| Primary | Number and Percentage of Subjects With American College of Rheumatology 20 (ACR20) at Week 12 | ACR 20 response is defined as:
-
20% improvement in tender joint count (TJC; 68 joints) relative to Week 0 AND
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20% improvement in swollen joint count (SJC; 66 joints) relative to Week 0 AND
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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. | Intent-to-treat population | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | 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 |
| | Units | Counts |
|---|
| Participants | - OG00062
- OG00162
- OG00263
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00045
- OG00148
- OG00251
- OG003
|
|
| |
| Secondary | Number and Percentage of Subjects With ACR50 and ACR70 Response at Week 12 | 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. | Intent-to-treat population | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | ALX-0061 225 mg q2w |
|
| Secondary | 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 | 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. | Intent-to-treat population | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
|
| Secondary | Number and Percentage of Subjects With LDA Using DAS28 Using Erythrocyte Sedimentation Rate (ESR) at Week 12 | 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. | Intent-to-treat population | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
|
| Secondary | Number and Percentage of Subjects With LDA Using Simplified Disease Activity Index (SDAI) at Week 12 | 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. | Intent-to-treat population | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
|
| Secondary | Number and Percentage of Subjects With LDA Using Clinical Disease Activity Index (CDAI) at Week 12 | 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. | Intent-to-treat population | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
|
| Secondary | Number and Percentage of Subjects With European League Against Rheumatism (EULAR) (CRP) Good Response at Week 12 | 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. | Intent-to-treat population | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 |
|
| Secondary | Number and Percentage of Subjects in Remission Using DAS28 (ESR) at 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. | | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | TCZ 162 mg q1w or q2w |
|
| Secondary | Number and Percentage of Subjects in Remission Using SDAI at Week 12 | 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. | Intent-to-treat population | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | TCZ 162 mg q1w or q2w |
|
| Secondary | Number and Percentage of Subjects in Remission Using CDAI at Week 12 | 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. | Intent-to-treat population | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | TCZ 162 mg q1w or q2w |
|
| Secondary | Number and Percentage of Subjects in Remission Using Boolean Defined Remission Criteria at 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. | | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | TCZ 162 mg q1w or q2w |
|
| Secondary | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12 | 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. | Intent-to-treat population, number of participants with data available | Posted | | Mean | Standard Error | score on a scale | | From baseline until Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | ALX-0061 150 mg q2w | |
|
| Secondary | Change From Baseline in Physical and Mental Component Scores of Short Form Health Survey (SF-36) at Week 12 | 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. | Intent-to-treat population | Posted | | Mean | Standard Error | score on a scale | | From baseline until week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 |
|
| Secondary | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale at Week 12 | 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. | Intent-to-treat population, number of subjects with data available | Posted | | Mean | Standard Error | score on a scale | | From baseline until Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Secondary | Pharmacodynamics: Concentrations of Soluble Interleukin-6 Receptor (sIL-6R) | Values below the limit of quantification are imputed with the lower limit of quantification (LLOQ). | | Posted | | Mean | Standard Error | ng/mL | | From baseline until Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | TCZ 162 mg q1w or q2w | |
|
| Secondary | Pharmacokinetics: ALX-0061 Concentration in Serum at Week 12 | | PK Population, participants with data available | Posted | | Geometric Mean | Standard Deviation | micrograms/milliliter | | From baseline until Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
| |
| Secondary | Number and Percentage of Subjects With Development of a Treatment-emergent Antidrug Antibody Response | | | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | ALX-0061 Total | This group includes all participants who received at least one dose of ALX-0061 |
|
| Secondary | Number and Percentage of Subjects With Treatment-emergent Adverse Event by Severity | | | Posted | | Count of Participants | | Participants | | From baseline until Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | 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 |
|
| Secondary | Number of Treatment-emergent Adverse Event by Severity | | | Posted | | Number | | Treatment-emergent adverse events | | From baseline until Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | 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 |
|
| Secondary | Number and Percentage of Subjects With a Treatment-related Treatment-emergent Adverse Event | treatment related = considered at least possibly related to study drug by the Investigator | | Posted | | Count of Participants | | Participants | | From baseline until Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | TCZ 162 mg q1w or q2w | |
|
| Secondary | Number of Treatment-related Treatment-emergent Adverse Event | treatment related = considered at least possibly related to study drug by the Investigator | | Posted | | Number | | treatment-emergent adverse events | | From baseline until Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | TCZ 162 mg q1w or q2w | |
|