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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003033-26 | EudraCT Number |
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The purpose of this study is to assess the efficacy and safety of dose regimens of ALX-0061 administered subcutaneously (s.c.) in combination with methotrexate (MTX) to subjects with active rheumatoid arthritis (RA) despite MTX therapy, compared with placebo.
To assess the effects of ALX-0061 on quality of life, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ALX-0061, and to define the optimal dose regimen for ALX-0061, based on safety and efficacy, for further clinical development.
Subjects who completed the 24-week assessment period and achieved at least 20% improvement in swollen joint count (SJC) and/or tender joint count (TJC) at Week 24 of study ALX0061-C201 were invited to participate in an open-label extension (OLE) study ALX0061-C203 (NCT02518620), if the study was approved in their country and selection criteria were met.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo q2w + MTX | Placebo Comparator | Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. |
|
| ALX-0061 75 mg q4w + MTX | Experimental | ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. |
|
| ALX-0061 150 mg q4w + MTX | Experimental | ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. |
|
| ALX-0061 150 mg q2w + MTX | Experimental | ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. |
|
| ALX-0061 225 mg q2w + MTX |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALX-0061 | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Response at Week 12 | ACR 20 response is defined as:
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. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Subjects With ACR20 Response at Week 24 | ACR 20 response is defined as:
This endpoint was analyzed using NRI, i.e., subjects with missing response at Week 24 were treated as non responders. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ablynx Clinical Department | Ablynx, a Sanofi company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site | Birmingham | Alabama | 35216 | United States | ||
| Investigator Site |
Of the 712 subjects screened, 367 were screen failures and 345 were randomly assigned to treatment (Intent-to-treat population). All subjects enrolled received study drug and were included in the safety population. All subjects who received at least one dose of ALX-0061 (i.e., 276 subjects) were included in the pharmacokinetic (PK) population.
A total of 345 subjects were recruited at 63 sites located in Europe (46 sites; 259 subjects), Latin America (7 sites; 59 subjects) and North America (10 sites; 27 subjects). Consent was obtained from the first subject on 30 Jan 2015; the last subject completed the final visit on 8 Aug 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | ALX-0061 75 mg q4w + MTX | ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + Methotrexate (MTX; at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 9, 2015 |
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ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. |
|
| Placebo | Other |
|
| Methotrexate | Drug | Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
|
| 24 weeks |
| Number and Percentage of Subjects With ACR50 Response at Weeks 12 and 24 | ACR50 response is defined as:
This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non responders. | 24 weeks |
| Number and Percentage of Subjects With ACR70 Response at Weeks 12 and 24 | ACR70 response is defined as:
This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non responders. | 24 weeks |
| Number and Percentage of Subjects With Low Disease Activity (LDA) Using Disease Activity Score 28 (DAS28) Using C-reactive Protein (CRP) at Weeks 12 and 24 | 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 This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non responders. | 24 weeks |
| Number and Percentage of Subjects With LDA Using DAS28 Using Erythrocyte Sedimentation Rate (ESR) at Weeks 12 and 24 | 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. | 24 weeks |
| Number and Percentage of Subjects With LDA Using Simplified Disease Activity Index (SDAI) at Weeks 12 and 24 | SDAI = TJC28 + SJC28 + Patient's Global Assessment of Disease Activity (VASPA) + Physician's Global Assessment of Disease Activity (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 NRI, i.e., subjects with missing response at the concerned visit were treated as non responders. | 24 weeks |
| Number and Percentage of Subjects With LDA Using Clinical Disease Activity Index (CDAI) at Weeks 12 and 24 | 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. | 24 weeks |
| Number and Percentage of Subjects With European League Against Rheumatism (EULAR) (CRP) Good Response at Weeks 12 and 24 | 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. | 24 weeks |
| Number and Percentage of Subjects in Remission Using DAS28 (ESR) at Weeks 12 and 24 | 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. | 24 weeks |
| Number and Percentage of Subjects in Remission Using SDAI at Weeks 12 and 24 | 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. | 24 weeks |
| Number and Percentage of Subjects in Remission Using CDAI at Weeks 12 and 24 | 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. | 24 weeks |
| Number and Percentage of Subjects in Remission Using Boolean Defined Remission Criteria at Weeks 12 and 24 | 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 non-responder imputation (NRI), i.e., subjects with missing response at the concerned visit were treated as non responders. | 24 weeks |
| Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Weeks 12 and 24 | 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. | from baseline till Week 24 |
| Change From Baseline in Physical Component Score of Short Form Health Survey (SF-36) at Weeks 12 and 24 | 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. The lower the score the more disability. The higher the score the less disability. | from baseline till Week 24 |
| Change From Baseline in Mental Component Score of Short Form Health Survey (SF-36) at Weeks 12 and 24 | 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. The lower the score the more disability. The higher the score the less disability. | from baseline till Week 24 |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale at Weeks 12 and 24 | 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. | from baseline till Week 24 |
| Pharmacokinetics: ALX-0061 Concentration in Serum at Weeks 12 and 24 | ALX-0061 concentrations were only measured in samples of subjects randomized to any of the ALX-0061 treatment arms. Samples were taken predose at the concerned visits. | at Week 12 and Week 24 visits |
| Pharmacodynamics: Concentrations of Soluble Interleukin-6 Receptor (sIL-6R) at Weeks 12 and 24 | Values below the limit of quantification are imputed with the lower limit of quantification (LLOQ). | from baseline till Week 24 |
| Number of Subjects With Development of a Treatment-emergent Antidrug Antibody Response | from baseline till follow-up (FU) (i.e., 12 weeks after last study drug dosing at Week 22 or after early treatment discontinuation) |
| Number and Percentage of Subjects With Treatment-emergent Adverse Events by Severity | From first study drug intake until the Week 24 or Early Termination visit. Only safety data through Week 24 is reported as 256 of the 293 subjects who completed the 24-week treatment period rolled-over to the C203 Study and did not perform the FU visit |
| Number of Treatment-emergent Adverse Events by Severity | From first study drug intake until the Week 24 or Early Termination visit. Only safety data through Week 24 is reported as 256 of the 293 subjects who completed the 24-week treatment period rolled-over to the C203 Study and did not perform the FU visit |
| Number and Percentage of Subjects With Treatment-related Treatment-emergent Adverse Events | From first study drug intake until the Week 24 or Early Termination visit. Only safety data through Week 24 is reported as 256 of the 293 subjects who completed the 24-week treatment period rolled-over to the C203 Study and did not perform the FU visit |
| Number of Treatment-related Treatment-emergent Adverse Events | From first study drug intake until the Week 24 or Early Termination visit. Only safety data through Week 24 is reported as 256 of the 293 subjects who completed the 24-week treatment period rolled-over to the C203 Study and did not perform the FU visit |
| Hemet |
| California |
| 92543 |
| United States |
| Investigator Site | La Palma | California | 90712 | United States |
| Investigator Site | Los Angeles | California | 90017 | United States |
| Investigator site | Los Angeles | California | 90036 | United States |
| Investigator Site | Ventura | California | 93003 | United States |
| Investigator Sites | Hialeah | Florida | 33016 | United States |
| Investigator Site | Homestead | Florida | 33030 | United States |
| Investigator Site | Miami | Florida | 33135 | United States |
| Investigator Site | Miami Lakes | Florida | 33016 | United States |
| Investigator Site | Orlando | Florida | 32804 | United States |
| Investigator Site | Stockbridge | Georgia | 30281 | United States |
| Investigator Site | Overland Park | Kansas | 66209 | United States |
| Investigator Site | Monroe | Louisiana | 71203 | United States |
| Investigator Site | Worcester | Massachusetts | 01605 | United States |
| Investigator Site | Albuquerque | New Mexico | 87102 | United States |
| Investigator Site | Brooklyn | New York | 11201 | United States |
| Investigator Site | New York | New York | 10018 | United States |
| Investigator Sie | Charleston | South Carolina | 29406 | United States |
| Investigator Site | Myrtle Beach | South Carolina | 29572 | United States |
| Investigator Site | Memphis | Tennessee | 38119 | United States |
| Investigator Site | Mesquite | Texas | 75150 | United States |
| Investigator Site | Brussels | 1070 | Belgium |
| Investigator Site | Brussels | 1200 | Belgium |
| Investigator Site | Ghent | 9000 | Belgium |
| Investigator Site | Liège | 4000 | Belgium |
| Investigator Site | Pleven | 5800 | Bulgaria |
| Investigator Site | Plovdiv | 4001 | Bulgaria |
| Investigator Site 1 | Rousse | 7000 | Bulgaria |
| Investigator Site 2 | Rousse | 7000 | Bulgaria |
| Investigator Site | Sofia | 1233 | Bulgaria |
| Investigator Site | Sofia | 1612 | Bulgaria |
| Investigator Site | Varna | 9000 | Bulgaria |
| Investigator Site | Brno | 60200 | Czechia |
| Investigator Site | Olomouc | 77900 | Czechia |
| Investigator Site | Prague | 12850 | Czechia |
| Investigator Site | Prague | Czechia |
| Investigator Site | Zlín | 76001 | Czechia |
| Investigator Site | Tbilisi | 0102 | Georgia |
| Investigator Site 1 | Tbilisi | 0159 | Georgia |
| Investigator Site 2 | Tbilisi | 0159 | Georgia |
| Investigator Site | Tbilisi | 0160 | Georgia |
| Investigator Site | Tbilisi | 0179 | Georgia |
| Investigator Site | Bad Nauheim | 61231 | Germany |
| Investigator Site | Berlin | 10117 | Germany |
| Investigator Site | Berlin | Germany |
| Investigator Site | Cologne | 50973 | Germany |
| Investigator Site | Frankfurt | Germany |
| Investigator Site | Hamburg | 22081 | Germany |
| Investigator Site | Baja | 6500 | Hungary |
| Investigator Site | Balatonfüred | 8230 | Hungary |
| Investigator Site | Békéscsaba | 5600 | Hungary |
| Investigator Site | Budapest | 1038 | Hungary |
| Investigator Site | Gyula | 5700 | Hungary |
| Investigator Site | Székesfehérvar | 8000 | Hungary |
| Investigator Site | Szikszó | 3800 | Hungary |
| Investigator Site | Veszprém | 8200 | Hungary |
| Investigator Site | Culiacán | 80000 | Mexico |
| Investigator Site | León | 37000 | Mexico |
| Investigator Site 1 | Mexico City | 03100 | Mexico |
| Investigator Site 2 | Mexico City | 06700 | Mexico |
| Investigator Site | Mérida | 97070 | Mexico |
| Investigator Site | Monclova | 25714 | Mexico |
| Investigator Site | Monterrey | 64000 | Mexico |
| Investigator Site | Monterrey | 64460 | Mexico |
| Investigator Site | Chisinau | 2025 | Moldova |
| Investigator Site 1 | Skopje | 1000 | North Macedonia |
| Investigator Site 2 | Skopje | 1000 | North Macedonia |
| Investigator Site | Bydgoszcz | 85168 | Poland |
| Investigator Site | Elblag | 82300 | Poland |
| Investigator Site | Elblag | Poland |
| Investigator Site | Gdynia | 81338 | Poland |
| Investigator Site | Grodzisk Mazowiecki | 05825 | Poland |
| Investigator Site | Katowice | 40954 | Poland |
| Investigator Site | Lublin | 20582 | Poland |
| Investigator Site | Poznan | 60773 | Poland |
| Investigator Site | Sochaczew | 96500 | Poland |
| Investigator Site | Torun | 87100 | Poland |
| Investigator Site | Warsaw | 02653 | Poland |
| Investigator Site | Brăila | 800578 | Romania |
| Investigator Site | Bucharest | 010976 | Romania |
| Investigator Site | Bucharest | 020475 | Romania |
| Investigator Site | Oradea | 410028 | Romania |
| Investigator Site | Târgu Mureş | 540142 | Romania |
| Investigator Site | Timișoara | 300057 | Romania |
| Investigator Site 1 | Belgrade | 11000 | Serbia |
| Investigator Site 2 | Belgrade | 11000 | Serbia |
| Investigator Site 3 | Belgrade | 11000 | Serbia |
| Investigator Site | Niška Banja | 18205 | Serbia |
| Investigator Site | Novi Sad | 21112 | Serbia |
| Investigator Site | Madrid | 28007 | Spain |
| Investigator Site | Madrid | 28041 | Spain |
| Investigator Site | Salamanca | 37007 | Spain |
| Investigator Site | Santiago de Compostela | 15702 | Spain |
| FG001 |
| ALX-0061 150 mg q4w + MTX |
ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| FG002 | ALX-0061 150 mg q2w + MTX | ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| FG003 | ALX-0061 225 mg q2w + MTX | ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| FG004 | Placebo q2w + MTX | Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ALX-0061 75 mg q4w + MTX | ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| BG001 | ALX-0061 150 mg q4w + MTX | ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| BG002 | ALX-0061 150 mg q2w + MTX | ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| BG003 | ALX-0061 225 mg q2w + MTX | ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| BG004 | Placebo q2w + MTX | Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number and Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Response at Week 12 | ACR 20 response is defined as:
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 |
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| Secondary | Number and Percentage of Subjects With ACR20 Response at Week 24 | ACR 20 response is defined as:
This endpoint was analyzed using NRI, i.e., subjects with missing response at Week 24 were treated as non responders. | Intent-to-treat population | Posted | Count of Participants | Participants | 24 weeks |
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| Secondary | Number and Percentage of Subjects With ACR50 Response at Weeks 12 and 24 | ACR50 response is defined as:
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 | 24 weeks |
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| Secondary | Number and Percentage of Subjects With ACR70 Response at Weeks 12 and 24 | ACR70 response is defined as:
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 | 24 weeks |
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| Secondary | Number and Percentage of Subjects With Low Disease Activity (LDA) Using Disease Activity Score 28 (DAS28) Using C-reactive Protein (CRP) at Weeks 12 and 24 | 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 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 | 24 weeks |
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| Secondary | Number and Percentage of Subjects With LDA Using DAS28 Using Erythrocyte Sedimentation Rate (ESR) at Weeks 12 and 24 | 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 | 24 weeks |
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| Secondary | Number and Percentage of Subjects With LDA Using Simplified Disease Activity Index (SDAI) at Weeks 12 and 24 | SDAI = TJC28 + SJC28 + Patient's Global Assessment of Disease Activity (VASPA) + Physician's Global Assessment of Disease Activity (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 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 | 24 weeks |
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| Secondary | Number and Percentage of Subjects With LDA Using Clinical Disease Activity Index (CDAI) at Weeks 12 and 24 | 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 | 24 weeks |
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| Secondary | Number and Percentage of Subjects With European League Against Rheumatism (EULAR) (CRP) Good Response at Weeks 12 and 24 | 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 | 24 weeks |
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| Secondary | Number and Percentage of Subjects in Remission Using DAS28 (ESR) at Weeks 12 and 24 | 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. | Intent-to-treat population | Posted | Count of Participants | Participants | 24 weeks |
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| Secondary | Number and Percentage of Subjects in Remission Using SDAI at Weeks 12 and 24 | 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 | 24 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number and Percentage of Subjects in Remission Using CDAI at Weeks 12 and 24 | 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 | 24 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number and Percentage of Subjects in Remission Using Boolean Defined Remission Criteria at Weeks 12 and 24 | 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 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 | 24 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Weeks 12 and 24 | 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 | Posted | Mean | Standard Error | score on a scale | from baseline till Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Physical Component Score of Short Form Health Survey (SF-36) at Weeks 12 and 24 | 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. The lower the score the more disability. The higher the score the less disability. | Intent-to-treat population; "Number Analyzed" reflect the number of non-missing, non-imputed observations at that specific timepoint. | Posted | Mean | Standard Error | score on a scale | from baseline till Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mental Component Score of Short Form Health Survey (SF-36) at Weeks 12 and 24 | 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. The lower the score the more disability. The higher the score the less disability. | Intent-to-treat population; "Number Analyzed" reflect the number of non-missing, non-imputed observations at that specific timepoint. | Posted | Mean | Standard Error | score on a scale | from baseline till Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale at Weeks 12 and 24 | 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 Analyzed" reflect the number of non-missing, non-imputed observations at that specific timepoint. | Posted | Mean | Standard Error | score on a scale | from baseline till Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics: ALX-0061 Concentration in Serum at Weeks 12 and 24 | ALX-0061 concentrations were only measured in samples of subjects randomized to any of the ALX-0061 treatment arms. Samples were taken predose at the concerned visits. | PK population | Posted | Geometric Mean | Standard Deviation | micrograms/milliliter | at Week 12 and Week 24 visits |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacodynamics: Concentrations of Soluble Interleukin-6 Receptor (sIL-6R) at Weeks 12 and 24 | Values below the limit of quantification are imputed with the lower limit of quantification (LLOQ). | Safety Population; "Number Analyzed" reflect the number of subjects with data available at that specific timepoint. | Posted | Mean | Standard Error | ng/mL | from baseline till Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Development of a Treatment-emergent Antidrug Antibody Response | Safety population | Posted | Count of Participants | Participants | from baseline till follow-up (FU) (i.e., 12 weeks after last study drug dosing at Week 22 or after early treatment discontinuation) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number and Percentage of Subjects With Treatment-emergent Adverse Events by Severity | Safety population | Posted | Count of Participants | Participants | From first study drug intake until the Week 24 or Early Termination visit. Only safety data through Week 24 is reported as 256 of the 293 subjects who completed the 24-week treatment period rolled-over to the C203 Study and did not perform the FU visit |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Treatment-emergent Adverse Events by Severity | Safety population | Posted | Number | Adverse events | From first study drug intake until the Week 24 or Early Termination visit. Only safety data through Week 24 is reported as 256 of the 293 subjects who completed the 24-week treatment period rolled-over to the C203 Study and did not perform the FU visit |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number and Percentage of Subjects With Treatment-related Treatment-emergent Adverse Events | Safety population | Posted | Count of Participants | Participants | From first study drug intake until the Week 24 or Early Termination visit. Only safety data through Week 24 is reported as 256 of the 293 subjects who completed the 24-week treatment period rolled-over to the C203 Study and did not perform the FU visit |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Treatment-related Treatment-emergent Adverse Events | Safety population | Posted | Number | Adverse events | From first study drug intake until the Week 24 or Early Termination visit. Only safety data through Week 24 is reported as 256 of the 293 subjects who completed the 24-week treatment period rolled-over to the C203 Study and did not perform the FU visit |
|
From first study drug intake up to and including follow-up, i.e., maximum of 34 weeks (22 weeks of treatment + 12 weeks of follow-up).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ALX-0061 75 mg q4w + MTX | ALX-0061 75 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). | 1 | 69 | 5 | 69 | 29 | 69 |
| EG001 | ALX-0061 150 mg q4w + MTX | ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). | 0 | 70 | 5 | 70 | 34 | 70 |
| EG002 | ALX-0061 150 mg q2w + MTX | ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). | 0 | 68 | 0 | 68 | 27 | 68 |
| EG003 | ALX-0061 225 mg q2w + MTX | ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). | 0 | 69 | 2 | 69 | 38 | 69 |
| EG004 | Placebo q2w + MTX | Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). | 0 | 69 | 4 | 69 | 17 | 69 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Ovarian adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cytopenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
None reported
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Monitor | Ablynx NV | +32 (0)9 262 00 00 | clinicaltrials@ablynx.com |
| Jul 2, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000606096 | ALX-0061 |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| OG002 | ALX-0061 150 mg q2w + MTX | ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| OG003 | ALX-0061 225 mg q2w + MTX | ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| OG004 | Placebo q2w + MTX | Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
|
|
| OG002 | ALX-0061 150 mg q2w + MTX | ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| OG003 | ALX-0061 225 mg q2w + MTX | ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| OG004 | Placebo q2w + MTX | Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
|
|
| OG002 | ALX-0061 150 mg q2w + MTX | ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| OG003 | ALX-0061 225 mg q2w + MTX | ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| OG004 | Placebo q2w + MTX | Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
|
|
ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.
ALX-0061
Placebo
Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).
| OG003 | ALX-0061 225 mg q2w + MTX | ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| OG004 | Placebo q2w + MTX | Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
|
|
ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| OG003 | ALX-0061 225 mg q2w + MTX | ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| OG004 | Placebo q2w + MTX | Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
|
|
| ALX-0061 150 mg q2w + MTX |
ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| OG003 | ALX-0061 225 mg q2w + MTX | ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| OG004 | Placebo q2w + MTX | Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
|
|
ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.
ALX-0061
Placebo
Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).
| OG003 | ALX-0061 225 mg q2w + MTX | ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| OG004 | Placebo q2w + MTX | Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
|
|
| OG003 | ALX-0061 225 mg q2w + MTX | ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| OG004 | Placebo q2w + MTX | Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
|
|
| OG003 | ALX-0061 225 mg q2w + MTX | ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| OG004 | Placebo q2w + MTX | Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
|
|
| OG003 | ALX-0061 225 mg q2w + MTX | ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| OG004 | Placebo q2w + MTX | Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
|
|
| OG003 | ALX-0061 225 mg q2w + MTX | ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| OG004 | Placebo q2w + MTX | Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
|
|
ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit.
ALX-0061
Placebo
Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor).
| OG003 | ALX-0061 225 mg q2w + MTX | ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| OG004 | Placebo q2w + MTX | Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
|
|
ALX-0061 150 mg every 4 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| OG002 | ALX-0061 150 mg q2w + MTX | ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| OG003 | ALX-0061 225 mg q2w + MTX | ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| OG004 | Placebo q2w + MTX | Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
|
|
| OG002 | ALX-0061 150 mg q2w + MTX | ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| OG003 | ALX-0061 225 mg q2w + MTX | ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| OG004 | Placebo q2w + MTX | Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
|
|
| OG002 | ALX-0061 150 mg q2w + MTX | ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| OG003 | ALX-0061 225 mg q2w + MTX | ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| OG004 | Placebo q2w + MTX | Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
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| OG002 | ALX-0061 150 mg q2w + MTX | ALX-0061 150 mg every 2 weeks + placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| OG003 | ALX-0061 225 mg q2w + MTX | ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| OG004 | Placebo q2w + MTX | Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
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| OG003 | ALX-0061 225 mg q2w + MTX | ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
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| OG003 | ALX-0061 225 mg q2w + MTX | ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| OG004 | Placebo q2w + MTX | Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
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| OG003 | ALX-0061 225 mg q2w + MTX | ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| OG004 | Placebo q2w + MTX | Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| OG005 | ALX-0061 Total | All participants who received ALX-0061 |
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| OG003 | ALX-0061 225 mg q2w + MTX | ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| OG004 | Placebo q2w + MTX | Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
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| OG003 | ALX-0061 225 mg q2w + MTX | ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| OG004 | Placebo q2w + MTX | Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
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| OG003 | ALX-0061 225 mg q2w + MTX | ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| OG004 | Placebo q2w + MTX | Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
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| OG003 | ALX-0061 225 mg q2w + MTX | ALX-0061 225 mg every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. ALX-0061 Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
| OG004 | Placebo q2w + MTX | Placebo every 2 weeks + MTX (at a stable dose and route) from baseline through Week 24. The last study drug administration was at the Week 22 visit. Placebo Methotrexate: Stable background dose of commercially available methotrexate (not provided by the Sponsor). |
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