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Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (SARIL-RA-MONARCH)

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Sarilumab

Adalimumab

Placebo (for sarilumab)

Placebo (for adalimumab)

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Diagnosis of RA greater than or equal to (>=)3 months duration.
American College of Rheumatology (ACR) Class I-III functional status.
Active RA was defined as:

At least 6 of 66 swollen joints and 8 of 68 tender joints, high sensitivity C-reactive protein (hs-CRP) >=8 mg/L or ESR >=28 millimeter per hour (mm/H), and DAS28-ESR greater than (>) 5.1.

Participants as per Investigator judgment were either intolerant of, or considered inappropriate candidates for continued treatment with MTX, or after at least 12 weeks of continued treatment with MTX, or inadequate responders treated with an adequate MTX dose for at least 12 weeks.

Exclusion criteria:

Age <18 years or the legal age of consent in the country of the study site, whichever was higher.
Current treatment with disease-modifying antirheumatic drug (DMARDs)/immunosuppressive agents including MTX, cyclosporine, mycophenolate, tacrolimus, gold, penicillamine, sulfasalazine or hydroxychloroquine within 2 weeks prior to the baseline (Randomization Visit) or azathioprine, cyclophosphamide within 12 weeks prior to baseline (Randomization Visit) or leflunomide within 8 weeks prior to the Randomization Visit, or 4 weeks after cholestyramine washout.
Treatment with any prior biologic agent, including anti-interleukin 6 (IL-6), IL-6 receptor (IL-6R) antagonists, and prior treatment with a Janus kinase inhibitor.
Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks prior to screening.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Adalimumab 40 mg/Sarilumab 200 mg

Sarilumab 200 mg/Sarilumab 200 mg

Arm Description

Adalimumab 40 milligrams (mg) subcutaneous (SC) injection in combination with placebo for sarilumab every 2 weeks (q2w) for 24 weeks during the double-blind (DB) period. The dosing frequency of adalimumab was adjusted to 40 mg every week (qw) dosing in case of participants with inadequate response (less than [<] 20% improvement from baseline in tender joint count [TJC] and swollen joint count [SJC] for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in open label extension (OLE) period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).

Sarilumab 200 mg SC injection in combination with placebo for adalimumab q2w for 24 weeks during the DB period. The dosing frequency of placebo for adalimumab was adjusted to 40 mg qw dosing in case of participants with inadequate response (<20% improvement from baseline in TJC and SJC for 2 consecutive visits) at or after Week 16 until Week 23. Participants who completed 24 weeks in the DB period had the option to continue in OLE period and received sarilumab 200 mg q2w until commercial availability of sarilumab in their country or up to a maximum of an additional 276 weeks (i.e. up to Week 300).

Outcomes

Primary Outcome Measures

DB Period: Change From Baseline in Disease Activity Score for 28 Joints - Erythrocyte Sedimentation Rate (DAS28-ESR) Score at Week 24

DAS28-ESR is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH assessment by the participant assessed from the ACR and RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by ESR in mm/hr. The DAS28-ESR score provides a number indicating the current disease activity of the RA. DAS28-ESR total score ranges from 2-10. A DAS28-ESR score above 5.1 means high disease activity, DAS28-ESR score below 3.2 indicates low disease activity and DAS28-ESR score below 2.6 means disease remission. Least square (LS) mean and standard error (SE) at Week 24 were obtained using Mixed-effect model with repeated measures (MMRM) approach.

Secondary Outcome Measures

DB Period: Percentage of Participants Achieving Clinical Remission Score (DAS28-ESR <2.6) at Week 24

DAS28-ESR is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH assessment by the participant assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by ESR in mm/hr. The DAS28-ESR score provides a number indicating the current disease activity of the RA. DAS28-ESR total score ranges from 2-10. A DAS28-ESR score above 5.1 means high disease activity, DAS28-ESR score below 3.2 indicates low disease activity and DAS28-ESR score below 2.6 means disease remission. Participants who discontinued treatment prior to Week 24 were analyzed as non-responders.

DB Period: Percentage of Participants Achieving ACR50 Criteria at Week 24

ACR responses are assessed with a composite rating scale of the ACR that includes 7 variables: TJC (68 joints); SJC (66 joints); levels of an acute phase reactant (C-reactive protein [CRP] level); participant's assessment of pain (measured on 0 [no pain]-100 mm [worst pain] VAS); participant's global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); physician's global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); participant's assessment of physical function (measured by Health Assessment Questionnaire - Disability Index [HAQ-DI], with scoring range of 0 [better physical function] - 3 [worst physical function]). ACR50 is defined as achieving at least 50% improvement in both TJC and SJC, and at least 50% improvement in at least 3 of the 5 other assessments of the ACR. Participants were analyzed as non-responders from the time they discontinued treatment.

DB Period: Percentage of Participants Achieving ACR70 Criteria at Week 24

ACR responses are assessed with a composite rating scale of the ACR that includes 7 variables: TJC (68 joints); SJC (66 joints); levels of an acute phase reactant (CRP level); participant's assessment of pain (measured on 0 [no pain]-100 mm [worst pain] VAS); participant's global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); physician's global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); participant's assessment of physical function (measured by HAQ-DI, with scoring range of 0 [better physical function] - 3 [worst physical function]). ACR70 was defined as achieving at least 70% improvement in both TJC and SJC, and at least 70% improvement in at least 3 of the 5 other assessments. Participants were analyzed as non-responders from the time they discontinued treatment.

DB Period: Percentage of Participants Achieving ACR20 Criteria at Week 24

ACR responses are assessed with a composite rating scale of the ACR that includes 7 variables: TJC (68 joints); SJC (66 joints); levels of an acute phase reactant (CRP level); participant's assessment of pain (measured on 0 [no pain]-100 mm [worst pain] VAS); participant's global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); physician's global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); participant's assessment of physical function (measured by HAQ-DI, with scoring range of 0 [better physical function] - 3 [worst physical function]). ACR20 was defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments. Participants were analyzed as non-responders from the time they discontinued treatment.

DB Period: Change From Baseline in HAQ-DI at Week 24

Physical function was assessed by HAQ-DI. It consisted of at least 2 or 3 questions per category, participant reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week rated on a 4-point scale where 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of category scores and divided by the number of categories answered, ranging from 0 to 3, where 0 = no disability and 3 = unable to do, high-dependency disability. LS mean and SE at Week 24 were obtained using MMRM approach.

DB Period: Change From Baseline in Short-Form-36 (SF-36) - Physical Component Summary (PCS) Score at Week 24

SF-36 is a generic 36-item questionnaire consisting of 8 sub-scales, measures health-related quality of life (HRQL) in the last 4 weeks covering 2 summary measures: PCS and mental component summary (MCS). PCS with 4 sub-scales: physical function, role limitations due to physical problems, pain, and general health perception; and MCS with 4 sub-scales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a sub-scale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same sub-scale give the sub-scale scores, which are transformed into a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Both PCS and MCS range from 0-100 with higher scores indicating better physical and mental health. LS mean and SE at Week 24 by MMRM approach.

DB Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 24

The FACIT-F is a 13-item questionnaire assessing fatigue where participants scored each item on a 5-point scale (0-4): 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much. A total score ranged from 0 to 52, where higher score corresponds to a lower level of fatigue. A positive change from baseline score indicates an improvement. LS mean and SE at Week 24 by MMRM approach.

DB Period: Change From Baseline in SF-36 - Mental Health Component Summary Score at Week 24

SF-36 is a generic 36-item questionnaire consisting of 8 sub-scales, measures HRQL in the last 4 weeks covering 2 summary measures: PCS and MCS. PCS with 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception; and MCS with 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same sub-scale give the sub-scale scores, which are transformed into a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Both PCS and MCS range from 0-100 with higher scores indicating better physical and mental health. LS mean and SE at Week 24 by MMRM approach.

DB Period: Change From Baseline in Disease Activity Score for 28 Joints Based on C-Reactive Protein (DAS28-CRP Score) at Week 24

DAS28-CRP is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH assessment by the participant assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by high sensitivity C-reactive protein (hs-CRP) in mg/L. The DAS28-CRP score provides a number indicating the current disease activity of the RA. DAS28-CRP total score ranges from 2-10. A DAS28-CRP score above 5.1 means high disease activity, whereas a DAS28-CRP score below 3.2 indicates low disease activity and a DAS28-CRP score below 2.6 means disease remission. LS mean and SE at Week 24 were obtained using MMRM approach.

DB Period: Percentage of Participants Achieving Clinical Remission Score (DAS28-CRP <2.6) at Week 24

DAS28-CRP is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH assessment by the participant assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by hs-CRP in mg/L. The DAS28-CRP score provides a number indicating the current disease activity of the RA. DAS28-CRP total score ranges from 2-10. A DAS28-CRP score above 5.1 means high disease activity, whereas a DAS28-CRP score below 3.2 indicates low disease activity and a DAS28-CRP score below 2.6 means disease remission. Participants were analyzed as non-responders from the time they discontinued treatment.

DB Period: Percentage of Participants Achieving Low Disease Activity (DAS28-ESR < 3.2) at Week 24

DAS28-ESR is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH assessment by the participant assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by ESR in mm/hr. The DAS28-ESR score provides a number indicating the current disease activity of the RA. DAS28-ESR total score ranges from 2-10. A DAS28-ESR score above 5.1 means high disease activity, DAS28-ESR score below 3.2 indicates low disease activity and DAS28-ESR score below 2.6 means disease remission. Participants were analyzed as non-responders from the time they discontinued treatment.

DB Period: Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Remission (CDAI ≤2.8) at Week 24

CDAI is a composite index constructed to measure clinical remission in RA that does not include a laboratory test, and is a numerical summation of 4 components: SJC (28 joints), TJC (28 joints), participant's global assessment of disease activity (in cm), and physician's global assessment of disease activity (in cm). Total score ranges from 0 to 76 with a lower score indicating less disease activity. Participants were analyzed as non-responders from the time they discontinued treatment.

DB Period: Change From Baseline in CDAI at Week 24

CDAI is a composite index constructed to measure clinical remission in RA that does not include a laboratory test, and is a numerical summation of 4 components: SJC (28 joints), TJC (28 joints), participant's global assessment of disease activity (in cm), and physician's global assessment of disease activity (VAS in cm). Total score ranges from 0 to 76 with a lower score indicating less disease activity. A negative change in CDAI score indicates an improvement in disease activity and a positive change in score indicates a worsening of disease activity. LS means and SE at Week 24 were obtained using MMRM approach.

DB Period: Change From Baseline in European Quality of Life-5 Dimension 3 Level (EQ-5D-3L) Scores at Week 24

EQ-5D-3L is a standardized, generic measure of health outcome. EQ-5D was designed for self-completion by participants. EQ-5D was specifically included to address concerns regarding the health economic impact of RA. EQ-5D-3L comprises of 5 questions on mobility, self-care, pain/discomfort, usual activities, and psychological status with 3 possible answers for each item (1=no problem, 2=moderate problems, 3=severe problems). The 5-dimensional 3-level systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state. EQ-5D-3L-VAS records the participant's self-rated health on a vertical VAS that allows the participants to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable). LS mean and SE at Week 24 were obtained using MMRM approach.

DB Period: Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) at Week 24

RAID is a composite measure of the impact of RA on participants that takes into account 7 domains: pain, functional disability, fatigue, physical and emotional well-being, quality of sleep, and coping. The RAID is calculated based on 7 numerical rating scales (NRS) questions. Each NRS is assessed as a number between 0 and 10 that corresponds to the 7 domains. The values for each of these domains are weighed by participant assessment of relative importance and combined in a single score with a total score range of 0 (not affected, very good) to 10 (most affected). LS mean and SE at Week 24 were obtained using MMRM approach.

DB Period: Change From Baseline in Work Productivity Survey - Rheumatoid Arthritis (WPS-RA) at Week 24: Work Days Missed Due to Arthritis

The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of work days missed in the last month by the participant was reported. LS mean and SE at Week 24 were obtained using MMRM approach.

DB Period: Change From Baseline in WPS-RA at Week 24: Days With Work Productivity Reduced by ≥ 50% Due to Arthritis

The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of work days with reduced productivity by >= 50% in the last month by the participants was reported. LS mean and SE at Week 24 were obtained using MMRM approach.

DB Period: Change From Baseline in WPS-RA at Week 24: Arthritis Interference With Work Productivity

The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Interference in the last month with work productivity was measured on a scale that ranges from 0 (no interference) to 10 (complete interference). LS mean and SE at Week 24 were obtained using MMRM approach.

DB Period: Change From Baseline in WPS-RA at Week 24: House Work Days Missed Due to Arthritis

The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with no household work in the last month by the participants was reported. LS mean and SE at Week 24 were obtained using MMRM approach.

DB Period: Change From Baseline in WPS-RA at Week 24: Days With Household Work Productivity Reduced by >= 50% Due to Arthritis

The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with reduced household work productivity by >= 50% in the last month by the participants was reported. LS mean and SE at Week 24 were obtained using MMRM approach.

DB Period: Change From Baseline in WPS-RA at Week 24: Days With Family/Social/Leisure Activities Missed Due to Arthritis

The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days missed of family/social/leisure activities in the last month by the participants was reported. LS mean and SE at Week 24 were obtained using MMRM approach.

DB Period: Change From Baseline in WPS-RA at Week 24: Days With Outside Help Hired Due to Arthritis

The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with outside help hired in the last month by the participant was reported. LS mean and SE at Week 24 were obtained using MMRM approach.

DB Period: Change From Baseline in WPS-RA at Week 24: RA Interference With Household Work Productivity

The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). The RA interference in the last month with household work productivity was measured on a scale that ranges from 0 (no interference) to 10 (complete interference). LS mean and SE at Week 24 were obtained using MMRM approach.

DB Period: Change From Baseline in Morning Stiffness VAS at Week 24

RA is associated with stiffness of joints, especially in the morning after prolonged stationery state. The degree of stiffness can be an indicator of disease severity. The severity of morning stiffness was assessed on a VAS scale from 0 mm (no problem) to 100 mm (major problem). LS mean and SE at Week 24 were obtained using MMRM approach.

DB Period: Change From Baseline in Individual ACR Component - TJC and SJC at Week 24

ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS, HAQ-DI & acute phase reactant (hs-CRP and ESR levels). 68 joints were assessed for tenderness (TJC scoring 0-68) and 66 joints for swelling (SJC scoring 0-66). The 66 SJC evaluated the following joints: temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal, interphalangeal of thumb, distal interphalangeal, proximal interphalangeal, knee, ankle mortise, ankle tarsus, metatarsophalangeal, interphalangeal of great toe, and proximal/distal interphalangeal of the toes. The TJC examined hip joints, in addition to the joints assessed for SJC. Increase in number of tender joints/swollen joints indicated severity. LS mean and SE at Week 24 were obtained using MMRM approach.

DB Period: Change From Baseline in Individual ACR Component - Physician Global VAS, Participant Global VAS and Pain VAS at Week 24

ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS, HAQ-DI & acute phase reactant (hs-CRP and ESR levels). Physician global VAS & participant global VAS was done on 100 mm horizontal anchored VAS, ranging from 0 "no arthritis activity" to 100 "maximal arthritis activity" and Pain VAS on 100 mm VAS, ranging from 0 "no pain" to 100 "worst pain". LS mean and SE at Week 24 were obtained using MMRM approach.

DB Period: Change From Baseline in Individual ACR Component - CRP Level at Week 24

ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS, HAQ-DI & acute phase reactant (hs-CRP and ESR levels). An elevated CRP level is considered a non-specific "marker" for RA. A decrease indicates improvement. LS mean and SE at Week 24 were obtained using MMRM approach.

DB Period: Change From Baseline in Individual ACR Component- ESR Level at Week 24

ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS, HAQ-DI & acute phase reactant (hs-CRP and ESR levels). The ESR is a blood test that can reveal inflammatory activity. Inflammation can cause the cells to clump together. The farther the red blood cells have descended, the greater the inflammatory response. LS mean and SE at Week 24 were obtained using MMRM approach.

DB Period: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Adverse event (AE) was defined as any untoward medical occurrence in participant who received investigational medicinal product (IMP) and did not necessarily had to have causal relationship with treatment. All reported AEs are TEAEs developed/worsened during 'on treatment period' (time from first dose of study drug up to day before first dose of open-label treatment for participants who completed 24-week randomized//DB treatment). SAEs were AEs resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or a medically important event.

OLE Period: Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events

AE was defined as any untoward medical occurrence in participant who received IMP and did not necessarily had to have causal relationship with treatment. All reported AEs are TEAEs developed/worsened during 'on treatment period' (from end of week 24 [Baseline of OLE Period] up to last dose in OLE period + 6 weeks [follow-up], regardless of unplanned intermittent discontinuations). SAEs were AEs resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or a medically important event.

DB Period: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) - Hematological Parameters

Criteria for potentially clinically significant laboratory abnormalities included: Hemoglobin (Hb): less than or equal to (<=) 115 grams per liter (g/L) (Male), <= 95 g/L (Female); greater than or equal to (>=) 185 g/L (18.5 g/dL) (Male), >= 165 g/L (16.5 g/dL) (Female); Decrease From Baseline (DFB) = 20 g/L (2 g/dL). Hematocrit: <= 0.37 volume/volume (v/v) (Male); <= 0.32 v/v (F); >= 0.55 v/v (Male); >= 0.5 v/v (Female). Red Blood Cells (RBCs): >=6 Tera/ liter (L). Platelets: < 50 Giga/L, 50 - 100 Giga/L, >= 700 Giga/L. White blood cells (WBC): < 3.0 Giga/L (Non-Black); < 2.0 Giga/L (Black), >= 16.0 Giga/L. Neutrophils: < 1.0 Giga/L, < 1.5 Giga/L (Non-Black); < 1.0 Giga/L (Black). Lymphocytes: < 0.5 Giga/L, >= 0.5 Giga/L - lower limit of normal (LLN), > 4.0 Giga/L. Monocytes: > 0.7 Giga/L. Basophils: > 0.1 Giga/L. Eosinophils: > 0.5 Giga/L or > upper limit of normal (ULN) (if ULN >= 0.5 Giga/L).

OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameters

Criteria for potentially clinically significant laboratory abnormalities included: Hb: <=115 g/L (Male), <= 95 g/L (Female); >=185 g/L (18.5 g/dL) (Male), >= 165 g/L (16.5 g/dL) (Female); DFB >= 20 g/L (2 g/dL). Hematocrit: <= 0.37 v/v (Male); <= 0.32 v/v (Female); >= 0.55 v/v (Male); >= 0.5 v/v (Female). RBCs: >=6 Tera/ L. Platelets: < 50 Giga/L, >=50 - 100 Giga/L, >= 700 Giga/L. WBC: < 3.0 Giga/L (Non-Black); < 2.0 Giga/L (Black), >= 16.0 Giga/L. Neutrophils: < 1.0 Giga/L, < 1.5 Giga/L (Non-Black); < 1.0 Giga/L (Black). Lymphocytes: < 0.5 Giga/L, >= 0.5 Giga/L - LLN, > 4.0 Giga/L. Monocytes: > 0.7 Giga/L. Basophils: > 0.1 Giga/L. Eosinophils: > 0.5 Giga/L or > ULN (if ULN >= 0.5 Giga/L).

DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests

Criteria for potentially clinically significant abnormalities: Alanine Aminotransferase (ALT): >1 ULN and <=1.5 ULN; >1.5 ULN and <=3 ULN; >3 ULN and <=5 ULN; >5 ULN and <=10 ULN; >10 ULN and <=20 ULN; >20 ULN. Aspartate aminotransferase (AST): >1 ULN and <=1.5 ULN; >1.5 ULN and <=3 ULN; >3 ULN and <=5 ULN; >5 ULN and <=10 ULN; >10 ULN and <=20 ULN; >20 ULN. Alkaline phosphatase: >1.5 ULN. Total bilirubin (TBILI): >1.5 ULN; >2 ULN. Conjugated bilirubin (CBILI): >1.5 ULN. Unconjugated bilirubin: >1.5 ULN, >2 ULN. ALT >3 ULN and TBILI >2 ULN. CBILI >35% TBILI and TBILI >1.5 ULN. Albumin: <=25 g/L.

OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests

Criteria for potentially clinically significant abnormalities: ALT: >1 ULN and <=1.5 ULN; >1.5 ULN and <=3 ULN; >3 ULN and <=5 ULN; >5 ULN and <=10 ULN; >10 ULN and <=20 ULN; >20 ULN. AST: >1 ULN and <=1.5 ULN; >1.5 ULN and <=3 ULN; >3 ULN and <=5 ULN; >5 ULN and <=10 ULN; >10 ULN and <=20 ULN; >20 ULN. Alkaline phosphatase: >1.5 ULN. TBILI: >1.5 ULN; >2 ULN. CBILI: >1.5 ULN. Unconjugated bilirubin: >1.5 ULN, >2 ULN. ALT >3 ULN and TBILI >2 ULN. CBILI >35% TBILI and TBILI >1.5 ULN. Albumin: <=25 g/L.

DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Metabolic Parameters

Criteria for potentially clinically significant abnormalities: Glucose: <=3.9 millimole/liter (mmol/L) and <LLN; >=11.1 mmol/L (unfasted [unfas]) or >=7 mmol/L (fasted [fas]). Hemoglobin A1c (HbA1c): >8%. Total cholesterol: >=6.2 mmol/L; >=7.74 mmol/L. LDL cholesterol: >=4.1 mmol/L; >=4.9 mmol/L. Triglycerides: >=4.6 mmol/L; >=5.6 mmol/L.

OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Metabolic Parameters

Criteria for potentially clinically significant abnormalities: Glucose: <=3.9 mmol/L and <LLN; >=11.1 mmol/L (unfas) or >=7 mmol/L (fas). HbA1c: >8%. Total cholesterol: >=6.2 mmol/L; >=7.74 mmol/L. LDL cholesterol: >=4.1 mmol/L; >=4.9 mmol/L. Triglycerides: >=4.6 mmol/L; >=5.6 mmol/L.

DB Period: Number of Participants With Different Post-baseline Categories of High-density Lipoprotein (HDL)

Number of participants with different post-baseline status of HDL: < 40 mg/dL, 40 - < 60 mg/dL, >= 60 mg/dL, is reported here.

OLE Period: Number of Participants With Different Post-baseline Categories of High-density Lipoprotein

Number of participants with different post-baseline status of HDL: < 40 mg/dL, 40 - < 60 mg/dL, >=60 mg/dL, is reported here.

DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function

Criteria for potentially clinically significant abnormalities: Creatinine: >=150 micromol/L (adults); >=30% change from baseline, >=100% change from baseline. Creatinine clearance: <15 mL/min; >=15 to <30 mL/min; >=30 to <60 mL/min; >=60 to <90 mL/min. Blood urea nitrogen: >=17 mmol/L. Uric acid: <120 micromol/L; >408 micromol/L.

OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function

DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Urinalysis

Criteria with potentially clinically significant urine abnormalities: pH: <= 4.6; pH: >= 8.0.

OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Urinalysis

Criteria with potentially clinically significant urine abnormalities: pH: <= 4.6; pH: >= 8.0.

DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Electrolytes

Criteria for potentially clinically significant abnormalities: Sodium: <=129 mmol/L; >=160 mmol/L. Potassium: <3 mmol/L; >=5.5 mmol/L. Chloride: <80 mmol/L; >115 mmol/L.

OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Electrolytes

Criteria for potentially clinically significant abnormalities: Sodium: <=129 mmol/L; >=160 mmol/L. Potassium: <3 mmol/L; >=5.5 mmol/L. Chloride: <80 mmol/L; >115 mmol/L.

DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities

Criteria for potentially clinically significant ECG abnormalities: Heart rate (HR): <50 beats per minute (bpm); <50 bpm and DFB >=20 bpm; <40 bpm; <40 bpm and DFB >=20 bpm; <30 bpm; <30 bpm and DFB >=20 bpm; >90 bpm; >=90 bpm and increase from baseline (IFB) >=20 bpm; >100 bpm; >=100 bpm and IFB >=20 bpm; >120 bpm; >=120 bpm and IFB >=20 bpm. PR Interval: >200 millisecond (ms); >200 ms and IFB >=25%; >220 ms; >220 ms and IFB >=25%; >240 ms; >240 ms and IFB >=25%. QRS Interval: >110 ms; >110 ms and IFB >=25%; >120 ms; >120 ms and IFB >=25%. QT Interval: >500 ms. QTc Bazett (QTc B): >450 ms; >480 ms; >500 ms; IFB >30 and <=60 ms; IFB >60 ms. QTc Fridericia (QTc F): >450 ms; >480 ms; >500 ms; IFB >30 and <=60 ms; IFB >60 ms.

OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities

Criteria for potentially clinically significant ECG abnormalities: HR: <50 bpm; <50 bpm and DFB >=20 bpm; <40 bpm; <40 bpm and DFB >=20 bpm; <30 bpm; <30 bpm and DFB >=20 bpm; >90 bpm; >=90 bpm and IFB >=20 bpm; >100 bpm; >=100 bpm and IFB >=20 bpm; >120 bpm; >=120 bpm and IFB >=20 bpm. PR Interval: >200 ms; >200 ms and IFB >=25%; >220 ms; >220 ms and IFB >=25%; >240 ms; >240 ms and IFB >=25%. QRS Interval: >110 ms; >110 ms and IFB >=25%; >120 ms; >120 ms and IFB >=25%. QT Interval: >500 ms. QTc B: >450 ms; >480 ms; >500 ms; IFB >30 and <=60 ms; IFB >60 ms. QTc F: >450 ms; >480 ms; >500 ms; IFB >30 and <=60 ms; IFB >60 ms.

DB Period: Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities

Criteria for potentially clinically significant vital sign abnormalities: Systolic blood pressure (SBP) supine: <=95 mmHg and DFB>=20 mmHg; >=160 mmHg and IFB >=20 mmHg. Diastolic blood pressure (DBP) supine: <=45 mmHg and DFB >=10 mmHg; >=110 mmHg and IFB >=10 mmHg. SBP (Orthostatic): <=-20 mmHg. DBP (Orthostatic): <=-10 mmHg. HR supine: <=50 bpm and DFB >=20 bpm; >=120 bpm and IFB >=20 bpm. Weight: >=5% DFB; >=5% IFB.

OLE Period: Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities

Criteria for potentially clinically significant vital sign abnormalities: SBP supine: <=95 mmHg and DFB >=20 mmHg; >=160 mmHg and IFB >=20 mmHg. DBP supine: <=45 mmHg and DFB >=10 mmHg; >=110 mmHg and IFB >=10 mmHg. SBP (Orthostatic): <=-20 mmHg. DBP (Orthostatic): <=-10 mmHg. HR supine: <=50 bpm and DFB >=20 bpm; >=120 bpm and IFB >=20 bpm. Weight: >=5% DFB; >=5% IFB.

DB Period: Number of Participants With Treatment-emergent and Treatment-boosted Anti-drug Antibody (ADA) Response

Anti-drug antibody response was categorized as: Treatment emergent and Treatment-boosted. Treatment emergent ADAs was defined as a participant with no positive assay response at baseline but with a positive assay response during the TEAE period. Treatment boosted ADAs: defined as participants with a positive ADA assay response at baseline and with at least a 4-fold increase in titer compared to baseline during the TEAE period. TEAE period: time from first dose of study drug up to day before first dose of open-label treatment for participants who completed 24-week randomized/DB treatment.

Number of Participants With Treatment-emergent and Treatment-boosted Anti-drug Antibody Response During Entire Treatment-emergent Adverse Event Period

Anti-drug antibody response was categorized as: Treatment emergent and Treatment-boosted. Treatment emergent ADAs was defined as a participant with no positive assay response at baseline but with a positive assay response during the entire TEAE period. Treatment boosted ADAs: defined as participants with a positive ADA assay response at baseline and with at least a 4-fold increase in titer compared to baseline during the entire TEAE period. Entire TEAE period: last OLE dose - first DB dose date + 6 weeks (follow-up), regardless of unplanned intermittent discontinuations.

DB Period: Pharmacokinetics: Serum Trough (Pre-dose) Concentrations of Functional Sarilumab

Data for this outcome measure was not planned to be collected and analyzed for "Adalimumab 40 mg/Sarilumab 200 mg" arm.

OLE Period: Pharmacokinetics: Serum Trough (Pre-dose) Concentrations of Functional Sarilumab

Full Information

NCT ID

NCT02332590

First Posted

January 5, 2015

Last Updated

March 15, 2022

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02332590

Brief Title

Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (SARIL-RA-MONARCH)

Official Title

A Randomized, Double-blind, Parallel-group Study Assessing the Efficacy and Safety of Sarilumab Monotherapy Versus Adalimumab Monotherapy in Patients With Rheumatoid Arthritis

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

January 28, 2015 (Actual)

Primary Completion Date

January 20, 2016 (Actual)

Study Completion Date

December 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Primary Objective: To demonstrate that sarilumab monotherapy was superior to adalimumab monotherapy with respect to signs and symptoms as assessed by disease activity score 28 (DAS28)-erythrocyte sedimentation rate (ESR) in participants with active rheumatoid arthritis (RA) who were either intolerant of, or considered inappropriate candidates for continued treatment with methotrexate (MTX), or after at least 12 weeks of continued treatment with MTX, were determined to be inadequate responders. Secondary Objectives: To demonstrate that sarilumab monotherapy was superior to adalimumab monotherapy in participants with active RA who were either intolerant of, or considered inappropriate candidates for continued treatment with MTX, or after at least 12 weeks of continued treatment with MTX, were determined to be inadequate responders, with respect to: Reduction of signs and symptoms of RA. Improvement in quality of life assessed by participant reported outcome questionnaires. Assessment of the safety and tolerability of sarilumab monotherapy (including immunogenicity) throughout the study.

Detailed Description

Total study duration was up to 310 weeks: Up to a 4 week screening period, 24 week randomized double-blind treatment phase, 276-week open-label extension, and 6 weeks post-treatment final study visit.

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 3

Interventional Study Model

Parallel Assignment

Model Description

During the OLE period of this study, all participants received sarilumab 200 mg or 150 mg q2w via prefilled syringe.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

369 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Adalimumab 40 mg/Sarilumab 200 mg

Arm Type

Active Comparator

Arm Description

Arm Title

Sarilumab 200 mg/Sarilumab 200 mg

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Sarilumab

Other Intervention Name(s)

SAR153191, REGN88

Intervention Description

Pharmaceutical form: solution for injection in pre-filled syringe; Route of administration: SC

Intervention Type

Drug

Intervention Name(s)

Adalimumab

Other Intervention Name(s)

Humira

Intervention Description

Pharmaceutical form: solution for injection in pre-filled syringe; Route of administration: SC

Intervention Type

Drug

Intervention Name(s)

Placebo (for sarilumab)

Intervention Description

Pharmaceutical form: solution for injection in pre-filled syringe; Route of administration: SC

Intervention Type

Drug

Intervention Name(s)

Placebo (for adalimumab)

Intervention Description

Pharmaceutical form: solution for injection in pre-filled syringe; Route of administration: SC

Primary Outcome Measure Information:

Title

DB Period: Change From Baseline in Disease Activity Score for 28 Joints - Erythrocyte Sedimentation Rate (DAS28-ESR) Score at Week 24

Description

Time Frame

Baseline, Week 24

Secondary Outcome Measure Information:

Title

DB Period: Percentage of Participants Achieving Clinical Remission Score (DAS28-ESR <2.6) at Week 24

Description

Time Frame

Week 24

Title

DB Period: Percentage of Participants Achieving ACR50 Criteria at Week 24

Description

Time Frame

Week 24

Title

DB Period: Percentage of Participants Achieving ACR70 Criteria at Week 24

Description

Time Frame

Week 24

Title

DB Period: Percentage of Participants Achieving ACR20 Criteria at Week 24

Description

ACR responses are assessed with a composite rating scale of the ACR that includes 7 variables: TJC (68 joints); SJC (66 joints); levels of an acute phase reactant (CRP level); participant's assessment of pain (measured on 0 [no pain]-100 mm [worst pain] VAS); participant's global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); physician's global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); participant's assessment of physical function (measured by HAQ-DI, with scoring range of 0 [better physical function] - 3 [worst physical function]). ACR20 was defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments. Participants were analyzed as non-responders from the time they discontinued treatment.

Time Frame

Week 24

Title

DB Period: Change From Baseline in HAQ-DI at Week 24

Description

Time Frame

Baseline, Week 24

Title

DB Period: Change From Baseline in Short-Form-36 (SF-36) - Physical Component Summary (PCS) Score at Week 24

Description

Time Frame

Baseline, Week 24

Title

DB Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 24

Description

Time Frame

Baseline, Week 24

Title

DB Period: Change From Baseline in SF-36 - Mental Health Component Summary Score at Week 24

Description

Time Frame

Baseline, Week 24

Title

DB Period: Change From Baseline in Disease Activity Score for 28 Joints Based on C-Reactive Protein (DAS28-CRP Score) at Week 24

Description

Time Frame

Baseline, Week 24

Title

DB Period: Percentage of Participants Achieving Clinical Remission Score (DAS28-CRP <2.6) at Week 24

Description

DAS28-CRP is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH assessment by the participant assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by hs-CRP in mg/L. The DAS28-CRP score provides a number indicating the current disease activity of the RA. DAS28-CRP total score ranges from 2-10. A DAS28-CRP score above 5.1 means high disease activity, whereas a DAS28-CRP score below 3.2 indicates low disease activity and a DAS28-CRP score below 2.6 means disease remission. Participants were analyzed as non-responders from the time they discontinued treatment.

Time Frame

Week 24

Title

DB Period: Percentage of Participants Achieving Low Disease Activity (DAS28-ESR < 3.2) at Week 24

Description

DAS28-ESR is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH assessment by the participant assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by ESR in mm/hr. The DAS28-ESR score provides a number indicating the current disease activity of the RA. DAS28-ESR total score ranges from 2-10. A DAS28-ESR score above 5.1 means high disease activity, DAS28-ESR score below 3.2 indicates low disease activity and DAS28-ESR score below 2.6 means disease remission. Participants were analyzed as non-responders from the time they discontinued treatment.

Time Frame

Week 24

Title

DB Period: Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Remission (CDAI ≤2.8) at Week 24

Description

Time Frame

Week 24

Title

DB Period: Change From Baseline in CDAI at Week 24

Description

CDAI is a composite index constructed to measure clinical remission in RA that does not include a laboratory test, and is a numerical summation of 4 components: SJC (28 joints), TJC (28 joints), participant's global assessment of disease activity (in cm), and physician's global assessment of disease activity (VAS in cm). Total score ranges from 0 to 76 with a lower score indicating less disease activity. A negative change in CDAI score indicates an improvement in disease activity and a positive change in score indicates a worsening of disease activity. LS means and SE at Week 24 were obtained using MMRM approach.

Time Frame

Baseline, Week 24

Title

DB Period: Change From Baseline in European Quality of Life-5 Dimension 3 Level (EQ-5D-3L) Scores at Week 24

Description

Time Frame

Baseline, Week 24

Title

DB Period: Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) at Week 24

Description

Time Frame

Baseline, Week 24

Title

DB Period: Change From Baseline in Work Productivity Survey - Rheumatoid Arthritis (WPS-RA) at Week 24: Work Days Missed Due to Arthritis

Description

Time Frame

Baseline, Week 24

Title

DB Period: Change From Baseline in WPS-RA at Week 24: Days With Work Productivity Reduced by ≥ 50% Due to Arthritis

Description

The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of work days with reduced productivity by >= 50% in the last month by the participants was reported. LS mean and SE at Week 24 were obtained using MMRM approach.

Time Frame

Baseline, Week 24

Title

DB Period: Change From Baseline in WPS-RA at Week 24: Arthritis Interference With Work Productivity

Description

The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Interference in the last month with work productivity was measured on a scale that ranges from 0 (no interference) to 10 (complete interference). LS mean and SE at Week 24 were obtained using MMRM approach.

Time Frame

Baseline, Week 24

Title

DB Period: Change From Baseline in WPS-RA at Week 24: House Work Days Missed Due to Arthritis

Description

The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with no household work in the last month by the participants was reported. LS mean and SE at Week 24 were obtained using MMRM approach.

Time Frame

Baseline, Week 24

Title

DB Period: Change From Baseline in WPS-RA at Week 24: Days With Household Work Productivity Reduced by >= 50% Due to Arthritis

Description

The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with reduced household work productivity by >= 50% in the last month by the participants was reported. LS mean and SE at Week 24 were obtained using MMRM approach.

Time Frame

Baseline, Week 24

Title

DB Period: Change From Baseline in WPS-RA at Week 24: Days With Family/Social/Leisure Activities Missed Due to Arthritis

Description

The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days missed of family/social/leisure activities in the last month by the participants was reported. LS mean and SE at Week 24 were obtained using MMRM approach.

Time Frame

Baseline, Week 24

Title

DB Period: Change From Baseline in WPS-RA at Week 24: Days With Outside Help Hired Due to Arthritis

Description

The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with outside help hired in the last month by the participant was reported. LS mean and SE at Week 24 were obtained using MMRM approach.

Time Frame

Baseline, Week 24

Title

DB Period: Change From Baseline in WPS-RA at Week 24: RA Interference With Household Work Productivity

Description

The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). The RA interference in the last month with household work productivity was measured on a scale that ranges from 0 (no interference) to 10 (complete interference). LS mean and SE at Week 24 were obtained using MMRM approach.

Time Frame

Baseline, Week 24

Title

DB Period: Change From Baseline in Morning Stiffness VAS at Week 24

Description

Time Frame

Baseline, Week 24

Title

DB Period: Change From Baseline in Individual ACR Component - TJC and SJC at Week 24

Description

Time Frame

Baseline, Week 24

Title

DB Period: Change From Baseline in Individual ACR Component - Physician Global VAS, Participant Global VAS and Pain VAS at Week 24

Description

Time Frame

Baseline, Week 24

Title

DB Period: Change From Baseline in Individual ACR Component - CRP Level at Week 24

Description

Time Frame

Baseline, Week 24

Title

DB Period: Change From Baseline in Individual ACR Component- ESR Level at Week 24

Description

Time Frame

Baseline, Week 24

Title

DB Period: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Description

Time Frame

From Week 0 to Week 24

Title

OLE Period: Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events

Description

Time Frame

From end of Week 24 (Baseline of OLE Period) up to last dose in OLE + 6 weeks of follow up (i.e. up to Week 306)

Title

DB Period: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) - Hematological Parameters

Description

Time Frame

From Week 0 to Week 24

Title

OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Hematological Parameters

Description

Time Frame

From end of Week 24 (Baseline of OLE Period) up to Week 300

Title

DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests

Description

Time Frame

From Week 0 to Week 24

Title

OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Liver Function Tests

Description

Time Frame

From end of Week 24 (Baseline of OLE Period) up to Week 300

Title

DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Metabolic Parameters

Description

Time Frame

From Week 0 to Week 24

Title

OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Metabolic Parameters

Description

Time Frame

From end of Week 24 (Baseline of OLE Period) up to Week 300

Title

DB Period: Number of Participants With Different Post-baseline Categories of High-density Lipoprotein (HDL)

Description

Number of participants with different post-baseline status of HDL: < 40 mg/dL, 40 - < 60 mg/dL, >= 60 mg/dL, is reported here.

Time Frame

From Week 0 to Week 24

Title

OLE Period: Number of Participants With Different Post-baseline Categories of High-density Lipoprotein

Description

Number of participants with different post-baseline status of HDL: < 40 mg/dL, 40 - < 60 mg/dL, >=60 mg/dL, is reported here.

Time Frame

From end of Week 24 (Baseline of OLE Period) up to Week 300

Title

DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function

Description

Time Frame

From Week 0 to Week 24

Title

OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Renal Function

Description

Time Frame

From end of Week 24 (Baseline of OLE Period) up to Week 300

Title

DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Urinalysis

Description

Criteria with potentially clinically significant urine abnormalities: pH: <= 4.6; pH: >= 8.0.

Time Frame

From Week 0 to Week 24

Title

OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Urinalysis

Description

Criteria with potentially clinically significant urine abnormalities: pH: <= 4.6; pH: >= 8.0.

Time Frame

From end of Week 24 (Baseline of OLE Period) up to Week 300

Title

DB Period: Number of Participants With Potentially Clinically Significant Abnormalities - Electrolytes

Description

Criteria for potentially clinically significant abnormalities: Sodium: <=129 mmol/L; >=160 mmol/L. Potassium: <3 mmol/L; >=5.5 mmol/L. Chloride: <80 mmol/L; >115 mmol/L.

Time Frame

From Week 0 to Week 24

Title

OLE Period: Number of Participants With Potentially Clinically Significant Abnormalities - Electrolytes

Description

Criteria for potentially clinically significant abnormalities: Sodium: <=129 mmol/L; >=160 mmol/L. Potassium: <3 mmol/L; >=5.5 mmol/L. Chloride: <80 mmol/L; >115 mmol/L.

Time Frame

From end of Week 24 (Baseline of OLE Period) up to Week 300

Title

DB Period: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities

Description

Time Frame

From Week 0 to Week 24

Title

OLE Period: Number of Participants With Potentially Clinically Significant Electrocardiogram Abnormalities

Description

Time Frame

From end of Week 24 (Baseline of OLE Period) up to Week 300

Title

DB Period: Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities

Description

Time Frame

From Week 0 to Week 24

Title

OLE Period: Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities

Description

Time Frame

From end of Week 24 (Baseline of OLE Period) up to Week 300

Title

DB Period: Number of Participants With Treatment-emergent and Treatment-boosted Anti-drug Antibody (ADA) Response

Description

Time Frame

From Week 0 to Week 24

Title

Number of Participants With Treatment-emergent and Treatment-boosted Anti-drug Antibody Response During Entire Treatment-emergent Adverse Event Period

Description

Anti-drug antibody response was categorized as: Treatment emergent and Treatment-boosted. Treatment emergent ADAs was defined as a participant with no positive assay response at baseline but with a positive assay response during the entire TEAE period. Treatment boosted ADAs: defined as participants with a positive ADA assay response at baseline and with at least a 4-fold increase in titer compared to baseline during the entire TEAE period. Entire TEAE period: last OLE dose - first DB dose date + 6 weeks (follow-up), regardless of unplanned intermittent discontinuations.

Time Frame

From Week 0 up to last dose in OLE + 6 weeks of follow-up (i.e. up to Week 306)

Title

DB Period: Pharmacokinetics: Serum Trough (Pre-dose) Concentrations of Functional Sarilumab

Description

Data for this outcome measure was not planned to be collected and analyzed for "Adalimumab 40 mg/Sarilumab 200 mg" arm.

Time Frame

Pre-dose at Week 0 (Baseline), 2, 4, 12, 16, 20, and 24

Title

OLE Period: Pharmacokinetics: Serum Trough (Pre-dose) Concentrations of Functional Sarilumab

Time Frame

Pre-dose at Week 24 (Baseline of OLE period), 36, 48, 60, 84, 108, 132, 156, 180, 204, 228, 252, 276, 300 and 306

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Diagnosis of RA greater than or equal to (>=)3 months duration. American College of Rheumatology (ACR) Class I-III functional status. Active RA was defined as: At least 6 of 66 swollen joints and 8 of 68 tender joints, high sensitivity C-reactive protein (hs-CRP) >=8 mg/L or ESR >=28 millimeter per hour (mm/H), and DAS28-ESR greater than (>) 5.1. Participants as per Investigator judgment were either intolerant of, or considered inappropriate candidates for continued treatment with MTX, or after at least 12 weeks of continued treatment with MTX, or inadequate responders treated with an adequate MTX dose for at least 12 weeks. Exclusion criteria: Age <18 years or the legal age of consent in the country of the study site, whichever was higher. Current treatment with disease-modifying antirheumatic drug (DMARDs)/immunosuppressive agents including MTX, cyclosporine, mycophenolate, tacrolimus, gold, penicillamine, sulfasalazine or hydroxychloroquine within 2 weeks prior to the baseline (Randomization Visit) or azathioprine, cyclophosphamide within 12 weeks prior to baseline (Randomization Visit) or leflunomide within 8 weeks prior to the Randomization Visit, or 4 weeks after cholestyramine washout. Treatment with any prior biologic agent, including anti-interleukin 6 (IL-6), IL-6 receptor (IL-6R) antagonists, and prior treatment with a Janus kinase inhibitor. Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks prior to screening. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 840407

City

Covina

State/Province

California

ZIP/Postal Code

91723

Country

United States

Facility Name

Investigational Site Number 840400

City

Long Beach

State/Province

California

ZIP/Postal Code

90808

Country

United States

Facility Name

Investigational Site Number 840141

City

Whittier

State/Province

California

ZIP/Postal Code

90606

Country

United States

Facility Name

Investigational Site Number 840130

City

Lewes

State/Province

Delaware

ZIP/Postal Code

19958

Country

United States

Facility Name

Investigational Site Number 840229

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

Investigational Site Number 840128

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174

Country

United States

Facility Name

Investigational Site Number 840403

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33708

Country

United States

Facility Name

Investigational Site Number 840140

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614

Country

United States

Facility Name

Investigational Site Number 840073

City

Cumberland

State/Province

Maryland

ZIP/Postal Code

21502

Country

United States

Facility Name

Investigational Site Number 840202

City

Hagerstown

State/Province

Maryland

ZIP/Postal Code

21740

Country

United States

Facility Name

Investigational Site Number 840232

City

Flint

State/Province

Michigan

ZIP/Postal Code

48504

Country

United States

Facility Name

Investigational Site Number 840112

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68516

Country

United States

Facility Name

Investigational Site Number 840402

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28210

Country

United States

Facility Name

Investigational Site Number 840406

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28601

Country

United States

Facility Name

Investigational Site Number 840404

City

Middleburg Heights

State/Province

Ohio

ZIP/Postal Code

44130

Country

United States

Facility Name

Investigational Site Number 840127

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Investigational Site Number 840074

City

Mesquite

State/Province

Texas

ZIP/Postal Code

75150

Country

United States

Facility Name

Investigational Site Number 152005

City

Osorno

ZIP/Postal Code

5311092

Country

Chile

Facility Name

Investigational Site Number 152001

City

Puerto Varas

Country

Chile

Facility Name

Investigational Site Number 152002

City

Santiago

ZIP/Postal Code

7501126

Country

Chile

Facility Name

Investigational Site Number 152050

City

Santiago

ZIP/Postal Code

8207257

Country

Chile

Facility Name

Investigational Site Number 152014

City

Talca

Country

Chile

Facility Name

Investigational Site Number 152015

City

Temuco IX Region

ZIP/Postal Code

4790928

Country

Chile

Facility Name

Investigational Site Number 152007

City

Viña Del Mar

Country

Chile

Facility Name

Investigational Site Number 203033

City

Praha 11

ZIP/Postal Code

14800

Country

Czechia

Facility Name

Investigational Site Number 203001

City

Praha 2

ZIP/Postal Code

12850

Country

Czechia

Facility Name

Investigational Site Number 203030

City

Praha 4

Country

Czechia

Facility Name

Investigational Site Number 203002

City

Uherske Hradiste

ZIP/Postal Code

686 01

Country

Czechia

Facility Name

Investigational Site Number 276058

City

Köln

ZIP/Postal Code

50937

Country

Germany

Facility Name

Investigational Site Number 276021

City

Osnabrück

ZIP/Postal Code

49074

Country

Germany

Facility Name

Investigational Site Number 348025

City

Budapest

ZIP/Postal Code

1027

Country

Hungary

Facility Name

Investigational Site Number 348020

City

Budapest

ZIP/Postal Code

1033

Country

Hungary

Facility Name

Investigational Site Number 348022

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Investigational Site Number 348024

City

Szombathely

ZIP/Postal Code

9700

Country

Hungary

Facility Name

Investigational Site Number 348023

City

Veszprém

ZIP/Postal Code

8200

Country

Hungary

Facility Name

Investigational Site Number 376032

City

Ashkelon

ZIP/Postal Code

78278

Country

Israel

Facility Name

Investigational Site Number 376031

City

Haifa

ZIP/Postal Code

34362

Country

Israel

Facility Name

Investigational Site Number 376030

City

Ramat Gan

ZIP/Postal Code

52621

Country

Israel

Facility Name

Investigational Site Number 376011

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Investigational Site Number 410005

City

Daegu

ZIP/Postal Code

42601

Country

Korea, Republic of

Facility Name

Investigational Site Number 410004

City

Daejeon

ZIP/Postal Code

35233

Country

Korea, Republic of

Facility Name

Investigational Site Number 410006

City

Seoul

ZIP/Postal Code

01830

Country

Korea, Republic of

Facility Name

Investigational Site Number 410001

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Investigational Site Number 604003

City

Lima

ZIP/Postal Code

LIMA 27

Country

Peru

Facility Name

Investigational Site Number 604005

City

Lima

ZIP/Postal Code

LIMA 41

Country

Peru

Facility Name

Investigational Site Number 604022

City

Lima

ZIP/Postal Code

Lima29

Country

Peru

Facility Name

Investigational Site Number 616056

City

Bytom

ZIP/Postal Code

41-902

Country

Poland

Facility Name

Investigational Site Number 616015

City

Elblag

Country

Poland

Facility Name

Investigational Site Number 616005

City

Lublin

ZIP/Postal Code

20-582

Country

Poland

Facility Name

Investigational Site Number 616030

City

Lublin

ZIP/Postal Code

20-954

Country

Poland

Facility Name

Investigational Site Number 616055

City

Nadarzyn

ZIP/Postal Code

05-830

Country

Poland

Facility Name

Investigational Site Number 616018

City

Poznan

ZIP/Postal Code

61-397

Country

Poland

Facility Name

Investigational Site Number 616016

City

Szczecin

ZIP/Postal Code

71-252

Country

Poland

Facility Name

Investigational Site Number 616004

City

Warszawa

ZIP/Postal Code

02-118

Country

Poland

Facility Name

Investigational Site Number 616031

City

Warszawa

ZIP/Postal Code

03-291

Country

Poland

Facility Name

Investigational Site Number 642006

City

Braila

ZIP/Postal Code

810019

Country

Romania

Facility Name

Investigational Site Number 642010

City

Bucharest

ZIP/Postal Code

011172

Country

Romania

Facility Name

Investigational Site Number 642001

City

Bucuresti

ZIP/Postal Code

010976

Country

Romania

Facility Name

Investigational Site Number 642002

City

Bucuresti

ZIP/Postal Code

020983

Country

Romania

Facility Name

Investigational Site Number 642005

City

Galati

ZIP/Postal Code

800578

Country

Romania

Facility Name

Investigational Site Number 643006

City

Kemerovo

ZIP/Postal Code

650000

Country

Russian Federation

Facility Name

Investigational Site Number 643020

City

Moscow

ZIP/Postal Code

115404

Country

Russian Federation

Facility Name

Investigational Site Number 643001

City

Moscow

ZIP/Postal Code

115522

Country

Russian Federation

Facility Name

Investigational Site Number 643031

City

Moscow

ZIP/Postal Code

121374

Country

Russian Federation

Facility Name

Investigational Site Number 643030

City

Moscow

ZIP/Postal Code

125284

Country

Russian Federation

Facility Name

Investigational Site Number 643008

City

Saint-Petersburg

ZIP/Postal Code

192242

Country

Russian Federation

Facility Name

Investigational Site Number 643011

City

Saratov

ZIP/Postal Code

410053

Country

Russian Federation

Facility Name

Investigational Site Number 710011

City

Cape Town

ZIP/Postal Code

7405

Country

South Africa

Facility Name

Investigational Site Number 710007

City

Cape Town

ZIP/Postal Code

7500

Country

South Africa

Facility Name

Investigational Site Number 710004

City

Kempton Park

ZIP/Postal Code

1619

Country

South Africa

Facility Name

Investigational Site Number 724003

City

Barakaldo

ZIP/Postal Code

48903

Country

Spain

Facility Name

Investigational Site Number 724011

City

Barcelona / Sabadell

ZIP/Postal Code

08208

Country

Spain

Facility Name

Investigational Site Number 724015

City

Barcelona

ZIP/Postal Code

08034

Country

Spain

Facility Name

Investigational Site Number 724001

City

Málaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Investigational Site Number 724012

City

Santiago De Compostela

ZIP/Postal Code

15705

Country

Spain

Facility Name

Investigational Site Number 724007

City

Sevilla

ZIP/Postal Code

41009

Country

Spain

Facility Name

Investigational Site Number 804029

City

Ivano-Frankivsk

ZIP/Postal Code

76018

Country

Ukraine

Facility Name

Investigational Site Number 804048

City

Kharkiv

ZIP/Postal Code

61058

Country

Ukraine

Facility Name

Investigational Site Number 804014

City

Kyiv

ZIP/Postal Code

01103

Country

Ukraine

Facility Name

Investigational Site Number 804047

City

Kyiv

ZIP/Postal Code

02125

Country

Ukraine

Facility Name

Investigational Site Number 804037

City

Lutsk

ZIP/Postal Code

43005

Country

Ukraine

Facility Name

Investigational Site Number 804046

City

Lviv

ZIP/Postal Code

79010

Country

Ukraine

Facility Name

Investigational Site Number 804049

City

Poltava

ZIP/Postal Code

36011

Country

Ukraine

Facility Name

Investigational Site Number 804011

City

Vinnitsya

ZIP/Postal Code

21018

Country

Ukraine

Facility Name

Investigational Site Number 804043

City

Vinnitsya

ZIP/Postal Code

21100

Country

Ukraine

Facility Name

Investigational Site Number 826001

City

Leytonstone

ZIP/Postal Code

E11 1NR

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Citations:

PubMed Identifier

36008838

Citation

Rubbert-Roth A, Furst DE, Fiore S, Praestgaard A, Bykerk V, Bingham CO, Charles-Schoeman C, Burmester G. Association between low hemoglobin, clinical measures, and patient-reported outcomes in patients with rheumatoid arthritis: results from post hoc analyses of three phase III trials of sarilumab. Arthritis Res Ther. 2022 Aug 25;24(1):207. doi: 10.1186/s13075-022-02891-x.

Results Reference

derived

PubMed Identifier

34519964

Citation

Rehberg M, Giegerich C, Praestgaard A, van Hoogstraten H, Iglesias-Rodriguez M, Curtis JR, Gottenberg JE, Schwarting A, Castaneda S, Rubbert-Roth A, Choy EHS; MOBILITY, MONARCH, TARGET, and ASCERTAIN investigators. Identification of a Rule to Predict Response to Sarilumab in Patients with Rheumatoid Arthritis Using Machine Learning and Clinical Trial Data. Rheumatol Ther. 2021 Dec;8(4):1661-1675. doi: 10.1007/s40744-021-00361-5. Epub 2021 Sep 14. Erratum In: Rheumatol Ther. 2021 Oct 29;:

Results Reference

derived

PubMed Identifier

33081825

Citation

Strand V, Boklage SH, Kimura T, Joly F, Boyapati A, Msihid J. High levels of interleukin-6 in patients with rheumatoid arthritis are associated with greater improvements in health-related quality of life for sarilumab compared with adalimumab. Arthritis Res Ther. 2020 Oct 20;22(1):250. doi: 10.1186/s13075-020-02344-3.

Results Reference

derived

PubMed Identifier

32907617

Citation

Genovese MC, Burmester GR, Hagino O, Thangavelu K, Iglesias-Rodriguez M, John GS, Gonzalez-Gay MA, Mandrup-Poulsen T, Fleischmann R. Interleukin-6 receptor blockade or TNFalpha inhibition for reducing glycaemia in patients with RA and diabetes: post hoc analyses of three randomised, controlled trials. Arthritis Res Ther. 2020 Sep 9;22(1):206. doi: 10.1186/s13075-020-02229-5.

Results Reference

derived

PubMed Identifier

32522251

Citation

Genovese MC, Fleischmann R, Kivitz A, Lee EB, van Hoogstraten H, Kimura T, St John G, Mangan EK, Burmester GR. Efficacy and safety of sarilumab in combination with csDMARDs or as monotherapy in subpopulations of patients with moderately to severely active rheumatoid arthritis in three phase III randomized, controlled studies. Arthritis Res Ther. 2020 Jun 10;22(1):139. doi: 10.1186/s13075-020-02194-z.

Results Reference

derived

PubMed Identifier

32343882

Citation

Boyapati A, Schwartzman S, Msihid J, Choy E, Genovese MC, Burmester GR, Lam G, Kimura T, Sadeh J, Weinreich DM, Yancopoulos GD, Graham NMH. Association of High Serum Interleukin-6 Levels With Severe Progression of Rheumatoid Arthritis and Increased Treatment Response Differentiating Sarilumab From Adalimumab or Methotrexate in a Post Hoc Analysis. Arthritis Rheumatol. 2020 Sep;72(9):1456-1466. doi: 10.1002/art.41299. Epub 2020 Aug 25.

Results Reference

derived

PubMed Identifier

32264972

Citation

Gabay C, Burmester GR, Strand V, Msihid J, Zilberstein M, Kimura T, van Hoogstraten H, Boklage SH, Sadeh J, Graham NMH, Boyapati A. Sarilumab and adalimumab differential effects on bone remodelling and cardiovascular risk biomarkers, and predictions of treatment outcomes. Arthritis Res Ther. 2020 Apr 7;22(1):70. doi: 10.1186/s13075-020-02163-6.

Results Reference

derived

PubMed Identifier

31673415

Citation

Burmester GR, Strand V, Rubbert-Roth A, Amital H, Raskina T, Gomez-Centeno A, Pena-Rossi C, Gervitz L, Thangavelu K, St John G, Boklage S, Genovese MC. Safety and efficacy of switching from adalimumab to sarilumab in patients with rheumatoid arthritis in the ongoing MONARCH open-label extension. RMD Open. 2019 Oct 18;5(2):e001017. doi: 10.1136/rmdopen-2019-001017. eCollection 2019.

Results Reference

derived

PubMed Identifier

30877216

Citation

Gossec L, Strand V, Proudfoot C, Chen CI, Guillonneau S, Kimura T, van Hoogstraten H, Mangan E, Reaney M. Effects of Sarilumab on Rheumatoid Arthritis as Reported by Patients Using the Rheumatoid Arthritis Impact of Disease Scale. J Rheumatol. 2019 Oct;46(10):1259-1267. doi: 10.3899/jrheum.180904. Epub 2019 Mar 15.

Results Reference

derived

PubMed Identifier

27856432

Citation

Burmester GR, Lin Y, Patel R, van Adelsberg J, Mangan EK, Graham NM, van Hoogstraten H, Bauer D, Ignacio Vargas J, Lee EB. Efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy for the treatment of patients with active rheumatoid arthritis (MONARCH): a randomised, double-blind, parallel-group phase III trial. Ann Rheum Dis. 2017 May;76(5):840-847. doi: 10.1136/annrheumdis-2016-210310. Epub 2016 Nov 17.

Results Reference

derived

Learn more about this trial

Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (SARIL-RA-MONARCH)

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Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (SARIL-RA-MONARCH)

Rheumatoid Arthritis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial