Study of Two Doses of ABX464 in Participants With Moderate to Severe Rheumatoid Arthritis

• Sponsor: Abivax S.A. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03813199
• Collaborator: (none)
• Enrollment: 60
• Locations: 24
• Arms: 3
• Actual Duration (Months): 21.8
• Patients Per Site: 2.5
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: ABX464 50mg; Drug: Matching Placebo; Drug: ABX464 100mg; Drug: Methotrexate	Phase 2

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

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Phase IIa Randomized, Double Blind, Placebo Controlled, Parallel Group, 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 an Anti- Tumor Necrosis Factor Alpha (Tnfα) Therapy, or Intolerance to Anti-Tnfα Therapy
• Actual Study Start Date: Jul 4, 2019
• Actual Primary Completion Date: Apr 27, 2021
• Actual Study Completion Date: Apr 27, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ABX464 50mg + methotrexate Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks + methotrexate	Drug: ABX464 50mg; ABX464 is a new anti-inflammatory drug; Drug: Matching Placebo; placebo matching with ABX464; Drug: Methotrexate; MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Experimental: ABX464 100mg + methotrexate Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks + methotrexate	Drug: ABX464 100mg; ABX464 is a new anti-inflammatory drug; Drug: Methotrexate; MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
Placebo Comparator: Placebo + methotrexate Participants will receive two capsules of matching placebo once daily for 12 weeks + methotrexate	Drug: Matching Placebo; placebo matching with ABX464; Drug: Methotrexate; MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study

Outcome Measures

Primary Outcome Measures

1. Incidence of Treatment-emergent Adverse Events in the ABX464 Treated Patients Versus Placebo, Categorized by Severity [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 Outcome Measures

1. Proportion 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.

2. Change From Baseline in the Individual Components of ACR Response [Week 2, Week 4, Week 8 and Week 12]

   American College of Rheumatology (ACR) criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.

3. Change From Baseline in Erythrocyte Sedimentation Rate (ESR) [Week 2, Week 4, Week 8 and Week 12]

4. Change From Baseline in Disease Activity Scores (DAS) (28 Joints) [DAS28] [Week 2, Week 4, Week 8 and 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 or 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) DAS28-CRP = 0.56 √ (TJC28) + 0.28 √ (SJC28) + 0.36 Ln [CRP(mg/L)+1] + 0.014 PtGA(VAS100mm) + 0.96 Scores on the DAS28 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.

5. Change From Baseline in Simplified Disease Activity Index Score (SDAI) [Week 2, Week 4, Week 8 and 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 = tender28 + swollen28 + CRP + (PtGA/10) + (PrGA/10). A moderate activity is defined by a SDAI >11 to 26 included. A high activity is defined by a SDAI >26.

6. Change From Baseline in Clinical Disease Activity Index Score (CDAI) [Week 2, Week 4, Week 8 and 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 = tender28 + swollen28 + (PtGA/10) + (PrGA/10). A moderate activity is defined by a CDAI >10 to 22 included. A high activity is defined by a CDAI >22.

7. Proportion of Patients Achieving ACR20/50/70 Response [Week 2, Week 4, Week 8 and Week 12]

   Proportion of patients who achieved at least 20%, 50% or 70% improvement in the American College of Rheumatology (ACR) response.

8. Proportion of Patients Achieving DAS28-CRP Response [Week 2, Week 4, Week 8 and Week 12]

   Proportion 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

9. Proportion of Patients Achieving Low Disease Activity (LDA) [Week 2, Week 4, Week 8 and Week 12]

   Low Disease Activity (LDA) is defined as DAS28-ESR <=3.2

10. Proportion of Patients Achieving Disease Activity Score (DAS) DAS28-Erythrocyte Sedimentation Rate (ESR) [DAS28-ESR] Remission [Week 2, Week 4, Week 8 and Week 12]

    DAS28-ESR remission is defined as DAS2-ESR < 2.6

11. Proportion of Patients Achieving Simplified Disease Activity Score (SDAI) Remission [Week 2, Week 4, Week 8 and Week 12]

    The SDAI remission is considered achieved if the SDAI score ≤ 3.3

12. Proportion of Patients Achieving Clinical Disease Activity (CDAI) Remission [Week 2, Week 4, Week 8 and Week 12]

    The CDAI remission is considered achieved if the CDAI score ≤ 2.8

13. Proportion of Patients Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission [Week 2, Week 4, Week 8 and 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cliniques Universitaires Saint-Luc	Bruxelles		Belgium
2	UZ Gent	Gent		Belgium
3	UZ Leuven	Leuven		Belgium
4	ZNA Jan Palfijn	Merksem		Belgium
5	Fakultni Tomayerova nemocnice	Praha		Czechia
6	Revmatologicky ustav	Praha		Czechia
7	CHU de Brest - Hôpital Cavale Blanche	Brest		France
8	CHD Vendée	La Roche-sur-Yon		France
9	CHU de Montpellier - Lapeyronie	Montpellier		France
10	GHR Mulhouse Sud-Alsace	Mulhouse		France
11	CHU de Nice - Hôpital Pasteur	Nice		France
12	CHR d'Orléans	Orléans		France
13	APHP - Hôpital Salpétrière	Paris		France
14	CHU de Tours - Hôpital Trousseau	Tours		France
15	Complex Medical Centre - Déli Klinika	Budapest		Hungary
16	CRU Hungary Ltd.	Miskolc		Hungary
17	CMed Rehabilitációs és Diagnosztikai Központ	Székesfehérvár		Hungary
18	ClinicMed Daniluk, Nowak Sp. J.	Białystok		Poland
19	Pratia MCM	Kraków		Poland
20	Zespół Poradni Specjalistycznych REUMED	Lublin		Poland
21	NZOZ Lecznica MAK-MED S.C.	Nadarzyn		Poland
22	Medyczne Centrum Hetmańska	Poznań		Poland
23	National Institute of Geriatrics	Warszawa		Poland
24	RHEUMA MEDICUS Zakład Opieki Zdrowotnej	Warszawa		Poland

Sponsors and Collaborators

• Abivax S.A.

Investigators

• Study Director: Paul GINESTE, PharmD, Abivax S.A.

Study Documents (Full-Text)

• Study Protocol - Oct 24, 2019
• Statistical Analysis Plan - Dec 10, 2020

More Information

Publications

None provided.

• Responsible Party: Abivax S.A.
• ClinicalTrials.gov Identifier: NCT03813199
• Other Study ID Numbers: ABX464-301
• First Posted: Jan 23, 2019
• Last Update Posted: Apr 7, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Methotrexate

Study Results

Participant Flow

Arm/Group Title	ABX464 50mg + Methotrexate	ABX464 100mg + Methotrexate	Placebo + Methotrexate
Arm/Group Description	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	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	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
Period Title: Overall Study
STARTED	21	19	20
COMPLETED	18	6	19
NOT COMPLETED	3	13	1

Baseline Characteristics

Arm/Group Title	ABX464 50mg + Methotrexate	ABX464 100mg + Methotrexate	Placebo + Methotrexate	Total
Arm/Group Description	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	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	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	Total of all reporting groups
Overall Participants	21	19	20	60
Age, Customized (years) [Mean (Standard Deviation) ]
Age	57.9 (11.4)	54.4 (10.6)	58.6 (11.0)	57.0 (11.0)
Sex: Female, Male (Count of Participants)
Female	15 71.4%	11 57.9%	11 55%	37 61.7%
Male	6 28.6%	8 42.1%	9 45%	23 38.3%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

Title	Incidence of Treatment-emergent Adverse Events in the ABX464 Treated Patients Versus Placebo, Categorized by Severity
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ABX464 50mg + Methotrexate	ABX464 100mg + Methotrexate	Placebo + Methotrexate
Arm/Group Description	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	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	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
Measure Participants	21	19	20
Count of Participants [Participants]	18 85.7%	18 94.7%	14 70%

2. Secondary Outcome

Title	Proportion 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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Change From Baseline in the Individual Components of ACR Response
Description	American College of Rheumatology (ACR) criteria measure improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.
Time Frame	Week 2, Week 4, Week 8 and Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Time Frame	Week 2, Week 4, Week 8 and Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Change From Baseline in Disease Activity Scores (DAS) (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 or 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) DAS28-CRP = 0.56 √ (TJC28) + 0.28 √ (SJC28) + 0.36 Ln [CRP(mg/L)+1] + 0.014 PtGA(VAS100mm) + 0.96 Scores on the DAS28 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 2, Week 4, Week 8 and Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

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 = tender28 + swollen28 + CRP + (PtGA/10) + (PrGA/10). A moderate activity is defined by a SDAI >11 to 26 included. A high activity is defined by a SDAI >26.
Time Frame	Week 2, Week 4, Week 8 and Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

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 = tender28 + swollen28 + (PtGA/10) + (PrGA/10). A moderate activity is defined by a CDAI >10 to 22 included. A high activity is defined by a CDAI >22.
Time Frame	Week 2, Week 4, Week 8 and Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Secondary Outcome

Title	Proportion of Patients Achieving ACR20/50/70 Response
Description	Proportion of patients who achieved at least 20%, 50% or 70% improvement in the American College of Rheumatology (ACR) response.
Time Frame	Week 2, Week 4, Week 8 and Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Secondary Outcome

Title	Proportion of Patients Achieving DAS28-CRP Response
Description	Proportion 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 2, Week 4, Week 8 and Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

10. Secondary Outcome

Title	Proportion of Patients Achieving Low Disease Activity (LDA)
Description	Low Disease Activity (LDA) is defined as DAS28-ESR <=3.2
Time Frame	Week 2, Week 4, Week 8 and Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

11. Secondary Outcome

Title	Proportion of Patients Achieving Disease Activity Score (DAS) DAS28-Erythrocyte Sedimentation Rate (ESR) [DAS28-ESR] Remission
Description	DAS28-ESR remission is defined as DAS2-ESR < 2.6
Time Frame	Week 2, Week 4, Week 8 and Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

12. Secondary Outcome

Title	Proportion of Patients Achieving Simplified Disease Activity Score (SDAI) Remission
Description	The SDAI remission is considered achieved if the SDAI score ≤ 3.3
Time Frame	Week 2, Week 4, Week 8 and Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

13. Secondary Outcome

Title	Proportion of Patients Achieving Clinical Disease Activity (CDAI) Remission
Description	The CDAI remission is considered achieved if the CDAI score ≤ 2.8
Time Frame	Week 2, Week 4, Week 8 and Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

14. Secondary Outcome

Title	Proportion 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 2, Week 4, Week 8 and Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	15 weeks
Arm/Group Title	ABX464 50mg + Methotrexate		ABX464 100mg + Methotrexate		Placebo + Methotrexate
Arm/Group Description	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		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		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
All Cause Mortality
	ABX464 50mg + Methotrexate		ABX464 100mg + Methotrexate		Placebo + Methotrexate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/19 (0%)		0/20 (0%)
Serious Adverse Events
	ABX464 50mg + Methotrexate		ABX464 100mg + Methotrexate		Placebo + Methotrexate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		1/19 (5.3%)		1/20 (5%)
Cardiac disorders
Atrial fibrillation	0/21 (0%)	0	1/19 (5.3%)	1	0/20 (0%)	0
Infections and infestations
Covid-19	0/21 (0%)	0	0/19 (0%)	0	1/20 (5%)	1
Other (Not Including Serious) Adverse Events
	ABX464 50mg + Methotrexate		ABX464 100mg + Methotrexate		Placebo + Methotrexate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/21 (71.4%)		17/19 (89.5%)		5/20 (25%)
Gastrointestinal disorders
nausea	3/21 (14.3%)	4	9/19 (47.4%)	12	0/20 (0%)	0
Diarrhoea	4/21 (19%)	7	7/19 (36.8%)	11	1/20 (5%)	1
Abdominal pain upper	5/21 (23.8%)	6	4/19 (21.1%)	10	1/20 (5%)	1
abdominal pain	2/21 (9.5%)	3	1/19 (5.3%)	1	0/20 (0%)	0
Dyspepsia	1/21 (4.8%)	1	3/19 (15.8%)	3	0/20 (0%)	0
Vomiting	2/21 (9.5%)	2	3/19 (15.8%)	4	0/20 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	0/21 (0%)	0	2/19 (10.5%)	3	1/20 (5%)	1
Rheumatoid arthritis	2/21 (9.5%)	2	1/19 (5.3%)	1	1/20 (5%)	1
Nervous system disorders
Headache	8/21 (38.1%)	19	10/19 (52.6%)	16	4/20 (20%)	6
Respiratory, thoracic and mediastinal disorders
Cough	2/21 (9.5%)	2	1/19 (5.3%)	1	0/20 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.