| Primary | Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24 | The percentage of participants with a ≥ 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. | Intent-to-treat population; non-responder imputation (NRI) was used, where participants with a missing value were counted as a non-responders. | | | Number | | percentage of participants | | Baseline and Week 24 | | | | ID | Title | Description |
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| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Other Pre-specified | Change From Baseline in Hemoglobin | Safety variables included laboratory data, vital signs and adverse events. | Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis. | | | Mean | Standard Deviation | g/L | | Baseline and Week 24 (or Early Termination Visit) | | | | ID | Title | Description |
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| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Other Pre-specified | Change From Baseline in Hematocrit | Safety variables included laboratory data, vital signs and adverse events. The hematocrit measures the volume of red blood cells compared to the total blood volume (red blood cells and plasma). | Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis. | | | Mean | Standard Deviation | liters/liter | | Baseline and Week 24 (or Early Termination Visit) | | | | ID | Title | Description |
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| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Other Pre-specified | Change From Baseline in Red Blood Cell Count | Safety variables included laboratory data, vital signs and adverse events. | Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis. | | | Mean | Standard Deviation | × 10^12 cells/L | | Baseline and Week 24 (or Early Termination Visit) | | | | ID | Title | Description |
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| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Secondary | Percentage of Participants Achieving a Physician's Global Assessment of Clear | The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:
- 0: No evidence of scaling, erythema, or plaque elevation, overall score of cleared;
- 1: Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation, overall score of minimal;
- 2: Fine scale dominates, light red coloration, mild plaque elevation, overall score of mild;
- 3: Course scale dominates, moderate red coloration, moderate plaque elevation, overall score of moderate;
- 4: Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation, overall score of marked;
- 5: Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation, overall score of severe.
The percentage of participants achieving a PGA score of clear (0) is reported. | Intent-to-treat population; non-responder imputation was used. | | | Number | | percentage of participants | | Weeks 2, 4, 8, 12, 16 and 24 | | | | ID | Title | Description |
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| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Secondary | Percentage of Participants Achieving a Physician's Global Assessment of Clear or Minimal | The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:
- 0: No evidence of scaling, erythema, or plaque elevation, overall score of cleared;
- 1: Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation, overall score of minimal;
- 2: Fine scale dominates, light red coloration, mild plaque elevation, overall score of mild;
- 3: Course scale dominates, moderate red coloration, moderate plaque elevation, overall score of moderate;
- 4: Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation, overall score of marked;
- 5: Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation, overall score of severe.
The percentage of participants achieving a PGA score of clear (0) or minimal (1) is reported. | Intent-to-treat population; non-responder imputation was used. | | | Number | | percentage of participants | | Weeks 2, 4, 8, 12, 16 and 24 | | | | ID | Title | Description |
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| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Secondary | Percentage of Participants Achieving a One Grade Improvement in Physician's Global Assessment (PGA) | The PGA is a 6-point scale used to measure the severity of disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:
- 0: No evidence of scaling, erythema, or plaque elevation, overall score of cleared;
- 1: Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation, overall score of minimal;
- 2: Fine scale dominates, light red coloration, mild plaque elevation, overall score of mild;
- 3: Course scale dominates, moderate red coloration, moderate plaque elevation, overall score of moderate;
- 4: Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation, overall score of marked;
- 5: Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation, overall score of severe.
The percentage of participants achieving a shift from Baseline to a less severe category is reported. | Intent-to-treat population; non-responder imputation was used. | | | Number | | percentage of participants | | Baseline and Weeks 2, 4, 8, 12, 16 and 24 | | | | ID | Title | Description |
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| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Secondary | Percentage of Participants Achieving a PASI 50 Response | The percentage of participants with a ≥ 50% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. | Intent-to-treat population; non-responder imputation was used. | | | Number | | percentage of participants | | Baseline and Weeks 2, 4, 8, 12, 16, and 24 | | | | ID | Title | Description |
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| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Secondary | Percentage of Participants Achieving a PASI 75 Response | The percentage of participants with a ≥ 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. | Intent-to-treat population; non-responder imputation was used. | | | Number | | percentage of participants | | Baseline and Weeks 2, 4, 8, 12, and 16 | | | | ID | Title | Description |
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| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Secondary | Percentage of Participants Achieving a PASI 90 Response | The percentage of participants with a ≥ 90% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. | Intent-to-treat population; non-responder imputation was used. | | | Number | | percentage of participants | | Baseline and Weeks 2, 4, 8, 12, 16, and 24 | | | | ID | Title | Description |
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| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Secondary | Percentage of Participants Achieving a PASI 100 Response | The percentage of participants with a 100% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. | Intent-to-treat population; non-responder analysis was used. | | | Number | | percentage of participants | | Baseline and Weeks 2, 4, 8, 12, 16, and 24 | | | | ID | Title | Description |
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| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Secondary | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Baseline is presented as a percentage of the Baseline value: Post-baseline value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement. | Intent-to-treat population; last observation carried forward (LOCF) imputation was used. | | | Mean | Standard Deviation | percent change | | Baseline and Weeks 2, 4, 8, 12, 16, and 24 | | | | ID | Title | Description |
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| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Secondary | Percent Change From Baseline in Dermatology Life Quality Index (DLQI) | The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Change from Baseline is presented as a percentage of the Baseline value: Post-baseline value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement. | Intent-to-treat population with available data; last observation carried forward (LOCF) imputation was used. | | | Mean | Standard Deviation | percent change | | Baseline and Weeks 8, 12, and 24 | | | | ID | Title | Description |
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| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Secondary | Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) | NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The most affected fingernail was determined at Baseline and used for the analysis. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salman patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale:
- 0 = none;
- 1 = present in 1/4 nail quadrants;
- 2 = present in 2/4 nail quadrants;
- 3 = present in 3/4 nail quadrants;
- 4 = present in 4/4 nail quadrants.
The sum of these two scores is the total score for the nail, and ranges from 0 (no nail psoriasis) to 8 (psoriasis in 4/4 nail quadrants). Change from Baseline is presented as a percentage of the Baseline value, calculated as: Week 24 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement. | Intent-to-treat population who had a NAPSI score ≥ 0 at the Baseline visit; last observation carried forward (LOCF) imputation was used. | | | Mean | Standard Deviation | percent change | | Baseline and Week 24 | | | | ID | Title | Description |
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| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Other Pre-specified | Change From Baseline in Blood Cell Counts | Safety variables included laboratory data, vital signs and adverse events. | Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis. | | | Mean | Standard Deviation | × 10^9 cells/L | | Baseline and Week 24 (or Early Termination Visit) | | | | ID | Title | Description |
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| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Other Pre-specified | Change From Baseline in Erythrocyte Sedimentation Rate | Safety variables included laboratory data, vital signs and adverse events. | Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis. | | | Mean | Standard Deviation | mm/hour | | Baseline and Week 24 (or Early Termination Visit) | | | | ID | Title | Description |
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| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Other Pre-specified | Change From Baseline in Alanine Aminotransferase | Safety variables included laboratory data, vital signs and adverse events. | Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis. | | | Mean | Standard Deviation | U/L | | Baseline and Week 24 (or Early Termination Visit) | | | | ID | Title | Description |
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| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Other Pre-specified | Change From Baseline in Aspartate Aminotransferase | Safety variables included laboratory data, vital signs and adverse events. | Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis. | | | Mean | Standard Deviation | U/L | | Baseline and Week 24 (or Early Termination Visit) | | | | ID | Title | Description |
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| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Other Pre-specified | Change From Baseline in Alkaline Phosphatase | Safety variables included laboratory data, vital signs and adverse events. | Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis. | | | Mean | Standard Deviation | U/L | | Baseline and Week 24 (or Early Termination Visit) | | | | ID | Title | Description |
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| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Other Pre-specified | Change From Baseline in Total Bilirubin | Safety variables included laboratory data, vital signs and adverse events. | Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis. | | | Mean | Standard Deviation | µmol/L | | Baseline and Week 24 (or Early Termination Visit) | | | | ID | Title | Description |
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| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Other Pre-specified | Change From Baseline in Creatinine | Safety variables included laboratory data, vital signs and adverse events. | Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis. | | | Mean | Standard Deviation | µmol/L | | Baseline and Week 24 (or Early Termination Visit) | | | | ID | Title | Description |
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| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Other Pre-specified | Change From Baseline in Blood Urea Nitrogen (BUN) | Safety variables included laboratory data, vital signs and adverse events. | Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis. | | | Mean | Standard Deviation | mmol/L | | Baseline and Week 24 (or Early Termination Visit) | | | | ID | Title | Description |
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| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Other Pre-specified | Change From Baseline in Uric Acid | Safety variables included laboratory data, vital signs and adverse events. | Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis. | | | Mean | Standard Deviation | µmol/L | | Baseline and Week 24 (or Early Termination Visit) | | | | ID | Title | Description |
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| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Other Pre-specified | Change From Baseline in Inorganic Phosphate | Safety variables included laboratory data, vital signs and adverse events. | Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis. | | | Mean | Standard Deviation | mmol/L | | Baseline and Week 24 (or Early Termination Visit) | | | | ID | Title | Description |
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| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Other Pre-specified | Change From Baseline in Calcium, Sodium and Potassium | Safety variables included laboratory data, vital signs and adverse events. | Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis. | | | Mean | Standard Deviation | mmol/L | | Baseline and Week 24 (or Early Termination Visit) | | | | ID | Title | Description |
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| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Other Pre-specified | Change From Baseline in Glucose | Safety variables included laboratory data, vital signs and adverse events. | Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis. | | | Mean | Standard Deviation | mmol/L | | Baseline and Week 24 (or Early Termination Visit) | | | | ID | Title | Description |
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| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Other Pre-specified | Change From Baseline in Albumin | Safety variables included laboratory data, vital signs and adverse events. | Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis. | | | Mean | Standard Deviation | g/L | | Baseline and Week 24 (or Early Termination Visit) | | | | ID | Title | Description |
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| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Other Pre-specified | Change From Baseline in Total Protein | Safety variables included laboratory data, vital signs and adverse events. | Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis. | | | Mean | Standard Deviation | g/L | | Baseline and Week 24 (or Early Termination Visit) | | | | ID | Title | Description |
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| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Other Pre-specified | Change From Baseline in Cholesterol | Safety variables included laboratory data, vital signs and adverse events. | Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis. | | | Mean | Standard Deviation | mmol/L | | Baseline and Week 24 (or Early Termination Visit) | | | | ID | Title | Description |
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| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Other Pre-specified | Change From Baseline in Triglycerides | Safety variables included laboratory data, vital signs and adverse events. | Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis. | | | Mean | Standard Deviation | mmol/L | | Baseline and Week 24 (or Early Termination Visit) | | | | ID | Title | Description |
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| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Other Pre-specified | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) | Safety variables included laboratory data, vital signs and adverse events. | Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis. | | | Mean | Standard Deviation | mg/L | | Baseline and Week 24 (or Early Termination Visit) | | | | ID | Title | Description |
|---|
| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Other Pre-specified | Change From Baseline in Urine pH | Safety variables included laboratory data, vital signs and adverse events. | Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis. | | | Mean | Standard Deviation | pH units | | Baseline and Week 24 (or Early Termination Visit) | | | | ID | Title | Description |
|---|
| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Other Pre-specified | Change From Baseline in Urine Specific Gravity | Safety variables included laboratory data, vital signs and adverse events. Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. | Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis. | | | Mean | Standard Deviation | ratio | | Baseline and Week 24 (or Early Termination Visit) | | | | ID | Title | Description |
|---|
| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Other Pre-specified | Change From Baseline in Blood Pressure | Safety variables included laboratory data, vital signs and adverse events. | | | | Mean | Standard Deviation | mm Hg | | Baseline and Week 24 (or Early Termination Visit) | | | | ID | Title | Description |
|---|
| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Other Pre-specified | Change From Baseline in Pulse | Safety variables included laboratory data, vital signs and adverse events. | Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis. | | | Mean | Standard Deviation | beats per minute | | Baseline and Week 24 (or Early Termination Visit) | | | | ID | Title | Description |
|---|
| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Other Pre-specified | Change From Baseline in Respiratory Rate | Safety variables included laboratory data, vital signs and adverse events. | Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis. | | | Mean | Standard Deviation | respirations per minute | | Baseline and Week 24 (or Early Termination Visit) | | | | ID | Title | Description |
|---|
| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Other Pre-specified | Change From Baseline in Weight | Safety variables included laboratory data, vital signs and adverse events. | Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis. | | | Mean | Standard Deviation | kg | | Baseline and Week 24 (or Early Termination Visit) | | | | ID | Title | Description |
|---|
| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Other Pre-specified | Change From Baseline in Body Temperature | Safety variables included laboratory data, vital signs and adverse events. | Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis. | | | Mean | Standard Deviation | degrees celsius | | Baseline and Week 24 (or Early Termination Visit) | | | | ID | Title | Description |
|---|
| OG000 | Adalimumab | Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks. |
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| Other Pre-specified | Number of Participants With Adverse Events (AEs) | An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. The investigator rated the severity of each AE as either: Mild: The AE is transient and easily tolerated; Moderate: The AE causes the participant discomfort and interrupts usual activities. Severe: The AE causes considerable interference with usual activities and may be incapacitating or life-threatening. A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. Drug-related AEs are those assessed by the investigator as either probably or possibly related. Other malignancy excludes lymphoma, hepatosplenic T-cell lymphoma (HSTCL), leukemia, non-melanoma skin cancer (NMSC), and melanoma. | | | | Number | | participants | | From the first dose of study drug until 70 days after the last dose (up to 33 weeks). | | | | ID | Title | Description |
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| OG000 | Adalimumab | Number of participants with adverse events |
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