A Phase 3 Study of NI-071 in Participants With Rheumatoid Arthritis (RADIANCE)

A Randomized, Double-Blind, Multicenter, 3 Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients With Rheumatoid Arthritis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02990806

Enrollment

683

Registered

2016-12-13

Start date

2017-01-19

Completion date

2019-05-20

Last updated

2023-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

The purpose of this study was to demonstrate similarity of NI-071 (proposed biosimilar to infliximab) to US REMICADE® (reference product) in terms of safety and efficacy in participants with rheumatoid arthritis (RA) not adequately responding to methotrexate (MTX).

Interventions

DRUGNI-071

IV infusion.

DRUGRemicade

IV infusion.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Patients with a diagnosis of rheumatoid arthritis (RA) as defined by the 2010 American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) classification criteria. * Patients have active RA, as confirmed by the following criteria: * ≥6 swollen joints and ≥6 tender joints at screening and baseline (28-joint count). * Either C-reactive protein (CRP) ≥0.7 mg/dL (≥7.0 mg/L) or erythrocyte sedimentation rate (ESR) ≥28 mm/h at screening. * Patients taking methotrexate (MTX) (oral or parenteral) for at least 3 months prior to screening and at a stable dose of between 10 and 25 mg/week for at least 8 weeks. Concomitant folic/folinic acid at a dose of at least 5 mg/week is to be taken during the study; patients can start treatment with folic/folinic acid at screening if not already receiving it. * If the patient is currently taking non-steroidal anti-inflammatory drugs (NSAIDs), the patient must be on a stable dose for at least 4 weeks prior to screening and during the study. * Patients who are ≥18 and ≤75 years of age at screening.

Exclusion criteria

* Patients who are rated as Class IV according to the 1991 ACR revised criteria for classification of global functional status for RA. * Patients who have received disease-modifying anti rheumatic drugs (DMARDs), other than MTX, within a period prior to screening shorter than the washout period appropriate to the pharmacodynamic profile of the specific drug. * Patients who have received immunosuppressive drugs within 4 weeks prior to screening. Patients on a stable dose of oral corticosteroids (≤10 mg/day prednisone or equivalent) for ≥4 weeks prior to screening are permitted. * Patients who have received intra-articular, intramuscular, intravenous, or epidural injection of corticosteroids within 4 weeks prior to screening. * Patients who have received intra-articular sodium hyaluronate injections within 4 weeks prior to screening. * Patients who have received surgical therapy for RA such as synovectomy or arthroplasty within 6 months prior to screening. * Patients who have received arthrocentesis within 4 weeks prior to screening. * Patients who have had prior treatment with infliximab. * Patients who have had prior treatment with \>1 biological drug or \>1 protein kinase inhibitor for RA either as part of clinical management or during a clinical study. * Patients who have had prior treatment with tumor necrosis factor alpha (TNF-α) inhibitors for RA who had lack of efficacy as per clinical judgment (primary failure). Patients who have discontinued TNF-α inhibitors for RA (other than infliximab) for any reason other than lack of efficacy are allowed. * Presence of chronic or acute infection at screening, including positive result for active tuberculosis (TB). * Patients with an acute infection requiring parenteral antibiotics within 4 weeks of study dosing or requiring oral/topical antibiotics within 2 weeks of study dosing.

Design outcomes

Primary

Measure	Time frame	Description
Stage 1: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR20-CRP) Response Rate at Week 22	At Week 22	ACR20 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 20% improvement from baseline in the tender/painful joint count. ii) A 20% improvement from baseline in the swollen joint count. iii) A 20% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity visual analog scale (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS) (0= no symptoms;100=severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) Health Assessment Questionnaire-Disability Index (HAQ-DI), total score ranging from 0-3 with lower scores meaning less disability, e) CRP.
Stage 2 and 3: Area Under the Serum Concentration-time Curve Interval (AUCtau) of NI-071 and Remicade US	Week 46: Pre-dose, 1 hour after infusion, at end of infusion, at 4 hours and 24 hours after infusion and at Week 47, Week 48, Week 50, Week 52, and Week 54 post-dose	AUCtau of NI-071 and Remicade US in stage 2 and 3 was reported. As this was an interchangeability study, the NI-071 and Remicade only were the comparators and then switch study showed same measurement in relationship to the non-switched participants. Hence, combined data was assessed and collected in participants from Remicade US to Switch Group.
Stage 2 and 3: Maximum Observed Serum Concentration (Cmax) of NI-071 and Remicade US	Week 46: Pre-dose, 1 hour after infusion, at end of infusion, at 4 hours and 24 hours after infusion and at Week 47, Week 48, Week 50, Week 52, and Week 54 post-dose	Cmax of NI-071 and Remicade US was reported. As this was an interchangeability study, the NI-071 and Remicade only were the comparators and then switch study showed same measurement in relationship to the non-switched participants. Hence, combined data was assessed and collected in participants from Remicade US to Switch Group.

Secondary

Measure	Time frame	Description
Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Baseline, Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	DAS28 is a measure of disease activity in participants with rheumatoid arthritis, derived using differential weighting given to each of the four components. The components of the DAS28 (ESR) assessment included: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (millimeters per hour) and Patient Global Assessment (PtGA) recorded on 100mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). DAS28 (ESR) was calculated as 0.56\sqrt (TJC28) + 0.28\sqrt (SJC28) + 0.70\ln(ESR \[mm/hour\] + 0.014\GH \[mm\]; where, TJC28 = number of painful joints out of 28 joints, SJC28 = number of swollen joints out of 28 joints, GH = score of the participant global assessment of disease activity, ln = natural logarithm, sqrt = square root of. Total score range: 0 to 9.4, higher score indicated more disease activity. A negative change from baseline indicates improvement in disease activity.
Stage 1: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Weeks 2, 6, 14, 18, and 22	ACR20 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 20% improvement from baseline in the tender/painful joint count. ii) A 20% improvement from baseline in the swollen joint count. iii) A 20% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3 with lower scores meaning less disability, e) CRP.
Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	ACR20 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 20% improvement from baseline in the tender/painful joint count. ii) A 20% improvement from baseline in the swollen joint count. iii) A 20% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3 with lower scores meaning less disability, e) CRP.
Stage 1: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Weeks 2, 6, 14, 18, and 22	ACR20-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 20% improvement from baseline in the tender/painful joint count. ii) A 20% improvement from baseline in the swollen joint count. iii) A 20% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3 with lower scores meaning less disability, e) erythrocyte sedimentation rate (ESR).
Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	ACR20-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 20% improvement from baseline in the tender/painful joint count. ii) A 20% improvement from baseline in the swollen joint count. iii) A 20% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3 with lower scores meaning less disability, e) (ESR.
Stage 1: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Weeks 2, 6, 14, 18, and 22	ACR50 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 50% improvement from baseline in the swollen joint count. iii) A 50% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) CRP.
Stage 2 and 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	ACR50 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 50% improvement from baseline in the swollen joint count. iii) A 50% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) CRP.
Stage 1: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Weeks 2, 6, 14, 18, and 22	ACR50-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 50% improvement from baseline in the swollen joint count. iii) A 50% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) ESR.
Stage 2 and Stage 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	ACR50-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 50% improvement from baseline in the swollen joint count. iii) A 50% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) ESR.
Stage 1: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Weeks 2, 6, 14, 18, and 22	ACR70 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 70% improvement from baseline in the swollen joint count. iii) A 70% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) CRP.
Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	ACR70 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 70% improvement from baseline in the swollen joint count. iii) A 70% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) CRP.
Stage 1: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Weeks 2, 6, 14, 18, 22	ACR70-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 70% improvement from baseline in the swollen joint count. iii) A 70% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) ESR.
Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	ACR70-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 70% improvement from baseline in the swollen joint count. iii) A 70% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) ESR.
Stage 1: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 6, 14, 18, and 22	Baseline, Weeks 2, 6, 14, 18, and 22	The HAQ-DI score was defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled), where lower scores indicated less disability. Negative change from baseline indicates improvement (less disability).
Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 2, 6, 14, 18, and 22	Baseline, Weeks 2, 6, 14, 18, and 22	The DAS28-CRP was a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints \[assessed on 2-point scale (0=absent; 1=present\]), swollen joint count (out of 28 evaluated joints\[assessed on 2-point scale (0=absent; 1=present)\]), Participant's global assessment of disease activity (assessed on 0-100 mm VAS; where higher scores denotes severe symptoms), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Total Scores on the DAS28-CRP range from 0 to approximately 10 (0=very good, no symptoms; 10=very poor, severe symptoms), where higher scores indicate more disease activity. A negative change from baseline indicates improvement in disease activity.
Stage 1: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores at Weeks 2, 6, 14, 18, and 22	Baseline, Weeks 2, 6, 14, 18, and 22	Disease activity was assessed using RAPID3, based on participant-reported multi-dimensional health assessment questionnaire (MDHAQ). RAPID3 included 3 core data set measures of physical function, pain, and participant global estimate.Physical function=mean of scores from 10 individual questions on activities of daily living (each question scored from '0'=no difficulty to '3'=much difficulty), scores were transformed to give total score=0-10, higher scores=greater difficulty.Pain and global estimate of health measured on Likert scale from '0'=no pain to '10'=pain as bad as it could be. RAPID3 composite score: mean of physical function, pain, and global assessment scores, ranging from 0 to 10, higher values=greater disease activity. Total score range of RAPID3 score was 0=no difficulty; 30=greater difficultly, and disease activity categories were as follows: remission: 0-3, low: \>3.1 to 6, moderate: \>6.1-12, and high: \>12.1. Negative change from baseline indicates less disease activity.
Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Baseline, Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Disease activity was assessed using RAPID3, based on participant-reported multi-dimensional health assessment questionnaire (MDHAQ). RAPID3 included 3 core data set measures of physical function, pain and participant global estimate. Physical function=mean of scores from 10 individual questions on activities of daily living (each question scored from '0'=no difficulty to '3'=much difficulty), scores were transformed to give total score=0-10, higher scores=greater difficulty. Pain and global estimate of health measured on Likert scale from '0'=no pain to '10'=pain as bad as it could be. RAPID3 composite score: mean of physical function, pain, and global assessment scores, ranging from 0 to 10, higher values=greater disease activity. Total score range of RAPID3 score was 0=no difficulty-30=greater difficultly, and disease activity categories were as follows: remission: 0-3, low: \>3.1 to 6, moderate: \>6.1-12, and high: \>12.1. Negative change from baseline indicates less disease activity.
Stage 1: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Total Score at Weeks 14 and 22	Baseline, Weeks 14 and 22	SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental heallth) with a Subscale Total score for each scaled from 0 (minimum) to 100 (maximum) with a Total Overall score on a 0-800 scale, with higher scores indicating better health. where higher score indicates highest level of functioning. These 8 aspects can also be summarized as Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life). A positive change indicates improvement while a negative change indicates worsening of health status and quality of life. Change from baseline in overall total score for SF-36 was reported in this outcome measure.
Stage 2 and 3: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Total Score at Weeks 38 and 62	Baseline, Weeks 38 and 62	SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental heallth) with a Subscale Total score for each scaled from 0 (minimum) to 100 (maximum) with a Total Overall score on a 0-800 scale, with higher scores indicating better health. where higher score indicates highest level of functioning. Total score for each subscale scaled from 0 (minimum) to 100 (maximum), where higher score indicates highest level of functioning. These 8 aspects can also be summarized as PCS with score range 0-100 (higher score-better quality of life) and a MCS with score range 0-100 (higher score-better quality of life). A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Stage 1: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 14 and 22	Baseline, Weeks 14 and 22	SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. A Subscale Total score for each scaled from 0 (minimum) to 100 (maximum). Total score for each subscale scaled from 0 (minimum) to 100 (maximum), where higher score indicates highest level of functioning. These 2 subscale aspects can also be summarized as PCS with score range 0-100 (higher score-better quality of life) and a MCS with score range 0-100 (higher score-better quality of life). A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Stage 2 and 3: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 38 and 62	Baseline, Weeks 38 and 62	SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. A Subscale Total score for each scaled from 0 (minimum) to 100 (maximum). Total score for each subscale scaled from 0 (minimum) to 100 (maximum), where higher score indicates highest level of functioning. These 2 subscale aspects can also be summarized as PCS with score range 0-100 (higher score-better quality of life) and a MCS with score range 0-100 (higher score-better quality of life). A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.
Stage 2 and 3: Minimum Observed Serum Concentration (Cmin) of NI-071 and Remicade US	Week 46: Pre-dose, 1 hour after infusion, at end of infusion, at 4 hours and 24 hours after infusion and at Week 47, Week 48, Week 50, Week 52, and Week 54 post-dose	Drug concentrations in blood were evaluated from week 46 to week 54 after the initial administration date. Blood sampling was performed before administration of week 46, at the end of the infusion, and at 4 hours, 24 hours, 7 days (week 47), 14 days (week 48), 28 days (week 50), and 56 days (before administration of week 54). Cmin was define as the lowest drug concentration among all blood sampling points for an individual patient.
Stage 2 and 3: Time to Reach the Maximum Serum Concentration (Tmax) of NI-071 and Remicade US	Week 46: Pre-dose, 1 hour after infusion, at end of infusion, at 4 hours and 24 hours after infusion and at Week 47, Week 48, Week 50, Week 52, and Week 54 post-dose	—
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs	Baseline up to Week 62	An adverse event (AE) was defined as any untoward medical condition that occurs in participants while participating in a clinical study and does not necessarily have a causal relationship with the use of the study treatment. A TEAE was defined as an adverse event with a start date on or after the first dose of Investigational product (IP), or a start date before the date of the first dose of IP but increased in severity on or after the date of the first dose of IP. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Number of participants with TEAEs and Serious TEAEs were reported.
Number of Participants With TEAEs of Special Interest	Baseline up to Week 62	A TEAE was defined as an adverse event with a start date on or after the first dose of IP or a start date before the date of the first dose of IP but increased in severity on or after the date of the first dose of IP.
Stage 1: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)	Baseline, Weeks 2, 6, 14, and 22	Number of Participants With Positive Serum ADA are reported.
Stage 2 and 3: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)	At Weeks 30, 38, 46, 54, and 62	Number of Participants With Positive Serum Anti-drug Antibodies (ADA) are reported.
Stage 1: Number of Participants With Positive Serum Neutralizing Antibodies	Baseline, Weeks 2, 6, 14, and 22	Number of Participants with Positive Serum neutralizing Antibodies were reported.
Stage 2 and 3: Number of Participants With Positive Serum Neutralizing Antibodies	At Weeks 30, 38, 46, 54, and 62	Number of Participants with Positive Serum neutralizing Antibodies were reported.
Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Baseline, Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	The HAQ-DI score was defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled), where lower scores indicated less disability. Negative change from baseline indicates improvement (less disability).
Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Baseline, Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	The DAS28-CRP was a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints \[assessed on 2-point scale (0=absent; 1=present\]), swollen joint count (out of 28 evaluated joints\[assessed on 2-point scale (0=absent; 1=present)\]), Participant's global assessment of disease activity (assessed on 0-100 mm VAS; where higher scores denotes severe symptoms), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Total Scores on the DAS28-CRP range from 0 to approximately 10 (0=very good, no symptoms; 10=very poor, severe symptoms), where higher scores indicate more disease activity. A negative change from baseline indicates improvement in disease activity.
Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 6, 14, 18, and 22	Baseline, Weeks 2, 6, 14, 18, and 22	DAS28 is a measure of disease activity in participants with rheumatoid arthritis, derived using differential weighting given to each of the four components. The components of the DAS28 (ESR) assessment included: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (millimeters per hour) and GH recorded on 100mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). DAS28 (ESR) was calculated as 0.56\sqrt (TJC28) + 0.28\sqrt (SJC28) + 0.70\ln(ESR \[mm/hour\] + 0.014\GH \[mm\]; where, TJC28 = number of painful joints out of 28 joints, SJC28 = number of swollen joints out of 28 joints, GH = score of the participant global assessment of disease activity, ln = natural logarithm, sqrt = square root of. Total score range: 0 to 9.4, higher score indicated more disease activity. A negative change from baseline indicates improvement in disease activity.

Countries

Czechia, Poland, Puerto Rico, Russia, Spain, Ukraine, United Kingdom, United States

Participant flow

Recruitment details

Participants were enrolled from 97 investigative site in Czech Republic, Poland, Russia, Spain, Ukraine, and the United States in the study from 19 January 2017 to 20 May 2019.

Pre-assignment details

The study consisted of 3 stages: the biosimilarity stage (Stage 1), the interchangeability stage (Stage 2), and the safety follow-up stage (Stage 3). A total of 683 participants were randomized in a 2:1 ratio to the Remicade-US and NI-071 groups during Stage 1. In Stage 2 participants in the original Remicade-US group were re-randomized (1:1) to a Remicade-US group and a Switch group (to assess the effects of switching between Remicade-US and NI-071).

Participants by arm

Arm	Count
Stage 1: NI-071 Group Participants received intravenous (IV) infusion of NI-071 at a dose of 3 milligrams/kilograms (mg/kg) at Weeks 0, 2, 6, 14 during stage 1.	228
Stage 1: Remicade-US Group Participants received IV infusion of Remicade-US (infliximab) at a dose of 3 mg/kg at Weeks 0, 2, 6, 14 during stage 1.	455
Total	683

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Stage 1 (22 Weeks)	Adverse Event	1	15	0	0
Stage 1 (22 Weeks)	Death	0	1	0	0
Stage 1 (22 Weeks)	Initiated protocol-prohibited medication	2	2	0	0
Stage 1 (22 Weeks)	Lack of Efficacy	1	2	0	0
Stage 1 (22 Weeks)	Lost to Follow-up	2	2	0	0
Stage 1 (22 Weeks)	Noncompliant with visit schedule and/or protocol	2	2	0	0
Stage 1 (22 Weeks)	Other	1	3	0	0
Stage 1 (22 Weeks)	Physician Decision	1	1	0	0
Stage 1 (22 Weeks)	Protocol deviation	0	1	0	0
Stage 1 (22 Weeks)	Required antibiotics resulting in drug interruption >2 weeks	0	1	0	0
Stage 1 (22 Weeks)	Withdrawal by Subject	4	26	0	0
Stage 2 (32 Weeks)	Adverse Event	9	0	7	7
Stage 2 (32 Weeks)	Death	1	0	0	0
Stage 2 (32 Weeks)	Diagnosed with malignancy	1	0	0	1
Stage 2 (32 Weeks)	Ineligible according to Tuberculosis (TB) criteria	0	0	0	1
Stage 2 (32 Weeks)	Initiated protocol-prohibited medication	1	0	0	2
Stage 2 (32 Weeks)	Lack of Efficacy	4	0	2	3
Stage 2 (32 Weeks)	Lost to Follow-up	1	0	1	2
Stage 2 (32 Weeks)	Noncompliant with visit schedule and/or protocol	2	0	6	5
Stage 2 (32 Weeks)	Other	3	0	4	1
Stage 2 (32 Weeks)	Physician Decision	3	0	1	0
Stage 2 (32 Weeks)	Protocol deviation	2	0	2	3
Stage 2 (32 Weeks)	Required antibiotics resulting in drug interruption	1	0	1	1
Stage 2 (32 Weeks)	Withdrawal by Subject	14	0	4	8
Stage 3 (Safety Follow-up) (8 Weeks)	Adverse Event	5	0	4	3
Stage 3 (Safety Follow-up) (8 Weeks)	Initiated protocol-prohibited medication	0	0	1	0
Stage 3 (Safety Follow-up) (8 Weeks)	Lack of Efficacy	0	0	1	0
Stage 3 (Safety Follow-up) (8 Weeks)	Lost to Follow-up	1	0	0	1
Stage 3 (Safety Follow-up) (8 Weeks)	Noncompliant with visit schedule and/or protocol	2	0	2	2
Stage 3 (Safety Follow-up) (8 Weeks)	Other	0	0	0	2
Stage 3 (Safety Follow-up) (8 Weeks)	Physician Decision	1	0	1	1
Stage 3 (Safety Follow-up) (8 Weeks)	Withdrawal by Subject	0	0	2	1

Baseline characteristics

Characteristic	Stage 1: Remicade-US Group	Total	Stage 1: NI-071 Group
Age, Continuous	53.7 years STANDARD_DEVIATION 11.9	53.6 years STANDARD_DEVIATION 11.9	53.3 years STANDARD_DEVIATION 12
Ethnicity (NIH/OMB) Hispanic or Latino	103 Participants	153 Participants	50 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	350 Participants	524 Participants	174 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants	6 Participants	4 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants	2 Participants	0 Participants
Race (NIH/OMB) Asian	3 Participants	3 Participants	0 Participants
Race (NIH/OMB) Black or African American	25 Participants	42 Participants	17 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) White	424 Participants	635 Participants	211 Participants
Sex: Female, Male Female	372 Participants	545 Participants	173 Participants
Sex: Female, Male Male	83 Participants	138 Participants	55 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	1 / 227	1 / 451	0 / 254	0 / 197
other Total, other adverse events	96 / 227	174 / 451	80 / 254	94 / 197
serious Total, serious adverse events	19 / 227	41 / 451	28 / 254	13 / 197

Outcome results

Primary

Stage 1: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR20-CRP) Response Rate at Week 22

ACR20 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 20% improvement from baseline in the tender/painful joint count. ii) A 20% improvement from baseline in the swollen joint count. iii) A 20% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity visual analog scale (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS) (0= no symptoms;100=severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) Health Assessment Questionnaire-Disability Index (HAQ-DI), total score ranging from 0-3 with lower scores meaning less disability, e) CRP.

Time frame: At Week 22

Population: The Intent to Treat (ITT) included all participants who were randomized, irrespective of any deviation from the protocol or premature discontinuation. Data for this outcome measure was planned to be collected and analyzed for Stage 1.

Arm	Measure	Value (NUMBER)
Stage 1: NI-071 Group	Stage 1: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR20-CRP) Response Rate at Week 22	56.6 percentage of participants
Stage 1: Remicade-US Group	Stage 1: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR20-CRP) Response Rate at Week 22	53.0 percentage of participants

95% CI: [-4.3, 11.5]

Primary

Stage 2 and 3: Area Under the Serum Concentration-time Curve Interval (AUCtau) of NI-071 and Remicade US

AUCtau of NI-071 and Remicade US in stage 2 and 3 was reported. As this was an interchangeability study, the NI-071 and Remicade only were the comparators and then switch study showed same measurement in relationship to the non-switched participants. Hence, combined data was assessed and collected in participants from Remicade US to Switch Group.

Time frame: Week 46: Pre-dose, 1 hour after infusion, at end of infusion, at 4 hours and 24 hours after infusion and at Week 47, Week 48, Week 50, Week 52, and Week 54 post-dose

Population: Pharmacokinetic (PK) population included all participants in the full analysis set (FAS) in Stage 1 who have valid PK assessments through Stage 2. The FAS included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Stage 1.

Arm	Measure	Value (MEAN)	Dispersion
Stage 1: NI-071 Group	Stage 2 and 3: Area Under the Serum Concentration-time Curve Interval (AUCtau) of NI-071 and Remicade US	12949622.78 hournanograms per milliliter (hng/mL)	Standard Deviation 6999387.76
Stage 1: Remicade-US Group	Stage 2 and 3: Area Under the Serum Concentration-time Curve Interval (AUCtau) of NI-071 and Remicade US	12859923.90 hournanograms per milliliter (hng/mL)	Standard Deviation 8228379.79
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Area Under the Serum Concentration-time Curve Interval (AUCtau) of NI-071 and Remicade US	12040415.23 hournanograms per milliliter (hng/mL)	Standard Deviation 6624933.11

Primary

Stage 2 and 3: Maximum Observed Serum Concentration (Cmax) of NI-071 and Remicade US

Cmax of NI-071 and Remicade US was reported. As this was an interchangeability study, the NI-071 and Remicade only were the comparators and then switch study showed same measurement in relationship to the non-switched participants. Hence, combined data was assessed and collected in participants from Remicade US to Switch Group.

Time frame: Week 46: Pre-dose, 1 hour after infusion, at end of infusion, at 4 hours and 24 hours after infusion and at Week 47, Week 48, Week 50, Week 52, and Week 54 post-dose

Population: PK population included all participants in the FAS in Stage 1 who have valid PK assessments through Stage 2. The FAS included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Stage 1.

Arm	Measure	Value (MEAN)	Dispersion
Stage 1: NI-071 Group	Stage 2 and 3: Maximum Observed Serum Concentration (Cmax) of NI-071 and Remicade US	66298.1 nanograms per milliliter (ng/mL)	Standard Deviation 21756.8
Stage 1: Remicade-US Group	Stage 2 and 3: Maximum Observed Serum Concentration (Cmax) of NI-071 and Remicade US	63649.0 nanograms per milliliter (ng/mL)	Standard Deviation 16566.2
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Maximum Observed Serum Concentration (Cmax) of NI-071 and Remicade US	61660.8 nanograms per milliliter (ng/mL)	Standard Deviation 18696.5

Secondary

Number of Participants With TEAEs of Special Interest

A TEAE was defined as an adverse event with a start date on or after the first dose of IP or a start date before the date of the first dose of IP but increased in severity on or after the date of the first dose of IP.

Time frame: Baseline up to Week 62

Population: The safety population included participants who received at least 1 dose of study drug.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Stage 1: NI-071 Group	Number of Participants With TEAEs of Special Interest	33 Participants
Stage 1: Remicade-US Group	Number of Participants With TEAEs of Special Interest	68 Participants
Stage 2 and Stage 3: Remicade US to Switch Group	Number of Participants With TEAEs of Special Interest	43 Participants
Stage 2 and Stage 3: Remicade US to Switch Group	Number of Participants With TEAEs of Special Interest	25 Participants

Secondary

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs

An adverse event (AE) was defined as any untoward medical condition that occurs in participants while participating in a clinical study and does not necessarily have a causal relationship with the use of the study treatment. A TEAE was defined as an adverse event with a start date on or after the first dose of Investigational product (IP), or a start date before the date of the first dose of IP but increased in severity on or after the date of the first dose of IP. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Number of participants with TEAEs and Serious TEAEs were reported.

Time frame: Baseline up to Week 62

Population: The safety population included participants who received at least 1 dose of study drug.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Stage 1: NI-071 Group	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs	Participants with Serious TEAEs	19 Participants
Stage 1: NI-071 Group	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs	Participants with TEAEs	157 Participants
Stage 1: Remicade-US Group	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs	Participants with Serious TEAEs	41 Participants
Stage 1: Remicade-US Group	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs	Participants with TEAEs	330 Participants
Stage 2 and Stage 3: Remicade US to Switch Group	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs	Participants with TEAEs	181 Participants
Stage 2 and Stage 3: Remicade US to Switch Group	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs	Participants with Serious TEAEs	28 Participants
Stage 2 and Stage 3: Remicade US to Switch Group	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs	Participants with TEAEs	149 Participants
Stage 2 and Stage 3: Remicade US to Switch Group	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs	Participants with Serious TEAEs	13 Participants

Secondary

Stage 1: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 14 and 22

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. A Subscale Total score for each scaled from 0 (minimum) to 100 (maximum). Total score for each subscale scaled from 0 (minimum) to 100 (maximum), where higher score indicates highest level of functioning. These 2 subscale aspects can also be summarized as PCS with score range 0-100 (higher score-better quality of life) and a MCS with score range 0-100 (higher score-better quality of life). A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.

Time frame: Baseline, Weeks 14 and 22

Population: The ITT population included all participants who were randomized. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specific time point.

Arm	Measure	Group	Value (MEAN)	Dispersion
Stage 1: NI-071 Group	Stage 1: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 14 and 22	Baseline (Physical Component)	30.22 score on a scale	Standard Deviation 7.72
Stage 1: NI-071 Group	Stage 1: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 14 and 22	Change at Week 14 (Physical Component)	5.42 score on a scale	Standard Deviation 7.86
Stage 1: NI-071 Group	Stage 1: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 14 and 22	Change at Week 22 (Physical Component)	5.61 score on a scale	Standard Deviation 8.36
Stage 1: NI-071 Group	Stage 1: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 14 and 22	Baseline (Mental Component)	43.59 score on a scale	Standard Deviation 11.57
Stage 1: NI-071 Group	Stage 1: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 14 and 22	Change at Week 14 (Mental Component)	3.05 score on a scale	Standard Deviation 10.36
Stage 1: NI-071 Group	Stage 1: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 14 and 22	Change at Week 22 (Mental Component)	4.05 score on a scale	Standard Deviation 9.48
Stage 1: Remicade-US Group	Stage 1: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 14 and 22	Change at Week 14 (Mental Component)	2.56 score on a scale	Standard Deviation 10.38
Stage 1: Remicade-US Group	Stage 1: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 14 and 22	Baseline (Physical Component)	30.53 score on a scale	Standard Deviation 7.24
Stage 1: Remicade-US Group	Stage 1: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 14 and 22	Baseline (Mental Component)	43.02 score on a scale	Standard Deviation 12.45
Stage 1: Remicade-US Group	Stage 1: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 14 and 22	Change at Week 14 (Physical Component)	5.64 score on a scale	Standard Deviation 8.82
Stage 1: Remicade-US Group	Stage 1: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 14 and 22	Change at Week 22 (Mental Component)	2.71 score on a scale	Standard Deviation 10.83
Stage 1: Remicade-US Group	Stage 1: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 14 and 22	Change at Week 22 (Physical Component)	6.03 score on a scale	Standard Deviation 8.79

Secondary

Stage 1: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Total Score at Weeks 14 and 22

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental heallth) with a Subscale Total score for each scaled from 0 (minimum) to 100 (maximum) with a Total Overall score on a 0-800 scale, with higher scores indicating better health. where higher score indicates highest level of functioning. These 8 aspects can also be summarized as Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life). A positive change indicates improvement while a negative change indicates worsening of health status and quality of life. Change from baseline in overall total score for SF-36 was reported in this outcome measure.

Time frame: Baseline, Weeks 14 and 22

Arm	Measure	Group	Value (MEAN)	Dispersion
Stage 1: NI-071 Group	Stage 1: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Total Score at Weeks 14 and 22	Baseline	360.46 score on a scale	Standard Deviation 116.64
Stage 1: NI-071 Group	Stage 1: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Total Score at Weeks 14 and 22	Change at Week 14	79.90 score on a scale	Standard Deviation 124.86
Stage 1: NI-071 Group	Stage 1: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Total Score at Weeks 14 and 22	Change at Week 22	90.02 score on a scale	Standard Deviation 122.36
Stage 1: Remicade-US Group	Stage 1: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Total Score at Weeks 14 and 22	Baseline	358.20 score on a scale	Standard Deviation 126.93
Stage 1: Remicade-US Group	Stage 1: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Total Score at Weeks 14 and 22	Change at Week 14	77.59 score on a scale	Standard Deviation 124.72
Stage 1: Remicade-US Group	Stage 1: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Total Score at Weeks 14 and 22	Change at Week 22	82.94 score on a scale	Standard Deviation 129.28

Secondary

Stage 1: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores at Weeks 2, 6, 14, 18, and 22

Disease activity was assessed using RAPID3, based on participant-reported multi-dimensional health assessment questionnaire (MDHAQ). RAPID3 included 3 core data set measures of physical function, pain, and participant global estimate.Physical function=mean of scores from 10 individual questions on activities of daily living (each question scored from '0'=no difficulty to '3'=much difficulty), scores were transformed to give total score=0-10, higher scores=greater difficulty.Pain and global estimate of health measured on Likert scale from '0'=no pain to '10'=pain as bad as it could be. RAPID3 composite score: mean of physical function, pain, and global assessment scores, ranging from 0 to 10, higher values=greater disease activity. Total score range of RAPID3 score was 0=no difficulty; 30=greater difficultly, and disease activity categories were as follows: remission: 0-3, low: \>3.1 to 6, moderate: \>6.1-12, and high: \>12.1. Negative change from baseline indicates less disease activity.

Time frame: Baseline, Weeks 2, 6, 14, 18, and 22

Population: The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specific time point.

Arm	Measure	Group	Value (MEAN)	Dispersion
Stage 1: NI-071 Group	Stage 1: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores at Weeks 2, 6, 14, 18, and 22	Baseline	17.03 score on a scale	Standard Deviation 4.76
Stage 1: NI-071 Group	Stage 1: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores at Weeks 2, 6, 14, 18, and 22	Change at Week 2	-2.99 score on a scale	Standard Deviation 4.42
Stage 1: NI-071 Group	Stage 1: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores at Weeks 2, 6, 14, 18, and 22	Change at Week 6	-4.15 score on a scale	Standard Deviation 5.14
Stage 1: NI-071 Group	Stage 1: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores at Weeks 2, 6, 14, 18, and 22	Change at Week 14	-5.04 score on a scale	Standard Deviation 5.8
Stage 1: NI-071 Group	Stage 1: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores at Weeks 2, 6, 14, 18, and 22	Change at Week 18	-5.99 score on a scale	Standard Deviation 5.96
Stage 1: NI-071 Group	Stage 1: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores at Weeks 2, 6, 14, 18, and 22	Change at Week 22	-4.71 score on a scale	Standard Deviation 6.42
Stage 1: Remicade-US Group	Stage 1: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores at Weeks 2, 6, 14, 18, and 22	Change at Week 18	-5.73 score on a scale	Standard Deviation 6.51
Stage 1: Remicade-US Group	Stage 1: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores at Weeks 2, 6, 14, 18, and 22	Baseline	17.37 score on a scale	Standard Deviation 4.76
Stage 1: Remicade-US Group	Stage 1: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores at Weeks 2, 6, 14, 18, and 22	Change at Week 14	-4.91 score on a scale	Standard Deviation 6.47
Stage 1: Remicade-US Group	Stage 1: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores at Weeks 2, 6, 14, 18, and 22	Change at Week 2	-3.79 score on a scale	Standard Deviation 4.89
Stage 1: Remicade-US Group	Stage 1: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores at Weeks 2, 6, 14, 18, and 22	Change at Week 22	-5.41 score on a scale	Standard Deviation 6.54
Stage 1: Remicade-US Group	Stage 1: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores at Weeks 2, 6, 14, 18, and 22	Change at Week 6	-5.05 score on a scale	Standard Deviation 5.62

Secondary

Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 2, 6, 14, 18, and 22

The DAS28-CRP was a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints \[assessed on 2-point scale (0=absent; 1=present\]), swollen joint count (out of 28 evaluated joints\[assessed on 2-point scale (0=absent; 1=present)\]), Participant's global assessment of disease activity (assessed on 0-100 mm VAS; where higher scores denotes severe symptoms), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Total Scores on the DAS28-CRP range from 0 to approximately 10 (0=very good, no symptoms; 10=very poor, severe symptoms), where higher scores indicate more disease activity. A negative change from baseline indicates improvement in disease activity.

Time frame: Baseline, Weeks 2, 6, 14, 18, and 22

Arm	Measure	Group	Value (MEAN)	Dispersion
Stage 1: NI-071 Group	Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 2, 6, 14, 18, and 22	Baseline	5.816 score on a scale	Standard Deviation 0.822
Stage 1: NI-071 Group	Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 2, 6, 14, 18, and 22	Change at Week 2	-1.094 score on a scale	Standard Deviation 0.881
Stage 1: NI-071 Group	Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 2, 6, 14, 18, and 22	Change at Week 6	-1.542 score on a scale	Standard Deviation 1.041
Stage 1: NI-071 Group	Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 2, 6, 14, 18, and 22	Change at Week 14	-1.828 score on a scale	Standard Deviation 1.137
Stage 1: NI-071 Group	Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 2, 6, 14, 18, and 22	Change at Week 18	-2.070 score on a scale	Standard Deviation 1.159
Stage 1: NI-071 Group	Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 2, 6, 14, 18, and 22	Change at Week 22	-1.835 score on a scale	Standard Deviation 1.247
Stage 1: Remicade-US Group	Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 2, 6, 14, 18, and 22	Change at Week 18	-2.156 score on a scale	Standard Deviation 1.193
Stage 1: Remicade-US Group	Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 2, 6, 14, 18, and 22	Baseline	5.898 score on a scale	Standard Deviation 0.787
Stage 1: Remicade-US Group	Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 2, 6, 14, 18, and 22	Change at Week 14	-1.812 score on a scale	Standard Deviation 1.221
Stage 1: Remicade-US Group	Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 2, 6, 14, 18, and 22	Change at Week 2	-1.169 score on a scale	Standard Deviation 0.931
Stage 1: Remicade-US Group	Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 2, 6, 14, 18, and 22	Change at Week 22	-1.978 score on a scale	Standard Deviation 1.209
Stage 1: Remicade-US Group	Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 2, 6, 14, 18, and 22	Change at Week 6	-1.650 score on a scale	Standard Deviation 1.114

Secondary

Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 6, 14, 18, and 22

DAS28 is a measure of disease activity in participants with rheumatoid arthritis, derived using differential weighting given to each of the four components. The components of the DAS28 (ESR) assessment included: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (millimeters per hour) and GH recorded on 100mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). DAS28 (ESR) was calculated as 0.56\*sqrt (TJC28) + 0.28\*sqrt (SJC28) + 0.70\*ln(ESR \[mm/hour\] + 0.014\*GH \[mm\]; where, TJC28 = number of painful joints out of 28 joints, SJC28 = number of swollen joints out of 28 joints, GH = score of the participant global assessment of disease activity, ln = natural logarithm, sqrt = square root of. Total score range: 0 to 9.4, higher score indicated more disease activity. A negative change from baseline indicates improvement in disease activity.

Time frame: Baseline, Weeks 2, 6, 14, 18, and 22

Arm	Measure	Group	Value (MEAN)	Dispersion
Stage 1: NI-071 Group	Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 6, 14, 18, and 22	Baseline	6.552 score on a scale	Standard Deviation 0.861
Stage 1: NI-071 Group	Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 6, 14, 18, and 22	Change at Week 2	-1.060 score on a scale	Standard Deviation 0.915
Stage 1: NI-071 Group	Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 6, 14, 18, and 22	Change at Week 6	-1.588 score on a scale	Standard Deviation 1.112
Stage 1: NI-071 Group	Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 6, 14, 18, and 22	Change at Week 14	-2.002 score on a scale	Standard Deviation 1.254
Stage 1: NI-071 Group	Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 6, 14, 18, and 22	Change at Week 18	-2.291 score on a scale	Standard Deviation 1.3
Stage 1: NI-071 Group	Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 6, 14, 18, and 22	Change at Week 22	-2.060 score on a scale	Standard Deviation 1.386
Stage 1: Remicade-US Group	Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 6, 14, 18, and 22	Change at Week 18	-2.345 score on a scale	Standard Deviation 1.278
Stage 1: Remicade-US Group	Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 6, 14, 18, and 22	Baseline	6.655 score on a scale	Standard Deviation 0.755
Stage 1: Remicade-US Group	Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 6, 14, 18, and 22	Change at Week 14	-1.951 score on a scale	Standard Deviation 1.266
Stage 1: Remicade-US Group	Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 6, 14, 18, and 22	Change at Week 2	-1.161 score on a scale	Standard Deviation 0.893
Stage 1: Remicade-US Group	Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 6, 14, 18, and 22	Change at Week 22	-2.195 score on a scale	Standard Deviation 1.326
Stage 1: Remicade-US Group	Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 6, 14, 18, and 22	Change at Week 6	-1.778 score on a scale	Standard Deviation 1.174

Secondary

Stage 1: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 6, 14, 18, and 22

The HAQ-DI score was defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled), where lower scores indicated less disability. Negative change from baseline indicates improvement (less disability).

Time frame: Baseline, Weeks 2, 6, 14, 18, and 22

Arm	Measure	Group	Value (MEAN)	Dispersion
Stage 1: NI-071 Group	Stage 1: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 6, 14, 18, and 22	Baseline	1.32 score on a scale	Standard Deviation 0.55
Stage 1: NI-071 Group	Stage 1: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 6, 14, 18, and 22	Change at Week 2	-0.21 score on a scale	Standard Deviation 0.42
Stage 1: NI-071 Group	Stage 1: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 6, 14, 18, and 22	Change at Week 6	-0.33 score on a scale	Standard Deviation 0.5
Stage 1: NI-071 Group	Stage 1: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 6, 14, 18, and 22	Change at Week 14	-0.35 score on a scale	Standard Deviation 0.55
Stage 1: NI-071 Group	Stage 1: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 6, 14, 18, and 22	Change at Week 18	-0.41 score on a scale	Standard Deviation 0.53
Stage 1: NI-071 Group	Stage 1: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 6, 14, 18, and 22	Change at Week 22	-0.35 score on a scale	Standard Deviation 0.59
Stage 1: Remicade-US Group	Stage 1: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 6, 14, 18, and 22	Change at Week 18	-0.43 score on a scale	Standard Deviation 0.58
Stage 1: Remicade-US Group	Stage 1: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 6, 14, 18, and 22	Baseline	1.34 score on a scale	Standard Deviation 0.58
Stage 1: Remicade-US Group	Stage 1: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 6, 14, 18, and 22	Change at Week 14	-0.35 score on a scale	Standard Deviation 0.54
Stage 1: Remicade-US Group	Stage 1: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 6, 14, 18, and 22	Change at Week 2	-0.28 score on a scale	Standard Deviation 0.45
Stage 1: Remicade-US Group	Stage 1: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 6, 14, 18, and 22	Change at Week 22	-0.39 score on a scale	Standard Deviation 0.59
Stage 1: Remicade-US Group	Stage 1: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 6, 14, 18, and 22	Change at Week 6	-0.37 score on a scale	Standard Deviation 0.53

Secondary

Stage 1: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)

Number of Participants With Positive Serum ADA are reported.

Time frame: Baseline, Weeks 2, 6, 14, and 22

Population: The safety population included participants who received at least 1 dose of study drug. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specific time point.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Stage 1: NI-071 Group	Stage 1: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)	At Week 2	18 Participants
Stage 1: NI-071 Group	Stage 1: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)	At Week 14	150 Participants
Stage 1: NI-071 Group	Stage 1: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)	At Week 6	59 Participants
Stage 1: NI-071 Group	Stage 1: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)	At Week 22	187 Participants
Stage 1: NI-071 Group	Stage 1: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)	Baseline	2 Participants
Stage 1: Remicade-US Group	Stage 1: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)	At Week 22	337 Participants
Stage 1: Remicade-US Group	Stage 1: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)	Baseline	15 Participants
Stage 1: Remicade-US Group	Stage 1: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)	At Week 2	44 Participants
Stage 1: Remicade-US Group	Stage 1: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)	At Week 6	143 Participants
Stage 1: Remicade-US Group	Stage 1: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)	At Week 14	303 Participants

Secondary

Stage 1: Number of Participants With Positive Serum Neutralizing Antibodies

Number of Participants with Positive Serum neutralizing Antibodies were reported.

Time frame: Baseline, Weeks 2, 6, 14, and 22

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Stage 1: NI-071 Group	Stage 1: Number of Participants With Positive Serum Neutralizing Antibodies	At Week 2	1 Participants
Stage 1: NI-071 Group	Stage 1: Number of Participants With Positive Serum Neutralizing Antibodies	At Week 14	53 Participants
Stage 1: NI-071 Group	Stage 1: Number of Participants With Positive Serum Neutralizing Antibodies	At Week 6	11 Participants
Stage 1: NI-071 Group	Stage 1: Number of Participants With Positive Serum Neutralizing Antibodies	At Week 22	80 Participants
Stage 1: NI-071 Group	Stage 1: Number of Participants With Positive Serum Neutralizing Antibodies	Baseline	1 Participants
Stage 1: Remicade-US Group	Stage 1: Number of Participants With Positive Serum Neutralizing Antibodies	At Week 22	143 Participants
Stage 1: Remicade-US Group	Stage 1: Number of Participants With Positive Serum Neutralizing Antibodies	Baseline	7 Participants
Stage 1: Remicade-US Group	Stage 1: Number of Participants With Positive Serum Neutralizing Antibodies	At Week 2	10 Participants
Stage 1: Remicade-US Group	Stage 1: Number of Participants With Positive Serum Neutralizing Antibodies	At Week 6	34 Participants
Stage 1: Remicade-US Group	Stage 1: Number of Participants With Positive Serum Neutralizing Antibodies	At Week 14	122 Participants

Secondary

Stage 1: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate

ACR20 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 20% improvement from baseline in the tender/painful joint count. ii) A 20% improvement from baseline in the swollen joint count. iii) A 20% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3 with lower scores meaning less disability, e) CRP.

Time frame: At Weeks 2, 6, 14, 18, and 22

Population: The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure. Last observation carried forward (LOCF) method was used to carry forward any of the individually missing component values, and from that mix of actual and carried-forward values, the ACR responder status was determined.

Arm	Measure	Group	Value (NUMBER)
Stage 1: NI-071 Group	Stage 1: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 6	47.1 percentage of participants
Stage 1: NI-071 Group	Stage 1: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 18	62.6 percentage of participants
Stage 1: NI-071 Group	Stage 1: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 14	56.4 percentage of participants
Stage 1: NI-071 Group	Stage 1: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 22	56.8 percentage of participants
Stage 1: NI-071 Group	Stage 1: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 2	31.3 percentage of participants
Stage 1: Remicade-US Group	Stage 1: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 22	54.5 percentage of participants
Stage 1: Remicade-US Group	Stage 1: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 2	32.5 percentage of participants
Stage 1: Remicade-US Group	Stage 1: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 6	54.3 percentage of participants
Stage 1: Remicade-US Group	Stage 1: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 14	51.1 percentage of participants
Stage 1: Remicade-US Group	Stage 1: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 18	61.7 percentage of participants

Secondary

Stage 1: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR

ACR50-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 50% improvement from baseline in the swollen joint count. iii) A 50% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) ESR.

Time frame: At Weeks 2, 6, 14, 18, and 22

Population: The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure. LOCF method was used to carry forward any of the individually missing component values, and from that mix of actual and carried-forward values, the ACR responder status was determined.

Arm	Measure	Group	Value (NUMBER)
Stage 1: NI-071 Group	Stage 1: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 6	14.5 percentage of participants
Stage 1: NI-071 Group	Stage 1: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 18	31.7 percentage of participants
Stage 1: NI-071 Group	Stage 1: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 14	23.3 percentage of participants
Stage 1: NI-071 Group	Stage 1: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 22	27.8 percentage of participants
Stage 1: NI-071 Group	Stage 1: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 2	6.6 percentage of participants
Stage 1: Remicade-US Group	Stage 1: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 22	26.7 percentage of participants
Stage 1: Remicade-US Group	Stage 1: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 2	6.7 percentage of participants
Stage 1: Remicade-US Group	Stage 1: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 6	17.9 percentage of participants
Stage 1: Remicade-US Group	Stage 1: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 14	21.7 percentage of participants
Stage 1: Remicade-US Group	Stage 1: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 18	29.6 percentage of participants

Secondary

Stage 1: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate

ACR50 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 50% improvement from baseline in the swollen joint count. iii) A 50% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) CRP.

Time frame: At Weeks 2, 6, 14, 18, and 22

Population: The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure. LOCF method was used to carry forward any of the individually missing component values, and from that mix of actual and carried-forward values, the ACR responder status was determined.

Arm	Measure	Group	Value (NUMBER)
Stage 1: NI-071 Group	Stage 1: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 6	16.3 percentage of participants
Stage 1: NI-071 Group	Stage 1: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 18	32.2 percentage of participants
Stage 1: NI-071 Group	Stage 1: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 14	24.7 percentage of participants
Stage 1: NI-071 Group	Stage 1: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 22	27.8 percentage of participants
Stage 1: NI-071 Group	Stage 1: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 2	8.4 percentage of participants
Stage 1: Remicade-US Group	Stage 1: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 22	25.6 percentage of participants
Stage 1: Remicade-US Group	Stage 1: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 2	8.3 percentage of participants
Stage 1: Remicade-US Group	Stage 1: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 6	19.1 percentage of participants
Stage 1: Remicade-US Group	Stage 1: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 14	21.3 percentage of participants
Stage 1: Remicade-US Group	Stage 1: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 18	30.9 percentage of participants

Secondary

Stage 1: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR

ACR70-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 70% improvement from baseline in the swollen joint count. iii) A 70% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) ESR.

Time frame: At Weeks 2, 6, 14, 18, 22

Population: The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure. LOCF method was used to carry forward any of the individually missing component values, and from that mix of actual and carried-forward values, the ACR responder status was determined.

Arm	Measure	Group	Value (NUMBER)
Stage 1: NI-071 Group	Stage 1: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 6	5.7 percentage of participants
Stage 1: NI-071 Group	Stage 1: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 18	14.5 percentage of participants
Stage 1: NI-071 Group	Stage 1: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 14	9.7 percentage of participants
Stage 1: NI-071 Group	Stage 1: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 22	11.0 percentage of participants
Stage 1: NI-071 Group	Stage 1: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 2	0.9 percentage of participants
Stage 1: Remicade-US Group	Stage 1: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 22	11.2 percentage of participants
Stage 1: Remicade-US Group	Stage 1: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 2	1.1 percentage of participants
Stage 1: Remicade-US Group	Stage 1: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 6	6.1 percentage of participants
Stage 1: Remicade-US Group	Stage 1: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 14	7.4 percentage of participants
Stage 1: Remicade-US Group	Stage 1: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 18	11.0 percentage of participants

Secondary

Stage 1: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate

ACR70 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 70% improvement from baseline in the swollen joint count. iii) A 70% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) CRP.

Time frame: At Weeks 2, 6, 14, 18, and 22

Population: The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure. LOCF method was used to carry forward any of the individually missing component values, and from that mix of actual and carried-forward values, the ACR responder status was determined.

Arm	Measure	Group	Value (NUMBER)
Stage 1: NI-071 Group	Stage 1: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 6	6.6 percentage of participants
Stage 1: NI-071 Group	Stage 1: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 18	15.0 percentage of participants
Stage 1: NI-071 Group	Stage 1: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 14	11.0 percentage of participants
Stage 1: NI-071 Group	Stage 1: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 22	10.6 percentage of participants
Stage 1: NI-071 Group	Stage 1: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 2	0.9 percentage of participants
Stage 1: Remicade-US Group	Stage 1: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 22	12.1 percentage of participants
Stage 1: Remicade-US Group	Stage 1: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 2	1.3 percentage of participants
Stage 1: Remicade-US Group	Stage 1: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 6	7.2 percentage of participants
Stage 1: Remicade-US Group	Stage 1: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 14	7.8 percentage of participants
Stage 1: Remicade-US Group	Stage 1: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 18	11.7 percentage of participants

Secondary

Stage 1: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)

ACR20-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 20% improvement from baseline in the tender/painful joint count. ii) A 20% improvement from baseline in the swollen joint count. iii) A 20% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3 with lower scores meaning less disability, e) erythrocyte sedimentation rate (ESR).

Time frame: At Weeks 2, 6, 14, 18, and 22

Population: The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure. LOCF method was used to carry forward any of the individually missing component values, and from that mix of actual and carried-forward values, the ACR responder status was determined.

Arm	Measure	Group	Value (NUMBER)
Stage 1: NI-071 Group	Stage 1: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 6	46.7 percentage of participants
Stage 1: NI-071 Group	Stage 1: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 18	62.6 percentage of participants
Stage 1: NI-071 Group	Stage 1: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 14	56.8 percentage of participants
Stage 1: NI-071 Group	Stage 1: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 22	55.9 percentage of participants
Stage 1: NI-071 Group	Stage 1: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 2	29.1 percentage of participants
Stage 1: Remicade-US Group	Stage 1: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 22	56.3 percentage of participants
Stage 1: Remicade-US Group	Stage 1: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 2	31.8 percentage of participants
Stage 1: Remicade-US Group	Stage 1: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 6	54.3 percentage of participants
Stage 1: Remicade-US Group	Stage 1: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 14	52.2 percentage of participants
Stage 1: Remicade-US Group	Stage 1: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 18	62.3 percentage of participants

Secondary

Stage 2 and 3: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 38 and 62

Time frame: Baseline, Weeks 38 and 62

Arm	Measure	Group	Value (MEAN)	Dispersion
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 38 and 62	Change at Week 38 (Physical Component)	6.94 score on a scale	Standard Deviation 8.37
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 38 and 62	Change at Week 62 (Physical Component)	6.14 score on a scale	Standard Deviation 8.79
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 38 and 62	Change at Week 38 (Mental Component)	3.09 score on a scale	Standard Deviation 10.55
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 38 and 62	Change at Week 62 (Mental Component)	2.45 score on a scale	Standard Deviation 10.92
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 38 and 62	Change at Week 62 (Mental Component)	3.93 score on a scale	Standard Deviation 11.59
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 38 and 62	Change at Week 38 (Physical Component)	6.86 score on a scale	Standard Deviation 9.31
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 38 and 62	Change at Week 38 (Mental Component)	3.38 score on a scale	Standard Deviation 11.32
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 38 and 62	Change at Week 62 (Physical Component)	6.23 score on a scale	Standard Deviation 9.78
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 38 and 62	Change at Week 62 (Mental Component)	3.16 score on a scale	Standard Deviation 10.29
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 38 and 62	Change at Week 62 (Physical Component)	6.11 score on a scale	Standard Deviation 8.6
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 38 and 62	Change at Week 38 (Mental Component)	3.10 score on a scale	Standard Deviation 10.58
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 38 and 62	Change at Week 38 (Physical Component)	6.22 score on a scale	Standard Deviation 9.62

Secondary

Stage 2 and 3: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Total Score at Weeks 38 and 62

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental heallth) with a Subscale Total score for each scaled from 0 (minimum) to 100 (maximum) with a Total Overall score on a 0-800 scale, with higher scores indicating better health. where higher score indicates highest level of functioning. Total score for each subscale scaled from 0 (minimum) to 100 (maximum), where higher score indicates highest level of functioning. These 8 aspects can also be summarized as PCS with score range 0-100 (higher score-better quality of life) and a MCS with score range 0-100 (higher score-better quality of life). A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.

Time frame: Baseline, Weeks 38 and 62

Arm	Measure	Group	Value (MEAN)	Dispersion
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Total Score at Weeks 38 and 62	Change at Week 38	95.10 score on a scale	Standard Deviation 127.26
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Total Score at Weeks 38 and 62	Change at Week 62	81.56 score on a scale	Standard Deviation 143.91
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Total Score at Weeks 38 and 62	Change at Week 38	96.93 score on a scale	Standard Deviation 136.8
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Total Score at Weeks 38 and 62	Change at Week 62	95.24 score on a scale	Standard Deviation 148.23
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Total Score at Weeks 38 and 62	Change at Week 38	87.61 score on a scale	Standard Deviation 129.67
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Total Score at Weeks 38 and 62	Change at Week 62	87.51 score on a scale	Standard Deviation 122.36

Secondary

Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62

Disease activity was assessed using RAPID3, based on participant-reported multi-dimensional health assessment questionnaire (MDHAQ). RAPID3 included 3 core data set measures of physical function, pain and participant global estimate. Physical function=mean of scores from 10 individual questions on activities of daily living (each question scored from '0'=no difficulty to '3'=much difficulty), scores were transformed to give total score=0-10, higher scores=greater difficulty. Pain and global estimate of health measured on Likert scale from '0'=no pain to '10'=pain as bad as it could be. RAPID3 composite score: mean of physical function, pain, and global assessment scores, ranging from 0 to 10, higher values=greater disease activity. Total score range of RAPID3 score was 0=no difficulty-30=greater difficultly, and disease activity categories were as follows: remission: 0-3, low: \>3.1 to 6, moderate: \>6.1-12, and high: \>12.1. Negative change from baseline indicates less disease activity.

Time frame: Baseline, Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62

Population: The FAS population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline RAPID3 efficacy assessment. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies those participants who were evaluable at specific time point.

Arm	Measure	Group	Value (MEAN)	Dispersion
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 26	-5.81 score on a scale	Standard Deviation 6.23
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 30	-5.43 score on a scale	Standard Deviation 6.38
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 34	-6.24 score on a scale	Standard Deviation 6.06
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 38	-5.91 score on a scale	Standard Deviation 6.25
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 42	-6.69 score on a scale	Standard Deviation 6.1
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 46	-6.34 score on a scale	Standard Deviation 6.35
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 50	-6.85 score on a scale	Standard Deviation 6.36
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 54	-6.63 score on a scale	Standard Deviation 6.33
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 58	-6.84 score on a scale	Standard Deviation 6.54
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 62	-5.35 score on a scale	Standard Deviation 6.83
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 58	-7.83 score on a scale	Standard Deviation 7.05
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 26	-6.34 score on a scale	Standard Deviation 6.55
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 46	-7.11 score on a scale	Standard Deviation 6.99
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 42	-7.40 score on a scale	Standard Deviation 6.82
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 30	-6.41 score on a scale	Standard Deviation 6.81
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 62	-6.28 score on a scale	Standard Deviation 7.46
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 54	-7.11 score on a scale	Standard Deviation 7.27
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 34	-7.39 score on a scale	Standard Deviation 6.51
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 50	-7.94 score on a scale	Standard Deviation 7.22
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 38	-6.59 score on a scale	Standard Deviation 7.14
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 54	-5.38 score on a scale	Standard Deviation 6.64
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 38	-5.86 score on a scale	Standard Deviation 6.94
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 42	-6.49 score on a scale	Standard Deviation 6.49
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 46	-5.79 score on a scale	Standard Deviation 6.53
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 58	-6.41 score on a scale	Standard Deviation 6.25
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 50	-6.48 score on a scale	Standard Deviation 6.63
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 26	-5.64 score on a scale	Standard Deviation 6.43
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 62	-5.74 score on a scale	Standard Deviation 6.67
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 30	-5.26 score on a scale	Standard Deviation 6.67
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 34	-6.22 score on a scale	Standard Deviation 6.75

Secondary

Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62

Time frame: Baseline, Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62

Arm	Measure	Group	Value (MEAN)	Dispersion
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 26	-2.199 score on a scale	Standard Deviation 1.238
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 30	-2.106 score on a scale	Standard Deviation 1.269
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 34	-2.379 score on a scale	Standard Deviation 1.251
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 38	-2.281 score on a scale	Standard Deviation 1.234
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 42	-2.415 score on a scale	Standard Deviation 1.228
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 46	-2.242 score on a scale	Standard Deviation 1.203
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 50	-2.444 score on a scale	Standard Deviation 1.156
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 54	-2.443 score on a scale	Standard Deviation 1.212
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 58	-2.568 score on a scale	Standard Deviation 1.211
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 62	-2.466 score on a scale	Standard Deviation 1.238
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 58	-2.739 score on a scale	Standard Deviation 1.236
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 26	-2.317 score on a scale	Standard Deviation 1.227
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 46	-2.387 score on a scale	Standard Deviation 1.27
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 42	-2.630 score on a scale	Standard Deviation 1.226
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 30	-2.298 score on a scale	Standard Deviation 1.251
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 62	-2.605 score on a scale	Standard Deviation 1.276
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 54	-2.462 score on a scale	Standard Deviation 1.189
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 34	-2.586 score on a scale	Standard Deviation 1.187
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 50	-2.679 score on a scale	Standard Deviation 1.245
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 38	-2.331 score on a scale	Standard Deviation 1.258
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 54	-2.247 score on a scale	Standard Deviation 1.298
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 38	-2.321 score on a scale	Standard Deviation 1.376
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 42	-2.519 score on a scale	Standard Deviation 1.236
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 46	-2.207 score on a scale	Standard Deviation 1.217
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 58	-2.450 score on a scale	Standard Deviation 1.227
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 50	-2.551 score on a scale	Standard Deviation 1.172
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 26	-2.192 score on a scale	Standard Deviation 1.18
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 62	-2.404 score on a scale	Standard Deviation 1.327
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 30	-2.092 score on a scale	Standard Deviation 1.23
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 34	-2.446 score on a scale	Standard Deviation 1.266

Secondary

Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62

DAS28 is a measure of disease activity in participants with rheumatoid arthritis, derived using differential weighting given to each of the four components. The components of the DAS28 (ESR) assessment included: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (millimeters per hour) and Patient Global Assessment (PtGA) recorded on 100mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). DAS28 (ESR) was calculated as 0.56\*sqrt (TJC28) + 0.28\*sqrt (SJC28) + 0.70\*ln(ESR \[mm/hour\] + 0.014\*GH \[mm\]; where, TJC28 = number of painful joints out of 28 joints, SJC28 = number of swollen joints out of 28 joints, GH = score of the participant global assessment of disease activity, ln = natural logarithm, sqrt = square root of. Total score range: 0 to 9.4, higher score indicated more disease activity. A negative change from baseline indicates improvement in disease activity.

Time frame: Baseline, Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62

Arm	Measure	Group	Value (MEAN)	Dispersion
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 26	-2.387 score on a scale	Standard Deviation 1.393
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 30	-2.346 score on a scale	Standard Deviation 1.457
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 34	-2.602 score on a scale	Standard Deviation 1.416
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 38	-2.516 score on a scale	Standard Deviation 1.478
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 42	-2.650 score on a scale	Standard Deviation 1.372
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 46	-2.494 score on a scale	Standard Deviation 1.352
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 50	-2.649 score on a scale	Standard Deviation 1.291
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 54	-2.619 score on a scale	Standard Deviation 1.385
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 58	-2.764 score on a scale	Standard Deviation 1.385
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 62	-2.663 score on a scale	Standard Deviation 1.439
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 58	-2.985 score on a scale	Standard Deviation 1.337
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 26	-2.533 score on a scale	Standard Deviation 1.395
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 46	-2.625 score on a scale	Standard Deviation 1.322
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 42	-2.847 score on a scale	Standard Deviation 1.258
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 30	-2.533 score on a scale	Standard Deviation 1.349
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 62	-2.864 score on a scale	Standard Deviation 1.371
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 54	-2.662 score on a scale	Standard Deviation 1.221
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 34	-2.864 score on a scale	Standard Deviation 1.303
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 50	-2.964 score on a scale	Standard Deviation 1.302
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 38	-2.535 score on a scale	Standard Deviation 1.314
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 54	-2.403 score on a scale	Standard Deviation 1.41
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 38	-2.493 score on a scale	Standard Deviation 1.518
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 42	-2.691 score on a scale	Standard Deviation 1.433
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 46	-2.406 score on a scale	Standard Deviation 1.364
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 58	-2.617 score on a scale	Standard Deviation 1.376
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 50	-2.708 score on a scale	Standard Deviation 1.303
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 26	-2.375 score on a scale	Standard Deviation 1.304
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 62	-2.574 score on a scale	Standard Deviation 1.47
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 30	-2.261 score on a scale	Standard Deviation 1.374
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 34	-2.609 score on a scale	Standard Deviation 1.376

Secondary

Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62

Time frame: Baseline, Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62

Arm	Measure	Group	Value (MEAN)	Dispersion
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 50	-0.49 score on a scale	Standard Deviation 0.58
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 34	-0.47 score on a scale	Standard Deviation 0.58
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 54	-0.49 score on a scale	Standard Deviation 0.58
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 58	-0.49 score on a scale	Standard Deviation 0.59
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 26	-0.40 score on a scale	Standard Deviation 0.59
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 62	-0.47 score on a scale	Standard Deviation 0.59
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 38	-0.43 score on a scale	Standard Deviation 0.59
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 30	-0.40 score on a scale	Standard Deviation 0.57
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 42	-0.48 score on a scale	Standard Deviation 0.56
Stage 1: NI-071 Group	Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 46	-0.48 score on a scale	Standard Deviation 0.6
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 50	-0.55 score on a scale	Standard Deviation 0.64
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 38	-0.46 score on a scale	Standard Deviation 0.61
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 46	-0.51 score on a scale	Standard Deviation 0.67
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 54	-0.49 score on a scale	Standard Deviation 0.64
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 34	-0.50 score on a scale	Standard Deviation 0.61
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 26	-0.44 score on a scale	Standard Deviation 0.63
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 58	-0.52 score on a scale	Standard Deviation 0.64
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 42	-0.52 score on a scale	Standard Deviation 0.65
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 30	-0.46 score on a scale	Standard Deviation 0.62
Stage 1: Remicade-US Group	Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 62	-0.51 score on a scale	Standard Deviation 0.64
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 62	-0.42 score on a scale	Standard Deviation 0.61
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 26	-0.40 score on a scale	Standard Deviation 0.58
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 30	-0.38 score on a scale	Standard Deviation 0.59
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 34	-0.44 score on a scale	Standard Deviation 0.58
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 38	-0.41 score on a scale	Standard Deviation 0.63
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 42	-0.46 score on a scale	Standard Deviation 0.62
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 46	-0.43 score on a scale	Standard Deviation 0.6
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 50	-0.47 score on a scale	Standard Deviation 0.61
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 54	-0.39 score on a scale	Standard Deviation 0.63
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62	Change at Week 58	-0.44 score on a scale	Standard Deviation 0.6

Secondary

Stage 2 and 3: Minimum Observed Serum Concentration (Cmin) of NI-071 and Remicade US

Drug concentrations in blood were evaluated from week 46 to week 54 after the initial administration date. Blood sampling was performed before administration of week 46, at the end of the infusion, and at 4 hours, 24 hours, 7 days (week 47), 14 days (week 48), 28 days (week 50), and 56 days (before administration of week 54). Cmin was define as the lowest drug concentration among all blood sampling points for an individual patient.

Time frame: Week 46: Pre-dose, 1 hour after infusion, at end of infusion, at 4 hours and 24 hours after infusion and at Week 47, Week 48, Week 50, Week 52, and Week 54 post-dose

Arm	Measure	Value (MEAN)	Dispersion
Stage 1: NI-071 Group	Stage 2 and 3: Minimum Observed Serum Concentration (Cmin) of NI-071 and Remicade US	839.1 ng/mL	Standard Deviation 1322.2
Stage 1: Remicade-US Group	Stage 2 and 3: Minimum Observed Serum Concentration (Cmin) of NI-071 and Remicade US	754.1 ng/mL	Standard Deviation 1380
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Minimum Observed Serum Concentration (Cmin) of NI-071 and Remicade US	762.6 ng/mL	Standard Deviation 1207.2

Secondary

Stage 2 and 3: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)

Number of Participants With Positive Serum Anti-drug Antibodies (ADA) are reported.

Time frame: At Weeks 30, 38, 46, 54, and 62

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Stage 1: NI-071 Group	Stage 2 and 3: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)	At Week 54	147 Participants
Stage 1: NI-071 Group	Stage 2 and 3: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)	At Week 46	153 Participants
Stage 1: NI-071 Group	Stage 2 and 3: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)	At Week 30	185 Participants
Stage 1: NI-071 Group	Stage 2 and 3: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)	At Week 38	167 Participants
Stage 1: NI-071 Group	Stage 2 and 3: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)	At Week 62	187 Participants
Stage 1: Remicade-US Group	Stage 2 and 3: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)	At Week 46	150 Participants
Stage 1: Remicade-US Group	Stage 2 and 3: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)	At Week 30	166 Participants
Stage 1: Remicade-US Group	Stage 2 and 3: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)	At Week 38	162 Participants
Stage 1: Remicade-US Group	Stage 2 and 3: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)	At Week 54	145 Participants
Stage 1: Remicade-US Group	Stage 2 and 3: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)	At Week 62	191 Participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)	At Week 62	165 Participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)	At Week 54	141 Participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)	At Week 30	164 Participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)	At Week 46	141 Participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)	At Week 38	146 Participants

Secondary

Stage 2 and 3: Number of Participants With Positive Serum Neutralizing Antibodies

Number of Participants with Positive Serum neutralizing Antibodies were reported.

Time frame: At Weeks 30, 38, 46, 54, and 62

Population: The safety population included participants who received at least 1 dose of study drug. Here, Number Analyzed signifies those participants who were evaluable at specific time point. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Stage 1: NI-071 Group	Stage 2 and 3: Number of Participants With Positive Serum Neutralizing Antibodies	At Week 54	77 Participants
Stage 1: NI-071 Group	Stage 2 and 3: Number of Participants With Positive Serum Neutralizing Antibodies	At Week 46	78 Participants
Stage 1: NI-071 Group	Stage 2 and 3: Number of Participants With Positive Serum Neutralizing Antibodies	At Week 30	92 Participants
Stage 1: NI-071 Group	Stage 2 and 3: Number of Participants With Positive Serum Neutralizing Antibodies	At Week 38	94 Participants
Stage 1: NI-071 Group	Stage 2 and 3: Number of Participants With Positive Serum Neutralizing Antibodies	At Week 62	114 Participants
Stage 1: Remicade-US Group	Stage 2 and 3: Number of Participants With Positive Serum Neutralizing Antibodies	At Week 46	87 Participants
Stage 1: Remicade-US Group	Stage 2 and 3: Number of Participants With Positive Serum Neutralizing Antibodies	At Week 30	90 Participants
Stage 1: Remicade-US Group	Stage 2 and 3: Number of Participants With Positive Serum Neutralizing Antibodies	At Week 38	96 Participants
Stage 1: Remicade-US Group	Stage 2 and 3: Number of Participants With Positive Serum Neutralizing Antibodies	At Week 54	87 Participants
Stage 1: Remicade-US Group	Stage 2 and 3: Number of Participants With Positive Serum Neutralizing Antibodies	At Week 62	124 Participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Number of Participants With Positive Serum Neutralizing Antibodies	At Week 62	97 Participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Number of Participants With Positive Serum Neutralizing Antibodies	At Week 54	75 Participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Number of Participants With Positive Serum Neutralizing Antibodies	At Week 30	78 Participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Number of Participants With Positive Serum Neutralizing Antibodies	At Week 46	75 Participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Number of Participants With Positive Serum Neutralizing Antibodies	At Week 38	69 Participants

Secondary

Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate

ACR20 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 20% improvement from baseline in the tender/painful joint count. ii) A 20% improvement from baseline in the swollen joint count. iii) A 20% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3 with lower scores meaning less disability, e) CRP.

Time frame: At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62

Population: Full Analysis Set population included participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR20 efficacy assessment. Overall Number of Participants indicates the number of patients with FAS. The patient number of FAS is the number of patients evaluated at baseline, which is different from number of patients who started Stage 2 or 3. ACR 20 (CRP) response rate/visit was calculated based on the number of patients achieving ACR20 criteria divided by FAS number.

Arm	Measure	Group	Value (NUMBER)
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 26	62.6 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 30	55.5 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 34	61.7 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 38	52.0 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 42	54.6 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 46	51.1 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 50	54.2 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 54	52.4 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 58	52.4 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 62	52.0 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 58	46.4 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 26	56.5 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 46	48.0 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 42	53.6 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 30	48.8 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 62	46.4 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 54	47.2 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 34	55.6 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 50	50.0 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 38	47.6 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 54	49.2 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 38	57.9 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 42	59.4 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 46	51.3 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 58	56.9 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 50	59.9 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 26	61.9 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 62	55.3 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 30	57.9 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate	At Week 34	61.4 percentage of participants

Secondary

Stage 2 and 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate

Time frame: At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62

Population: Full Analysis Set population included participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR50 efficacy assessment. Overall Number of Participants indicates the number of patients with FAS. The patient number of FAS is the number of patients evaluated at baseline, which is different from number of patients who started Stage 2 or 3. ACR 50 (CRP) response rate/visit was calculated based on the number of patients achieving ACR50 criteria divided by FAS number.

Arm	Measure	Group	Value (NUMBER)
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 26	34.4 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 30	30.0 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 34	35.2 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 38	31.3 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 42	33.5 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 46	30.8 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 50	37.0 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 54	36.6 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 58	32.6 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 62	30.8 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 58	32.7 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 26	32.3 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 46	31.5 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 42	36.7 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 30	28.6 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 62	32.7 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 54	28.6 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 34	34.3 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 50	34.7 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 38	30.2 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 54	32.5 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 38	34.0 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 42	40.6 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 46	30.5 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 58	34.0 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 50	35.5 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 26	31.0 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 62	28.4 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 30	29.4 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate	At Week 34	39.1 percentage of participants

Secondary

Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR

ACR70-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 70% improvement from baseline in the swollen joint count. iii) A 70% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) ESR.

Time frame: At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62

Population: Full Analysis Set population included participants who received at least 1 dose of study drug and had at least 1 post-baseline ACR70 efficacy assessment. Overall Number of Participants indicates the number of patients with FAS. The patient number of FAS is the number of patients evaluated at baseline, which is different from number of patients who started Stage 2 or 3. ACR 70 (CRP) response rate/visit was calculated based on the number of patients achieving ACR70 criteria divided by FAS number.

Arm	Measure	Group	Value (NUMBER)
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 26	15.4 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 30	15.4 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 34	16.7 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 38	16.3 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 42	14.5 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 46	15.4 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 50	20.7 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 54	17.2 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 58	17.2 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 62	16.3 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 58	18.1 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 26	15.3 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 46	16.9 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 42	17.3 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 30	14.1 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 62	18.1 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 54	13.3 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 34	16.9 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 50	22.6 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 38	16.1 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 54	13.7 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 38	14.2 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 42	15.7 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 46	13.2 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 58	14.7 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 50	15.7 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 26	12.7 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 62	15.2 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 30	11.7 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR	At Week 34	19.3 percentage of participants

Secondary

Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate

ACR70 was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 50% improvement from baseline in the tender/painful joint count. ii) A 70% improvement from baseline in the swollen joint count. iii) A 70% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3, with lower scores meaning less disability, e) CRP.

Time frame: At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62

Arm	Measure	Group	Value (NUMBER)
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 26	16.3 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 30	16.3 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 34	18.1 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 38	17.6 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 42	17.2 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 46	15.0 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 50	22.0 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 54	18.1 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 58	18.9 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 62	17.2 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 58	19.8 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 26	14.5 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 46	18.5 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 42	18.5 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 30	15.3 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 62	18.5 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 54	14.9 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 34	18.1 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 50	23.0 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 38	15.7 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 54	15.7 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 38	14.7 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 42	18.3 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 46	14.7 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 58	16.2 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 50	18.3 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 26	13.2 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 62	13.2 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 30	13.2 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate	At Week 34	20.8 percentage of participants

Secondary

Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)

ACR20-ESR was defined as a dichotomous variable, for which a participant was defined as either a responder or a non-responder. Participant was defined as a responder if all of the following criteria are met: i) A 20% improvement from baseline in the tender/painful joint count. ii) A 20% improvement from baseline in the swollen joint count. iii) A 20% improvement from baseline in at least 3 of the following 5 variables: a) Participant global assessment of disease activity (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), b) Physician global assessment of disease activity (VAS)(0=very good, no symptoms;100=very poor, severe symptoms), c) Participant pain assessment (VAS) (0=very good, no symptoms;100=very poor, severe symptoms), d) HAQ-DI, total score ranged from 0-3 with lower scores meaning less disability, e) (ESR.

Time frame: At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62

Arm	Measure	Group	Value (NUMBER)
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 30	58.1 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 34	62.1 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 38	56.4 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 42	57.3 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 46	53.7 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 50	56.4 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 54	54.6 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 58	54.2 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 62	52.4 percentage of participants
Stage 1: NI-071 Group	Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 26	60.8 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 62	47.2 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 30	50.0 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 50	50.8 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 46	50.0 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 34	56.9 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 26	55.6 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 58	48.8 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 38	48.8 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 54	47.2 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 42	54.4 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 58	55.8 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 42	60.9 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 46	54.3 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 50	59.4 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 62	54.3 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 54	50.8 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 30	57.4 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 26	62.4 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 34	61.4 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)	At Week 38	59.4 percentage of participants

Secondary

Stage 2 and 3: Time to Reach the Maximum Serum Concentration (Tmax) of NI-071 and Remicade US

Time frame: Week 46: Pre-dose, 1 hour after infusion, at end of infusion, at 4 hours and 24 hours after infusion and at Week 47, Week 48, Week 50, Week 52, and Week 54 post-dose

Arm	Measure	Value (MEAN)	Dispersion
Stage 1: NI-071 Group	Stage 2 and 3: Time to Reach the Maximum Serum Concentration (Tmax) of NI-071 and Remicade US	52.37 hours	Standard Deviation 243.64
Stage 1: Remicade-US Group	Stage 2 and 3: Time to Reach the Maximum Serum Concentration (Tmax) of NI-071 and Remicade US	41.57 hours	Standard Deviation 217.28
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and 3: Time to Reach the Maximum Serum Concentration (Tmax) of NI-071 and Remicade US	32.98 hours	Standard Deviation 191.02

Secondary

Stage 2 and Stage 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR

Time frame: At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62

Arm	Measure	Group	Value (NUMBER)
Stage 1: NI-071 Group	Stage 2 and Stage 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 26	33.0 percentage of participants
Stage 1: NI-071 Group	Stage 2 and Stage 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 30	29.1 percentage of participants
Stage 1: NI-071 Group	Stage 2 and Stage 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 34	35.2 percentage of participants
Stage 1: NI-071 Group	Stage 2 and Stage 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 38	32.2 percentage of participants
Stage 1: NI-071 Group	Stage 2 and Stage 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 42	33.5 percentage of participants
Stage 1: NI-071 Group	Stage 2 and Stage 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 46	29.5 percentage of participants
Stage 1: NI-071 Group	Stage 2 and Stage 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 50	34.8 percentage of participants
Stage 1: NI-071 Group	Stage 2 and Stage 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 54	36.1 percentage of participants
Stage 1: NI-071 Group	Stage 2 and Stage 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 58	32.6 percentage of participants
Stage 1: NI-071 Group	Stage 2 and Stage 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 62	29.1 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and Stage 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 58	32.3 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and Stage 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 26	31.9 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and Stage 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 46	31.5 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and Stage 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 42	36.7 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and Stage 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 30	28.2 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and Stage 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 62	32.7 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and Stage 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 54	28.6 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and Stage 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 34	34.7 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and Stage 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 50	34.3 percentage of participants
Stage 1: Remicade-US Group	Stage 2 and Stage 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 38	30.6 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and Stage 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 54	29.4 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and Stage 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 38	32.5 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and Stage 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 42	37.1 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and Stage 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 46	29.4 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and Stage 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 58	33.5 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and Stage 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 50	34.5 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and Stage 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 26	30.5 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and Stage 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 62	27.9 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and Stage 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 30	28.4 percentage of participants
Stage 2 and Stage 3: Remicade US to Switch Group	Stage 2 and Stage 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR	At Week 34	39.1 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

A Phase 3 Study of NI-071 in Participants With Rheumatoid Arthritis (RADIANCE)

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Stage 1: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR20-CRP) Response Rate at Week 22

Stage 2 and 3: Area Under the Serum Concentration-time Curve Interval (AUCtau) of NI-071 and Remicade US

Stage 2 and 3: Maximum Observed Serum Concentration (Cmax) of NI-071 and Remicade US

Number of Participants With TEAEs of Special Interest

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs

Stage 1: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 14 and 22

Stage 1: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Total Score at Weeks 14 and 22

Stage 1: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores at Weeks 2, 6, 14, 18, and 22

Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 2, 6, 14, 18, and 22

Stage 1: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 6, 14, 18, and 22

Stage 1: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 6, 14, 18, and 22

Stage 1: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)

Stage 1: Number of Participants With Positive Serum Neutralizing Antibodies

Stage 1: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate

Stage 1: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR

Stage 1: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate

Stage 1: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR

Stage 1: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate

Stage 1: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)

Stage 2 and 3: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score for Physical and Mental Components at Weeks 38 and 62

Stage 2 and 3: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Total Score at Weeks 38 and 62

Stage 2 and 3: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Scores At Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62

Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28) C-reactive Protein (CRP) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62

Stage 2 and 3: Change From Baseline in the Disease Activity Score Based on 28 Joints (DAS28)-Erythrocyte Sedimentation Rate (ESR) at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62

Stage 2 and 3: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 26, 30, 34, 38, 42, 46, 50, 54, 58, and 62

Stage 2 and 3: Minimum Observed Serum Concentration (Cmin) of NI-071 and Remicade US

Stage 2 and 3: Number of Participants With Positive Serum Anti-drug Antibodies (ADA)

Stage 2 and 3: Number of Participants With Positive Serum Neutralizing Antibodies

Stage 2 and 3: Percentage of Participants Who Achieved 20 Percent (%) American College of Rheumatology C-reactive Protein (ACR-CRP) Response Rate

Stage 2 and 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology C-reactive Protein (ACR50-CRP) Response Rate

Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology (ACR70) Response Using ESR

Stage 2 and 3: Percentage of Participants Who Achieved >=70% American College of Rheumatology C-reactive Protein (ACR70-CRP) Response Rate

Stage 2 and 3: Percentage of Participants Who Achieved Greater Than or Equal to (>=) 20% American College of Rheumatology (ACR20) Response Using Erythrocyte Sedimentation Rate (ESR)

Stage 2 and 3: Time to Reach the Maximum Serum Concentration (Tmax) of NI-071 and Remicade US

Stage 2 and Stage 3: Percentage of Participants Who Achieved >=50% American College of Rheumatology (ACR50) Response Using ESR