Back to resultsStudy of Two Doses of ABX464 in Participants With Moderate to Severe Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ABX464 50mg
Matching Placebo
ABX464 100mg
Methotrexate
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
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.
Sites / Locations
- Cliniques Universitaires Saint-Luc
- UZ Gent
- UZ Leuven
- ZNA Jan Palfijn
- Fakultni Tomayerova nemocnice
- Revmatologicky ustav
- CHU de Brest - Hôpital Cavale Blanche
- CHD Vendée
- CHU de Montpellier - Lapeyronie
- GHR Mulhouse Sud-Alsace
- CHU de Nice - Hôpital Pasteur
- CHR d'Orléans
- APHP - Hôpital Salpétrière
- CHU de Tours - Hôpital Trousseau
- Complex Medical Centre - Déli Klinika
- CRU Hungary Ltd.
- CMed Rehabilitációs és Diagnosztikai Központ
- ClinicMed Daniluk, Nowak Sp. J.
- Pratia MCM
- Zespół Poradni Specjalistycznych REUMED
- NZOZ Lecznica MAK-MED S.C.
- Medyczne Centrum Hetmańska
- National Institute of Geriatrics
- RHEUMA MEDICUS Zakład Opieki Zdrowotnej
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
ABX464 50mg + methotrexate
ABX464 100mg + methotrexate
Placebo + methotrexate
Arm Description
Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks + methotrexate
Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks + methotrexate
Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
Change From Baseline in C-reactive Protein (CRP)
Change from baseline in C-reactive protein (CRP) at 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
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.
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
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
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)
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)
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)
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 Low Disease Activity (LDA)
Number of patients achieving a Low Disease Activity (LDA) which is defined as DAS28-ESR <=3.2
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
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
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
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
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
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
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03813199
Brief Title
Study of Two Doses of ABX464 in Participants With Moderate to Severe Rheumatoid Arthritis
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 4, 2019 (Actual)
Primary Completion Date
April 27, 2021 (Actual)
Study Completion Date
April 27, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abivax S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABX464 50mg + methotrexate
Arm Type
Experimental
Arm Description
Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks
+ methotrexate
Arm Title
ABX464 100mg + methotrexate
Arm Type
Experimental
Arm Description
Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks
+ methotrexate
Arm Title
Placebo + methotrexate
Arm Type
Placebo Comparator
Arm Description
Participants will receive two capsules of matching placebo once daily for 12 weeks
+ methotrexate
Intervention Type
Drug
Intervention Name(s)
ABX464 50mg
Other Intervention Name(s)
obefazimod 50mg
Intervention Description
ABX464 is a new anti-inflammatory drug
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Other Intervention Name(s)
Placebo
Intervention Description
placebo matching with ABX464
Intervention Type
Drug
Intervention Name(s)
ABX464 100mg
Other Intervention Name(s)
obefazimod 100mg
Intervention Description
ABX464 is a new anti-inflammatory drug
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Other Intervention Name(s)
MTX
Intervention Description
MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Primary Outcome Measure Information:
Title
Number of Treatment-emergent Adverse Events in the ABX464 Treated Patients Versus Placebo
Description
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
Secondary Outcome Measure Information:
Title
Number of Patients Achieving ACR20 Response
Description
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
Title
Number of Patients Achieving ACR20/50/70 Response
Description
Number of patients who achieved at least 20%, 50% or 70% improvement in the American College of Rheumatology (ACR) response.
Time Frame
Week 12
Title
Change From Baseline in C-reactive Protein (CRP)
Description
Change from baseline in C-reactive protein (CRP) at Week 12
Time Frame
Week 12
Title
Number of Patients Achieving DAS28-CRP Response
Description
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
Title
Change From Baseline in Disease Activity Scores (DAS-CRP) (28 Joints) [DAS28]
Description
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
Title
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Description
Change from baseline in erythrocyte sedimentation rate (ESR) at Week 12
Time Frame
Week 12
Title
Number of Patients Achieving Disease Activity Score (DAS) DAS28-Erythrocyte Sedimentation Rate (ESR) [DAS28-ESR] Remission
Description
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
Title
Change From Baseline in Disease Activtiy Score (DAS)28-Erythrocyte Sedimentation Rate (ESR)
Description
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
Title
Change From Baseline in Simplified Disease Activity Index Score (SDAI)
Description
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
Title
Change From Baseline in Clinical Disease Activity Index Score (CDAI)
Description
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
Title
Number of Patients Achieving Low Disease Activity (LDA)
Description
Number of patients achieving a Low Disease Activity (LDA) which is defined as DAS28-ESR <=3.2
Time Frame
Week 12
Title
Number of Patients Achieving Simplified Disease Activity Score (SDAI) Remission
Description
Number of patients achieving Simplified Disease Activity Score (SDAI) remission, which is considered achieved if the SDAI score ≤ 3.3
Time Frame
Week 12
Title
Number of Patients Achieving Clinical Disease Activity (CDAI) Remission
Description
Number of patients achieving Clinical Disease Activity (CDAI) remission, which is considered achieved if the CDAI score ≤ 2.8
Time Frame
Week 12
Title
Number of Patients Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission
Description
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
Title
Change From Baseline in Tender/Painful Joint Count (TJC28)
Description
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
Title
Change From Baseline in Swollen Joint Count (SJC)
Description
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
Title
Change From Baseline in Pain Visual Analog Scale
Description
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
Title
Change From Baseline in Patient Global Assessment of Disease (PtGA)
Description
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
Title
Change From Baseline in Investigator Global Assessment of Disease (PrGA)
Description
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
Title
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul GINESTE, PharmD
Organizational Affiliation
Abivax S.A.
Official's Role
Study Director
Facility Information:
Facility Name
Cliniques Universitaires Saint-Luc
City
Bruxelles
Country
Belgium
Facility Name
UZ Gent
City
Gent
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
Country
Belgium
Facility Name
ZNA Jan Palfijn
City
Merksem
Country
Belgium
Facility Name
Fakultni Tomayerova nemocnice
City
Praha
Country
Czechia
Facility Name
Revmatologicky ustav
City
Praha
Country
Czechia
Facility Name
CHU de Brest - Hôpital Cavale Blanche
City
Brest
Country
France
Facility Name
CHD Vendée
City
La Roche-sur-Yon
Country
France
Facility Name
CHU de Montpellier - Lapeyronie
City
Montpellier
Country
France
Facility Name
GHR Mulhouse Sud-Alsace
City
Mulhouse
Country
France
Facility Name
CHU de Nice - Hôpital Pasteur
City
Nice
Country
France
Facility Name
CHR d'Orléans
City
Orléans
Country
France
Facility Name
APHP - Hôpital Salpétrière
City
Paris
Country
France
Facility Name
CHU de Tours - Hôpital Trousseau
City
Tours
Country
France
Facility Name
Complex Medical Centre - Déli Klinika
City
Budapest
Country
Hungary
Facility Name
CRU Hungary Ltd.
City
Miskolc
Country
Hungary
Facility Name
CMed Rehabilitációs és Diagnosztikai Központ
City
Székesfehérvár
Country
Hungary
Facility Name
ClinicMed Daniluk, Nowak Sp. J.
City
Białystok
Country
Poland
Facility Name
Pratia MCM
City
Kraków
Country
Poland
Facility Name
Zespół Poradni Specjalistycznych REUMED
City
Lublin
Country
Poland
Facility Name
NZOZ Lecznica MAK-MED S.C.
City
Nadarzyn
Country
Poland
Facility Name
Medyczne Centrum Hetmańska
City
Poznań
Country
Poland
Facility Name
National Institute of Geriatrics
City
Warszawa
Country
Poland
Facility Name
RHEUMA MEDICUS Zakład Opieki Zdrowotnej
City
Warszawa
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35641124
Citation
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 May 31;81(8):1076-84. doi: 10.1136/annrheumdis-2022-222228. Online ahead of print.
Results Reference
derived
Learn more about this trial
Study of Two Doses of ABX464 in Participants With Moderate to Severe Rheumatoid Arthritis
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