Trial Outcomes & Findings for A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis (NCT NCT02287922)

NCT ID: NCT02287922

Last Updated: 2019-08-21

Results Overview

ACR 20 response is defined as: * 20% improvement in tender joint count (TJC; 68 joints) relative to Week 0 AND * 20% improvement in swollen joint count (SJC; 66 joints) relative to Week 0 AND * 20% improvement in 3 of the following 5 areas relative to Week 0: * Subject's Assessment of Pain (100 mm - visual analogue scale \[VAS\]) * Subject's Global Assessment of Disease Activity (VASPA) * Physician's Global Assessment of Disease Activity (VASPHA) * Subject's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI) * C-reactive protein (CRP) level The primary endpoint was analyzed using non-responder imputation (NRI), i.e., subjects with missing ACR20 response at Week 12 were treated as non-responders.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 251 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2019-08-21

Participant Flow

A total of 251 subjects were recruited at 58 sites located in Europe (42 sites; 199 subjects), Latin America (6 sites; 36 subjects) and North America (10 sites; 16 subjects). Consent was obtained from the first subject on 18 Mar 2015; the last subject completed the final visit in on 19 Jul 2016.

Of the 599 subjects screened, 348 were screen failures and 251 subjects were randomly assigned to treatment (Intent-to-treat population). All subjects enrolled received study treatment and were included in the safety population. All subjects who received at least one dose of ALX-0061 were included in the pharmacokinetic (PK) population.

Participant milestones

Measure	ALX-0061 150 mg q4w ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 150 mg q2w ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 225 mg q2w ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061	TCZ 162 mg q1w or q2w Open-label tocilizumab (TCZ). Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen). Tocilizumab
Overall Study STARTED	62	62	63	64
Overall Study COMPLETED	59	60	56	57
Overall Study NOT COMPLETED	3	2	7	7

Reasons for withdrawal

Measure	ALX-0061 150 mg q4w ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 150 mg q2w ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 225 mg q2w ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061	TCZ 162 mg q1w or q2w Open-label tocilizumab (TCZ). Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen). Tocilizumab
Overall Study Adverse Event	1	1	3	4
Overall Study Withdrawal by Subject	1	1	1	2
Overall Study Lost to Follow-up	0	0	1	0
Overall Study Sponsor's decision	0	0	0	1
Overall Study Other	1	0	2	0

Baseline Characteristics

A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis

Baseline characteristics by cohort

Measure	ALX-0061 150 mg q4w n=62 Participants ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 150 mg q2w n=62 Participants ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 225 mg q2w n=63 Participants ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061	TCZ 162 mg q1w or q2w n=64 Participants Open-label TCZ. Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen). Tocilizumab	Total n=251 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=5 Participants	53 Participants n=7 Participants	56 Participants n=5 Participants	58 Participants n=4 Participants	217 Participants n=21 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	6 Participants n=4 Participants	33 Participants n=21 Participants
Age, Continuous	53.0 years STANDARD_DEVIATION 12.25 • n=5 Participants	51.2 years STANDARD_DEVIATION 12.05 • n=7 Participants	51.3 years STANDARD_DEVIATION 11.81 • n=5 Participants	50.0 years STANDARD_DEVIATION 12.26 • n=4 Participants	51.4 years STANDARD_DEVIATION 12.07 • n=21 Participants
Sex: Female, Male Female	49 Participants n=5 Participants	53 Participants n=7 Participants	54 Participants n=5 Participants	56 Participants n=4 Participants	212 Participants n=21 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	8 Participants n=4 Participants	39 Participants n=21 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Intent-to-treat population

ACR 20 response is defined as:

• 20% improvement in tender joint count (TJC; 68 joints) relative to Week 0 AND
• 20% improvement in swollen joint count (SJC; 66 joints) relative to Week 0 AND
• 20% improvement in 3 of the following 5 areas relative to Week 0:

• Subject's Assessment of Pain (100 mm - visual analogue scale [VAS])
• Subject's Global Assessment of Disease Activity (VASPA)
• Physician's Global Assessment of Disease Activity (VASPHA)
• Subject's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI)
• C-reactive protein (CRP) level

The primary endpoint was analyzed using non-responder imputation (NRI), i.e., subjects with missing ACR20 response at Week 12 were treated as non-responders.

Outcome measures

Measure	ALX-0061 150 mg q4w n=62 Participants ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 150 mg q2w n=62 Participants ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 225 mg q2w n=63 Participants ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061	TCZ 162 mg q1w or q2w n=64 Participants Open-label TCZ. Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen). Tocilizumab
Number and Percentage of Subjects With American College of Rheumatology 20 (ACR20) at Week 12	45 Participants	48 Participants	51 Participants	50 Participants

SECONDARY outcome

Timeframe: Week 12

Population: Intent-to-treat population

ACR50/70 response is defined as:

• 50/70% improvement in TJC (68 joints) relative to Week 0 AND
• 50/70% improvement in SJC (66 joints) relative to Week 0 AND
• 50/70% improvement in 3 of the following 5 areas relative to Week 0:

• Subject's Assessment of Pain (100 mm - VAS)
• Subject's Global Assessment of Disease Activity (VASPA)
• Physician's Global Assessment of Disease Activity (VASPHA)
• Subject's assessment of physical function as measured by HAQ-DI
• CRP level

This endpoint was analyzed using NRI, i.e., subjects with missing response at Week 12 were treated as non-responders.

Outcome measures

Measure	ALX-0061 150 mg q4w n=62 Participants ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 150 mg q2w n=62 Participants ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 225 mg q2w n=63 Participants ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061	TCZ 162 mg q1w or q2w n=64 Participants Open-label TCZ. Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen). Tocilizumab
Number and Percentage of Subjects With ACR50 and ACR70 Response at Week 12 ACR50	27 Participants	23 Participants	31 Participants	29 Participants
Number and Percentage of Subjects With ACR50 and ACR70 Response at Week 12 ACR70	10 Participants	15 Participants	13 Participants	15 Participants

SECONDARY outcome

Timeframe: Week 12

Population: Intent-to-treat population

DAS28(CRP) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.36 × ln[CRP+1]) + (0.014 × VASPA) + 0.96

Low disease activity = 2.6 ≤ DAS28 ≤ 3.2

Subjects with low disease activity includes subjects who are in remission. This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders.

Outcome measures

Measure	ALX-0061 150 mg q4w n=62 Participants ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 150 mg q2w n=62 Participants ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 225 mg q2w n=63 Participants ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061	TCZ 162 mg q1w or q2w n=64 Participants Open-label TCZ. Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen). Tocilizumab
Number and Percentage of Subjects With Low Disease Activity (LDA) Using Disease Activity Score Using 28 Joint Counts (DAS28) Using C-reactive Protein (CRP) at Week 12	26 Participants	35 Participants	38 Participants	28 Participants

SECONDARY outcome

Timeframe: Week 12

Population: Intent-to-treat population

DAS28(ESR) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.70 × ln[ESR]) +(0.014 × VASPA)

Low disease activity = 2.6 ≤ DAS28 ≤ 3.2

Subjects with low disease activity includes subjects who are in remission. This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders.

Outcome measures

Measure	ALX-0061 150 mg q4w n=62 Participants ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 150 mg q2w n=62 Participants ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 225 mg q2w n=63 Participants ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061	TCZ 162 mg q1w or q2w n=64 Participants Open-label TCZ. Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen). Tocilizumab
Number and Percentage of Subjects With LDA Using DAS28 Using Erythrocyte Sedimentation Rate (ESR) at Week 12	26 Participants	32 Participants	34 Participants	20 Participants

SECONDARY outcome

Timeframe: Week 12

Population: Intent-to-treat population

SDAI = TJC28 + SJC28 + VASPA + VASPHA + CRP (mg/dL)

Low disease activity: 3.3 < SDAI ≤ 11.0

Subjects with low disease activity includes subjects who are in remission. This endpoint was analyzed using non-responder imputation (NRI), i.e., subjects with missing response at the concerned visit were treated as non-responders.

Outcome measures

Measure	ALX-0061 150 mg q4w n=62 Participants ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 150 mg q2w n=62 Participants ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 225 mg q2w n=63 Participants ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061	TCZ 162 mg q1w or q2w n=64 Participants Open-label TCZ. Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen). Tocilizumab
Number and Percentage of Subjects With LDA Using Simplified Disease Activity Index (SDAI) at Week 12	23 Participants	27 Participants	33 Participants	22 Participants

SECONDARY outcome

Timeframe: Week 12

Population: Intent-to-treat population

CDAI = TJC28 + SJC28 + VASPA + VASPHA

Low disease activity: 2.8 < CDAI ≤ 10

Subjects with low disease activity includes subjects who are in remission. This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders.

Outcome measures

Measure	ALX-0061 150 mg q4w n=62 Participants ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 150 mg q2w n=62 Participants ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 225 mg q2w n=63 Participants ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061	TCZ 162 mg q1w or q2w n=64 Participants Open-label TCZ. Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen). Tocilizumab
Number and Percentage of Subjects With LDA Using Clinical Disease Activity Index (CDAI) at Week 12	23 Participants	21 Participants	32 Participants	21 Participants

SECONDARY outcome

Timeframe: Week 12

Population: Intent-to-treat population

EULAR good response is defined as an improvement of >1.2 in DAS28 (CRP) relative to baseline.

This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders.

Outcome measures

Measure	ALX-0061 150 mg q4w n=62 Participants ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 150 mg q2w n=62 Participants ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 225 mg q2w n=63 Participants ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061	TCZ 162 mg q1w or q2w n=64 Participants Open-label TCZ. Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen). Tocilizumab
Number and Percentage of Subjects With European League Against Rheumatism (EULAR) (CRP) Good Response at Week 12	25 Participants	34 Participants	38 Participants	28 Participants

SECONDARY outcome

Timeframe: Week 12

DAS28(ESR) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.70 × ln[ESR]) +(0.014 × VASPA)

Remission = DAS28(ESR) < 2.6

This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders.

Outcome measures

Measure	ALX-0061 150 mg q4w n=62 Participants ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 150 mg q2w n=62 Participants ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 225 mg q2w n=63 Participants ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061	TCZ 162 mg q1w or q2w n=64 Participants Open-label TCZ. Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen). Tocilizumab
Number and Percentage of Subjects in Remission Using DAS28 (ESR) at Week 12	21 Participants	13 Participants	25 Participants	16 Participants

SECONDARY outcome

Timeframe: Week 12

Population: Intent-to-treat population

SDAI = TJC28 + SJC28 + VASPA + VASPHA + CRP (mg/dL)

Remission: SDAI ≤ 3.3

This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders.

Outcome measures

Measure	ALX-0061 150 mg q4w n=62 Participants ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 150 mg q2w n=62 Participants ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 225 mg q2w n=63 Participants ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061	TCZ 162 mg q1w or q2w n=64 Participants Open-label TCZ. Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen). Tocilizumab
Number and Percentage of Subjects in Remission Using SDAI at Week 12	5 Participants	3 Participants	5 Participants	7 Participants

SECONDARY outcome

Timeframe: Week 12

Population: Intent-to-treat population

CDAI = TJC28 + SJC28 + VASPA + VASPHA

Remission: CDAI ≤ 2.8

This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders.

Outcome measures

Measure	ALX-0061 150 mg q4w n=62 Participants ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 150 mg q2w n=62 Participants ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 225 mg q2w n=63 Participants ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061	TCZ 162 mg q1w or q2w n=64 Participants Open-label TCZ. Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen). Tocilizumab
Number and Percentage of Subjects in Remission Using CDAI at Week 12	6 Participants	3 Participants	4 Participants	6 Participants

SECONDARY outcome

Timeframe: Week 12

Boolean remission: tender joint count (TJC)28 ≤ 1 and swollen joint count (SJC)28 ≤ 1 and VASPA (cm) ≤ 1 and CRP (mg/dL) ≤ 1

This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders.

Outcome measures

Measure	ALX-0061 150 mg q4w n=62 Participants ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 150 mg q2w n=62 Participants ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 225 mg q2w n=63 Participants ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061	TCZ 162 mg q1w or q2w n=64 Participants Open-label TCZ. Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen). Tocilizumab
Number and Percentage of Subjects in Remission Using Boolean Defined Remission Criteria at Week 12	2 Participants	3 Participants	4 Participants	4 Participants

SECONDARY outcome

Timeframe: From baseline until Week 12

Population: Intent-to-treat population, number of participants with data available

The HAQ-DI is a 20-question instrument which assesses the degree of difficulty the subject had in accomplishing tasks in 8 functional areas over the previous week. The 8 areas are: dressing and grooming, hygiene, arising, reach, eating, grip, walking, common daily activities. Within each area, subjects report the amount of difficulty they have in performing the specific items. There are 4 response options ranging from: 0 = No Difficulty, 1 = With Some Difficulty, 2 = With Much Difficulty, 3 = Unable to Do. The 8 areas are each given a single score equal to the maximum value of their component activities (0, 1, 2, or 3). The sum of the area scores is then divided by the number of areas answered to obtain the final HAQ score (rounded to the nearest value evenly divisible by 0.125). The final HAQ-DI score ranges from 0 to 3. A high score means a high degree of disability (=worse outcome).

Missing values were imputed with the last non-missing observation.

Outcome measures

Measure	ALX-0061 150 mg q4w n=61 Participants ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 150 mg q2w n=60 Participants ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 225 mg q2w n=59 Participants ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061	TCZ 162 mg q1w or q2w n=64 Participants Open-label TCZ. Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen). Tocilizumab
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12	-0.541 score on a scale Standard Error 0.0809	-0.746 score on a scale Standard Error 0.0935	-0.817 score on a scale Standard Error 0.0802	-0.689 score on a scale Standard Error 0.0811

SECONDARY outcome

Timeframe: From baseline until week 12

Population: Intent-to-treat population

The Short Form (36) Health Survey (SF-36) consists of 36 items that can be summarized into 8 domains: physical functioning, role limitations due to physical health problems (role-physical), bodily pain, general health, vitality, social functioning, role limitations due to emotional problems (role-emotional), and mental health. Two summary measures, the physical component summary and the mental component summary, can be derived based on these domain scores. Each score is directly transformed into a 0-100 score on the assumption that each question carries equal weight. Low score indicates greater disability.

Outcome measures

Measure	ALX-0061 150 mg q4w n=62 Participants ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 150 mg q2w n=62 Participants ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 225 mg q2w n=63 Participants ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061	TCZ 162 mg q1w or q2w n=64 Participants Open-label TCZ. Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen). Tocilizumab
Change From Baseline in Physical and Mental Component Scores of Short Form Health Survey (SF-36) at Week 12 physical component	7.808 score on a scale Standard Error 0.8533	7.979 score on a scale Standard Error 1.1895	8.861 score on a scale Standard Error 1.0818	7.611 score on a scale Standard Error 0.9562
Change From Baseline in Physical and Mental Component Scores of Short Form Health Survey (SF-36) at Week 12 mental component	5.49 score on a scale Standard Error 1.221	8.836 score on a scale Standard Error 1.5243	8.913 score on a scale Standard Error 1.3903	6.156 score on a scale Standard Error 1.3192

SECONDARY outcome

Timeframe: From baseline until Week 12

Population: Intent-to-treat population, number of subjects with data available

The FACIT Measurement System is a collection of health-related quality of life questionnaires that assess multidimensional health status in people with various chronic illnesses. The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). To score the FACIT-fatigue, all items are summed to create a single fatigue score with a range from 0 to 52. Items are reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.

Outcome measures

Measure	ALX-0061 150 mg q4w n=58 Participants ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 150 mg q2w n=60 Participants ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 225 mg q2w n=56 Participants ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061	TCZ 162 mg q1w or q2w n=57 Participants Open-label TCZ. Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen). Tocilizumab
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale at Week 12	7.832 score on a scale Standard Error 1.3438	11.41 score on a scale Standard Error 1.53	12.996 score on a scale Standard Error 1.3702	8.971 score on a scale Standard Error 1.4461

SECONDARY outcome

Timeframe: From baseline until Week 12

Population: Safety population

Values below the limit of quantification are imputed with the lower limit of quantification (LLOQ).

Outcome measures

Measure	ALX-0061 150 mg q4w n=62 Participants ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 150 mg q2w n=62 Participants ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 225 mg q2w n=63 Participants ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061	TCZ 162 mg q1w or q2w n=64 Participants Open-label TCZ. Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen). Tocilizumab
Pharmacodynamics: Concentrations of Soluble Interleukin-6 Receptor (sIL-6R) Baseline	33.0 ng/mL Standard Error 4.65	42.3 ng/mL Standard Error 8.71	30.9 ng/mL Standard Error 3.72	31.0 ng/mL Standard Error 2.54
Pharmacodynamics: Concentrations of Soluble Interleukin-6 Receptor (sIL-6R) Week 12	376 ng/mL Standard Error 21.6	460 ng/mL Standard Error 19.9	459 ng/mL Standard Error 18.8	269 ng/mL Standard Error 11.1

SECONDARY outcome

Timeframe: From baseline until Week 12

Population: PK Population, participants with data available

Outcome measures

Measure	ALX-0061 150 mg q4w n=54 Participants ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 150 mg q2w n=55 Participants ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 225 mg q2w n=52 Participants ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061	TCZ 162 mg q1w or q2w Open-label TCZ. Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen). Tocilizumab
Pharmacokinetics: ALX-0061 Concentration in Serum at Week 12	1.4 micrograms/milliliter Standard Deviation 3.61	18.4 micrograms/milliliter Standard Deviation 2.95	27.9 micrograms/milliliter Standard Deviation 2.53	—

SECONDARY outcome

Timeframe: From first study drug intake up to and including follow-up (FU), i.e., maximum of 22 weeks (10 weeks of treatment + 12 weeks of FU)

Population: Safety population

Outcome measures

Measure	ALX-0061 150 mg q4w n=62 Participants ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 150 mg q2w n=62 Participants ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 225 mg q2w n=63 Participants ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061	TCZ 162 mg q1w or q2w n=187 Participants Open-label TCZ. Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen). Tocilizumab
Number and Percentage of Subjects With Development of a Treatment-emergent Antidrug Antibody Response	7 Participants	25 Participants	26 Participants	58 Participants

SECONDARY outcome

Timeframe: From baseline until Week 12

Population: Safety Population

Outcome measures

Measure	ALX-0061 150 mg q4w n=62 Participants ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 150 mg q2w n=62 Participants ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 225 mg q2w n=63 Participants ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061	TCZ 162 mg q1w or q2w n=64 Participants Open-label TCZ. Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen). Tocilizumab
Number and Percentage of Subjects With Treatment-emergent Adverse Event by Severity Mild	22 Participants	18 Participants	21 Participants	19 Participants
Number and Percentage of Subjects With Treatment-emergent Adverse Event by Severity Moderate	12 Participants	13 Participants	9 Participants	10 Participants
Number and Percentage of Subjects With Treatment-emergent Adverse Event by Severity Severe	0 Participants	2 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: From baseline until Week 12

Population: Safety population

Outcome measures

Measure	ALX-0061 150 mg q4w n=62 Participants ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 150 mg q2w n=62 Participants ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 225 mg q2w n=63 Participants ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061	TCZ 162 mg q1w or q2w n=64 Participants Open-label TCZ. Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen). Tocilizumab
Number of Treatment-emergent Adverse Event by Severity Mild	46 Treatment-emergent adverse events	75 Treatment-emergent adverse events	84 Treatment-emergent adverse events	47 Treatment-emergent adverse events
Number of Treatment-emergent Adverse Event by Severity Moderate	18 Treatment-emergent adverse events	22 Treatment-emergent adverse events	15 Treatment-emergent adverse events	15 Treatment-emergent adverse events
Number of Treatment-emergent Adverse Event by Severity Severe	0 Treatment-emergent adverse events	2 Treatment-emergent adverse events	3 Treatment-emergent adverse events	2 Treatment-emergent adverse events

SECONDARY outcome

Timeframe: From baseline until Week 12

Population: Safety population

treatment related = considered at least possibly related to study drug by the Investigator

Outcome measures

Measure	ALX-0061 150 mg q4w n=62 Participants ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 150 mg q2w n=62 Participants ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 225 mg q2w n=63 Participants ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061	TCZ 162 mg q1w or q2w n=64 Participants Open-label TCZ. Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen). Tocilizumab
Number and Percentage of Subjects With a Treatment-related Treatment-emergent Adverse Event	21 Participants	20 Participants	21 Participants	20 Participants

SECONDARY outcome

Timeframe: From baseline until Week 12

Population: Safety Population

treatment related = considered at least possibly related to study drug by the Investigator

Outcome measures

Measure	ALX-0061 150 mg q4w n=62 Participants ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 150 mg q2w n=62 Participants ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 225 mg q2w n=63 Participants ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061	TCZ 162 mg q1w or q2w n=64 Participants Open-label TCZ. Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen). Tocilizumab
Number of Treatment-related Treatment-emergent Adverse Event	46 treatment-emergent adverse events	53 treatment-emergent adverse events	64 treatment-emergent adverse events	32 treatment-emergent adverse events

Adverse Events

ALX-0061 150 mg q4w

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

ALX-0061 150 mg q2w

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

ALX-0061 225 mg q2w

Serious events: 2 serious events

Other events: 17 other events

Deaths: 0 deaths

TCZ 162 mg q1w or q2w

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	ALX-0061 150 mg q4w n=62 participants at risk ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 150 mg q2w n=62 participants at risk ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 225 mg q2w n=63 participants at risk ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061	TCZ 162 mg q1w or q2w n=64 participants at risk Open-label TCZ. Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen). Tocilizumab
Infections and infestations Diverticulitis	0.00% 0/62 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)	0.00% 0/62 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)	0.00% 0/63 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)	1.6% 1/64 • Number of events 1 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)
Infections and infestations Erysipelas	0.00% 0/62 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)	0.00% 0/62 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)	1.6% 1/63 • Number of events 1 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)	0.00% 0/64 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)
Infections and infestations Nail bed infection bacterial	0.00% 0/62 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)	0.00% 0/62 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)	0.00% 0/63 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)	1.6% 1/64 • Number of events 1 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.6% 1/62 • Number of events 1 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)	0.00% 0/62 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)	0.00% 0/63 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)	0.00% 0/64 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)
Metabolism and nutrition disorders Dehydration	0.00% 0/62 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)	0.00% 0/62 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)	1.6% 1/63 • Number of events 1 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)	0.00% 0/64 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)

Other adverse events

Measure	ALX-0061 150 mg q4w n=62 participants at risk ALX-0061 150 mg every 4 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 150 mg q2w n=62 participants at risk ALX-0061 150 mg every 2 weeks from baseline through Week 12 + placebo every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061 Placebo	ALX-0061 225 mg q2w n=63 participants at risk ALX-0061 225 mg every 2 weeks from baseline through Week 12. The last injection with study drug was administered at the Week 10 visit. ALX-0061	TCZ 162 mg q1w or q2w n=64 participants at risk Open-label TCZ. Injections were to be performed q1w or q2w depending on the approved label per region (last injection was administered at Week 10 or Week 11, depending on the dose regimen). Tocilizumab
Infections and infestations Alanine aminotransferase increased	1.6% 1/62 • Number of events 1 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)	0.00% 0/62 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)	6.3% 4/63 • Number of events 5 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)	1.6% 1/64 • Number of events 1 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)
Blood and lymphatic system disorders Leukopenia	6.5% 4/62 • Number of events 5 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)	1.6% 1/62 • Number of events 1 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)	0.00% 0/63 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)	3.1% 2/64 • Number of events 2 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)
Blood and lymphatic system disorders Neutropenia	6.5% 4/62 • Number of events 5 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)	4.8% 3/62 • Number of events 3 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)	0.00% 0/63 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)	7.8% 5/64 • Number of events 5 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)
General disorders Injection site erythema	6.5% 4/62 • Number of events 7 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)	11.3% 7/62 • Number of events 10 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)	7.9% 5/63 • Number of events 20 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)	3.1% 2/64 • Number of events 2 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)
Gastrointestinal disorders Abdominal pain	0.00% 0/62 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)	6.5% 4/62 • Number of events 4 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)	1.6% 1/63 • Number of events 1 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)	0.00% 0/64 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)
Metabolism and nutrition disorders Hypercholesterolaemia	3.2% 2/62 • Number of events 2 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)	8.1% 5/62 • Number of events 5 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)	11.1% 7/63 • Number of events 7 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)	3.1% 2/64 • Number of events 2 • From first study drug intake up to and including follow-up, i.e., maximum of 22 weeks when assigned to the ALX-0061 or TCZ q2w treatment groups (10 weeks of treatment + 12 weeks of follow-up), or 23 weeks when assigned to the TCZ q1w treatment group (11 weeks of treatment + 12 weeks of follow-up)

Additional Information

Medical Monitor

Ablynx NV

Phone: +32 (0)9 262 00 00

Email: clinicaltrials@ablynx.com

Results disclosure agreements

• Principal investigator is a sponsor employee Publication of any results from this study will be according to the principles of the Declaration of Helsinki and will require prior review and written agreement of the Sponsor.
• Publication restrictions are in place

Restriction type: OTHER