1.43 mm/h | Standard Deviation 1.39 |
| ABX464 100mg + Methotrexate | Change From Baseline in Disease Activtiy Score (DAS)28-Erythrocyte Sedimentation Rate (ESR) | -0.74 mm/h | Standard Deviation 1.11 |
| Placebo + Methotrexate | Change From Baseline in Disease Activtiy Score (DAS)28-Erythrocyte Sedimentation Rate (ESR) | -0.59 mm/h | Standard Deviation 1 |
Secondary
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Change from baseline in erythrocyte sedimentation rate (ESR) at Week 12
Time frame: Week 12
Population: Intent to Treat population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABX464 50mg + Methotrexate | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) | -2.6 mm/h | Standard Deviation 19.3 |
| ABX464 100mg + Methotrexate | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) | -0.3 mm/h | Standard Deviation 6.8 |
| Placebo + Methotrexate | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) | -2.7 mm/h | Standard Deviation 16.6 |
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
Time frame: 12 weeks
Population: Intent to Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABX464 50mg + Methotrexate | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | -0.4345 units on a scale | Standard Deviation 0.6182 |
| ABX464 100mg + Methotrexate | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | -0.1053 units on a scale | Standard Deviation 0.3443 |
| Placebo + Methotrexate | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | -0.1813 units on a scale | Standard Deviation 0.4824 |
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
Time frame: 12 weeks
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABX464 50mg + Methotrexate | Change From Baseline in Investigator Global Assessment of Disease (PrGA) | -3.26 units on a scale | Standard Deviation 2.7 |
| ABX464 100mg + Methotrexate | Change From Baseline in Investigator Global Assessment of Disease (PrGA) | -1.89 units on a scale | Standard Deviation 2.95 |
| Placebo + Methotrexate | Change From Baseline in Investigator Global Assessment of Disease (PrGA) | -1.63 units on a scale | Standard Deviation 2.38 |
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
Time frame: 12 weeks
Population: Intent to Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABX464 50mg + Methotrexate | Change From Baseline in Pain Visual Analog Scale | -2.63 units on a scale | Standard Deviation 2.43 |
| ABX464 100mg + Methotrexate | Change From Baseline in Pain Visual Analog Scale | -0.89 units on a scale | Standard Deviation 1.97 |
| Placebo + Methotrexate | Change From Baseline in Pain Visual Analog Scale | -0.78 units on a scale | Standard Deviation 2.36 |
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
Time frame: 12 weeks
Population: Intent to Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABX464 50mg + Methotrexate | Change From Baseline in Patient Global Assessment of Disease (PtGA) | -1.44 units on a scale | Standard Deviation 1.92 |
| ABX464 100mg + Methotrexate | Change From Baseline in Patient Global Assessment of Disease (PtGA) | -0.89 units on a scale | Standard Deviation 1.93 |
| Placebo + Methotrexate | Change From Baseline in Patient Global Assessment of Disease (PtGA) | -0.36 units on a scale | Standard Deviation 2.16 |
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
Time frame: Week 12
Population: Intent to Treat population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABX464 50mg + Methotrexate | Change From Baseline in Simplified Disease Activity Index Score (SDAI) | -20.21 score on a scale | Standard Deviation 33.27 |
| ABX464 100mg + Methotrexate | Change From Baseline in Simplified Disease Activity Index Score (SDAI) | -9.37 score on a scale | Standard Deviation 14.44 |
| Placebo + Methotrexate | Change From Baseline in Simplified Disease Activity Index Score (SDAI) | -7.58 score on a scale | Standard Deviation 22.69 |
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
Time frame: 12 weeks
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABX464 50mg + Methotrexate | Change From Baseline in Swollen Joint Count (SJC) | -4.4 joints | Standard Deviation 4.2 |
| ABX464 100mg + Methotrexate | Change From Baseline in Swollen Joint Count (SJC) | -3.2 joints | Standard Deviation 5.3 |
| Placebo + Methotrexate | Change From Baseline in Swollen Joint Count (SJC) | -2.1 joints | Standard Deviation 4.2 |
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
Time frame: 12 weeks
Population: intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABX464 50mg + Methotrexate | Change From Baseline in Tender/Painful Joint Count (TJC28) | -6.8 joints | Standard Deviation 6.4 |
| ABX464 100mg + Methotrexate | Change From Baseline in Tender/Painful Joint Count (TJC28) | -4.1 joints | Standard Deviation 6.6 |
| Placebo + Methotrexate | Change From Baseline in Tender/Painful Joint Count (TJC28) | -2.9 joints | Standard Deviation 3.8 |
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.
Time frame: Week 12
Population: Intent to Treat Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ABX464 50mg + Methotrexate | Number of Patients Achieving ACR20/50/70 Response | ACR50 response | 5 Participants |
| ABX464 50mg + Methotrexate | Number of Patients Achieving ACR20/50/70 Response | ACR20 response | 9 Participants |
| ABX464 50mg + Methotrexate | Number of Patients Achieving ACR20/50/70 Response | ACR70 response | 4 Participants |
| ABX464 100mg + Methotrexate | Number of Patients Achieving ACR20/50/70 Response | ACR50 response | 2 Participants |
| ABX464 100mg + Methotrexate | Number of Patients Achieving ACR20/50/70 Response | ACR70 response | 1 Participants |
| ABX464 100mg + Methotrexate | Number of Patients Achieving ACR20/50/70 Response | ACR20 response | 3 Participants |
| Placebo + Methotrexate | Number of Patients Achieving ACR20/50/70 Response | ACR70 response | 1 Participants |
| Placebo + Methotrexate | Number of Patients Achieving ACR20/50/70 Response | ACR20 response | 4 Participants |
| Placebo + Methotrexate | Number of Patients Achieving ACR20/50/70 Response | ACR50 response | 1 Participants |
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.
Time frame: at Week 12
Population: Intent to treat population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABX464 50mg + Methotrexate | Number of Patients Achieving ACR20 Response | 9 Participants |
| ABX464 100mg + Methotrexate | Number of Patients Achieving ACR20 Response | 3 Participants |
| Placebo + Methotrexate | Number of Patients Achieving ACR20 Response | 4 Participants |
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
Time frame: Week 12
Population: Intent to Treat population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABX464 50mg + Methotrexate | Number of Patients Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission | 1 Participants |
| ABX464 100mg + Methotrexate | Number of Patients Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission | 0 Participants |
| Placebo + Methotrexate | Number of Patients Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission | 0 Participants |
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
Time frame: Week 12
Population: Intent to Treat population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABX464 50mg + Methotrexate | Number of Patients Achieving Clinical Disease Activity (CDAI) Remission | 3 Participants |
| ABX464 100mg + Methotrexate | Number of Patients Achieving Clinical Disease Activity (CDAI) Remission | 0 Participants |
| Placebo + Methotrexate | Number of Patients Achieving Clinical Disease Activity (CDAI) Remission | 0 Participants |
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
Time frame: Week 12
Population: Intent to Treat population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABX464 50mg + Methotrexate | Number of Patients Achieving DAS28-CRP Response | 14 Participants |
| ABX464 100mg + Methotrexate | Number of Patients Achieving DAS28-CRP Response | 6 Participants |
| Placebo + Methotrexate | Number of Patients Achieving DAS28-CRP Response | 8 Participants |
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
Time frame: Week 12
Population: Intent to Treat population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABX464 50mg + Methotrexate | Number of Patients Achieving Disease Activity Score (DAS) DAS28-Erythrocyte Sedimentation Rate (ESR) [DAS28-ESR] Remission | 2 Participants |
| ABX464 100mg + Methotrexate | Number of Patients Achieving Disease Activity Score (DAS) DAS28-Erythrocyte Sedimentation Rate (ESR) [DAS28-ESR] Remission | 0 Participants |
| Placebo + Methotrexate | Number of Patients Achieving Disease Activity Score (DAS) DAS28-Erythrocyte Sedimentation Rate (ESR) [DAS28-ESR] Remission | 0 Participants |
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
Time frame: Week 12
Population: Intent to Treat population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABX464 50mg + Methotrexate | Number of Patients Achieving Low Disease Activity (LDA) | 4 Participants |
| ABX464 100mg + Methotrexate | Number of Patients Achieving Low Disease Activity (LDA) | 2 Participants |
| Placebo + Methotrexate | Number of Patients Achieving Low Disease Activity (LDA) | 2 Participants |
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
Time frame: Week 12
Population: Intent to Treat population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABX464 50mg + Methotrexate | Number of Patients Achieving Simplified Disease Activity Score (SDAI) Remission | 1 Participants |
| ABX464 100mg + Methotrexate | Number of Patients Achieving Simplified Disease Activity Score (SDAI) Remission | 0 Participants |
| Placebo + Methotrexate | Number of Patients Achieving Simplified Disease Activity Score (SDAI) Remission | 0 Participants |