Trial Outcomes & Findings for Phase 3 Study of M923 and Humira® in Subjects With Chronic Plaque-type Psoriasis (NCT NCT02581345)

Last Updated: 2018-10-17

Results Overview

The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Participants achieving PASI 75 are defined as having an improvement (reduction) of at least 75% in the Week 16 PASI score compared to the score at Baseline.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

572 participants

Primary outcome timeframe

Baseline; Week 16

Results posted on

2018-10-17

Participant Flow

A total of 572 participants were enrolled and randomized equally into M923 and European Union reference protein product (EU RPP) arms. One participant in each arm did not receive any treatment. The 263 participants completing EU RPP treatment in Part 1 were randomized to 1 of 2 treatment arms in Part 2 (Transition and Continuous).

Participant milestones

Participant milestones
Measure	Part 1 and Part 2: M923 Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection. Participants who received M923 in Part 1 continued to receive 40 mg M923 every 2 weeks from Week 17 to Week 48 (last dose at Week 47) as a subcutaneous injection.	Part 1: EU RPP Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection	Part 1: EU RPP; Part 2: Transition Participants received 80 mg EU RPP at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection. At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 1: EU RPP; Part 2: Continous Participants received 80 mg EU RPP at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection. Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Part 1: up to Week 16 STARTED	286	286	0	0
Part 1: up to Week 16 COMPLETED	271	263	0	0
Part 1: up to Week 16 NOT COMPLETED	15	23	0	0
Part 2: Week 17 to Week 47 STARTED	271	0	132	131
Part 2: Week 17 to Week 47 COMPLETED	242	0	117	119
Part 2: Week 17 to Week 47 NOT COMPLETED	29	0	15	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1 and Part 2: M923 Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection. Participants who received M923 in Part 1 continued to receive 40 mg M923 every 2 weeks from Week 17 to Week 48 (last dose at Week 47) as a subcutaneous injection.	Part 1: EU RPP Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection	Part 1: EU RPP; Part 2: Transition Participants received 80 mg EU RPP at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection. At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 1: EU RPP; Part 2: Continous Participants received 80 mg EU RPP at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection. Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Part 1: up to Week 16 Adverse Event	3	8	0	0
Part 1: up to Week 16 Physician Decision	2	4	0	0
Part 1: up to Week 16 Withdrawal by Subject	4	7	0	0
Part 1: up to Week 16 Lost to Follow-up	2	0	0	0
Part 1: up to Week 16 Unspecified Reason	3	3	0	0
Part 1: up to Week 16 Did Not Receive Treatment	1	1	0	0
Part 2: Week 17 to Week 47 Adverse Event	5	0	2	2
Part 2: Week 17 to Week 47 Physician Decision	3	0	2	1
Part 2: Week 17 to Week 47 Withdrawal by Subject	9	0	7	5
Part 2: Week 17 to Week 47 Failure to Achieve at Least a PASI 50	8	0	3	2
Part 2: Week 17 to Week 47 Lost to Follow-up	2	0	0	1
Part 2: Week 17 to Week 47 Unspecified Reason	2	0	1	1

Baseline Characteristics

Analysis was conducted using the Modified Intent-to-treat (mITT) Analysis Set including all consenting subjects randomized to study treatment (Arm A or Arm B) and contributed post-baseline data for at least one efficacy endpoint.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1 and Part 2: M923 n=286 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 48 as a subcutaneous injection.	Part 1 and Part 2: EU RPP n=286 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection. Participants from this arm were then randomized at Week 16 into either Arm: Continuous EU RPP (continued EU RPP from Weeks 17 to 48 \[last dose at Week 47\]) or Arm: Transition EU RPP (transition to M923 at Week 17; then to EU RPP at Week 25; and then to M923 at Week 37 \[last dose at Week 47\]).	Total n=572 Participants Total of all reporting groups
Age, Continuous	44.6 years STANDARD_DEVIATION 12.4 • n=286 Participants	45.5 years STANDARD_DEVIATION 12.9 • n=286 Participants	45.0 years STANDARD_DEVIATION 12.6 • n=572 Participants
Sex: Female, Male Female	95 Participants n=286 Participants	100 Participants n=286 Participants	195 Participants n=572 Participants
Sex: Female, Male Male	191 Participants n=286 Participants	186 Participants n=286 Participants	377 Participants n=572 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=286 Participants	1 Participants n=286 Participants	1 Participants n=572 Participants
Race (NIH/OMB) Asian	2 Participants n=286 Participants	1 Participants n=286 Participants	3 Participants n=572 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=286 Participants	0 Participants n=286 Participants	0 Participants n=572 Participants
Race (NIH/OMB) Black or African American	3 Participants n=286 Participants	1 Participants n=286 Participants	4 Participants n=572 Participants
Race (NIH/OMB) White	281 Participants n=286 Participants	282 Participants n=286 Participants	563 Participants n=572 Participants
Race (NIH/OMB) More than one race	0 Participants n=286 Participants	0 Participants n=286 Participants	0 Participants n=572 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=286 Participants	1 Participants n=286 Participants	1 Participants n=572 Participants
Psoriasis Area and Severity Index (PASI) Score	21.24 units on a scale STANDARD_DEVIATION 9.27 • n=285 Participants • Analysis was conducted using the Modified Intent-to-treat (mITT) Analysis Set including all consenting subjects randomized to study treatment (Arm A or Arm B) and contributed post-baseline data for at least one efficacy endpoint.	20.16 units on a scale STANDARD_DEVIATION 8.16 • n=285 Participants • Analysis was conducted using the Modified Intent-to-treat (mITT) Analysis Set including all consenting subjects randomized to study treatment (Arm A or Arm B) and contributed post-baseline data for at least one efficacy endpoint.	20.70 units on a scale STANDARD_DEVIATION 8.74 • n=570 Participants • Analysis was conducted using the Modified Intent-to-treat (mITT) Analysis Set including all consenting subjects randomized to study treatment (Arm A or Arm B) and contributed post-baseline data for at least one efficacy endpoint.
Number of Participants with the Indicated Static Physician's Global Assessment (sPGA) Score Moderate	170 Participants n=285 Participants • mITT Analysis Set	182 Participants n=285 Participants • mITT Analysis Set	352 Participants n=570 Participants • mITT Analysis Set
Number of Participants with the Indicated Static Physician's Global Assessment (sPGA) Score Severe	103 Participants n=285 Participants • mITT Analysis Set	91 Participants n=285 Participants • mITT Analysis Set	194 Participants n=570 Participants • mITT Analysis Set
Number of Participants with the Indicated Static Physician's Global Assessment (sPGA) Score Very Severe	12 Participants n=285 Participants • mITT Analysis Set	12 Participants n=285 Participants • mITT Analysis Set	24 Participants n=570 Participants • mITT Analysis Set
Number of Participants with the Indicated Static Physician's Global Assessment (sPGA) Score Clear	0 Participants n=285 Participants • mITT Analysis Set	0 Participants n=285 Participants • mITT Analysis Set	0 Participants n=570 Participants • mITT Analysis Set
Number of Participants with the Indicated Static Physician's Global Assessment (sPGA) Score Almost Clear	0 Participants n=285 Participants • mITT Analysis Set	0 Participants n=285 Participants • mITT Analysis Set	0 Participants n=570 Participants • mITT Analysis Set
Number of Participants with the Indicated Static Physician's Global Assessment (sPGA) Score Mild	0 Participants n=285 Participants • mITT Analysis Set	0 Participants n=285 Participants • mITT Analysis Set	0 Participants n=570 Participants • mITT Analysis Set

PRIMARY outcome

Timeframe: Baseline; Week 16

Population: Per Protocol (PP) Analysis Set: subgroup of the Intent-To-Treat (ITT) Analysis Set that included all participants who did not have any deviations from the protocol deemed significant enough for exclusion from the efficacy analysis and received at least 1 dose of study drug

Outcome measures

Outcome measures
Measure	Part 1: M923 n=267 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=271 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Percentage of Participants Who Achieved a 75% Reduction in Psoriasis Area and Severity Index (PASI) (PASI 75) Scores at Week 16	80.1 percentage of participants Interval 74.9 to 84.8	79.0 percentage of participants Interval 73.6 to 83.7	—	—	—

SECONDARY outcome

Timeframe: Week 16

Population: PP Analysis Set

The sPGA response rate was defined as the percentage of participants who had achieved a clear or almost clear response on the 6-point sPGA scale. The sPGA was the physician's determination of the participant's psoriasis lesions overall at a given time point. Overall lesions were categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis was assessed at a given time point on a 6-point scale on which 0 = cleared, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe.

Outcome measures

Outcome measures
Measure	Part 1: M923 n=267 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=271 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Percentage of Participants With a Response of Clear or Almost Clear on the Static Physician Global Assessment (sPGA) at Week 16	68.9 percentage of participants Interval 63.0 to 74.4	66.1 percentage of participants Interval 60.1 to 71.7	—	—	—

SECONDARY outcome

Timeframe: Baseline; Week 16

Population: PP Analysis Set

The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Participants achieving PASI 50 are defined as having an improvement (reduction) of at least 50% compared to Baseline.

Outcome measures

Outcome measures
Measure	Part 1: M923 n=267 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=271 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Number of Participants Achieving PASI 50 Response at Week 16	243 Participants	253 Participants	—	—	—

SECONDARY outcome

Timeframe: Baseline; Week 52

Population: PP Analysis Set. Only those participants contributing data at Week 52 were analyzed.

The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Participants achieving PASI 50 are defined as having an improvement (reduction) of at least 50% compared to Baseline.

Outcome measures

Outcome measures
Measure	Part 1: M923 n=258 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=130 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP n=129 Participants Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Number of Participants Achieving PASI 50 Response at Week 52 (Follow-Up Visit)	228 Participants	111 Participants	113 Participants	—	—

SECONDARY outcome

Timeframe: Baseline; Week 52

Population: PP Analysis Set. Only those participants contributing data at Week 52 were analyzed.

Outcome measures

Outcome measures
Measure	Part 1: M923 n=258 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=130 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP n=129 Participants Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Number of Participants Achieving PASI 75 Response at Week 52 (Follow-Up Visit)	202 Participants	96 Participants	101 Participants	—	—

SECONDARY outcome

Timeframe: Baseline; Week 16

Population: PP Analysis Set

The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Participants achieving PASI 90 are defined as having an improvement (reduction) of at least 90% compared to Baseline.

Outcome measures

Outcome measures
Measure	Part 1: M923 n=267 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=271 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Number of Participants Achieving PASI 90 Response at Week 16	165 Participants	147 Participants	—	—	—

SECONDARY outcome

Timeframe: Baseline; Week 52

Population: PP Analysis Set. Only those participants contributing data at Week 52 were analyzed.

The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Participants achieving PASI 90 are defined as having an improvement (reduction) of at least 90% compared to Baseline.

Outcome measures

Outcome measures
Measure	Part 1: M923 n=258 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=130 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP n=129 Participants Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Number of Participants Achieving PASI 90 Response at Week 52 (Follow-Up Visit)	159 Participants	71 Participants	77 Participants	—	—

SECONDARY outcome

Timeframe: Baseline

Population: Analysis was performed using PP Analysis Set including participants with evaluable data for part 1 and part 2 of the study are included in the analyses.

Outcome measures

Outcome measures
Measure	Part 1: M923 n=267 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=271 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Absolute PASI Score at Baseline	21.34 units on a scale Standard Deviation 9.268	20.29 units on a scale Standard Deviation 8.266	—	—	—

SECONDARY outcome

Timeframe: Week 16

Population: PP Analysis Set. Only those participants contributing data at Week 16 were analyzed.

Outcome measures

Outcome measures
Measure	Part 1: M923 n=261 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=263 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Absolute PASI Score at Week 16	2.58 units on a scale Standard Deviation 4.092	2.50 units on a scale Standard Deviation 3.098	—	—	—

SECONDARY outcome

Timeframe: Week 52

Population: PP Analysis Set. Only those participants contributing data at Week 52 were analyzed.

Outcome measures

Outcome measures
Measure	Part 1: M923 n=246 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=120 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP n=124 Participants Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Absolute PASI Score at Week 52 (Follow-Up Visit)	2.76 units on a scale Standard Deviation 4.768	2.85 units on a scale Standard Deviation 4.913	2.67 units on a scale Standard Deviation 3.919	—	—

SECONDARY outcome

Timeframe: Baseline; Week 16

Population: PP Analysis Set. Only those participants contributing data at Week 16 were analyzed.

The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Percent change from Baseline was calculated as: (post-Baseline value - Baseline value) / (Baseline value) \* 100.

Outcome measures

Outcome measures
Measure	Part 1: M923 n=261 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=263 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Percent Change From Baseline in PASI Score at Week 16	-86.21 percent change Standard Deviation 20.065	-86.79 percent change Standard Deviation 15.756	—	—	—

SECONDARY outcome

Timeframe: Baseline; Week 52

Population: PP Analysis Set. Only those participants contributing data at Week 52 were analyzed.

The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Percent change from Baseline was calculated as: (post-Baseline value - Baseline value) / (Baseline value) \* 100.

Outcome measures

Outcome measures
Measure	Part 1: M923 n=246 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=120 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP n=124 Participants Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Percent Change From Baseline in PASI Score at Week 52 (Follow-Up Visit)	-86.43 percent change Standard Deviation 22.570	-85.53 percent change Standard Deviation 21.771	-85.64 percent change Standard Deviation 20.968	—	—

SECONDARY outcome

Timeframe: Baseline

Population: Analysis was performed using PP Analysis Set including participants with evaluable data for part 1 and part 2 of the study.

The DLQI score was calculated by summing the individual scores of each question at a given time point, resulting in a maximum score of 30 and a minimum score of 0. The higher the score, the more quality of life is impaired. For the analysis of responses, the participant's results were assessed on a scoring scale on which 3 = very much or yes (applicable to question 7 only), 2 = a lot, 1 = a little, 0 = not at all or not relevant. Interpretation of DLQI scoring can be taken as 0 - 1 = no effect at all on participant's life, 2 - 5 = small effect on participant's life, 6 - 10 = moderate effect on participant's life, 11 - 20 = very large effect on participant's life, and 21 - 30 = extremely large effect on participant's life.

Outcome measures

Outcome measures
Measure	Part 1: M923 n=267 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=271 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Health-Related Quality of Life During Treatment: Dermatology Life Quality Index (DLQI) Score at Baseline	12.5 units on a scale Standard Deviation 7.13	10.5 units on a scale Standard Deviation 6.71	—	—	—

SECONDARY outcome

Timeframe: Week 16

Population: PP Analysis Set. Only those participants contributing data at Week 16 were analyzed.

Outcome measures

Outcome measures
Measure	Part 1: M923 n=258 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=259 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Health-Related Quality of Life During Treatment: DLQI Score at Week 16	2.4 units on a scale Standard Deviation 4.04	2.1 units on a scale Standard Deviation 3.50	—	—	—

SECONDARY outcome

Timeframe: Week 48

Population: PP Analysis Set. Only those participants contributing data at Week 48 were analyzed.

Outcome measures

Outcome measures
Measure	Part 1: M923 n=232 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=115 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP n=117 Participants Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Health-Related Quality of Life During Treatment: DLQI Score at Week 48 (Completion/Termination Visit)	2.1 units on a scale Standard Deviation 3.77	1.6 units on a scale Standard Deviation 2.83	2.1 units on a scale Standard Deviation 3.97	—	—

SECONDARY outcome

Timeframe: Baseline

Population: Analysis was performed using PP Analysis Set including participants with evaluable data for part 1 and part 2 of the study.

The EQ-5D-5L health score was measured on a Visual Analog Scale (VAS) anchored by 0 = "worst health you can imagine" and 100 = "best health you can imagine". Baseline was defined as the last scheduled observation prior to dosing, typically Day 1, predose.

Outcome measures

Outcome measures
Measure	Part 1: M923 n=267 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=271 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Health-Related Quality of Life During Treatment: EuroQoL 5-Dimension Health Status Questionnaire (EQ-5D-5L) at Baseline	71.3 units on a scale Standard Deviation 18.70	72.5 units on a scale Standard Deviation 20.27	—	—	—

SECONDARY outcome

Timeframe: Week 16

Population: PP Analysis Set. Only those participants contributing data at Week 16 were analyzed.

The EQ-5D-5L health score was measured on a Visual Analog Scale (VAS) anchored by 0 = "worst health you can imagine" and 100 = "best health you can imagine".

Outcome measures

Outcome measures
Measure	Part 1: M923 n=258 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=259 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Health-Related Quality of Life During Treatment: EQ-5D-5L at Week 16	83.7 units on a scale Standard Deviation 12.38	83.4 units on a scale Standard Deviation 13.92	—	—	—

SECONDARY outcome

Timeframe: Week 48

Population: PP Analysis Set. Only those participants contributing data at Week 48 were analyzed.

The EQ-5D-5L health score was measured on a Visual Analog Scale (VAS) anchored by 0 = "worst health you can imagine" and 100 = "best health you can imagine".

Outcome measures

Outcome measures
Measure	Part 1: M923 n=232 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=115 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP n=117 Participants Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Health-Related Quality of Life During Treatment: EQ-5D-5L at Week 48 (Completion/Termination Visit)	85.3 units on a scale Standard Deviation 13.83	83.9 units on a scale Standard Deviation 14.92	84.2 units on a scale Standard Deviation 12.98	—	—

SECONDARY outcome

Timeframe: Up to Week 52

Population: Safety Analysis Set

Vital signs included body temperature, respiratory rate, pulse rate, systolic and diastolic blood pressure, and weight. Clinically meaningful changes were classified as such by the Investigator and reported as adverse events.

Outcome measures

Outcome measures
Measure	Part 1: M923 n=285 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=285 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP n=271 Participants Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP n=132 Participants At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP n=131 Participants Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Number of Participants With Clinically Meaningful Changes in Vital Signs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline

Population: Safety Analysis Set

Laboratory results included hematology \[Hemoglobin, Hematocrit, Platelet count, Mean cell volume, White blood cell count (total leucocytes), Neutrophils absolute, Neutrophils, Lymphocytes absolute, Lymphocytes, Monocytes, Eosinophils absolute, and Eosinophils\], chemistry (Aspartate transaminase, Alanine transaminase, Gamma glutamyl transferase, Creatine kinase, C-reactive protein, Cholesterol, Triglycerides, Total protein, Potassium, Urea, Creatinine, Phosphate, Glucose, and Uric acid) and urinalysis \[Specific Gravity\] parameters. Laboratory results of a few hematology (Red Blood Cell Count and Monocytes absolute), chemistry (Alkaline Phosphatase, Total bilirubin, Sodium, Chloride, and Albumin), and urinalysis (pH) parameters were not assessed at Baseline and Week 16. Clinically meaningful changes were classified as such by the Investigator and reported as adverse events.

Outcome measures

Outcome measures
Measure	Part 1: M923 n=285 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=285 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline Hemoglobin	0 Participants	0 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline Hematocrit	0 Participants	0 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline Platelet count	0 Participants	0 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline Mean cell volume	0 Participants	0 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline White blood cell count (total leucocytes)	1 Participants	1 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline Neutrophils absolute	2 Participants	1 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline Neutrophils	1 Participants	0 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline Lymphocytes absolute	1 Participants	1 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline Lymphocytes	1 Participants	1 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline Monocytes	0 Participants	0 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline Eosinophils absolute	0 Participants	0 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline Eosinophils	0 Participants	0 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline Aspartate transaminase	0 Participants	0 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline Alanine transaminase	1 Participants	1 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline Gamma glutamyl transferase	1 Participants	4 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline Creatine kinase	2 Participants	0 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline C-reactive protein	6 Participants	2 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline Cholesterol	2 Participants	4 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline Triglycerides	3 Participants	2 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline Total protein	0 Participants	1 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline Potassium	1 Participants	0 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline Urea	1 Participants	0 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline Creatinine	0 Participants	0 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline Phosphate	0 Participants	0 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline Glucose	1 Participants	2 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline Uric acid	2 Participants	0 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline Specific Gravity	0 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Week 16

Population: Safety Analysis Set

Outcome measures

Outcome measures
Measure	Part 1: M923 n=285 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=285 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16 Hemoglobin	1 Participants	1 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16 Hematocrit	1 Participants	1 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16 Platelet count	0 Participants	0 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16 Mean cell volume	0 Participants	1 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16 White blood cell count (total leucocytes)	2 Participants	0 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16 Neutrophils absolute	1 Participants	0 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16 Neutrophils	0 Participants	0 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16 Lymphocytes absolute	0 Participants	1 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16 Lymphocytes	0 Participants	1 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16 Monocytes	0 Participants	0 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16 Eosinophils absolute	1 Participants	0 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16 Eosinophils	1 Participants	0 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16 Aspartate transaminase	2 Participants	0 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16 Alanine transaminase	3 Participants	1 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16 Gamma glutamyl transferase	3 Participants	2 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16 Creatine kinase	2 Participants	0 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16 C-reactive protein	1 Participants	0 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16 Cholesterol	4 Participants	3 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16 Triglycerides	5 Participants	3 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16 Total protein	0 Participants	1 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16 Potassium	1 Participants	0 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16 Urea	0 Participants	0 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16 Creatinine	0 Participants	0 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16 Phosphate	0 Participants	0 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16 Glucose	2 Participants	3 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16 Uric acid	1 Participants	1 Participants	—	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16 Specific Gravity	0 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Week 48

Population: Safety Analysis Set

Laboratory results included hematology \[Red Blood Cell Count, Hemoglobin, Hematocrit, Platelet count, Mean cell volume, White blood cell count (total leucocytes), Neutrophils absolute, Neutrophils, Lymphocytes absolute, Lymphocytes, Monocytes absolute, Monocytes, Eosinophils absolute, and Eosinophils\], chemistry (Aspartate transaminase, Alanine transaminase, Alkaline Phosphatase, Gamma glutamyl transferase, Total bilirubin, Creatine kinase, C-reactive protein, Cholesterol, Triglycerides, Total protein, Sodium, Potassium, Chloride, Urea, Creatinine, Albumin, Phosphate, Glucose, and Uric acid) and urinalysis \[pH and Specific Gravity\] parameters. Clinically meaningful changes were classified as such by the Investigator and reported as adverse events.

Outcome measures

Outcome measures
Measure	Part 1: M923 n=271 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=132 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP n=131 Participants Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) Red Blood Cell Count	1 Participants	0 Participants	1 Participants	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) Hemoglobin	1 Participants	0 Participants	1 Participants	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) Hematocrit	1 Participants	0 Participants	1 Participants	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) Platelet count	1 Participants	0 Participants	0 Participants	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) Mean cell volume	0 Participants	0 Participants	1 Participants	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) White blood cell count (total leucocytes)	2 Participants	1 Participants	1 Participants	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) Neutrophils absolute	3 Participants	1 Participants	2 Participants	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) Neutrophils	3 Participants	0 Participants	0 Participants	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) Lymphocytes absolute	0 Participants	0 Participants	1 Participants	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) Lymphocytes	1 Participants	0 Participants	0 Participants	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) Monocytes absolute	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) Monocytes	1 Participants	0 Participants	0 Participants	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) Eosinophils absolute	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) Eosinophils	2 Participants	0 Participants	0 Participants	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) Aspartate transaminase	2 Participants	0 Participants	1 Participants	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) Alanine transaminase	5 Participants	0 Participants	3 Participants	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) Alkaline Phosphatase	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) Gamma glutamyl transferase	3 Participants	0 Participants	3 Participants	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) Total bilirubin	1 Participants	0 Participants	1 Participants	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) Creatine kinase	0 Participants	1 Participants	1 Participants	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) C-reactive protein	3 Participants	0 Participants	0 Participants	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) Cholesterol	7 Participants	3 Participants	2 Participants	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) Triglycerides	11 Participants	4 Participants	2 Participants	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) Total protein	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) Sodium	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) Potassium	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) Chloride	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) Urea	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) Creatinine	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) Albumin	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) Phosphate	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) Glucose	5 Participants	3 Participants	0 Participants	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) Uric acid	1 Participants	3 Participants	3 Participants	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) pH	1 Participants	1 Participants	0 Participants	—	—
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit) Specific Gravity	0 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Baseline

Population: Safety Analysis Set

Clinically significant abnormalities were classified as such by the Investigator and reported as adverse events.

Outcome measures

Outcome measures
Measure	Part 1: M923 n=285 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=285 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram Parameters at Baseline	0 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Week 16

Population: Safety Analysis Set

Clinically significant abnormalities were classified as such by the Investigator and reported as adverse events.

Outcome measures

Outcome measures
Measure	Part 1: M923 n=285 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=285 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram Parameters at Week 16	2 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Week 48

Population: Safety Analysis Set

Clinically significant abnormalities were classified as such by the Investigator and reported as adverse events.

Outcome measures

Outcome measures
Measure	Part 1: M923 n=271 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=132 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP n=131 Participants Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram Parameters at Week 48 (Completion/Termination Visit)	3 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Up to Week 52

Population: Safety Analysis Set

TEAEs are adverse events that occurred during or after study drug administration. For more details on adverse events please refer the safety section.

Outcome measures

Outcome measures
Measure	Part 1: M923 n=285 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=285 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP n=271 Participants Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP n=132 Participants At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP n=131 Participants Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	169 Participants	194 Participants	199 Participants	99 Participants	103 Participants

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 8, 16, 17, 21, 25, 29, 37, and 41

Population: Pharmacokinetic (PK) Analysis Set: all participants who received at least 1 dose of study drug and had at least 1 measured concentration at a scheduled PK time point after start of dosing. Only participants with evaluable data were analyzed.

Serum samples were collected at Baseline (Week 0, perdose), approximately 1 week (peak) after IP administration (Weeks 8 and 16), and 2 weeks after dose administration as a trough sample collected prior to the next dose administration (Weeks 17, 21, 25, 29, 37, 41).

Outcome measures

Outcome measures
Measure	Part 1: M923 n=282 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=281 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP n=267 Participants Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP n=130 Participants At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP n=130 Participants Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Pharmacokinetics: Serum Concentrations by Treatment Baseline (Week 0)/Predose	302 nanograms per milliter (ng/mL) Standard Deviation 16.5	301 nanograms per milliter (ng/mL) Standard Deviation 9.69	—	—	—
Pharmacokinetics: Serum Concentrations by Treatment Week 8/Peak	9100 nanograms per milliter (ng/mL) Standard Deviation 5450	7640 nanograms per milliter (ng/mL) Standard Deviation 4370	—	—	—
Pharmacokinetics: Serum Concentrations by Treatment Week 16/Peak	8580 nanograms per milliter (ng/mL) Standard Deviation 5700	6990 nanograms per milliter (ng/mL) Standard Deviation 5100	—	—	—
Pharmacokinetics: Serum Concentrations by Treatment Week 17/Trough	—	—	6900 nanograms per milliter (ng/mL) Standard Deviation 5270	5840 nanograms per milliter (ng/mL) Standard Deviation 4840	5340 nanograms per milliter (ng/mL) Standard Deviation 4050
Pharmacokinetics: Serum Concentrations by Treatment Week 21/Trough	—	—	6630 nanograms per milliter (ng/mL) Standard Deviation 4960	6260 nanograms per milliter (ng/mL) Standard Deviation 4960	5100 nanograms per milliter (ng/mL) Standard Deviation 4040
Pharmacokinetics: Serum Concentrations by Treatment Week 25/Trough	—	—	6790 nanograms per milliter (ng/mL) Standard Deviation 5210	6320 nanograms per milliter (ng/mL) Standard Deviation 5260	4970 nanograms per milliter (ng/mL) Standard Deviation 3870
Pharmacokinetics: Serum Concentrations by Treatment Week 29/Trough	—	—	5990 nanograms per milliter (ng/mL) Standard Deviation 4020	5330 nanograms per milliter (ng/mL) Standard Deviation 4000	4840 nanograms per milliter (ng/mL) Standard Deviation 3480
Pharmacokinetics: Serum Concentrations by Treatment Week 37/Trough	—	—	6120 nanograms per milliter (ng/mL) Standard Deviation 4220	5250 nanograms per milliter (ng/mL) Standard Deviation 4190	4830 nanograms per milliter (ng/mL) Standard Deviation 3680
Pharmacokinetics: Serum Concentrations by Treatment Week 41/Trough	—	—	5950 nanograms per milliter (ng/mL) Standard Deviation 4230	5480 nanograms per milliter (ng/mL) Standard Deviation 4140	4740 nanograms per milliter (ng/mL) Standard Deviation 3710

SECONDARY outcome

Timeframe: Baseline (Week 0)

Population: Safety Analysis Set

The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose; if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. The same convention applied for the neutralizing assay results.

Outcome measures

Outcome measures
Measure	Part 1: M923 n=285 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=285 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Immunogenicity: Number of Participants With Anti-Drug Antibodies (ADA) at Baseline EU Humera	15 Participants	11 Participants	—	—	—
Immunogenicity: Number of Participants With Anti-Drug Antibodies (ADA) at Baseline M923	1 Participants	2 Participants	—	—	—
Immunogenicity: Number of Participants With Anti-Drug Antibodies (ADA) at Baseline Overall Results	16 Participants	13 Participants	—	—	—
Immunogenicity: Number of Participants With Anti-Drug Antibodies (ADA) at Baseline Neutralizing ADA	4 Participants	2 Participants	—	—	—

SECONDARY outcome

Timeframe: Week 16

Population: Safety Analysis Set

Outcome measures

Outcome measures
Measure	Part 1: M923 n=285 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=285 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Immunogenicity: Number of Participants With ADA at Week 16 EU Humera	135 Participants	144 Participants	—	—	—
Immunogenicity: Number of Participants With ADA at Week 16 M923	4 Participants	8 Participants	—	—	—
Immunogenicity: Number of Participants With ADA at Week 16 Overall Results	139 Participants	152 Participants	—	—	—
Immunogenicity: Number of Participants With ADA at Week 16 Neutralizing ADA	28 Participants	30 Participants	—	—	—

SECONDARY outcome

Timeframe: Week 25

Population: Safety Analysis Set

Outcome measures

Outcome measures
Measure	Part 1: M923 n=271 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=132 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP n=131 Participants Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Immunogenicity: Number of Participants With ADA at Week 25 EU Humera	144 Participants	80 Participants	92 Participants	—	—
Immunogenicity: Number of Participants With ADA at Week 25 M923	12 Participants	5 Participants	5 Participants	—	—
Immunogenicity: Number of Participants With ADA at Week 25 Overall result	156 Participants	85 Participants	97 Participants	—	—
Immunogenicity: Number of Participants With ADA at Week 25 Neutralizing ADA	55 Participants	25 Participants	32 Participants	—	—

SECONDARY outcome

Timeframe: Week 52

Population: Safety Analysis Set

Outcome measures

Outcome measures
Measure	Part 1: M923 n=271 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=132 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP n=131 Participants Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Immunogenicity: Number of Participants With ADA at Week 52 (Completion/Termination Visit) M923	10 Participants	6 Participants	7 Participants	—	—
Immunogenicity: Number of Participants With ADA at Week 52 (Completion/Termination Visit) Overall result	141 Participants	79 Participants	87 Participants	—	—
Immunogenicity: Number of Participants With ADA at Week 52 (Completion/Termination Visit) Neutralizing ADA	40 Participants	28 Participants	23 Participants	—	—
Immunogenicity: Number of Participants With ADA at Week 52 (Completion/Termination Visit) EU Humera	131 Participants	73 Participants	80 Participants	—	—

SECONDARY outcome

Timeframe: Baseline (Week 0)

Population: Safety Analysis Set

The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose); if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. In confirmed positive samples, an assay was used to determine the relative titer of the ADA; a subsequent neutralizing antibodies assay was used to determine the presence of neutralizing antibodies.

Outcome measures

Outcome measures
Measure	Part 1: M923 n=285 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=285 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Immunogenicity: Number of Participants With ADA and nADA by Titer at Baseline No positive result	266 Participants	271 Participants	—	—	—
Immunogenicity: Number of Participants With ADA and nADA by Titer at Baseline Predose positive result	16 Participants	13 Participants	—	—	—

SECONDARY outcome

Timeframe: Week 16

Population: Safety Analysis Set

The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose); if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. In confirmed positive samples, an assay was used to determine the relative titer of the ADA; a subsequent neutralizing antibodies assay was used to determine the presence of neutralizing antibodies.

Outcome measures

Outcome measures
Measure	Part 1: M923 n=285 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=285 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 16 Titers ≤ 1:16 (postdose positive ADAs)	16 Participants	26 Participants	—	—	—
Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 16 Titers ≤ 1:16 (postdose positive nADAs)	2 Participants	2 Participants	—	—	—
Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 16 Titers > 1:16 to ≤ 1:128 (postdose positive ADAs)	90 Participants	73 Participants	—	—	—
Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 16 Titers > 1:16 to ≤ 1:128 (postdose positive nADAs)	17 Participants	6 Participants	—	—	—
Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 16 Titers >1:128 to ≤ 1:152 (postdose positive ADAs)	27 Participants	40 Participants	—	—	—
Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 16 Titers >1:128 to ≤ 1:152 (postdose positive nADAs)	3 Participants	11 Participants	—	—	—
Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 16 Titers >1:152 (postdose positive ADAs)	6 Participants	13 Participants	—	—	—
Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 16 Titers >1:152 (postdose positive nADAs)	6 Participants	11 Participants	—	—	—

SECONDARY outcome

Timeframe: Week 25

Population: Safety Analysis Set

The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose); if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. In confirmed positive samples, an assay was used to determine the relative titer of the ADA; a subsequent neutralizing antibodies assay was used to determine the presence of neutralizing antibodies.

Outcome measures

Outcome measures
Measure	Part 1: M923 n=285 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=132 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP n=131 Participants Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 25 Titers ≤ 1:16 (postdose positive ADAs)	24 Participants	19 Participants	21 Participants	—	—
Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 25 Titers ≤ 1:16 (postdose positive nADAs)	6 Participants	2 Participants	4 Participants	—	—
Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 25 Titers > 1:16 to ≤ 1:128 (postdose positive ADAs)	86 Participants	37 Participants	42 Participants	—	—
Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 25 Titers > 1:16 to ≤ 1:128 (postdose positive nADAs)	17 Participants	4 Participants	7 Participants	—	—
Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 25 Titers >1:128 to ≤ 1:152 (postdose positive ADAs)	28 Participants	14 Participants	22 Participants	—	—
Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 25 Titers >1:128 to ≤ 1:152 (postdose positive nADAs)	16 Participants	6 Participants	10 Participants	—	—
Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 25 Titers >1:152 (postdose positive ADAs)	18 Participants	15 Participants	12 Participants	—	—
Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 25 Titers >1:152 (postdose positive nADAs)	16 Participants	13 Participants	11 Participants	—	—

SECONDARY outcome

Timeframe: Week 52

Population: Safety Analysis Set

The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose); if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. In confirmed positive samples, an assay was used to determine the relative titer of the ADA; a subsequent neutralizing antibodies assay was used to determine the presence of neutralizing antibodies.

Outcome measures

Outcome measures
Measure	Part 1: M923 n=285 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=132 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP n=131 Participants Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 52 (Completion/Termination Visit) Titers ≤ 1:16 (postdose positive ADAs)	26 Participants	11 Participants	17 Participants	—	—
Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 52 (Completion/Termination Visit) Titers ≤ 1:16 (postdose positive nADAs)	0 Participants	2 Participants	3 Participants	—	—
Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 52 (Completion/Termination Visit) Titers > 1:16 to ≤ 1:128 (postdose positive ADAs)	62 Participants	37 Participants	38 Participants	—	—
Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 52 (Completion/Termination Visit) Titers > 1:16 to ≤ 1:128 (postdose positive nADAs)	13 Participants	6 Participants	5 Participants	—	—
Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 52 (Completion/Termination Visit) Titers >1:128 to ≤ 1:152 (postdose positive ADAs)	23 Participants	12 Participants	15 Participants	—	—
Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 52 (Completion/Termination Visit) Titers >1:128 to ≤ 1:152 (postdose positive nADAs)	9 Participants	6 Participants	2 Participants	—	—
Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 52 (Completion/Termination Visit) Titers >1:152 (postdose positive ADAs)	13 Participants	7 Participants	10 Participants	—	—
Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 52 (Completion/Termination Visit) Titers >1:152 (postdose positive nADAs)	11 Participants	6 Participants	7 Participants	—	—

SECONDARY outcome

Timeframe: Up to Week 52

Population: Safety Analysis Set. Only those participants who had a postdose seroconversion time were analyzed.

Time to seroconversion (in days) was defined as the time to the observation of the first confirmed positive ADA response. Participants with confirmed positive ADA response at baseline (Week 0 predose) were excluded.

Outcome measures

Outcome measures
Measure	Part 1: M923 n=216 Participants Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=106 Participants Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: Continuous EU RPP n=120 Participants Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).	Part 2: Transition EU RPP At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Median Time to Seroconversion	113.0 days Interval 52.0 to 372.0	113.0 days Interval 51.0 to 375.0	112.0 days Interval 54.0 to 373.0	—	—

Adverse Events

Part 1: M923

Serious events: 4 serious events

Other events: 92 other events

Deaths: 0 deaths

Part 1: EU RPP

Serious events: 7 serious events

Other events: 104 other events

Deaths: 0 deaths

Part 2: M923

Serious events: 10 serious events

Other events: 96 other events

Deaths: 0 deaths

Part 2: Transition EU RPP

Serious events: 10 serious events

Other events: 47 other events

Deaths: 0 deaths

Part 2: Continuous EU RPP

Serious events: 8 serious events

Other events: 63 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1: M923 n=285 participants at risk Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=285 participants at risk Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: M923 n=271 participants at risk Participants who received M923 in Part 1 continued to receive 40 mg M923 every 2 weeks from Week 17 to Week 48 (last dose at Week 47) as a subcutaneous injection.	Part 2: Transition EU RPP n=132 participants at risk At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP n=131 participants at risk Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
Cardiac disorders Hypertensive cardiomyopathy	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.37% 1/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Cardiac disorders Left ventricular failure	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.76% 1/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Cardiac disorders Cardiomyopathy	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.37% 1/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.76% 1/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Cardiac disorders Acute Myocardial Infarction	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.35% 1/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Cardiac disorders Myocardial ischaemia	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.35% 1/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Cardiac disorders Angina pectoris	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.37% 1/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Cardiac disorders Cardiac failure	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.37% 1/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Cardiac disorders Supraventricular tachycardia	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.37% 1/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Ear and labyrinth disorders Vertigo	0.35% 1/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
General disorders Non-cardiac chest pain	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.35% 1/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.76% 1/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Immune system disorders Hypersensitivity	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.76% 1/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Injury, poisoning and procedural complications Brain contusion	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.35% 1/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Injury, poisoning and procedural complications Joint injury	0.35% 1/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.76% 1/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Injury, poisoning and procedural complications Hip fracture	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.76% 1/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.76% 1/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.76% 1/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.35% 1/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Injury, poisoning and procedural complications Skull fractured base	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.35% 1/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Infections and infestations Appendicitis	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.37% 1/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.76% 1/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Infections and infestations Peritonitis bacterial	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.76% 1/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Infections and infestations Peritonsillar abscess	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.76% 1/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Infections and infestations Pyelonephritis	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.76% 1/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Investigations Ejection fraction decreased	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.76% 1/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Investigations Blood creatine phosphokinase increased	0.35% 1/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder papilloma	0.35% 1/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.35% 1/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric adenoma	0.35% 1/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign ovarian tumor	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.37% 1/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.37% 1/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nodular melanoma	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.76% 1/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Nervous system disorders Cerebral haemorrhage	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.35% 1/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Nervous system disorders Epilepsy	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.35% 1/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Nervous system disorders Cervical myelopathy	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.76% 1/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Nervous system disorders Headache	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.76% 1/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Nervous system disorders Syncope	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.37% 1/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.76% 1/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.76% 1/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Product Issues Device loosening	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.37% 1/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Psychiatric disorders Suicide attempt	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.37% 1/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Renal and urinary disorders Ureterolithiasis	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.76% 1/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Renal and urinary disorders Acute kidney injury	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.35% 1/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.35% 1/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Reproductive system and breast disorders Cervical dysplasia	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.76% 1/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Reproductive system and breast disorders Endometrial hyperplasia	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.37% 1/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Reproductive system and breast disorders Genital prolapse	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.37% 1/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.76% 1/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.35% 1/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Skin and subcutaneous tissue disorders Pustular psoriasis	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.35% 1/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Skin and subcutaneous tissue disorders Rash	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.35% 1/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Vascular disorders Arteriosclerosis	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.37% 1/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Vascular disorders Peripheral vascular disorder	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.37% 1/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Vascular disorders Hypertension	0.35% 1/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.00% 0/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).

Other adverse events

Other adverse events
Measure	Part 1: M923 n=285 participants at risk Participants received 80 milligrams (mg) M923 (recombinant human immunoglobulin G subclass 1 \[IgG1\] monoclonal antibody specific for human tumor necrosis factor-alpha \[TNF-α\]) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 1: EU RPP n=285 participants at risk Participants received 80 mg European Union Reference Protein Product (EU RPP) at Baseline (Week 0) and 40 mg every 2 weeks from Week 1 to Week 16 as a subcutaneous injection.	Part 2: M923 n=271 participants at risk Participants who received M923 in Part 1 continued to receive 40 mg M923 every 2 weeks from Week 17 to Week 48 (last dose at Week 47) as a subcutaneous injection.	Part 2: Transition EU RPP n=132 participants at risk At Week 17, participants who received EU RPP in Part 1 transitioned from EU RPP to M923 (40 mg every 2 weeks), then to EU RPP at Week 25 (40 mg every 2 weeks), and then to M923 at Week 37 (last dose at Week 47).	Part 2: Continuous EU RPP n=131 participants at risk Participants who received EU RPP in Part 1 continued to receive EU RPP (40 mg every 2 weeks) from Week 17 to Week 48 (last dose at Week 47).
General disorders Injection site reaction	23.9% 68/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	27.7% 79/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	10.0% 27/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	11.4% 15/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	14.5% 19/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Infections and infestations Nasopharyngitis	6.7% 19/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	6.0% 17/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	14.8% 40/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	12.1% 16/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	15.3% 20/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Infections and infestations Upper respiratory tract infection	3.2% 9/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	2.1% 6/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	5.5% 15/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	4.5% 6/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	8.4% 11/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Nervous system disorders Headache	3.2% 9/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	3.5% 10/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	0.74% 2/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	5.3% 7/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	3.8% 5/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).
Skin and subcutaneous tissue disorders Psoriasis	2.8% 8/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	2.8% 8/285 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	10.3% 28/271 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	10.6% 14/132 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).	16.0% 21/131 • Up to Week 52 Adverse events were collected in members of the Safety Analysis Set, comprised of all participants who received at least 1 dose of study drug (M923 or European Union reference protein product \[EU RPP\]).

Additional Information

Jim Jin

Momenta

Phone: +16173954905

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place