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A Canadian Study to Evaluate Early Use of Adalimumab After Methotrexate Failure in Early Rheumatoid Arthritis (RADAR)

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ClinicalTrials.gov Identifier: NCT01162421
Recruitment Status : Completed
First Posted : July 14, 2010
Results First Posted : November 1, 2016
Last Update Posted : November 1, 2016
Sponsor:
Collaborator:
Mount Sinai Hospital, Canada
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Biological: adalimumab
Drug: Methotrexate
Enrollment 77

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard of Care Early Adalimumab
Hide Arm/Group Description Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months. Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
Period Title: Overall Study
Started 37 40
Completed 29 27
Not Completed 8 13
Reason Not Completed
Did not receive study drug             2             1
Adverse Event             2             5
Lost to Follow-up             0             2
Lack of Efficacy             2             2
Not specified             2             3
Arm/Group Title Standard of Care Early Adalimumab Total
Hide Arm/Group Description Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months. Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment. Total of all reporting groups
Overall Number of Baseline Participants 35 39 74
Hide Baseline Analysis Population Description
Intent-to-treat population: all participants who were randomized and received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 39 participants 74 participants
53.8  (10.46) 51.9  (11.55) 52.8  (11.01)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 35 participants 39 participants 74 participants
< 65 years 30 34 64
>/= 65 years 5 5 10
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 39 participants 74 participants
Female
24
  68.6%
26
  66.7%
50
  67.6%
Male
11
  31.4%
13
  33.3%
24
  32.4%
1.Primary Outcome
Title Percentage of Participants With No Radiographic Progression at Month 12
Hide Description Radiographic progression was defined as change from Baseline in the modified Total Sharp Score (mTSS) of ≤ 0.5 units). The mTSS is a measure of change in joint health: digitized images of radiographs of hands and feet obtained at Screening and Month 12 were scored in a blinded manner. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.
Time Frame Baseline, Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: all participants who were randomized and received at least one dose of study drug. Last observation carried forward (LOCF): missing responses were imputed by carrying forward the last non-missing post-baseline observation.
Arm/Group Title Standard of Care Early Adalimumab
Hide Arm/Group Description:
Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
Overall Number of Participants Analyzed 35 39
Measure Type: Number
Unit of Measure: percentage of participants
62.9 61.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.907
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson’s chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-23.4 to 20.8
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With No Radiographic Progression at Month 6 and Month 24
Hide Description Radiographic progression was defined as change from Baseline in the modified Total Sharp Score (mTSS) of ≤ 0.5 units). The mTSS is a measure of change in joint health: digitized images of radiographs of hands and feet obtained at Screening and Month 12 were scored in a blinded manner. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.
Time Frame Baseline, Month 6, Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: all participants who were randomized and received at least one dose of study drug (nonresponder imputation).
Arm/Group Title Standard of Care Early Adalimumab
Hide Arm/Group Description:
Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
Overall Number of Participants Analyzed 35 39
Measure Type: Number
Unit of Measure: percentage of participants
Month 6 68.6 71.8
Month 24 51.4 46.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.762
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson’s chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 3.2
Confidence Interval (2-Sided) 95%
-17.7 to 24.1
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.650
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson’s chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -5.3
Confidence Interval (2-Sided) 95%
-28.1 to 17.5
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in mTSS at Months 6, 12 and 24
Hide Description The mTSS is a measure of change in joint health: digitized images of radiographs of hands and feet obtained at Screening and Month 12 were scored in a blinded manner. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.
Time Frame Baseline, Month 6, Month 12, Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: all participants who were randomized and received at least one dose of study drug; n=number of participants with an assessment at Baseline and given timepoint (observed cases).
Arm/Group Title Standard of Care Early Adalimumab
Hide Arm/Group Description:
Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
Overall Number of Participants Analyzed 35 39
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Month 6; n=34, 36 0.88  (0.273) 0.02  (0.266)
Month 12; n=30, 34 1.62  (0.486) 0.16  (0.457)
Month 24; n=28, 21 2.24  (0.912) 0.01  (1.055)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and baseline value as the covariate.
Method ANCOVA
Comments The a priori threshold for statistical significance is P= 0.05.
Method of Estimation Estimation Parameter Least squares (LS) Mean Difference
Estimated Value -0.86
Confidence Interval (2-Sided) 95%
-1.62 to -0.10
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.382
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.033
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and baseline value as the covariate.
Method ANCOVA
Comments The a priori threshold for statistical significance is P= 0.05.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.46
Confidence Interval (2-Sided) 95%
-2.79 to -0.12
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.667
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.120
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.22
Confidence Interval (2-Sided) 95%
-5.05 to 0.60
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.403
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With Rapid Radiographic Progression at Month 12
Hide Description Radiographic progression was defined as a change from Baseline in mTSS that is ≥ 5 units. The mTSS is a measure of change in joint health: digitized images of radiographs of hands and feet obtained at Screening and Month 12 were scored in a blinded manner. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.
Time Frame Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: all participants who were randomized and received at least one dose of study drug ith an assessment (nonresponder imputation).
Arm/Group Title Standard of Care Early Adalimumab
Hide Arm/Group Description:
Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
Overall Number of Participants Analyzed 34 39
Measure Type: Number
Unit of Measure: percentage of participants
14.3 2.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.095
Comments P-value is based on two sided Fisher’s exact test.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -11.7
Confidence Interval (2-Sided) 95%
-27.0 to 1.6
Estimation Comments Confidence interval is based on Wilson confidence limits.
5.Secondary Outcome
Title Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Months 3, 6, 9, 12, 18 and 24
Hide Description

A participant is an ACR20 responder if the following 3 criteria for improvement from Baseline are met:

  • ≥ 20% improvement in tender joint count;
  • ≥ 20% improvement in swollen joint count; and
  • ≥ 20% improvement in at least 3 of the 5 following parameters: -

    • Physician global assessment of disease activity
    • Patient global assessment of disease activity
    • Patient assessment of pain
    • Disability Index of the Health Assessment Questionnaire
    • Acute phase reactant (erythrocyte sedimentation rate/C-reactive protein [CRP]).
Time Frame Baseline, Months 3, 6, 9, 12, 18, 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: all participants who were randomized and received at least one dose of study drug (nonresponder imputation).
Arm/Group Title Standard of Care Early Adalimumab
Hide Arm/Group Description:
Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
Overall Number of Participants Analyzed 35 39
Measure Type: Number
Unit of Measure: percentage of participants
Month 3 57.1 69.2
Month 6 37.1 64.1
Month 9 60.0 66.7
Month 12 68.6 56.4
Month 18 65.7 51.3
Month 24 65.7 46.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.281
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 12.1
Confidence Interval (2-Sided) 95%
-9.79 to 33.97
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments The a priori threshold for statistical significance is P=0.05.
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 27.0
Confidence Interval (2-Sided) 95%
4.98 to 48.93
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.552
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 6.7
Confidence Interval (2-Sided) 95%
-15.29 to 28.63
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.281
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -12.2
Confidence Interval (2-Sided) 95%
-34.04 to 9.72
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.209
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -14.4
Confidence Interval (2-Sided) 95%
-36.64 to 7.78
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.091
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -19.6
Confidence Interval (2-Sided) 95%
-41.74 to 2.62
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With American College of Rheumatology 50% (ACR50) Response at Months 3, 6, 9, 12, 18 and 24
Hide Description

A participant is an ACR50 responder if the following 3 criteria for improvement from Baseline are met:

  • ≥ 50% improvement in tender joint count;
  • ≥ 50% improvement in swollen joint count; and
  • ≥ 50% improvement in at least 3 of the 5 following parameters:

    • Physician global assessment of disease activity
    • Patient global assessment of disease activity
    • Patient assessment of pain
    • Disability Index of the Health Assessment Questionnaire
    • Acute phase reactant (erythrocyte sedimentation rate/CRP).
Time Frame Baseline, Months 3, 6, 9, 12, 18, 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: all participants who were randomized and received at least one dose of study drug (nonresponder imputation).
Arm/Group Title Standard of Care Early Adalimumab
Hide Arm/Group Description:
Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
Overall Number of Participants Analyzed 35 39
Measure Type: Number
Unit of Measure: percentage of participants
Month 3 22.9 38.5
Month 6 22.9 43.6
Month 9 40.0 48.7
Month 12 34.3 43.6
Month 18 45.7 38.5
Month 24 42.9 33.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.148
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 15.6
Confidence Interval (2-Sided) 95%
-5.05 to 36.26
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.060
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 20.7
Confidence Interval (2-Sided) 95%
-0.14 to 41.61
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.451
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 8.7
Confidence Interval (2-Sided) 95%
-13.85 to 31.29
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.413
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 9.3
Confidence Interval (2-Sided) 95%
-12.82 to 31.43
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.528
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -7.3
Confidence Interval (2-Sided) 95%
-29.74 to 15.23
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.399
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -9.5
Confidence Interval (2-Sided) 95%
-31.61 to 12.56
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With American College of Rheumatology 70% (ACR70) Response at Months 3, 6, 9, 12, 18 and 24
Hide Description

A participant is an ACR70 responder if the following 3 criteria for improvement from Baseline are met:

  • ≥ 70% improvement in tender joint count;
  • ≥ 70% improvement in swollen joint count; and
  • ≥ 70% improvement in at least 3 of the 5 following parameters: -

    • Physician global assessment of disease activity
    • Patient global assessment of disease activity
    • Patient assessment of pain
    • Disability Index of the Health Assessment Questionnaire
    • Acute phase reactant (erythrocyte sedimentation rate/CRP).
Time Frame Months 3, 6, 9, 12, 18, 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: all participants who were randomized and received at least one dose of study drug (nonresponder imputation).
Arm/Group Title Standard of Care Early Adalimumab
Hide Arm/Group Description:
Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
Overall Number of Participants Analyzed 35 39
Measure Type: Number
Unit of Measure: percentage of participants
Month 3 2.9 15.4
Month 6 8.6 28.2
Month 9 22.9 25.6
Month 12 14.3 30.8
Month 18 20.0 30.8
Month 24 40.0 23.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.111
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 12.5
Confidence Interval (2-Sided) 95%
-1.70 to 27.06
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments The a priori threshold for statistical significance is P=0.05.
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 19.6
Confidence Interval (2-Sided) 95%
2.74 to 36.53
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.780
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 2.8
Confidence Interval (2-Sided) 95%
-16.74 to 22.31
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.092
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 16.5
Confidence Interval (2-Sided) 95%
-2.07 to 35.04
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.290
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 10.8
Confidence Interval (2-Sided) 95%
-8.86 to 30.40
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.116
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -16.9
Confidence Interval (2-Sided) 95%
-37.86 to 4.01
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Swollen Joint Count 66 at Months 3, 6, 9, 12, 18 and 24
Hide Description Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The presence of swelling is scored 1 and no swelling is 0; range of score is 0-66, with higher scores indicating more swollen joints.
Time Frame Baseline, Months 3, 6, 9, 12, 18, 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.
Arm/Group Title Standard of Care Early Adalimumab
Hide Arm/Group Description:
Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
Overall Number of Participants Analyzed 35 38
Least Squares Mean (Standard Error)
Unit of Measure: swollen joints
Month 3 -5.6  (0.85) -9.2  (0.81)
Month 6 -5.9  (0.81) -10.4  (0.78)
Month 9 -8.1  (0.84) -10.8  (0.80)
Month 12 -9.2  (0.69) -11.3  (0.66)
Month 18 -9.4  (1.14) -10.0  (1.09)
Month 24 -10.1  (0.83) -10.6  (0.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments The a priori threshold for statistical significance is P=0.01.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.5
Confidence Interval (2-Sided) 95%
-5.9 to -1.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.18
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments The a priori threshold for statistical significance is P=0.001.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -4.5
Confidence Interval (2-Sided) 95%
-6.8 to -2.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.12
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments The a priori threshold for statistical significance is P=0.05.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.7
Confidence Interval (2-Sided) 95%
-5.1 to -0.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.16
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.037
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments The a priori threshold for statistical significance is P=0.05.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.0
Confidence Interval (2-Sided) 95%
-4.0 to -0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.96
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.702
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-3.7 to 2.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.58
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.644
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-2.8 to 1.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.15
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Swollen Joint Count 28 at Months 3, 6, 9, 12, 18 and 24
Hide Description Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The presence of swelling is scored 1 and no swelling is 0; range of score is 0-28, with higher scores indicating more swollen joints.
Time Frame Baseline, Months 3, 6, 9, 12, 18, 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.
Arm/Group Title Standard of Care Early Adalimumab
Hide Arm/Group Description:
Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
Overall Number of Participants Analyzed 35 38
Least Squares Mean (Standard Error)
Unit of Measure: swollen joints
Month 3 -4.6  (0.64) -6.5  (0.62)
Month 6 -4.5  (0.57) -7.9  (0.55)
Month 9 -6.1  (0.58) -8.3  (0.56)
Month 12 -6.9  (0.51) -8.5  (0.49)
Month 18 -7.4  (0.68) -8.1  (0.65)
Month 24 -7.6  (0.55) -8.4  (0.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments The a priori threshold for statistical significance is P=0.05.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-3.7 to -0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.89
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments The a priori threshold for statistical significance is P=0.001.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.4
Confidence Interval (2-Sided) 95%
-5.0 to -1.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.79
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments The a priori threshold for statistical significance is P=0.01.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.2
Confidence Interval (2-Sided) 95%
-3.8 to -0.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.81
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments The a priori threshold for statistical significance is P=0.05.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-3.0 to -0.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.71
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.452
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-2.6 to 1.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.94
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.343
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-2.3 to 0.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.77
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Tender Joint Count 68 at Months 3, 6, 9, 12, 18 and 24
Hide Description Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The presence of tenderness is scored 1 and no tenderness is 0; range of score is 0-68, with higher scores indicating more tender joints.
Time Frame Baseline, Months 3, 6, 9, 12, 18, 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.
Arm/Group Title Standard of Care Early Adalimumab
Hide Arm/Group Description:
Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
Overall Number of Participants Analyzed 35 38
Least Squares Mean (Standard Error)
Unit of Measure: tender joints
Month 3 -9.3  (1.63) -12.1  (1.56)
Month 6 -8.3  (1.38) -15.5  (1.33)
Month 9 -11.2  (1.35) -15.0  (1.30)
Month 12 -13.4  (1.41) -14.1  (1.35)
Month 18 -13.4  (1.67) -13.9  (1.60)
Month 24 -15.0  (1.32) -15.8  (1.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.220
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.8
Confidence Interval (2-Sided) 95%
-7.3 to 1.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.26
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments The a priori threshold for statistical significance is P=0.001.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -7.2
Confidence Interval (2-Sided) 95%
-11.0 to -3.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.92
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.050
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments The a priori threshold for statistical significance is P=0.05.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.7
Confidence Interval (2-Sided) 95%
-7.5 to 0.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.87
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.725
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-4.6 to 3.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.95
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.837
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-5.1 to 4.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.31
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.661
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-4.5 to 2.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.83
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in Tender Joint Count 28 at Months 3, 6, 9, 12, 18 and 24
Hide Description Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The presence of tenderness is scored 1 and no tenderness is 0; range of score is 0-28, with higher scores indicating more tender joints.
Time Frame Baseline, Months 3, 6, 9, 12, 18, 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.
Arm/Group Title Standard of Care Early Adalimumab
Hide Arm/Group Description:
Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
Overall Number of Participants Analyzed 35 38
Least Squares Mean (Standard Error)
Unit of Measure: tender joints
Month 3 -5.5  (0.93) -7.4  (0.90)
Month 6 -5.7  (0.78) -9.7  (0.74)
Month 9 -7.1  (0.86) -9.6  (0.83)
Month 12 -8.4  (0.82) -9.2  (0.79)
Month 18 -8.5  (0.94) -9.1  (0.90)
Month 24 -9.4  (0.80) -10.2  (0.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.156
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-4.4 to 0.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.29
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments The a priori threshold for statistical significance is P=0.001.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -4.0
Confidence Interval (2-Sided) 95%
-6.1 to -1.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.08
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.040
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments The a priori threshold for statistical significance is P=0.05.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.5
Confidence Interval (2-Sided) 95%
-4.9 to -0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.19
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.492
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-3.1 to 1.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.14
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.649
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-3.2 to 2.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.30
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.464
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-3.0 to 1.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.11
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Physician's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24
Hide Description Physicians were asked to indicate the participant’s disease activity (independent of the participant's self assessment) on a visual analogue scale (VAS) from 0 (very good) to 100 (very bad). A negative change from Baseline indicates improvement.
Time Frame Baseline, Months 3, 6, 9, 12, 18, 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.
Arm/Group Title Standard of Care Early Adalimumab
Hide Arm/Group Description:
Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
Overall Number of Participants Analyzed 35 38
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Month 3 -29.3  (3.66) -41.6  (3.51)
Month 6 -22.5  (4.25) -48.0  (4.08)
Month 9 -39.6  (4.21) -48.9  (4.04)
Month 12 -43.8  (4.12) -47.3  (3.96)
Month 18 -45.5  (4.29) -46.2  (4.12)
Month 24 -47.6  (4.23) -47.7  (4.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments The a priori threshold for statistical significance is P=0.05.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -12.3
Confidence Interval (2-Sided) 95%
-22.5 to -2.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.08
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments The a priori threshold for statistical significance is P=0.001.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -25.5
Confidence Interval (2-Sided) 95%
-37.3 to -13.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.90
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.113
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -9.4
Confidence Interval (2-Sided) 95%
-21.0 to 2.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.84
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.544
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.5
Confidence Interval (2-Sided) 95%
-14.9 to 7.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.72
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.916
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-12.5 to 11.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.96
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.983
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-11.8 to 11.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.86
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in Patient's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24
Hide Description Participants were asked to indicate how they were doing with their RA on a VAS from 0 (very well) to 100 (very poorly). A negative change from Baseline indicates improvement.
Time Frame Baseline, Months 3, 6, 9, 12, 18, 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.
Arm/Group Title Standard of Care Early Adalimumab
Hide Arm/Group Description:
Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
Overall Number of Participants Analyzed 35 38
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Month 3 -19.5  (3.58) -21.8  (3.43)
Month 6 -14.4  (4.05) -19.6  (3.88)
Month 9 -25.4  (4.02) -20.2  (3.86)
Month 12 -22.4  (3.81) -22.3  (3.65)
Month 18 -29.4  (3.86) -23.0  (3.71)
Month 24 -30.6  (3.99) -23.6  (3.83)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.641
Comments P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.3
Confidence Interval (2-Sided) 95%
-12.2 to 7.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.96
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.358
Comments P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -5.2
Confidence Interval (2-Sided) 95%
-16.4 to 6.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.61
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.352
Comments P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 5.2
Confidence Interval (2-Sided) 95%
-5.9 to 16.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.58
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.990
Comments P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-10.5 to 10.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.28
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.238
Comments P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 6.4
Confidence Interval (2-Sided) 95%
-4.3 to 17.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.36
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.207
Comments P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 7.1
Confidence Interval (2-Sided) 95%
-4.0 to 18.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.54
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in Patient's Global Assessment of Pain at Months 3, 6, 9, 12, 18 and 24
Hide Description Participants were asked to indicate how severe their pain had been in the previous week on a VAS from 0 (no pain) to 100 (pain as bad as it could be). A negative change from Baseline indicates improvement.
Time Frame Baseline, Months 3, 6, 9, 12, 18, 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.
Arm/Group Title Standard of Care Early Adalimumab
Hide Arm/Group Description:
Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
Overall Number of Participants Analyzed 35 38
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Month 3 -22.0  (3.79) -23.0  (3.64)
Month 6 -14.5  (3.94) -23.0  (3.78)
Month 9 -21.7  (4.03) -21.3  (3.87)
Month 12 -22.0  (4.01) -24.4  (3.85)
Month 18 -28.1  (4.07) -22.7  (3.90)
Month 24 -26.6  (4.40) -23.6  (4.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.850
Comments P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-11.5 to 9.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.28
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.129
Comments P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -8.4
Confidence Interval (2-Sided) 95%
-19.4 to 2.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.49
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.937
Comments P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-10.8 to 11.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.62
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.670
Comments P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.4
Confidence Interval (2-Sided) 95%
-13.5 to 8.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.59
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.341
Comments P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 5.4
Confidence Interval (2-Sided) 95%
-5.9 to 16.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.67
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.621
Comments P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.0
Confidence Interval (2-Sided) 95%
-9.2 to 15.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.13
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline in CRP at Months 3, 6, 9, 12, 18 and 24
Hide Description [Not Specified]
Time Frame Baseline, Months 3, 6, 9, 12, 18, 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation; n=number of participants with an assessment at given time point.
Arm/Group Title Standard of Care Early Adalimumab
Hide Arm/Group Description:
Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
Overall Number of Participants Analyzed 35 38
Least Squares Mean (Standard Error)
Unit of Measure: mg/L
Month 3; n=33, 38 -10.2  (2.39) -8.9  (2.23)
Month 6; n=34, 38 -7.6  (3.26) -9.1  (3.08)
Month 9; n=35, 38 -11.3  (2.84) -11.1  (2.72)
Month 12; n=35, 38 -13.7  (2.37) -10.8  (2.28)
Month 18; n=35, 38 -15.2  (2.51) -9.7  (2.41)
Month 24; n=26, 23 -13.5  (2.46) -11.2  (2.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.697
Comments P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
-5.3 to 7.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.29
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.744
Comments P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.5
Confidence Interval (2-Sided) 95%
-10.5 to 7.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.51
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.967
Comments P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-7.7 to 8.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.95
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.377
Comments P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.9
Confidence Interval (2-Sided) 95%
-3.7 to 9.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.30
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.122
Comments P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 5.5
Confidence Interval (2-Sided) 95%
-1.5 to 12.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.50
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.490
Comments P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.4
Confidence Interval (2-Sided) 95%
-4.4 to 9.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.42
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline in Disease Activity Score DAS28(CRP) at Months 3, 6, 9, 12, 18 and 24
Hide Description The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.
Time Frame Baseline, Months 3, 6, 9, 12, 18, 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation; n=number of participants with an assessment at given time point.
Arm/Group Title Standard of Care Early Adalimumab
Hide Arm/Group Description:
Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
Overall Number of Participants Analyzed 35 38
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Month 3; n=33, 38 -1.4  (0.20) -1.8  (0.18)
Month 6; n=34, 38 -1.4  (0.21) -2.3  (0.20)
Month 9; n=35, 38 -2.0  (0.21) -2.3  (0.20)
Month 12; n=35, 38 -2.1  (0.20) -2.4  (0.19)
Month 18; n=35, 38 -2.4  (0.22) -2.4  (0.21)
Month 24; n=35, 38 -2.6  (0.20) -2.6  (0.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.102
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-1.0 to 0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.27
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments The a priori threshold for statistical significance is P=0.01.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-1.5 to -0.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.29
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.214
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-0.9 to 0.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.29
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.339
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.8 to 0.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.27
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.973
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.6 to 0.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.30
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.755
Comments P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.6 to 0.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.28
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Percentage of Participants With DAS28(CRP) Remission at Months 3, 6, 9, 12, 18 and 24
Hide Description DAS28(CRP) remission was defined as DAS28(CRP) < 2.6. The DAS28(CRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.
Time Frame Months 3, 6, 9, 12, 18, 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment (non-responder imputation).
Arm/Group Title Standard of Care Early Adalimumab
Hide Arm/Group Description:
Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
Overall Number of Participants Analyzed 35 39
Measure Type: Number
Unit of Measure: percentage of participants
Month 3 8.6 17.9
Month 6 11.4 35.9
Month 9 31.4 28.2
Month 12 22.9 35.9
Month 18 34.3 30.8
Month 24 42.9 38.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.316
Comments [Not Specified]
Method Fisher Exact
Comments Two-sided Fisher Exact test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 9.4
Confidence Interval (2-Sided) 95%
-7.09 to 25.13
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test. The a priori threshold for statistical significance is P=0.05.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 24.5
Confidence Interval (2-Sided) 95%
6.09 to 42.85
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.762
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -3.2
Confidence Interval (2-Sided) 95%
-24.10 to 17.66
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.220
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 13.0
Confidence Interval (2-Sided) 95%
-7.46 to 33.54
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.747
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -3.5
Confidence Interval (2-Sided) 95%
-24.90 to 17.86
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.701
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -4.4
Confidence Interval (2-Sided) 95%
-26.80 to 18.01
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Percentage of Participants With DAS28(CRP) Low Disease Activity at Months 3, 6, 9, 12, 18 and 24
Hide Description DAS28(CRP) low disease activity was defined as DAS28(CRP) < 3.2. The DAS28(CRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.
Time Frame Months 3, 6, 9, 12, 18, 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment (non-responder imputation).
Arm/Group Title Standard of Care Early Adalimumab
Hide Arm/Group Description:
Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
Overall Number of Participants Analyzed 35 39
Measure Type: Number
Unit of Measure: percentage of participants
Month 3 22.9 33.3
Month 6 28.6 51.3
Month 9 51.4 56.4
Month 12 48.6 56.4
Month 18 51.4 48.7
Month 24 54.3 43.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.318
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 10.5
Confidence Interval (2-Sided) 95%
-9.83 to 30.78
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test. The a priori threshold for statistical significance is P=0.05.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 22.7
Confidence Interval (2-Sided) 95%
1.03 to 44.39
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.668
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 5.0
Confidence Interval (2-Sided) 95%
-17.74 to 27.71
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.500
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 7.8
Confidence Interval (2-Sided) 95%
-14.88 to 30.56
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.816
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -2.7
Confidence Interval (2-Sided) 95%
-25.52 to 20.10
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.358
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -10.7
Confidence Interval (2-Sided) 95%
-33.38 to 11.99
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Percentage of Participants With European League Against Rheumatism (EULAR) Good Response at Months 3, 6, 9, 12, 18 and 24
Hide Description A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity. A Good EULAR Response is defined as an improvement (decrease) in the DAS28 of ≥ 1.2 compared with Baseline and attainment of a DAS28 score of ≤ 3.2.
Time Frame Months 3, 6, 9, 12, 18, 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment (non-responder imputation).
Arm/Group Title Standard of Care Early Adalimumab
Hide Arm/Group Description:
Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
Overall Number of Participants Analyzed 35 39
Measure Type: Number
Unit of Measure: percentage of participants
Month 3 22.9 30.8
Month 6 28.6 48.7
Month 9 48.6 51.3
Month 12 45.7 53.8
Month 18 51.4 48.7
Month 24 54.3 43.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.444
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 7.9
Confidence Interval (2-Sided) 95%
-12.17 to 28.00
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.076
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 20.1
Confidence Interval (2-Sided) 95%
-1.53 to 41.83
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.816
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 2.7
Confidence Interval (2-Sided) 95%
-20.10 to 25.52
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.485
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 8.1
Confidence Interval (2-Sided) 95%
-14.61 to 30.87
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.816
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -2.7
Confidence Interval (2-Sided) 95%
-25.52 to 20.10
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.358
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -10.7
Confidence Interval (2-Sided) 95%
-33.38 to 11.99
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Percentage of Participants With EULAR Moderate Response at Months 3, 6, 9, 12, 18 and 24
Hide Description A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity. A Moderate EULAR Response is defined as either: an improvement (decrease) in the DAS28 of > 0.6 and < 1.2 from Baseline and attainment of a DAS28 score of ≤ 5.1; or an improvement (decrease) in the DAS28 of ≥ 1.2 from Baseline and attainment of a DAS28 score of > 3.2.
Time Frame Months 3, 6, 9, 12, 18, 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: all participants who were randomized and received at least one dose of study drug with an assessment (non-responder imputation).
Arm/Group Title Standard of Care Early Adalimumab
Hide Arm/Group Description:
Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
Overall Number of Participants Analyzed 35 39
Measure Type: Number
Unit of Measure: percentage of participants
Month 3 37.1 48.7
Month 6 25.7 30.8
Month 9 28.6 28.2
Month 12 37.1 23.1
Month 18 22.9 10.3
Month 24 14.3 10.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.316
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 11.6
Confidence Interval (2-Sided) 95%
-10.84 to 33.99
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.630
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 5.1
Confidence Interval (2-Sided) 95%
-15.43 to 25.54
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 9
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.972
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-20.94 to 20.21
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.186
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -14.1
Confidence Interval (2-Sided) 95%
-34.83 to 6.70
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.142
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -12.6
Confidence Interval (2-Sided) 95%
-29.46 to 4.26
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Standard of Care, Early Adalimumab
Comments Month 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.727
Comments [Not Specified]
Method Chi-squared
Comments P-value is based on two-sided Pearson's chi-square test.