Trial Outcomes & Findings for An Open-Label, Prospective Study to Assess the Safety and Effectiveness of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in the Russian Federation (NCT NCT01644396)
NCT ID: NCT01644396
Last Updated: 2014-10-01
Results Overview
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.
COMPLETED
PHASE4
50 participants
Baseline and Week 24
2014-10-01
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Open-Label, Prospective Study to Assess the Safety and Effectiveness of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in the Russian Federation
Baseline characteristics by cohort
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Age, Continuous
|
41.5 years
STANDARD_DEVIATION 9.86 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
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50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: Intent-to-treat population; non-responder imputation (NRI) was used, where participants with a missing value were counted as a non-responders.
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.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24
|
82.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16 and 24Population: Intent-to-treat population; non-responder imputation was used.
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.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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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|---|---|
|
Percentage of Participants Achieving a Physician's Global Assessment of Clear
Week 2
|
0 percentage of participants
|
|
Percentage of Participants Achieving a Physician's Global Assessment of Clear
Week 4
|
0 percentage of participants
|
|
Percentage of Participants Achieving a Physician's Global Assessment of Clear
Week 8
|
6.0 percentage of participants
|
|
Percentage of Participants Achieving a Physician's Global Assessment of Clear
Week 12
|
20.0 percentage of participants
|
|
Percentage of Participants Achieving a Physician's Global Assessment of Clear
Week 16
|
60.0 percentage of participants
|
|
Percentage of Participants Achieving a Physician's Global Assessment of Clear
Week 24
|
70.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16 and 24Population: Intent-to-treat population; non-responder imputation was used.
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.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Percentage of Participants Achieving a Physician's Global Assessment of Clear or Minimal
Week 2
|
2.0 percentage of participants
|
|
Percentage of Participants Achieving a Physician's Global Assessment of Clear or Minimal
Week 4
|
12.0 percentage of participants
|
|
Percentage of Participants Achieving a Physician's Global Assessment of Clear or Minimal
Week 8
|
34.0 percentage of participants
|
|
Percentage of Participants Achieving a Physician's Global Assessment of Clear or Minimal
Week 12
|
72.0 percentage of participants
|
|
Percentage of Participants Achieving a Physician's Global Assessment of Clear or Minimal
Week 16
|
86.0 percentage of participants
|
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Percentage of Participants Achieving a Physician's Global Assessment of Clear or Minimal
Week 24
|
80.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16 and 24Population: Intent-to-treat population; non-responder imputation was used.
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.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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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|---|---|
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Percentage of Participants Achieving a One Grade Improvement in Physician's Global Assessment (PGA)
Week 2
|
40.0 percentage of participants
|
|
Percentage of Participants Achieving a One Grade Improvement in Physician's Global Assessment (PGA)
Week 4
|
74.0 percentage of participants
|
|
Percentage of Participants Achieving a One Grade Improvement in Physician's Global Assessment (PGA)
Week 8
|
98.0 percentage of participants
|
|
Percentage of Participants Achieving a One Grade Improvement in Physician's Global Assessment (PGA)
Week 12
|
98.0 percentage of participants
|
|
Percentage of Participants Achieving a One Grade Improvement in Physician's Global Assessment (PGA)
Week 16
|
100 percentage of participants
|
|
Percentage of Participants Achieving a One Grade Improvement in Physician's Global Assessment (PGA)
Week 24
|
96.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, and 24Population: Intent-to-treat population; non-responder imputation was used.
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.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Percentage of Participants Achieving a PASI 50 Response
Week 2
|
8.0 percentage of participants
|
|
Percentage of Participants Achieving a PASI 50 Response
Week 4
|
36.0 percentage of participants
|
|
Percentage of Participants Achieving a PASI 50 Response
Week 8
|
84.0 percentage of participants
|
|
Percentage of Participants Achieving a PASI 50 Response
Week 12
|
88.0 percentage of participants
|
|
Percentage of Participants Achieving a PASI 50 Response
Week 16
|
94.0 percentage of participants
|
|
Percentage of Participants Achieving a PASI 50 Response
Week 24
|
96.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, and 16Population: Intent-to-treat population; non-responder imputation was used.
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.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Percentage of Participants Achieving a PASI 75 Response
Week 2
|
0 percentage of participants
|
|
Percentage of Participants Achieving a PASI 75 Response
Week 4
|
4.0 percentage of participants
|
|
Percentage of Participants Achieving a PASI 75 Response
Week 8
|
44.0 percentage of participants
|
|
Percentage of Participants Achieving a PASI 75 Response
Week 12
|
76.0 percentage of participants
|
|
Percentage of Participants Achieving a PASI 75 Response
Week 16
|
82.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, and 24Population: Intent-to-treat population; non-responder imputation was used.
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.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Percentage of Participants Achieving a PASI 90 Response
Week 2
|
0 percentage of participants
|
|
Percentage of Participants Achieving a PASI 90 Response
Week 4
|
0 percentage of participants
|
|
Percentage of Participants Achieving a PASI 90 Response
Week 8
|
20.0 percentage of participants
|
|
Percentage of Participants Achieving a PASI 90 Response
Week 12
|
48.0 percentage of participants
|
|
Percentage of Participants Achieving a PASI 90 Response
Week 16
|
72.0 percentage of participants
|
|
Percentage of Participants Achieving a PASI 90 Response
Week 24
|
76.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, and 24Population: Intent-to-treat population; non-responder analysis was used.
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.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Percentage of Participants Achieving a PASI 100 Response
Week 2
|
0 percentage of participants
|
|
Percentage of Participants Achieving a PASI 100 Response
Week 4
|
0 percentage of participants
|
|
Percentage of Participants Achieving a PASI 100 Response
Week 8
|
2.0 percentage of participants
|
|
Percentage of Participants Achieving a PASI 100 Response
Week 12
|
20.0 percentage of participants
|
|
Percentage of Participants Achieving a PASI 100 Response
Week 16
|
50.0 percentage of participants
|
|
Percentage of Participants Achieving a PASI 100 Response
Week 24
|
64.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, and 24Population: Intent-to-treat population; last observation carried forward (LOCF) imputation was used.
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.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
Week 2
|
-20.42 percent change
Standard Deviation 15.586
|
|
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
Week 4
|
-45.75 percent change
Standard Deviation 17.444
|
|
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
Week 8
|
-69.28 percent change
Standard Deviation 20.759
|
|
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
Week 12
|
-81.74 percent change
Standard Deviation 25.039
|
|
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
Week 16
|
-89.42 percent change
Standard Deviation 19.789
|
|
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
Week 24
|
-91.18 percent change
Standard Deviation 16.579
|
SECONDARY outcome
Timeframe: Baseline and Weeks 8, 12, and 24Population: Intent-to-treat population with available data; last observation carried forward (LOCF) imputation was used.
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.
Outcome measures
| Measure |
Adalimumab
n=49 Participants
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.
|
|---|---|
|
Percent Change From Baseline in Dermatology Life Quality Index (DLQI)
Week 8
|
-60.04 percent change
Standard Deviation 40.435
|
|
Percent Change From Baseline in Dermatology Life Quality Index (DLQI)
Week 12
|
-75.03 percent change
Standard Deviation 45.311
|
|
Percent Change From Baseline in Dermatology Life Quality Index (DLQI)
Week 24
|
-79.16 percent change
Standard Deviation 34.784
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Intent-to-treat population who had a NAPSI score ≥ 0 at the Baseline visit; last observation carried forward (LOCF) imputation was used.
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.
Outcome measures
| Measure |
Adalimumab
n=22 Participants
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.
|
|---|---|
|
Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI)
|
-68.06 percent change
Standard Deviation 34.134
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 24 (or Early Termination Visit)Population: Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.
Safety variables included laboratory data, vital signs and adverse events.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Change From Baseline in Hemoglobin
|
0.6 g/L
Standard Deviation 9.75
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 24 (or Early Termination Visit)Population: Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.
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).
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Change From Baseline in Hematocrit
|
0.007 liters/liter
Standard Deviation 0.0348
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 24 (or Early Termination Visit)Population: Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.
Safety variables included laboratory data, vital signs and adverse events.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Change From Baseline in Red Blood Cell Count
|
0.02 × 10^12 cells/L
Standard Deviation 0.352
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 24 (or Early Termination Visit)Population: Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.
Safety variables included laboratory data, vital signs and adverse events.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Change From Baseline in Blood Cell Counts
Platelets
|
-9.8 × 10^9 cells/L
Standard Deviation 55.51
|
|
Change From Baseline in Blood Cell Counts
White blood cells
|
0.00 × 10^9 cells/L
Standard Deviation 2.248
|
|
Change From Baseline in Blood Cell Counts
Neutrophils
|
-0.446 × 10^9 cells/L
Standard Deviation 2.1341
|
|
Change From Baseline in Blood Cell Counts
Lymphocytes
|
0.468 × 10^9 cells/L
Standard Deviation 0.6196
|
|
Change From Baseline in Blood Cell Counts
Monocytes
|
0.006 × 10^9 cells/L
Standard Deviation 0.1992
|
|
Change From Baseline in Blood Cell Counts
Eosinophils
|
-0.036 × 10^9 cells/L
Standard Deviation 0.2905
|
|
Change From Baseline in Blood Cell Counts
Basophils
|
0.013 × 10^9 cells/L
Standard Deviation 0.0602
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 24 (or Early Termination Visit)Population: Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.
Safety variables included laboratory data, vital signs and adverse events.
Outcome measures
| Measure |
Adalimumab
n=46 Participants
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.
|
|---|---|
|
Change From Baseline in Erythrocyte Sedimentation Rate
|
-4.087 mm/hour
Standard Deviation 9.8744
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 24 (or Early Termination Visit)Population: Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.
Safety variables included laboratory data, vital signs and adverse events.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Change From Baseline in Alanine Aminotransferase
|
2.8 U/L
Standard Deviation 28.95
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 24 (or Early Termination Visit)Population: Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.
Safety variables included laboratory data, vital signs and adverse events.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Change From Baseline in Aspartate Aminotransferase
|
1.5 U/L
Standard Deviation 16.81
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 24 (or Early Termination Visit)Population: Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.
Safety variables included laboratory data, vital signs and adverse events.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Change From Baseline in Alkaline Phosphatase
|
-4.7 U/L
Standard Deviation 14.84
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 24 (or Early Termination Visit)Population: Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.
Safety variables included laboratory data, vital signs and adverse events.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Change From Baseline in Total Bilirubin
|
0.5 µmol/L
Standard Deviation 4.83
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 24 (or Early Termination Visit)Population: Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.
Safety variables included laboratory data, vital signs and adverse events.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Change From Baseline in Creatinine
|
2.1 µmol/L
Standard Deviation 9.40
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 24 (or Early Termination Visit)Population: Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.
Safety variables included laboratory data, vital signs and adverse events.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Change From Baseline in Blood Urea Nitrogen (BUN)
|
0.42 mmol/L
Standard Deviation 1.521
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 24 (or Early Termination Visit)Population: Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.
Safety variables included laboratory data, vital signs and adverse events.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Change From Baseline in Uric Acid
|
-1.8 µmol/L
Standard Deviation 66.52
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 24 (or Early Termination Visit)Population: Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.
Safety variables included laboratory data, vital signs and adverse events.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Change From Baseline in Inorganic Phosphate
|
0.061 mmol/L
Standard Deviation 0.1900
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 24 (or Early Termination Visit)Population: Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.
Safety variables included laboratory data, vital signs and adverse events.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Change From Baseline in Calcium, Sodium and Potassium
Calcium
|
0.005 mmol/L
Standard Deviation 0.1035
|
|
Change From Baseline in Calcium, Sodium and Potassium
Sodium
|
-0.8 mmol/L
Standard Deviation 2.30
|
|
Change From Baseline in Calcium, Sodium and Potassium
Potassium
|
0.00 mmol/L
Standard Deviation 0.435
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 24 (or Early Termination Visit)Population: Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.
Safety variables included laboratory data, vital signs and adverse events.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Change From Baseline in Glucose
|
0.12 mmol/L
Standard Deviation 0.887
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 24 (or Early Termination Visit)Population: Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.
Safety variables included laboratory data, vital signs and adverse events.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Change From Baseline in Albumin
|
0.1 g/L
Standard Deviation 2.87
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 24 (or Early Termination Visit)Population: Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.
Safety variables included laboratory data, vital signs and adverse events.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Change From Baseline in Total Protein
|
-0.4 g/L
Standard Deviation 3.91
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 24 (or Early Termination Visit)Population: Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.
Safety variables included laboratory data, vital signs and adverse events.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Change From Baseline in Cholesterol
|
0.045 mmol/L
Standard Deviation 0.7723
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 24 (or Early Termination Visit)Population: Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.
Safety variables included laboratory data, vital signs and adverse events.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Change From Baseline in Triglycerides
|
0.194 mmol/L
Standard Deviation 1.0007
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 24 (or Early Termination Visit)Population: Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.
Safety variables included laboratory data, vital signs and adverse events.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)
|
-2.443 mg/L
Standard Deviation 5.2543
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 24 (or Early Termination Visit)Population: Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.
Safety variables included laboratory data, vital signs and adverse events.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Change From Baseline in Urine pH
|
0.14 pH units
Standard Deviation 0.663
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 24 (or Early Termination Visit)Population: Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.
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.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Change From Baseline in Urine Specific Gravity
|
0.0003 ratio
Standard Deviation 0.00792
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 24 (or Early Termination Visit)Safety variables included laboratory data, vital signs and adverse events.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Change From Baseline in Blood Pressure
Systolic blood pressure
|
0.9 mm Hg
Standard Deviation 8.13
|
|
Change From Baseline in Blood Pressure
Diastolic blood pressure
|
-0.4 mm Hg
Standard Deviation 7.03
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 24 (or Early Termination Visit)Population: Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.
Safety variables included laboratory data, vital signs and adverse events.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Change From Baseline in Pulse
|
0.2 beats per minute
Standard Deviation 4.05
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 24 (or Early Termination Visit)Population: Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.
Safety variables included laboratory data, vital signs and adverse events.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Change From Baseline in Respiratory Rate
|
-0.0 respirations per minute
Standard Deviation 1.33
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 24 (or Early Termination Visit)Population: Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.
Safety variables included laboratory data, vital signs and adverse events.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Change From Baseline in Weight
|
-0.18 kg
Standard Deviation 2.883
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 24 (or Early Termination Visit)Population: Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.
Safety variables included laboratory data, vital signs and adverse events.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Change From Baseline in Body Temperature
|
-0.03 degrees celsius
Standard Deviation 0.191
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the first dose of study drug until 70 days after the last dose (up to 33 weeks).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.
Outcome measures
| Measure |
Adalimumab
n=50 Participants
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.
|
|---|---|
|
Number of Participants With Adverse Events (AEs)
Any adverse event
|
14 participants
|
|
Number of Participants With Adverse Events (AEs)
Serious adverse event
|
0 participants
|
|
Number of Participants With Adverse Events (AEs)
AE leading to discontinuation of study drug
|
0 participants
|
|
Number of Participants With Adverse Events (AEs)
Severe adverse event
|
0 participants
|
|
Number of Participants With Adverse Events (AEs)
Drug-related adverse event
|
9 participants
|
|
Number of Participants With Adverse Events (AEs)
Adverse event leading to death
|
0 participants
|
|
Number of Participants With Adverse Events (AEs)
Any infection
|
7 participants
|
|
Number of Participants With Adverse Events (AEs)
Any serious infection
|
0 participants
|
|
Number of Participants With Adverse Events (AEs)
Any opportunistic infection
|
0 participants
|
|
Number of Participants With Adverse Events (AEs)
Latent tuberculosis
|
4 participants
|
|
Number of Participants With Adverse Events (AEs)
Any lymphoma
|
0 participants
|
|
Number of Participants With Adverse Events (AEs)
Any non-melanoma skin cancer
|
0 participants
|
|
Number of Participants With Adverse Events (AEs)
Any other malignancy
|
0 participants
|
|
Number of Participants With Adverse Events (AEs)
Any demyelinating disorder
|
0 participants
|
Adverse Events
Adalimumab
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Adalimumab
n=50 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
2.0%
1/50 • From the first dose of study drug until 70 days after the last dose (up to 33 weeks).
|
|
Infections and infestations
FURUNCLE
|
2.0%
1/50 • From the first dose of study drug until 70 days after the last dose (up to 33 weeks).
|
|
Infections and infestations
HERPES SIMPLEX
|
2.0%
1/50 • From the first dose of study drug until 70 days after the last dose (up to 33 weeks).
|
|
Infections and infestations
LATENT TUBERCULOSIS
|
8.0%
4/50 • From the first dose of study drug until 70 days after the last dose (up to 33 weeks).
|
|
Infections and infestations
ORAL HERPES
|
2.0%
1/50 • From the first dose of study drug until 70 days after the last dose (up to 33 weeks).
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
2.0%
1/50 • From the first dose of study drug until 70 days after the last dose (up to 33 weeks).
|
|
Infections and infestations
RHINITIS
|
6.0%
3/50 • From the first dose of study drug until 70 days after the last dose (up to 33 weeks).
|
|
Injury, poisoning and procedural complications
CONTUSION
|
2.0%
1/50 • From the first dose of study drug until 70 days after the last dose (up to 33 weeks).
|
|
Injury, poisoning and procedural complications
EXCORIATION
|
2.0%
1/50 • From the first dose of study drug until 70 days after the last dose (up to 33 weeks).
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
2.0%
1/50 • From the first dose of study drug until 70 days after the last dose (up to 33 weeks).
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
2.0%
1/50 • From the first dose of study drug until 70 days after the last dose (up to 33 weeks).
|
|
Investigations
BLOOD GLUCAGON INCREASED
|
2.0%
1/50 • From the first dose of study drug until 70 days after the last dose (up to 33 weeks).
|
|
Investigations
BLOOD TRIGLYCERIDES INCREASED
|
2.0%
1/50 • From the first dose of study drug until 70 days after the last dose (up to 33 weeks).
|
|
Renal and urinary disorders
RENAL COLIC
|
2.0%
1/50 • From the first dose of study drug until 70 days after the last dose (up to 33 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
2.0%
1/50 • From the first dose of study drug until 70 days after the last dose (up to 33 weeks).
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
2.0%
1/50 • From the first dose of study drug until 70 days after the last dose (up to 33 weeks).
|
Additional Information
Global Medical Services
AbbVie (prior sponsor, Abbott)
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER