Rheumatoid ArthritisPhase 2NCT03813199
Study of Two Doses of ABX464 in Participants With Moderate to Severe Rheumatoid Arthritis
A Phase 2 study testing ABX464 50mg, ABX464 100mg and Methotrexate in people with Rheumatoid Arthritis, run by Abivax S.A. at 24 sites in 5 countries.
Trial summary
This Phase IIa study aims at investigating the safety and tolerability of 2 dose-levels of ABX464 administered daily in combination with methotrexate (MTX) in patients with moderate to severe active Rheumatoid Arthritis (RA) who had an inadequate response to MTX or/and to one or more anti- tumor necrosis factor alpha… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- ABX464 50mg, ABX464 100mg and Methotrexate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 24 sitesin 5 countries
- Study dates
- 4 Jul 2019to 27 Apr 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
24 sites in 5 countries.
24 sites in 5 countries
France8 sites
CHU de Brest - Hôpital Cavale Blanche
Brest
CHD Vendée
La Roche-sur-Yon
CHU de Montpellier - Lapeyronie
Montpellier
GHR Mulhouse Sud-Alsace
Mulhouse
CHU de Nice - Hôpital Pasteur
Nice
CHR d'Orléans
Orléans
APHP - Hôpital Salpétrière
Paris
CHU de Tours - Hôpital Trousseau
Tours
Poland7 sites
ClinicMed Daniluk, Nowak Sp. J.
Bialystok
Pratia MCM
Krakow
Zespół Poradni Specjalistycznych REUMED
Lublin
NZOZ Lecznica MAK-MED S.C.
Nadarzyn
Medyczne Centrum Hetmańska
Poznan
National Institute of Geriatrics
Warsaw
RHEUMA MEDICUS Zakład Opieki Zdrowotnej
Warsaw
Belgium4 sites
Cliniques Universitaires Saint-Luc
Brussels
UZ Gent
Ghent
UZ Leuven
Leuven
ZNA Jan Palfijn
Merksem
Hungary3 sites
Complex Medical Centre - Déli Klinika
Budapest
CRU Hungary Ltd.
Miskolc
CMed Rehabilitációs és Diagnosztikai Központ
Székesfehérvár
Czechia2 sites
Fakultni Tomayerova nemocnice
Prague
Revmatologicky ustav
Prague
About this study
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
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- ABX464 50mg, Matching Placebo, ABX464 100mg, Methotrexate
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABX464 50mgDrug
Also called obefazimod 50mg
ABX464 is a new anti-inflammatory drug
Matching PlaceboDrug
Also called Placebo
placebo matching with ABX464
ABX464 100mgDrug
Also called obefazimod 100mg
ABX464 is a new anti-inflammatory drug
MethotrexateDrug
Also called MTX
MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
| Study group | Role | What they receive |
|---|---|---|
| ABX464 50mg + methotrexate | Experimental | Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks
+ methotrexate Receives: Drug: ABX464 50mg; Drug: Matching Placebo; Drug: Methotrexate |
| ABX464 100mg + methotrexate | Experimental | Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks
+ methotrexate Receives: Drug: ABX464 100mg; Drug: Methotrexate |
| Placebo + methotrexate | Placebo comparator | Participants will receive two capsules of matching placebo once daily for 12 weeks
+ methotrexate Receives: Drug: Matching Placebo; Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 15 weeks
Secondary outcomes (20)
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.
Measured: at Week 12
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.
Measured: Week 12
Change From Baseline in C-reactive Protein (CRP)
Change from baseline in C-reactive protein (CRP) at Week 12
Measured: 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
Measured: 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.
Measured: Week 12
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Change from baseline in erythrocyte sedimentation rate (ESR) at Week 12
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start4 Jul 2019
- Primary completion27 Apr 2021
- Study completion27 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abivax S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul GINESTE, PharmD, Study director, Abivax S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813199
- Sponsor's protocol ID
- ABX464-301
- Status last verified
- May 2022
- First submitted
- 15 Jan 2019
- Last updated
- 15 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35641124
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03813199
- Acronym / sponsor ID
- ABX464-301
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Abivax S.A.Industry (pharma, biotech, devices)
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- 27 Apr 2021 (actual)
- Study completion
- 27 Apr 2021 (actual)
- First posted
- 23 Jan 2019 (actual)
- Results
- Posted 7 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ABX464 50mg + methotrexate | Experimental | Drug: ABX464 50mg, Drug: Matching Placebo, Drug: MethotrexateParticipants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks + methotrexate |
| ABX464 100mg + methotrexate | Experimental | Drug: ABX464 100mg, Drug: MethotrexateParticipants will receive two capsules of 50mg ABX464 once daily for 12 weeks + methotrexate |
| Placebo + methotrexate | Placebo comparator | Drug: Matching Placebo, Drug: MethotrexateParticipants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABX464 50mgAlso: obefazimod 50mgABX464 is a new anti-inflammatory drug | Drug | ABX464 50mg + methotrexate |
| Matching PlaceboAlso: Placeboplacebo matching with ABX464 | Drug | ABX464 50mg + methotrexate, Placebo + methotrexate |
| ABX464 100mgAlso: obefazimod 100mgABX464 is a new anti-inflammatory drug | Drug | ABX464 100mg + methotrexate |
| MethotrexateAlso: MTXMTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study | Drug | ABX464 100mg + methotrexate, ABX464 50mg + methotrexate, Placebo + methotrexate |
Primary outcome
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
20 secondary outcomes
Number of Patients Achieving ACR20 Response
Time frame: at Week 12
Number of Patients Achieving ACR20/50/70 Response
Time frame: Week 12
Change From Baseline in C-reactive Protein (CRP)
Time frame: Week 12
Number of Patients Achieving DAS28-CRP Response
Time frame: Week 12
Change From Baseline in Disease Activity Scores (DAS-CRP) (28 Joints) [DAS28]
Time frame: Week 12
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Time frame: Week 12
Number of Patients Achieving Disease Activity Score (DAS) DAS28-Erythrocyte Sedimentation Rate (ESR) [DAS28-ESR] Remission
Time frame: Week 12
Change From Baseline in Disease Activtiy Score (DAS)28-Erythrocyte Sedimentation Rate (ESR)
Time frame: 12 weeks
Change From Baseline in Simplified Disease Activity Index Score (SDAI)
Time frame: Week 12
Change From Baseline in Clinical Disease Activity Index Score (CDAI)
Time frame: Week 12
Number of Patients Achieving Low Disease Activity (LDA)
Time frame: Week 12
Number of Patients Achieving Simplified Disease Activity Score (SDAI) Remission
Time frame: Week 12
Number of Patients Achieving Clinical Disease Activity (CDAI) Remission
Time frame: Week 12
Number of Patients Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission
Time frame: Week 12
Change From Baseline in Tender/Painful Joint Count (TJC28)
Time frame: 12 weeks
Change From Baseline in Swollen Joint Count (SJC)
Time frame: 12 weeks
Change From Baseline in Pain Visual Analog Scale
Time frame: 12 weeks
Change From Baseline in Patient Global Assessment of Disease (PtGA)
Time frame: 12 weeks
Change From Baseline in Investigator Global Assessment of Disease (PrGA)
Time frame: 12 weeks
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35641124Daien 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul GINESTE, PharmD study director
Abivax S.A.
24 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABX464 50mg, ABX464 100mg and Methotrexate in people with Rheumatoid Arthritis, run by Abivax S.A. at 24 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in France, Poland, Belgium, Hungary, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Treatment-emergent Adverse Events in the ABX464 Treated Patients Versus Placebo (time frame: through study completion, an average of 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03813199, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.