Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Anti-Inflammatory, Biological Therapy, adalimumab, Disease-Modifying Antirheumatic Drugs, Antirheumatic Agents, Agents
Brief summary
A Canadian study to evaluate early use of adalimumab after methotrexate failure in early rheumatoid arthritis. The study hypothesis will verify if adalimumab effectively reduces joint damage in more participants when introduced earlier than in current practice.
Interventions
BIOLOGICALadalimumab
Study drug will be provided to participants in Early Adalimumab arm as a sterile, preservative-free solution for subcutaneous injection, contained in a pre-filled syringe housed in a pen device (pre-filled pen). 40 mg of adalimumab will be administered subcutaneously at Baseline and then every other week for 24 months. Adalimumab may be initiated in participants in standard of care (SOC) arm after a minimum of 6 months of treatment recommended by their study doctor.
DRUGMethotrexate
Participants in both arms will receive a methotrexate regimen based on local guidelines and their study doctor's judgment.
Sponsors
Mount Sinai Hospital, Canada
AbbVie (prior sponsor, Abbott)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Subject has a diagnosis of Rheumatoid Arthritis as defined by the 1987-revised American College of Rheumatology-classification criteria and has disease duration of less than 2 years from diagnosis. 2. Subject must have been on a dose of methotrexate therapy either subcutaneously or orally administered (15-25 mg/week) for at least 3 months prior to baseline visit and has had an inadequate response to treatment defined as having a Disease Activity Score DAS28 \> 3.2 (at Screening visit). 3. Subject must also meet the following three criteria (at screening visit): at least 4 swollen joints out of 66 assessed; at least 4 tender joints out of 68 assessed; subject must have an elevated erythrocyte sedimentation rate \>/= 20 mm/1h or C-reactive protein \> upper limit of normal. 4. Subject must fulfill at least one of the following three criteria: history of rheumatoid factor positive; history of at least one erosion on X-ray or magnetic resonance imaging; history of anti-cyclic-citrullinated protein antibody positive.
Exclusion criteria
1. Subject has previous exposure to any biologic therapy including adalimumab. 2. Prior disease-modifying antirheumatic drugs triple therapy with methotrexate. 3. Subject has been treated with intra-articular or parenteral administration of corticosteroids in the preceding 4 weeks prior to baseline visit. Inhaled corticosteroids for stable medical conditions are allowed. 4. Subject has undergone joint surgery within the preceding two months (at joints to be assessed within the study) of Baseline. 5. Subject has a poorly controlled medical condition, such as uncontrolled diabetes, unstable heart disease, congestive heart failure, recent cerebrovascular accidents and any other condition which, in the opinion of the Investigator, would put the subject at risk by participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With No Radiographic Progression at Month 12 | Baseline, Month 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in mTSS at Months 6, 12 and 24 | Baseline, Month 6, Month 12, Month 24 | 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. |
| Percentage of Participants With Rapid Radiographic Progression at Month 12 | Month 12 | 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. |
| Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Months 3, 6, 9, 12, 18 and 24 | Baseline, Months 3, 6, 9, 12, 18, 24 | 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 \[CRP\]). |
| Percentage of Participants With American College of Rheumatology 50% (ACR50) Response at Months 3, 6, 9, 12, 18 and 24 | Baseline, Months 3, 6, 9, 12, 18, 24 | 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). |
| Percentage of Participants With American College of Rheumatology 70% (ACR70) Response at Months 3, 6, 9, 12, 18 and 24 | Months 3, 6, 9, 12, 18, 24 | 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). |
| Change From Baseline in Swollen Joint Count 66 at Months 3, 6, 9, 12, 18 and 24 | Baseline, Months 3, 6, 9, 12, 18, 24 | 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. |
| Change From Baseline in Swollen Joint Count 28 at Months 3, 6, 9, 12, 18 and 24 | Baseline, Months 3, 6, 9, 12, 18, 24 | 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. |
| Change From Baseline in Tender Joint Count 68 at Months 3, 6, 9, 12, 18 and 24 | Baseline, Months 3, 6, 9, 12, 18, 24 | 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. |
| Change From Baseline in Tender Joint Count 28 at Months 3, 6, 9, 12, 18 and 24 | Baseline, Months 3, 6, 9, 12, 18, 24 | 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. |
| Change From Baseline in Physician's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Baseline, Months 3, 6, 9, 12, 18, 24 | 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. |
| Change From Baseline in Patient's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Baseline, Months 3, 6, 9, 12, 18, 24 | 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. |
| Change From Baseline in Patient's Global Assessment of Pain at Months 3, 6, 9, 12, 18 and 24 | Baseline, Months 3, 6, 9, 12, 18, 24 | 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. |
| Change From Baseline in CRP at Months 3, 6, 9, 12, 18 and 24 | Baseline, Months 3, 6, 9, 12, 18, 24 | — |
| Change From Baseline in Disease Activity Score DAS28(CRP) at Months 3, 6, 9, 12, 18 and 24 | Baseline, Months 3, 6, 9, 12, 18, 24 | 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. |
| Percentage of Participants With DAS28(CRP) Remission at Months 3, 6, 9, 12, 18 and 24 | Months 3, 6, 9, 12, 18, 24 | 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. |
| Percentage of Participants With DAS28(CRP) Low Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Months 3, 6, 9, 12, 18, 24 | 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. |
| Percentage of Participants With European League Against Rheumatism (EULAR) Good Response at Months 3, 6, 9, 12, 18 and 24 | Months 3, 6, 9, 12, 18, 24 | 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. |
| Percentage of Participants With No Radiographic Progression at Month 6 and Month 24 | Baseline, Month 6, Month 24 | 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. |
| Percentage of Participants With Flare-Up After Remission by Month 24 | Month 24 | Percentage of participants with a flare-up after remission by Month 24, defined as participants who reached remission (DAS28 \< 2.6) but later had two consecutive visits with DAS28 ≥ 2.6 (based on observed cases only). 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. |
| Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Months 3, 6, 9, 12, 18 and 24 | Baseline, Months 3, 6, 9, 12, 18, 24 | HAQ is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A lower HAQ-DI score is better. |
| Percentage of Participants Achieving Minimal Clinical Important Difference (MCID) in HAQ at Months 3, 6, 9, 12, 18 and 24 | Months 3, 6, 9, 12, 18, 24 | The percentage of participants achieving MCID in HAQ, defined as a 0.22 unit decrease in HAQ. HAQ is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A lower HAQ-DI score is better. |
| Percentage of Participants Achieving HAQ < 0.5 at Months 3, 6, 9, 12, 18 and 24 | Months 3, 6, 9, 12, 18, 24 | The percentage of participants achieving HAQ \< 0.5. HAQ is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI \< 0.5. A lower HAQ-DI score is better. |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale at Months 3, 6, 9, 12, 18 and 24 | Baseline, Months 3, 6, 9, 12, 18, 24 | The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions on a scale from 'not at all' (0) to 'very much' (4). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue. |
| Percentage of Participants Achieving MCID in FACIT-Fatigue Scale at Months 3, 6, 9, 12, 18 and 24 | Months 3, 6, 9, 12, 18, 24 | The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions on a scale from 'not at all' (0) to 'very much' (4). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue. The MCID was defined as a 3.56-unit decrease in FACIT-Fatigue Scale. |
| Change From Baseline in Work Limitations Questionnaire (WLQ) at Months 3, 6, 9, 12, 18 and 24 | Baseline, Months 3, 6, 9, 12, 18, 24 | The WLQ was used to measure the impairment in work-related productivity, with reference to the previous two weeks. Each work-related question is scored from 0 to 4 and the total score ranges from 0-100, with lower scores signifying fewer limitations at work. |
| Change From Baseline in Beck Depression Inventory (BDI-II) Scores at Months 3, 6, 9, 12, 18 and 24 | Baseline, Months 3, 6, 9, 12, 18, 24 | BDI is a 21-item questionnaire, participant self-report rating inventory that measures characteristic attitudes and symptoms of depression. The range of scores is 0 to 63, with a higher value representing a worse outcome. |
| Change From Baseline in EuroQOL Questionnaire (EQ-5D) Index Score at Months 3, 6, 9, 12, 18 and 24 | Baseline, Months 3, 6, 9, 12, 18, 24 | The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.594 to 1 (with higher scores indicating better health state). |
| Change From Baseline in EQ-5D VAS at Months 3, 6, 9, 12, 18 and 24 | Baseline, Months 3, 6, 9, 12, 18, 24 | The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.' |
| Likert Scale for Participant's Satisfaction With Care at Months 3, 6, 9, 12, 18 and 24 | Months 3, 6, 9, 12, 18, 24 | Participants measured their satisfaction with care by specifying their in response to the question How satisfied are you with the results of your RA treatment? on a 5-point Likert scale, from the following 5 answers: not satisfied, a little satisfied, moderately satisfied, well satisfied, very well satisfied. Scores range from 1 to 5, with higher scores indicating more satisfaction with their care. |
| Health Care Resources Questionnaire (HCR): Medical Insurance at Baseline | Baseline | The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked whether and what type of health insurance they had. Types of Canadian insurance included: Régie de l'assurance maladie du Québec (RAMQ); Société de l'assurance automobile du Québec (SAAQ); Commission de la santé et de la sécurité du travail (CSST); Canadian Health Insurance Program (CHIP); and L'indemnisation des victimes d'actes criminals (IVAC). |
| HCR: Medical Insurance at Final Visit | Final Visit (up to Month 24) | The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked whether and what type of health insurance they had. Types of Canadian insurance included: Régie de l'assurance maladie du Québec (RAMQ); Société de l'assurance automobile du Québec (SAAQ); Commission de la santé et de la sécurité du travail (CSST); Canadian Health Insurance Program (CHIP); and L'indemnisation des victimes d'actes criminals (IVAC). |
| HCR: Health Care for RA in the Past 4 Weeks at Baseline | Baseline | The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked about their use of health care for RA in the past 4 weeks. |
| HCR: Health Care for RA in the Past 4 Weeks at Final Visit | Final Visit (up to Month 24) | The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked about their use of health care for RA in the past 4 weeks. |
| HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Baseline | Baseline | The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked what type of out-of-pocket expenses they had incurred for their RA in the past 4 weeks. Based on Canadian dollars. |
| HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Final Visit | Final Visit (up to Month 24) | The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked what type of out-of-pocket expenses they had incurred for their RA in the past 4 weeks. Based on Canadian dollars. |
| Percentage of Participants With EULAR Moderate Response at Months 3, 6, 9, 12, 18 and 24 | Months 3, 6, 9, 12, 18, 24 | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care 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. | 35 |
| Early Adalimumab 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. | 39 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 5 |
| Overall Study | Did not receive study drug | 2 | 1 |
| Overall Study | Lack of Efficacy | 2 | 2 |
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Other | 2 | 3 |
Baseline characteristics
| Characteristic | Standard of Care | Early Adalimumab | Total |
|---|---|---|---|
| Age, Continuous | 53.8 years STANDARD_DEVIATION 10.46 | 51.9 years STANDARD_DEVIATION 11.55 | 52.8 years STANDARD_DEVIATION 11.01 |
| Age, Customized < 65 years | 30 participants | 34 participants | 64 participants |
| Age, Customized >/= 65 years | 5 participants | 5 participants | 10 participants |
| Sex: Female, Male Female | 24 Participants | 26 Participants | 50 Participants |
| Sex: Female, Male Male | 11 Participants | 13 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 32 / 35 | 33 / 39 |
| serious Total, serious adverse events | 3 / 35 | 4 / 39 |
Outcome results
Primary
Percentage of Participants With No Radiographic Progression at Month 12
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care | Percentage of Participants With No Radiographic Progression at Month 12 | 62.9 percentage of participants |
| Early Adalimumab | Percentage of Participants With No Radiographic Progression at Month 12 | 61.5 percentage of participants |
p-value: 0.90795% CI: [-23.4, 20.8]Chi-squared
Secondary
Change From Baseline in Beck Depression Inventory (BDI-II) Scores at Months 3, 6, 9, 12, 18 and 24
BDI is a 21-item questionnaire, participant self-report rating inventory that measures characteristic attitudes and symptoms of depression. The range of scores is 0 to 63, with a higher value representing a worse outcome.
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24
Population: Intent-to-treat population: all participants who were randomized and received at least one dose of study drug and had an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care | Change From Baseline in Beck Depression Inventory (BDI-II) Scores at Months 3, 6, 9, 12, 18 and 24 | Month 3 | -4.3 units on a scale | Standard Error 1.15 |
| Standard of Care | Change From Baseline in Beck Depression Inventory (BDI-II) Scores at Months 3, 6, 9, 12, 18 and 24 | Month 6 | -1.0 units on a scale | Standard Error 1.28 |
| Standard of Care | Change From Baseline in Beck Depression Inventory (BDI-II) Scores at Months 3, 6, 9, 12, 18 and 24 | Month 9 | -4.3 units on a scale | Standard Error 1.04 |
| Standard of Care | Change From Baseline in Beck Depression Inventory (BDI-II) Scores at Months 3, 6, 9, 12, 18 and 24 | Month 12 | -5.1 units on a scale | Standard Error 1.24 |
| Standard of Care | Change From Baseline in Beck Depression Inventory (BDI-II) Scores at Months 3, 6, 9, 12, 18 and 24 | Month 18 | -4.8 units on a scale | Standard Error 1.22 |
| Standard of Care | Change From Baseline in Beck Depression Inventory (BDI-II) Scores at Months 3, 6, 9, 12, 18 and 24 | Month 24 | -4.8 units on a scale | Standard Error 1.15 |
| Early Adalimumab | Change From Baseline in Beck Depression Inventory (BDI-II) Scores at Months 3, 6, 9, 12, 18 and 24 | Month 18 | -3.5 units on a scale | Standard Error 1.14 |
| Early Adalimumab | Change From Baseline in Beck Depression Inventory (BDI-II) Scores at Months 3, 6, 9, 12, 18 and 24 | Month 3 | -3.1 units on a scale | Standard Error 1.07 |
| Early Adalimumab | Change From Baseline in Beck Depression Inventory (BDI-II) Scores at Months 3, 6, 9, 12, 18 and 24 | Month 12 | -3.5 units on a scale | Standard Error 1.15 |
| Early Adalimumab | Change From Baseline in Beck Depression Inventory (BDI-II) Scores at Months 3, 6, 9, 12, 18 and 24 | Month 6 | -2.4 units on a scale | Standard Error 1.19 |
| Early Adalimumab | Change From Baseline in Beck Depression Inventory (BDI-II) Scores at Months 3, 6, 9, 12, 18 and 24 | Month 24 | -3.4 units on a scale | Standard Error 1.07 |
| Early Adalimumab | Change From Baseline in Beck Depression Inventory (BDI-II) Scores at Months 3, 6, 9, 12, 18 and 24 | Month 9 | -3.7 units on a scale | Standard Error 0.97 |
Comparison: Month 3p-value: 0.45895% CI: [-2, 4.3]ANCOVA
Comparison: Month 6p-value: 0.41995% CI: [-4.9, 2.1]ANCOVA
Comparison: Month 9p-value: 0.69295% CI: [-2.3, 3.4]ANCOVA
Comparison: Month 12p-value: 0.35795% CI: [-1.8, 5]ANCOVA
Comparison: Month 18p-value: 0.4295% CI: [-2, 4.7]ANCOVA
Comparison: Month 24p-value: 0.3895% CI: [-1.8, 4.5]ANCOVA
Secondary
Change From Baseline in CRP at Months 3, 6, 9, 12, 18 and 24
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care | Change From Baseline in CRP at Months 3, 6, 9, 12, 18 and 24 | Month 3; n=33, 38 | -10.2 mg/L | Standard Error 2.39 |
| Standard of Care | Change From Baseline in CRP at Months 3, 6, 9, 12, 18 and 24 | Month 6; n=34, 38 | -7.6 mg/L | Standard Error 3.26 |
| Standard of Care | Change From Baseline in CRP at Months 3, 6, 9, 12, 18 and 24 | Month 9; n=35, 38 | -11.3 mg/L | Standard Error 2.84 |
| Standard of Care | Change From Baseline in CRP at Months 3, 6, 9, 12, 18 and 24 | Month 12; n=35, 38 | -13.7 mg/L | Standard Error 2.37 |
| Standard of Care | Change From Baseline in CRP at Months 3, 6, 9, 12, 18 and 24 | Month 18; n=35, 38 | -15.2 mg/L | Standard Error 2.51 |
| Standard of Care | Change From Baseline in CRP at Months 3, 6, 9, 12, 18 and 24 | Month 24; n=26, 23 | -13.5 mg/L | Standard Error 2.46 |
| Early Adalimumab | Change From Baseline in CRP at Months 3, 6, 9, 12, 18 and 24 | Month 18; n=35, 38 | -9.7 mg/L | Standard Error 2.41 |
| Early Adalimumab | Change From Baseline in CRP at Months 3, 6, 9, 12, 18 and 24 | Month 3; n=33, 38 | -8.9 mg/L | Standard Error 2.23 |
| Early Adalimumab | Change From Baseline in CRP at Months 3, 6, 9, 12, 18 and 24 | Month 12; n=35, 38 | -10.8 mg/L | Standard Error 2.28 |
| Early Adalimumab | Change From Baseline in CRP at Months 3, 6, 9, 12, 18 and 24 | Month 6; n=34, 38 | -9.1 mg/L | Standard Error 3.08 |
| Early Adalimumab | Change From Baseline in CRP at Months 3, 6, 9, 12, 18 and 24 | Month 24; n=26, 23 | -11.2 mg/L | Standard Error 2.36 |
| Early Adalimumab | Change From Baseline in CRP at Months 3, 6, 9, 12, 18 and 24 | Month 9; n=35, 38 | -11.1 mg/L | Standard Error 2.72 |
Comparison: Month 3p-value: 0.69795% CI: [-5.3, 7.9]ANCOVA
Comparison: Month 6p-value: 0.74495% CI: [-10.5, 7.5]ANCOVA
Comparison: Month 9p-value: 0.96795% CI: [-7.7, 8]ANCOVA
Comparison: Month 12p-value: 0.37795% CI: [-3.7, 9.5]ANCOVA
Comparison: Month 18p-value: 0.12295% CI: [-1.5, 12.4]ANCOVA
Comparison: Month 24p-value: 0.4995% CI: [-4.4, 9.2]ANCOVA
Secondary
Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Months 3, 6, 9, 12, 18 and 24
HAQ is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A lower HAQ-DI score is better.
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care | Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Months 3, 6, 9, 12, 18 and 24 | Month 3 | -0.41 units on a scale | Standard Error 0.094 |
| Standard of Care | Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Months 3, 6, 9, 12, 18 and 24 | Month 6 | -0.29 units on a scale | Standard Error 0.095 |
| Standard of Care | Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Months 3, 6, 9, 12, 18 and 24 | Month 9 | -0.52 units on a scale | Standard Error 0.095 |
| Standard of Care | Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Months 3, 6, 9, 12, 18 and 24 | Month 12 | -0.60 units on a scale | Standard Error 0.093 |
| Standard of Care | Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Months 3, 6, 9, 12, 18 and 24 | Month 18 | -0.60 units on a scale | Standard Error 0.102 |
| Standard of Care | Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Months 3, 6, 9, 12, 18 and 24 | Month 24 | -0.61 units on a scale | Standard Error 0.107 |
| Early Adalimumab | Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Months 3, 6, 9, 12, 18 and 24 | Month 18 | -0.55 units on a scale | Standard Error 0.098 |
| Early Adalimumab | Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Months 3, 6, 9, 12, 18 and 24 | Month 3 | -0.38 units on a scale | Standard Error 0.09 |
| Early Adalimumab | Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Months 3, 6, 9, 12, 18 and 24 | Month 12 | -0.50 units on a scale | Standard Error 0.089 |
| Early Adalimumab | Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Months 3, 6, 9, 12, 18 and 24 | Month 6 | -0.46 units on a scale | Standard Error 0.092 |
| Early Adalimumab | Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Months 3, 6, 9, 12, 18 and 24 | Month 24 | -0.53 units on a scale | Standard Error 0.102 |
| Early Adalimumab | Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Months 3, 6, 9, 12, 18 and 24 | Month 9 | -0.50 units on a scale | Standard Error 0.092 |
Comparison: Month 3p-value: 0.80995% CI: [-0.23, 0.29]ANCOVA
Comparison: Month 6p-value: 0.19495% CI: [-0.44, 0.09]ANCOVA
Comparison: Month 9p-value: 0.86395% CI: [-0.24, 0.29]ANCOVA
Comparison: Month 12p-value: 0.45295% CI: [-0.16, 0.35]ANCOVA
Comparison: Month 18p-value: 0.73895% CI: [-0.23, 0.33]ANCOVA
Comparison: Month 24p-value: 0.57295% CI: [-0.21, 0.38]ANCOVA
Secondary
Change From Baseline in Disease Activity Score DAS28(CRP) at Months 3, 6, 9, 12, 18 and 24
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
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care | Change From Baseline in Disease Activity Score DAS28(CRP) at Months 3, 6, 9, 12, 18 and 24 | Month 3; n=33, 38 | -1.4 units on a scale | Standard Error 0.2 |
| Standard of Care | Change From Baseline in Disease Activity Score DAS28(CRP) at Months 3, 6, 9, 12, 18 and 24 | Month 6; n=34, 38 | -1.4 units on a scale | Standard Error 0.21 |
| Standard of Care | Change From Baseline in Disease Activity Score DAS28(CRP) at Months 3, 6, 9, 12, 18 and 24 | Month 9; n=35, 38 | -2.0 units on a scale | Standard Error 0.21 |
| Standard of Care | Change From Baseline in Disease Activity Score DAS28(CRP) at Months 3, 6, 9, 12, 18 and 24 | Month 12; n=35, 38 | -2.1 units on a scale | Standard Error 0.2 |
| Standard of Care | Change From Baseline in Disease Activity Score DAS28(CRP) at Months 3, 6, 9, 12, 18 and 24 | Month 18; n=35, 38 | -2.4 units on a scale | Standard Error 0.22 |
| Standard of Care | Change From Baseline in Disease Activity Score DAS28(CRP) at Months 3, 6, 9, 12, 18 and 24 | Month 24; n=35, 38 | -2.6 units on a scale | Standard Error 0.2 |
| Early Adalimumab | Change From Baseline in Disease Activity Score DAS28(CRP) at Months 3, 6, 9, 12, 18 and 24 | Month 18; n=35, 38 | -2.4 units on a scale | Standard Error 0.21 |
| Early Adalimumab | Change From Baseline in Disease Activity Score DAS28(CRP) at Months 3, 6, 9, 12, 18 and 24 | Month 3; n=33, 38 | -1.8 units on a scale | Standard Error 0.18 |
| Early Adalimumab | Change From Baseline in Disease Activity Score DAS28(CRP) at Months 3, 6, 9, 12, 18 and 24 | Month 12; n=35, 38 | -2.4 units on a scale | Standard Error 0.19 |
| Early Adalimumab | Change From Baseline in Disease Activity Score DAS28(CRP) at Months 3, 6, 9, 12, 18 and 24 | Month 6; n=34, 38 | -2.3 units on a scale | Standard Error 0.2 |
| Early Adalimumab | Change From Baseline in Disease Activity Score DAS28(CRP) at Months 3, 6, 9, 12, 18 and 24 | Month 24; n=35, 38 | -2.6 units on a scale | Standard Error 0.19 |
| Early Adalimumab | Change From Baseline in Disease Activity Score DAS28(CRP) at Months 3, 6, 9, 12, 18 and 24 | Month 9; n=35, 38 | -2.3 units on a scale | Standard Error 0.2 |
Comparison: Month 3p-value: 0.10295% CI: [-1, 0.1]ANCOVA
Comparison: Month 6p-value: 0.00395% CI: [-1.5, -0.3]ANCOVA
Comparison: Month 9p-value: 0.21495% CI: [-0.9, 0.2]ANCOVA
Comparison: Month 12p-value: 0.33995% CI: [-0.8, 0.3]ANCOVA
Comparison: Month 18p-value: 0.97395% CI: [-0.6, 0.6]ANCOVA
Comparison: Month 24p-value: 0.75595% CI: [-0.6, 0.5]ANCOVA
Secondary
Change From Baseline in EQ-5D VAS at Months 3, 6, 9, 12, 18 and 24
The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.'
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24
Population: Intent-to-treat population: all participants who were randomized and received at least one dose of study drug and had an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care | Change From Baseline in EQ-5D VAS at Months 3, 6, 9, 12, 18 and 24 | Month 6 | 10.7 units on a scale | Standard Error 3.7 |
| Standard of Care | Change From Baseline in EQ-5D VAS at Months 3, 6, 9, 12, 18 and 24 | Month 12 | 22.2 units on a scale | Standard Error 3.46 |
| Standard of Care | Change From Baseline in EQ-5D VAS at Months 3, 6, 9, 12, 18 and 24 | Month 3 | 18.7 units on a scale | Standard Error 3.18 |
| Standard of Care | Change From Baseline in EQ-5D VAS at Months 3, 6, 9, 12, 18 and 24 | Month 18 | 22.3 units on a scale | Standard Error 3.62 |
| Standard of Care | Change From Baseline in EQ-5D VAS at Months 3, 6, 9, 12, 18 and 24 | Month 9 | 20.1 units on a scale | Standard Error 3.78 |
| Standard of Care | Change From Baseline in EQ-5D VAS at Months 3, 6, 9, 12, 18 and 24 | Month 24 | 22.1 units on a scale | Standard Error 4.11 |
| Early Adalimumab | Change From Baseline in EQ-5D VAS at Months 3, 6, 9, 12, 18 and 24 | Month 24 | 19.7 units on a scale | Standard Error 3.95 |
| Early Adalimumab | Change From Baseline in EQ-5D VAS at Months 3, 6, 9, 12, 18 and 24 | Month 3 | 16.2 units on a scale | Standard Error 3.05 |
| Early Adalimumab | Change From Baseline in EQ-5D VAS at Months 3, 6, 9, 12, 18 and 24 | Month 6 | 18.6 units on a scale | Standard Error 3.55 |
| Early Adalimumab | Change From Baseline in EQ-5D VAS at Months 3, 6, 9, 12, 18 and 24 | Month 9 | 17.7 units on a scale | Standard Error 3.63 |
| Early Adalimumab | Change From Baseline in EQ-5D VAS at Months 3, 6, 9, 12, 18 and 24 | Month 12 | 19.5 units on a scale | Standard Error 3.32 |
| Early Adalimumab | Change From Baseline in EQ-5D VAS at Months 3, 6, 9, 12, 18 and 24 | Month 18 | 21.2 units on a scale | Standard Error 3.47 |
Comparison: Month 3p-value: 0.57295% CI: [-11.3, 6.3]ANCOVA
Comparison: Month 6p-value: 0.1395% CI: [-2.4, 18.2]ANCOVA
Comparison: Month 9p-value: 0.64995% CI: [-12.9, 8.1]ANCOVA
Comparison: Month 12p-value: 0.57995% CI: [-12.3, 6.9]ANCOVA
Comparison: Month 18p-value: 0.82695% CI: [-11.1, 8.9]ANCOVA
Comparison: Month 24p-value: 0.67595% CI: [-13.8, 9]ANCOVA
Secondary
Change From Baseline in EuroQOL Questionnaire (EQ-5D) Index Score at Months 3, 6, 9, 12, 18 and 24
The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.594 to 1 (with higher scores indicating better health state).
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24
Population: Intent-to-treat population: all participants who were randomized and received at least one dose of study drug. 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care | Change From Baseline in EuroQOL Questionnaire (EQ-5D) Index Score at Months 3, 6, 9, 12, 18 and 24 | Month 3; n=34, 34 | 0.21 units on a scale | Standard Error 0.041 |
| Standard of Care | Change From Baseline in EuroQOL Questionnaire (EQ-5D) Index Score at Months 3, 6, 9, 12, 18 and 24 | Month 6; n=35, 36 | 0.18 units on a scale | Standard Error 0.044 |
| Standard of Care | Change From Baseline in EuroQOL Questionnaire (EQ-5D) Index Score at Months 3, 6, 9, 12, 18 and 24 | Month 9; n=35, 36 | 0.26 units on a scale | Standard Error 0.044 |
| Standard of Care | Change From Baseline in EuroQOL Questionnaire (EQ-5D) Index Score at Months 3, 6, 9, 12, 18 and 24 | Month 12; n=35, 36 | 0.25 units on a scale | Standard Error 0.04 |
| Standard of Care | Change From Baseline in EuroQOL Questionnaire (EQ-5D) Index Score at Months 3, 6, 9, 12, 18 and 24 | Month 18; n=35, 36 | 0.25 units on a scale | Standard Error 0.045 |
| Standard of Care | Change From Baseline in EuroQOL Questionnaire (EQ-5D) Index Score at Months 3, 6, 9, 12, 18 and 24 | Month 24; n=35, 36 | 0.26 units on a scale | Standard Error 0.049 |
| Early Adalimumab | Change From Baseline in EuroQOL Questionnaire (EQ-5D) Index Score at Months 3, 6, 9, 12, 18 and 24 | Month 18; n=35, 36 | 0.24 units on a scale | Standard Error 0.045 |
| Early Adalimumab | Change From Baseline in EuroQOL Questionnaire (EQ-5D) Index Score at Months 3, 6, 9, 12, 18 and 24 | Month 3; n=34, 34 | 0.22 units on a scale | Standard Error 0.041 |
| Early Adalimumab | Change From Baseline in EuroQOL Questionnaire (EQ-5D) Index Score at Months 3, 6, 9, 12, 18 and 24 | Month 12; n=35, 36 | 0.26 units on a scale | Standard Error 0.04 |
| Early Adalimumab | Change From Baseline in EuroQOL Questionnaire (EQ-5D) Index Score at Months 3, 6, 9, 12, 18 and 24 | Month 6; n=35, 36 | 0.23 units on a scale | Standard Error 0.044 |
| Early Adalimumab | Change From Baseline in EuroQOL Questionnaire (EQ-5D) Index Score at Months 3, 6, 9, 12, 18 and 24 | Month 24; n=35, 36 | 0.22 units on a scale | Standard Error 0.049 |
| Early Adalimumab | Change From Baseline in EuroQOL Questionnaire (EQ-5D) Index Score at Months 3, 6, 9, 12, 18 and 24 | Month 9; n=35, 36 | 0.22 units on a scale | Standard Error 0.044 |
Comparison: Month 3p-value: 0.80995% CI: [-0.1, 0.13]ANCOVA
Comparison: Month 6p-value: 0.44795% CI: [-0.08, 0.17]ANCOVA
Comparison: Month 9p-value: 0.57995% CI: [-0.16, 0.09]ANCOVA
Comparison: Month 12p-value: 0.92295% CI: [-0.11, 0.12]ANCOVA
Comparison: Month 18p-value: 0.89495% CI: [-0.14, 0.12]ANCOVA
Comparison: Month 24p-value: 0.61195% CI: [-0.17, 0.1]ANCOVA
Secondary
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale at Months 3, 6, 9, 12, 18 and 24
The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions on a scale from 'not at all' (0) to 'very much' (4). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue.
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale at Months 3, 6, 9, 12, 18 and 24 | Month 3 | 7.1 units on a scale | Standard Error 1.62 |
| Standard of Care | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale at Months 3, 6, 9, 12, 18 and 24 | Month 6 | 5.4 units on a scale | Standard Error 1.77 |
| Standard of Care | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale at Months 3, 6, 9, 12, 18 and 24 | Month 9 | 9.5 units on a scale | Standard Error 1.7 |
| Standard of Care | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale at Months 3, 6, 9, 12, 18 and 24 | Month 12 | 10.7 units on a scale | Standard Error 1.8 |
| Standard of Care | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale at Months 3, 6, 9, 12, 18 and 24 | Month 18 | 10.2 units on a scale | Standard Error 1.98 |
| Standard of Care | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale at Months 3, 6, 9, 12, 18 and 24 | Month 24 | 9.8 units on a scale | Standard Error 2 |
| Early Adalimumab | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale at Months 3, 6, 9, 12, 18 and 24 | Month 18 | 8.2 units on a scale | Standard Error 1.9 |
| Early Adalimumab | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale at Months 3, 6, 9, 12, 18 and 24 | Month 3 | 8.0 units on a scale | Standard Error 1.56 |
| Early Adalimumab | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale at Months 3, 6, 9, 12, 18 and 24 | Month 12 | 8.0 units on a scale | Standard Error 1.73 |
| Early Adalimumab | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale at Months 3, 6, 9, 12, 18 and 24 | Month 6 | 8.2 units on a scale | Standard Error 1.7 |
| Early Adalimumab | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale at Months 3, 6, 9, 12, 18 and 24 | Month 24 | 8.8 units on a scale | Standard Error 1.92 |
| Early Adalimumab | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale at Months 3, 6, 9, 12, 18 and 24 | Month 9 | 8.0 units on a scale | Standard Error 1.63 |
Comparison: Month 3p-value: 0.69995% CI: [-3.6, 5.4]ANCOVA
Comparison: Month 6p-value: 0.26195% CI: [-2.1, 7.7]ANCOVA
Comparison: Month 9p-value: 0.51495% CI: [-6.2, 3.2]ANCOVA
Comparison: Month 12p-value: 0.28395% CI: [-7.7, 2.3]ANCOVA
Comparison: Month 18p-value: 0.46195% CI: [-7.5, 3.4]ANCOVA
Comparison: Month 24p-value: 0.70395% CI: [-6.6, 4.5]ANCOVA
Secondary
Change From Baseline in mTSS at Months 6, 12 and 24
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
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care | Change From Baseline in mTSS at Months 6, 12 and 24 | Month 6; n=34, 36 | 0.88 units on a scale | Standard Error 0.273 |
| Standard of Care | Change From Baseline in mTSS at Months 6, 12 and 24 | Month 12; n=30, 34 | 1.62 units on a scale | Standard Error 0.486 |
| Standard of Care | Change From Baseline in mTSS at Months 6, 12 and 24 | Month 24; n=28, 21 | 2.24 units on a scale | Standard Error 0.912 |
| Early Adalimumab | Change From Baseline in mTSS at Months 6, 12 and 24 | Month 6; n=34, 36 | 0.02 units on a scale | Standard Error 0.266 |
| Early Adalimumab | Change From Baseline in mTSS at Months 6, 12 and 24 | Month 12; n=30, 34 | 0.16 units on a scale | Standard Error 0.457 |
| Early Adalimumab | Change From Baseline in mTSS at Months 6, 12 and 24 | Month 24; n=28, 21 | 0.01 units on a scale | Standard Error 1.055 |
Comparison: Month 24p-value: 0.1295% CI: [-5.05, 0.6]ANCOVA
Comparison: Month 6p-value: 0.02795% CI: [-1.62, -0.1]ANCOVA
Comparison: Month 12p-value: 0.03395% CI: [-2.79, -0.12]ANCOVA
Secondary
Change From Baseline in Patient's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24
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
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care | Change From Baseline in Patient's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 9 | -25.4 units on a scale | Standard Error 4.02 |
| Standard of Care | Change From Baseline in Patient's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 18 | -29.4 units on a scale | Standard Error 3.86 |
| Standard of Care | Change From Baseline in Patient's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 6 | -14.4 units on a scale | Standard Error 4.05 |
| Standard of Care | Change From Baseline in Patient's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 24 | -30.6 units on a scale | Standard Error 3.99 |
| Standard of Care | Change From Baseline in Patient's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 12 | -22.4 units on a scale | Standard Error 3.81 |
| Standard of Care | Change From Baseline in Patient's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 3 | -19.5 units on a scale | Standard Error 3.58 |
| Early Adalimumab | Change From Baseline in Patient's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 12 | -22.3 units on a scale | Standard Error 3.65 |
| Early Adalimumab | Change From Baseline in Patient's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 6 | -19.6 units on a scale | Standard Error 3.88 |
| Early Adalimumab | Change From Baseline in Patient's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 9 | -20.2 units on a scale | Standard Error 3.86 |
| Early Adalimumab | Change From Baseline in Patient's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 3 | -21.8 units on a scale | Standard Error 3.43 |
| Early Adalimumab | Change From Baseline in Patient's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 18 | -23.0 units on a scale | Standard Error 3.71 |
| Early Adalimumab | Change From Baseline in Patient's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 24 | -23.6 units on a scale | Standard Error 3.83 |
Comparison: Month 3p-value: 0.64195% CI: [-12.2, 7.6]ANCOVA
Comparison: Month 6p-value: 0.35895% CI: [-16.4, 6]ANCOVA
Comparison: Month 9p-value: 0.35295% CI: [-5.9, 16.4]ANCOVA
Comparison: Month 12p-value: 0.9995% CI: [-10.5, 10.6]ANCOVA
Comparison: Month 18p-value: 0.23895% CI: [-4.3, 17.1]ANCOVA
Comparison: Month 24p-value: 0.20795% CI: [-4, 18.1]ANCOVA
Secondary
Change From Baseline in Patient's Global Assessment of Pain at Months 3, 6, 9, 12, 18 and 24
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
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care | Change From Baseline in Patient's Global Assessment of Pain at Months 3, 6, 9, 12, 18 and 24 | Month 3 | -22.0 units on a scale | Standard Error 3.79 |
| Standard of Care | Change From Baseline in Patient's Global Assessment of Pain at Months 3, 6, 9, 12, 18 and 24 | Month 6 | -14.5 units on a scale | Standard Error 3.94 |
| Standard of Care | Change From Baseline in Patient's Global Assessment of Pain at Months 3, 6, 9, 12, 18 and 24 | Month 9 | -21.7 units on a scale | Standard Error 4.03 |
| Standard of Care | Change From Baseline in Patient's Global Assessment of Pain at Months 3, 6, 9, 12, 18 and 24 | Month 12 | -22.0 units on a scale | Standard Error 4.01 |
| Standard of Care | Change From Baseline in Patient's Global Assessment of Pain at Months 3, 6, 9, 12, 18 and 24 | Month 18 | -28.1 units on a scale | Standard Error 4.07 |
| Standard of Care | Change From Baseline in Patient's Global Assessment of Pain at Months 3, 6, 9, 12, 18 and 24 | Month 24 | -26.6 units on a scale | Standard Error 4.4 |
| Early Adalimumab | Change From Baseline in Patient's Global Assessment of Pain at Months 3, 6, 9, 12, 18 and 24 | Month 18 | -22.7 units on a scale | Standard Error 3.9 |
| Early Adalimumab | Change From Baseline in Patient's Global Assessment of Pain at Months 3, 6, 9, 12, 18 and 24 | Month 3 | -23.0 units on a scale | Standard Error 3.64 |
| Early Adalimumab | Change From Baseline in Patient's Global Assessment of Pain at Months 3, 6, 9, 12, 18 and 24 | Month 12 | -24.4 units on a scale | Standard Error 3.85 |
| Early Adalimumab | Change From Baseline in Patient's Global Assessment of Pain at Months 3, 6, 9, 12, 18 and 24 | Month 6 | -23.0 units on a scale | Standard Error 3.78 |
| Early Adalimumab | Change From Baseline in Patient's Global Assessment of Pain at Months 3, 6, 9, 12, 18 and 24 | Month 24 | -23.6 units on a scale | Standard Error 4.22 |
| Early Adalimumab | Change From Baseline in Patient's Global Assessment of Pain at Months 3, 6, 9, 12, 18 and 24 | Month 9 | -21.3 units on a scale | Standard Error 3.87 |
Comparison: Month 3p-value: 0.8595% CI: [-11.5, 9.5]ANCOVA
Comparison: Month 6p-value: 0.12995% CI: [-19.4, 2.5]ANCOVA
Comparison: Month 9p-value: 0.93795% CI: [-10.8, 11.6]ANCOVA
Comparison: Month 12p-value: 0.6795% CI: [-13.5, 8.8]ANCOVA
Comparison: Month 18p-value: 0.34195% CI: [-5.9, 16.7]ANCOVA
Comparison: Month 24p-value: 0.62195% CI: [-9.2, 15.3]ANCOVA
Secondary
Change From Baseline in Physician's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24
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
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care | Change From Baseline in Physician's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 3 | -29.3 units on a scale | Standard Error 3.66 |
| Standard of Care | Change From Baseline in Physician's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 6 | -22.5 units on a scale | Standard Error 4.25 |
| Standard of Care | Change From Baseline in Physician's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 9 | -39.6 units on a scale | Standard Error 4.21 |
| Standard of Care | Change From Baseline in Physician's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 12 | -43.8 units on a scale | Standard Error 4.12 |
| Standard of Care | Change From Baseline in Physician's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 18 | -45.5 units on a scale | Standard Error 4.29 |
| Standard of Care | Change From Baseline in Physician's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 24 | -47.6 units on a scale | Standard Error 4.23 |
| Early Adalimumab | Change From Baseline in Physician's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 18 | -46.2 units on a scale | Standard Error 4.12 |
| Early Adalimumab | Change From Baseline in Physician's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 3 | -41.6 units on a scale | Standard Error 3.51 |
| Early Adalimumab | Change From Baseline in Physician's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 12 | -47.3 units on a scale | Standard Error 3.96 |
| Early Adalimumab | Change From Baseline in Physician's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 6 | -48.0 units on a scale | Standard Error 4.08 |
| Early Adalimumab | Change From Baseline in Physician's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 24 | -47.7 units on a scale | Standard Error 4.06 |
| Early Adalimumab | Change From Baseline in Physician's Global Assessment of Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 9 | -48.9 units on a scale | Standard Error 4.04 |
Comparison: Month 3p-value: 0.01895% CI: [-22.5, -2.2]ANCOVA
Comparison: Month 6p-value: <0.00195% CI: [-37.3, -13.7]ANCOVA
Comparison: Month 9p-value: 0.11395% CI: [-21, 2.3]ANCOVA
Comparison: Month 12p-value: 0.54495% CI: [-14.9, 7.9]ANCOVA
Comparison: Month 18p-value: 0.91695% CI: [-12.5, 11.2]ANCOVA
Comparison: Month 24p-value: 0.98395% CI: [-11.8, 11.6]ANCOVA
Secondary
Change From Baseline in Swollen Joint Count 28 at Months 3, 6, 9, 12, 18 and 24
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
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care | Change From Baseline in Swollen Joint Count 28 at Months 3, 6, 9, 12, 18 and 24 | Month 3 | -4.6 swollen joints | Standard Error 0.64 |
| Standard of Care | Change From Baseline in Swollen Joint Count 28 at Months 3, 6, 9, 12, 18 and 24 | Month 6 | -4.5 swollen joints | Standard Error 0.57 |
| Standard of Care | Change From Baseline in Swollen Joint Count 28 at Months 3, 6, 9, 12, 18 and 24 | Month 9 | -6.1 swollen joints | Standard Error 0.58 |
| Standard of Care | Change From Baseline in Swollen Joint Count 28 at Months 3, 6, 9, 12, 18 and 24 | Month 12 | -6.9 swollen joints | Standard Error 0.51 |
| Standard of Care | Change From Baseline in Swollen Joint Count 28 at Months 3, 6, 9, 12, 18 and 24 | Month 18 | -7.4 swollen joints | Standard Error 0.68 |
| Standard of Care | Change From Baseline in Swollen Joint Count 28 at Months 3, 6, 9, 12, 18 and 24 | Month 24 | -7.6 swollen joints | Standard Error 0.55 |
| Early Adalimumab | Change From Baseline in Swollen Joint Count 28 at Months 3, 6, 9, 12, 18 and 24 | Month 18 | -8.1 swollen joints | Standard Error 0.65 |
| Early Adalimumab | Change From Baseline in Swollen Joint Count 28 at Months 3, 6, 9, 12, 18 and 24 | Month 3 | -6.5 swollen joints | Standard Error 0.62 |
| Early Adalimumab | Change From Baseline in Swollen Joint Count 28 at Months 3, 6, 9, 12, 18 and 24 | Month 12 | -8.5 swollen joints | Standard Error 0.49 |
| Early Adalimumab | Change From Baseline in Swollen Joint Count 28 at Months 3, 6, 9, 12, 18 and 24 | Month 6 | -7.9 swollen joints | Standard Error 0.55 |
| Early Adalimumab | Change From Baseline in Swollen Joint Count 28 at Months 3, 6, 9, 12, 18 and 24 | Month 24 | -8.4 swollen joints | Standard Error 0.53 |
| Early Adalimumab | Change From Baseline in Swollen Joint Count 28 at Months 3, 6, 9, 12, 18 and 24 | Month 9 | -8.3 swollen joints | Standard Error 0.56 |
Comparison: Month 3p-value: 0.03995% CI: [-3.7, -0.1]ANCOVA
Comparison: Month 6p-value: <0.00195% CI: [-5, -1.8]ANCOVA
Comparison: Month 9p-value: 0.00895% CI: [-3.8, -0.6]ANCOVA
Comparison: Month 12p-value: 0.02895% CI: [-3, -0.2]ANCOVA
Comparison: Month 18p-value: 0.45295% CI: [-2.6, 1.2]ANCOVA
Comparison: Month 24p-value: 0.34395% CI: [-2.3, 0.8]ANCOVA
Secondary
Change From Baseline in Swollen Joint Count 66 at Months 3, 6, 9, 12, 18 and 24
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
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care | Change From Baseline in Swollen Joint Count 66 at Months 3, 6, 9, 12, 18 and 24 | Month 12 | -9.2 swollen joints | Standard Error 0.69 |
| Standard of Care | Change From Baseline in Swollen Joint Count 66 at Months 3, 6, 9, 12, 18 and 24 | Month 24 | -10.1 swollen joints | Standard Error 0.83 |
| Standard of Care | Change From Baseline in Swollen Joint Count 66 at Months 3, 6, 9, 12, 18 and 24 | Month 9 | -8.1 swollen joints | Standard Error 0.84 |
| Standard of Care | Change From Baseline in Swollen Joint Count 66 at Months 3, 6, 9, 12, 18 and 24 | Month 3 | -5.6 swollen joints | Standard Error 0.85 |
| Standard of Care | Change From Baseline in Swollen Joint Count 66 at Months 3, 6, 9, 12, 18 and 24 | Month 18 | -9.4 swollen joints | Standard Error 1.14 |
| Standard of Care | Change From Baseline in Swollen Joint Count 66 at Months 3, 6, 9, 12, 18 and 24 | Month 6 | -5.9 swollen joints | Standard Error 0.81 |
| Early Adalimumab | Change From Baseline in Swollen Joint Count 66 at Months 3, 6, 9, 12, 18 and 24 | Month 18 | -10.0 swollen joints | Standard Error 1.09 |
| Early Adalimumab | Change From Baseline in Swollen Joint Count 66 at Months 3, 6, 9, 12, 18 and 24 | Month 9 | -10.8 swollen joints | Standard Error 0.8 |
| Early Adalimumab | Change From Baseline in Swollen Joint Count 66 at Months 3, 6, 9, 12, 18 and 24 | Month 12 | -11.3 swollen joints | Standard Error 0.66 |
| Early Adalimumab | Change From Baseline in Swollen Joint Count 66 at Months 3, 6, 9, 12, 18 and 24 | Month 6 | -10.4 swollen joints | Standard Error 0.78 |
| Early Adalimumab | Change From Baseline in Swollen Joint Count 66 at Months 3, 6, 9, 12, 18 and 24 | Month 24 | -10.6 swollen joints | Standard Error 0.8 |
| Early Adalimumab | Change From Baseline in Swollen Joint Count 66 at Months 3, 6, 9, 12, 18 and 24 | Month 3 | -9.2 swollen joints | Standard Error 0.81 |
Comparison: Month 3p-value: 0.00495% CI: [-5.9, -1.2]ANCOVA
Comparison: Month 6p-value: <0.00195% CI: [-6.8, -2.3]ANCOVA
Comparison: Month 9p-value: 0.02195% CI: [-5.1, -0.4]ANCOVA
Comparison: Month 12p-value: 0.03795% CI: [-4, -0.1]ANCOVA
Comparison: Month 18p-value: 0.70295% CI: [-3.7, 2.5]ANCOVA
Comparison: Month 24p-value: 0.64495% CI: [-2.8, 1.8]ANCOVA
Secondary
Change From Baseline in Tender Joint Count 28 at Months 3, 6, 9, 12, 18 and 24
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
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care | Change From Baseline in Tender Joint Count 28 at Months 3, 6, 9, 12, 18 and 24 | Month 3 | -5.5 tender joints | Standard Error 0.93 |
| Standard of Care | Change From Baseline in Tender Joint Count 28 at Months 3, 6, 9, 12, 18 and 24 | Month 6 | -5.7 tender joints | Standard Error 0.78 |
| Standard of Care | Change From Baseline in Tender Joint Count 28 at Months 3, 6, 9, 12, 18 and 24 | Month 9 | -7.1 tender joints | Standard Error 0.86 |
| Standard of Care | Change From Baseline in Tender Joint Count 28 at Months 3, 6, 9, 12, 18 and 24 | Month 12 | -8.4 tender joints | Standard Error 0.82 |
| Standard of Care | Change From Baseline in Tender Joint Count 28 at Months 3, 6, 9, 12, 18 and 24 | Month 18 | -8.5 tender joints | Standard Error 0.94 |
| Standard of Care | Change From Baseline in Tender Joint Count 28 at Months 3, 6, 9, 12, 18 and 24 | Month 24 | -9.4 tender joints | Standard Error 0.8 |
| Early Adalimumab | Change From Baseline in Tender Joint Count 28 at Months 3, 6, 9, 12, 18 and 24 | Month 18 | -9.1 tender joints | Standard Error 0.9 |
| Early Adalimumab | Change From Baseline in Tender Joint Count 28 at Months 3, 6, 9, 12, 18 and 24 | Month 3 | -7.4 tender joints | Standard Error 0.9 |
| Early Adalimumab | Change From Baseline in Tender Joint Count 28 at Months 3, 6, 9, 12, 18 and 24 | Month 12 | -9.2 tender joints | Standard Error 0.79 |
| Early Adalimumab | Change From Baseline in Tender Joint Count 28 at Months 3, 6, 9, 12, 18 and 24 | Month 6 | -9.7 tender joints | Standard Error 0.74 |
| Early Adalimumab | Change From Baseline in Tender Joint Count 28 at Months 3, 6, 9, 12, 18 and 24 | Month 24 | -10.2 tender joints | Standard Error 0.77 |
| Early Adalimumab | Change From Baseline in Tender Joint Count 28 at Months 3, 6, 9, 12, 18 and 24 | Month 9 | -9.6 tender joints | Standard Error 0.83 |
Comparison: Month 3p-value: 0.15695% CI: [-4.4, 0.7]ANCOVA
Comparison: Month 6p-value: <0.00195% CI: [-6.1, -1.9]ANCOVA
Comparison: Month 9p-value: 0.0495% CI: [-4.9, -0.1]ANCOVA
Comparison: Month 12p-value: 0.49295% CI: [-3.1, 1.5]ANCOVA
Comparison: Month 18p-value: 0.64995% CI: [-3.2, 2]ANCOVA
Comparison: Month 24p-value: 0.46495% CI: [-3, 1.4]ANCOVA
Secondary
Change From Baseline in Tender Joint Count 68 at Months 3, 6, 9, 12, 18 and 24
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
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care | Change From Baseline in Tender Joint Count 68 at Months 3, 6, 9, 12, 18 and 24 | Month 3 | -9.3 tender joints | Standard Error 1.63 |
| Standard of Care | Change From Baseline in Tender Joint Count 68 at Months 3, 6, 9, 12, 18 and 24 | Month 6 | -8.3 tender joints | Standard Error 1.38 |
| Standard of Care | Change From Baseline in Tender Joint Count 68 at Months 3, 6, 9, 12, 18 and 24 | Month 9 | -11.2 tender joints | Standard Error 1.35 |
| Standard of Care | Change From Baseline in Tender Joint Count 68 at Months 3, 6, 9, 12, 18 and 24 | Month 12 | -13.4 tender joints | Standard Error 1.41 |
| Standard of Care | Change From Baseline in Tender Joint Count 68 at Months 3, 6, 9, 12, 18 and 24 | Month 18 | -13.4 tender joints | Standard Error 1.67 |
| Standard of Care | Change From Baseline in Tender Joint Count 68 at Months 3, 6, 9, 12, 18 and 24 | Month 24 | -15.0 tender joints | Standard Error 1.32 |
| Early Adalimumab | Change From Baseline in Tender Joint Count 68 at Months 3, 6, 9, 12, 18 and 24 | Month 18 | -13.9 tender joints | Standard Error 1.6 |
| Early Adalimumab | Change From Baseline in Tender Joint Count 68 at Months 3, 6, 9, 12, 18 and 24 | Month 3 | -12.1 tender joints | Standard Error 1.56 |
| Early Adalimumab | Change From Baseline in Tender Joint Count 68 at Months 3, 6, 9, 12, 18 and 24 | Month 12 | -14.1 tender joints | Standard Error 1.35 |
| Early Adalimumab | Change From Baseline in Tender Joint Count 68 at Months 3, 6, 9, 12, 18 and 24 | Month 6 | -15.5 tender joints | Standard Error 1.33 |
| Early Adalimumab | Change From Baseline in Tender Joint Count 68 at Months 3, 6, 9, 12, 18 and 24 | Month 24 | -15.8 tender joints | Standard Error 1.27 |
| Early Adalimumab | Change From Baseline in Tender Joint Count 68 at Months 3, 6, 9, 12, 18 and 24 | Month 9 | -15.0 tender joints | Standard Error 1.3 |
Comparison: Month 3p-value: 0.2295% CI: [-7.3, 1.7]ANCOVA
Comparison: Month 6p-value: <0.00195% CI: [-11, -3.3]ANCOVA
Comparison: Month 9p-value: 0.0595% CI: [-7.5, 0]ANCOVA
Comparison: Month 12p-value: 0.72595% CI: [-4.6, 3.2]ANCOVA
Comparison: Month 18p-value: 0.83795% CI: [-5.1, 4.1]ANCOVA
Comparison: Month 24p-value: 0.66195% CI: [-4.5, 2.9]ANCOVA
Secondary
Change From Baseline in Work Limitations Questionnaire (WLQ) at Months 3, 6, 9, 12, 18 and 24
The WLQ was used to measure the impairment in work-related productivity, with reference to the previous two weeks. Each work-related question is scored from 0 to 4 and the total score ranges from 0-100, with lower scores signifying fewer limitations at work.
Time frame: Baseline, Months 3, 6, 9, 12, 18, 24
Population: Intent-to-treat population: all participants who were randomized and received at least one dose of study drug. 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care | Change From Baseline in Work Limitations Questionnaire (WLQ) at Months 3, 6, 9, 12, 18 and 24 | Month 3; n=23, 24 | -7.0 units on a scale | Standard Error 4.18 |
| Standard of Care | Change From Baseline in Work Limitations Questionnaire (WLQ) at Months 3, 6, 9, 12, 18 and 24 | Month 6; n=24, 25 | -6.1 units on a scale | Standard Error 4.2 |
| Standard of Care | Change From Baseline in Work Limitations Questionnaire (WLQ) at Months 3, 6, 9, 12, 18 and 24 | Month 9; n=25, 25 | -8.4 units on a scale | Standard Error 4.45 |
| Standard of Care | Change From Baseline in Work Limitations Questionnaire (WLQ) at Months 3, 6, 9, 12, 18 and 24 | Month 12; n=25, 25 | -15.2 units on a scale | Standard Error 4.05 |
| Standard of Care | Change From Baseline in Work Limitations Questionnaire (WLQ) at Months 3, 6, 9, 12, 18 and 24 | Month 18; n=25, 25 | -15.6 units on a scale | Standard Error 4.51 |
| Standard of Care | Change From Baseline in Work Limitations Questionnaire (WLQ) at Months 3, 6, 9, 12, 18 and 24 | Month 24; n=25, 25 | -13.7 units on a scale | Standard Error 4.34 |
| Early Adalimumab | Change From Baseline in Work Limitations Questionnaire (WLQ) at Months 3, 6, 9, 12, 18 and 24 | Month 18; n=25, 25 | -12.8 units on a scale | Standard Error 4.51 |
| Early Adalimumab | Change From Baseline in Work Limitations Questionnaire (WLQ) at Months 3, 6, 9, 12, 18 and 24 | Month 3; n=23, 24 | -11.5 units on a scale | Standard Error 4.1 |
| Early Adalimumab | Change From Baseline in Work Limitations Questionnaire (WLQ) at Months 3, 6, 9, 12, 18 and 24 | Month 12; n=25, 25 | -11.8 units on a scale | Standard Error 4.05 |
| Early Adalimumab | Change From Baseline in Work Limitations Questionnaire (WLQ) at Months 3, 6, 9, 12, 18 and 24 | Month 6; n=24, 25 | -13.9 units on a scale | Standard Error 4.11 |
| Early Adalimumab | Change From Baseline in Work Limitations Questionnaire (WLQ) at Months 3, 6, 9, 12, 18 and 24 | Month 24; n=25, 25 | -12.6 units on a scale | Standard Error 4.34 |
| Early Adalimumab | Change From Baseline in Work Limitations Questionnaire (WLQ) at Months 3, 6, 9, 12, 18 and 24 | Month 9; n=25, 25 | -11.8 units on a scale | Standard Error 4.45 |
Comparison: Month 3p-value: 0.45395% CI: [-16.3, 7.4]ANCOVA
Comparison: Month 6p-value: 0.18795% CI: [-19.7, 4]ANCOVA
Comparison: Month 9p-value: 0.59895% CI: [-16.1, 9.4]ANCOVA
Comparison: Month 12p-value: 0.55895% CI: [-8.2, 15]ANCOVA
Comparison: Month 18p-value: 0.66995% CI: [-10.1, 15.6]ANCOVA
Comparison: Month 24p-value: 0.86595% CI: [-11.3, 13.5]ANCOVA
Secondary
HCR: Health Care for RA in the Past 4 Weeks at Baseline
The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked about their use of health care for RA in the past 4 weeks.
Time frame: Baseline
Population: Intent-to-treat population: all participants who were randomized, received at least one dose of study drug, and had an assessment. n=the number of participants included in the percentage calculation (n=11, 10 is the number of participants who stated that they had used healthcare for RA in the past 4 weeks).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care | HCR: Health Care for RA in the Past 4 Weeks at Baseline | Visits to another physician; n=11, 10 | 27.3 percentage of participants |
| Standard of Care | HCR: Health Care for RA in the Past 4 Weeks at Baseline | Visit to hospital emergency room; n=11, 10 | 0 percentage of participants |
| Standard of Care | HCR: Health Care for RA in the Past 4 Weeks at Baseline | Unscheduled visits to study doctor; n=11, 10 | 27.3 percentage of participants |
| Standard of Care | HCR: Health Care for RA in the Past 4 Weeks at Baseline | Use of an ambulance service; n=11, 10 | 0 percentage of participants |
| Standard of Care | HCR: Health Care for RA in the Past 4 Weeks at Baseline | Visits to a healthcare professional; n=11, 10 | 9.1 percentage of participants |
| Standard of Care | HCR: Health Care for RA in the Past 4 Weeks at Baseline | Complementary/alternative therapy visits; n=11, 10 | 0 percentage of participants |
| Standard of Care | HCR: Health Care for RA in the Past 4 Weeks at Baseline | Used health care in past 4 weeks; n=35, 39 | 34.1 percentage of participants |
| Early Adalimumab | HCR: Health Care for RA in the Past 4 Weeks at Baseline | Complementary/alternative therapy visits; n=11, 10 | 0 percentage of participants |
| Early Adalimumab | HCR: Health Care for RA in the Past 4 Weeks at Baseline | Used health care in past 4 weeks; n=35, 39 | 25.6 percentage of participants |
| Early Adalimumab | HCR: Health Care for RA in the Past 4 Weeks at Baseline | Unscheduled visits to study doctor; n=11, 10 | 20.0 percentage of participants |
| Early Adalimumab | HCR: Health Care for RA in the Past 4 Weeks at Baseline | Visits to another physician; n=11, 10 | 0 percentage of participants |
| Early Adalimumab | HCR: Health Care for RA in the Past 4 Weeks at Baseline | Visits to a healthcare professional; n=11, 10 | 20.0 percentage of participants |
| Early Adalimumab | HCR: Health Care for RA in the Past 4 Weeks at Baseline | Visit to hospital emergency room; n=11, 10 | 10.0 percentage of participants |
| Early Adalimumab | HCR: Health Care for RA in the Past 4 Weeks at Baseline | Use of an ambulance service; n=11, 10 | 0 percentage of participants |
Secondary
HCR: Health Care for RA in the Past 4 Weeks at Final Visit
The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked about their use of health care for RA in the past 4 weeks.
Time frame: Final Visit (up to Month 24)
Population: Intent-to-treat population: all participants who were randomized, received at least one dose of study drug, and had an assessment. n=the number of participants included in the percentage calculation (n=2, 3 is the number of participants who stated that they had used healthcare for RA in the past 4 weeks).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care | HCR: Health Care for RA in the Past 4 Weeks at Final Visit | Visits to another physician; n=2, 3 | 0 percentage of participants |
| Standard of Care | HCR: Health Care for RA in the Past 4 Weeks at Final Visit | Visit to hospital emergency room; n=2, 3 | 0 percentage of participants |
| Standard of Care | HCR: Health Care for RA in the Past 4 Weeks at Final Visit | Unscheduled visits to study doctor; n=2, 3 | 0 percentage of participants |
| Standard of Care | HCR: Health Care for RA in the Past 4 Weeks at Final Visit | Use of an ambulance service; n=2, 3 | 0 percentage of participants |
| Standard of Care | HCR: Health Care for RA in the Past 4 Weeks at Final Visit | Visits to a healthcare professional; n=2, 3 | 50.0 percentage of participants |
| Standard of Care | HCR: Health Care for RA in the Past 4 Weeks at Final Visit | Complementary/alternative therapy visits; n=2, 3 | 0 percentage of participants |
| Standard of Care | HCR: Health Care for RA in the Past 4 Weeks at Final Visit | Used health care in past 4 weeks; n=33, 37 | 6.1 percentage of participants |
| Early Adalimumab | HCR: Health Care for RA in the Past 4 Weeks at Final Visit | Complementary/alternative therapy visits; n=2, 3 | 0 percentage of participants |
| Early Adalimumab | HCR: Health Care for RA in the Past 4 Weeks at Final Visit | Used health care in past 4 weeks; n=33, 37 | 8.1 percentage of participants |
| Early Adalimumab | HCR: Health Care for RA in the Past 4 Weeks at Final Visit | Unscheduled visits to study doctor; n=2, 3 | 0 percentage of participants |
| Early Adalimumab | HCR: Health Care for RA in the Past 4 Weeks at Final Visit | Visits to another physician; n=2, 3 | 33.3 percentage of participants |
| Early Adalimumab | HCR: Health Care for RA in the Past 4 Weeks at Final Visit | Visits to a healthcare professional; n=2, 3 | 33.3 percentage of participants |
| Early Adalimumab | HCR: Health Care for RA in the Past 4 Weeks at Final Visit | Visit to hospital emergency room; n=2, 3 | 33.3 percentage of participants |
| Early Adalimumab | HCR: Health Care for RA in the Past 4 Weeks at Final Visit | Use of an ambulance service; n=2, 3 | 0 percentage of participants |
Secondary
HCR: Medical Insurance at Final Visit
The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked whether and what type of health insurance they had. Types of Canadian insurance included: Régie de l'assurance maladie du Québec (RAMQ); Société de l'assurance automobile du Québec (SAAQ); Commission de la santé et de la sécurité du travail (CSST); Canadian Health Insurance Program (CHIP); and L'indemnisation des victimes d'actes criminals (IVAC).
Time frame: Final Visit (up to Month 24)
Population: Intent-to-treat population: all participants who were randomized, received at least one dose of study drug, and had an assessment. n=the number of participants included in the percentage calculation (n=26, 26 is the number of participants who answered that they did have health insurance).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care | HCR: Medical Insurance at Final Visit | Federal government; n=26, 26 | 0 percentage of participants |
| Standard of Care | HCR: Medical Insurance at Final Visit | 1 insurance; n=33, 37 | 78.8 percentage of participants |
| Standard of Care | HCR: Medical Insurance at Final Visit | CSST; n=26, 26 | 0 percentage of participants |
| Standard of Care | HCR: Medical Insurance at Final Visit | RMAQ; n=26, 26 | 0 percentage of participants |
| Standard of Care | HCR: Medical Insurance at Final Visit | OHIP; n=26, 26 | 11.5 percentage of participants |
| Standard of Care | HCR: Medical Insurance at Final Visit | Has health insurance; n=33, 37 | 78.8 percentage of participants |
| Standard of Care | HCR: Medical Insurance at Final Visit | IVAC; n=26, 26 | 0 percentage of participants |
| Standard of Care | HCR: Medical Insurance at Final Visit | Blue Cross; n=26, 26 | 11.5 percentage of participants |
| Standard of Care | HCR: Medical Insurance at Final Visit | SAAQ; n=26, 26 | 0 percentage of participants |
| Standard of Care | HCR: Medical Insurance at Final Visit | Other; n=26, 26 | 76.9 percentage of participants |
| Standard of Care | HCR: Medical Insurance at Final Visit | >/= 1 insurance; n=33, 37 | 0 percentage of participants |
| Early Adalimumab | HCR: Medical Insurance at Final Visit | Other; n=26, 26 | 73.1 percentage of participants |
| Early Adalimumab | HCR: Medical Insurance at Final Visit | Has health insurance; n=33, 37 | 70.3 percentage of participants |
| Early Adalimumab | HCR: Medical Insurance at Final Visit | 1 insurance; n=33, 37 | 70.3 percentage of participants |
| Early Adalimumab | HCR: Medical Insurance at Final Visit | >/= 1 insurance; n=33, 37 | 0 percentage of participants |
| Early Adalimumab | HCR: Medical Insurance at Final Visit | RMAQ; n=26, 26 | 3.8 percentage of participants |
| Early Adalimumab | HCR: Medical Insurance at Final Visit | SAAQ; n=26, 26 | 0 percentage of participants |
| Early Adalimumab | HCR: Medical Insurance at Final Visit | Federal government; n=26, 26 | 3.8 percentage of participants |
| Early Adalimumab | HCR: Medical Insurance at Final Visit | CSST; n=26, 26 | 0 percentage of participants |
| Early Adalimumab | HCR: Medical Insurance at Final Visit | OHIP; n=26, 26 | 11.5 percentage of participants |
| Early Adalimumab | HCR: Medical Insurance at Final Visit | Blue Cross; n=26, 26 | 7.7 percentage of participants |
| Early Adalimumab | HCR: Medical Insurance at Final Visit | IVAC; n=26, 26 | 0 percentage of participants |
Secondary
HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Baseline
The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked what type of out-of-pocket expenses they had incurred for their RA in the past 4 weeks. Based on Canadian dollars.
Time frame: Baseline
Population: Intent-to-treat population: all participants who were randomized, received at least one dose of study drug, and had an assessment. n=participants with non-zero expenses for given category, and included in the mean (SD) calculation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care | HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Baseline | Over-the-counter medications; n=11, 14 | 34.2 Canadian dollars | Standard Deviation 28.1 |
| Standard of Care | HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Baseline | Health care professional payments; n=0, 2 | NA Canadian dollars | — |
| Standard of Care | HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Baseline | Medical procedures/laboratory tests; n=0, 0 | NA Canadian dollars | — |
| Standard of Care | HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Baseline | Medical devices; n=2, 2 | 60.0 Canadian dollars | Standard Deviation 56.57 |
| Standard of Care | HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Baseline | Healthcare or extra help at home; n=0, 1 | NA Canadian dollars | — |
| Standard of Care | HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Baseline | Transportation costs; n=17, 12 | 36.3 Canadian dollars | Standard Deviation 19.53 |
| Early Adalimumab | HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Baseline | Healthcare or extra help at home; n=0, 1 | 80.0 Canadian dollars | — |
| Early Adalimumab | HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Baseline | Over-the-counter medications; n=11, 14 | 60.3 Canadian dollars | Standard Deviation 62.82 |
| Early Adalimumab | HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Baseline | Medical devices; n=2, 2 | 97.5 Canadian dollars | Standard Deviation 31.82 |
| Early Adalimumab | HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Baseline | Health care professional payments; n=0, 2 | 60.0 Canadian dollars | Standard Deviation 28.28 |
| Early Adalimumab | HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Baseline | Transportation costs; n=17, 12 | 30.3 Canadian dollars | Standard Deviation 18.24 |
| Early Adalimumab | HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Baseline | Medical procedures/laboratory tests; n=0, 0 | NA Canadian dollars | — |
Secondary
HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Final Visit
The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked what type of out-of-pocket expenses they had incurred for their RA in the past 4 weeks. Based on Canadian dollars.
Time frame: Final Visit (up to Month 24)
Population: Intent-to-treat population: all participants who were randomized, received at least one dose of study drug, and had an assessment. n=participants with non-zero expenses for given category, and included in the mean (SD) calculation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care | HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Final Visit | Over-the-counter medications; n=7, 7 | 108.3 Canadian dollars | Standard Deviation 78.75 |
| Standard of Care | HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Final Visit | Health care professional payments; n=1, 3 | 45.0 Canadian dollars | — |
| Standard of Care | HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Final Visit | Medical procedures/laboratory tests; n=0, 0 | NA Canadian dollars | — |
| Standard of Care | HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Final Visit | Medical devices; n=0, 0 | NA Canadian dollars | — |
| Standard of Care | HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Final Visit | Healthcare or extra help at home; n=0, 0 | NA Canadian dollars | — |
| Standard of Care | HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Final Visit | Transportation costs; n=4, 4 | 61.3 Canadian dollars | Standard Deviation 40.9 |
| Early Adalimumab | HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Final Visit | Healthcare or extra help at home; n=0, 0 | NA Canadian dollars | — |
| Early Adalimumab | HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Final Visit | Over-the-counter medications; n=7, 7 | 34.4 Canadian dollars | Standard Deviation 32.82 |
| Early Adalimumab | HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Final Visit | Medical devices; n=0, 0 | NA Canadian dollars | — |
| Early Adalimumab | HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Final Visit | Health care professional payments; n=1, 3 | 91.7 Canadian dollars | Standard Deviation 43.68 |
| Early Adalimumab | HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Final Visit | Transportation costs; n=4, 4 | 35.0 Canadian dollars | Standard Deviation 17.32 |
| Early Adalimumab | HCR: Out of Pocket Expenses Incurred for the Current Study Condition in the Past 4 Weeks at Final Visit | Medical procedures/laboratory tests; n=0, 0 | NA Canadian dollars | — |
Secondary
Health Care Resources Questionnaire (HCR): Medical Insurance at Baseline
The HCR consists of four aspects: medical insurance, health care for RA in the past 4 weeks, hospitalization in the past 4 weeks, and out of pocket expenses incurred for the current study condition. Participants were asked whether and what type of health insurance they had. Types of Canadian insurance included: Régie de l'assurance maladie du Québec (RAMQ); Société de l'assurance automobile du Québec (SAAQ); Commission de la santé et de la sécurité du travail (CSST); Canadian Health Insurance Program (CHIP); and L'indemnisation des victimes d'actes criminals (IVAC).
Time frame: Baseline
Population: Intent-to-treat population: all participants who were randomized, received at least one dose of study drug, and had an assessment. n=the number of participants included in the percentage calculation (n=25, 28 is the number of participants who answered that they did have health insurance).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care | Health Care Resources Questionnaire (HCR): Medical Insurance at Baseline | RMAQ; n=25, 28 | 4.0 percentage of participants |
| Standard of Care | Health Care Resources Questionnaire (HCR): Medical Insurance at Baseline | CSST; n=25, 28 | 0 percentage of participants |
| Standard of Care | Health Care Resources Questionnaire (HCR): Medical Insurance at Baseline | >/= 1 insurance; n=35, 39 | 0 percentage of participants |
| Standard of Care | Health Care Resources Questionnaire (HCR): Medical Insurance at Baseline | OHIP; n=25, 28 | 12.0 percentage of participants |
| Standard of Care | Health Care Resources Questionnaire (HCR): Medical Insurance at Baseline | SAAQ; n=25, 28 | 0 percentage of participants |
| Standard of Care | Health Care Resources Questionnaire (HCR): Medical Insurance at Baseline | IVAC; n=25, 28 | 0 percentage of participants |
| Standard of Care | Health Care Resources Questionnaire (HCR): Medical Insurance at Baseline | 1 insurance; n=35, 39 | 71.4 percentage of participants |
| Standard of Care | Health Care Resources Questionnaire (HCR): Medical Insurance at Baseline | Blue Cross; n=25, 28 | 20.0 percentage of participants |
| Standard of Care | Health Care Resources Questionnaire (HCR): Medical Insurance at Baseline | Federal government; n=25, 28 | 0 percentage of participants |
| Standard of Care | Health Care Resources Questionnaire (HCR): Medical Insurance at Baseline | Other; n=25, 28 | 64.0 percentage of participants |
| Standard of Care | Health Care Resources Questionnaire (HCR): Medical Insurance at Baseline | Has health insurance; n=35, 39 | 71.4 percentage of participants |
| Early Adalimumab | Health Care Resources Questionnaire (HCR): Medical Insurance at Baseline | Other; n=25, 28 | 64.3 percentage of participants |
| Early Adalimumab | Health Care Resources Questionnaire (HCR): Medical Insurance at Baseline | Has health insurance; n=35, 39 | 71.8 percentage of participants |
| Early Adalimumab | Health Care Resources Questionnaire (HCR): Medical Insurance at Baseline | 1 insurance; n=35, 39 | 66.7 percentage of participants |
| Early Adalimumab | Health Care Resources Questionnaire (HCR): Medical Insurance at Baseline | >/= 1 insurance; n=35, 39 | 2.6 percentage of participants |
| Early Adalimumab | Health Care Resources Questionnaire (HCR): Medical Insurance at Baseline | RMAQ; n=25, 28 | 3.6 percentage of participants |
| Early Adalimumab | Health Care Resources Questionnaire (HCR): Medical Insurance at Baseline | SAAQ; n=25, 28 | 0 percentage of participants |
| Early Adalimumab | Health Care Resources Questionnaire (HCR): Medical Insurance at Baseline | Federal government; n=25, 28 | 3.6 percentage of participants |
| Early Adalimumab | Health Care Resources Questionnaire (HCR): Medical Insurance at Baseline | CSST; n=25, 28 | 0 percentage of participants |
| Early Adalimumab | Health Care Resources Questionnaire (HCR): Medical Insurance at Baseline | OHIP; n=25, 28 | 21.4 percentage of participants |
| Early Adalimumab | Health Care Resources Questionnaire (HCR): Medical Insurance at Baseline | IVAC; n=25, 28 | 0 percentage of participants |
| Early Adalimumab | Health Care Resources Questionnaire (HCR): Medical Insurance at Baseline | Blue Cross; n=25, 28 | 7.1 percentage of participants |
Secondary
Likert Scale for Participant's Satisfaction With Care at Months 3, 6, 9, 12, 18 and 24
Participants measured their satisfaction with care by specifying their in response to the question How satisfied are you with the results of your RA treatment? on a 5-point Likert scale, from the following 5 answers: not satisfied, a little satisfied, moderately satisfied, well satisfied, very well satisfied. Scores range from 1 to 5, with higher scores indicating more satisfaction with their care.
Time frame: Months 3, 6, 9, 12, 18, 24
Population: Intent-to-treat population: all participants who were randomized and received at least one dose of study drug and had an assessment. LOCF: missing responses were imputed by carrying forward the last non-missing post-baseline observation.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care | Likert Scale for Participant's Satisfaction With Care at Months 3, 6, 9, 12, 18 and 24 | Month 6 | 3.3 units on a scale | Standard Error 0.19 |
| Standard of Care | Likert Scale for Participant's Satisfaction With Care at Months 3, 6, 9, 12, 18 and 24 | Month 9 | 3.7 units on a scale | Standard Error 0.17 |
| Standard of Care | Likert Scale for Participant's Satisfaction With Care at Months 3, 6, 9, 12, 18 and 24 | Month 12 | 3.9 units on a scale | Standard Error 0.16 |
| Standard of Care | Likert Scale for Participant's Satisfaction With Care at Months 3, 6, 9, 12, 18 and 24 | Month 18 | 4.2 units on a scale | Standard Error 0.17 |
| Standard of Care | Likert Scale for Participant's Satisfaction With Care at Months 3, 6, 9, 12, 18 and 24 | Month 24 | 4.1 units on a scale | Standard Error 0.16 |
| Standard of Care | Likert Scale for Participant's Satisfaction With Care at Months 3, 6, 9, 12, 18 and 24 | Month 3 | 3.5 units on a scale | Standard Error 0.2 |
| Early Adalimumab | Likert Scale for Participant's Satisfaction With Care at Months 3, 6, 9, 12, 18 and 24 | Month 24 | 4.3 units on a scale | Standard Error 0.15 |
| Early Adalimumab | Likert Scale for Participant's Satisfaction With Care at Months 3, 6, 9, 12, 18 and 24 | Month 6 | 4.1 units on a scale | Standard Error 0.18 |
| Early Adalimumab | Likert Scale for Participant's Satisfaction With Care at Months 3, 6, 9, 12, 18 and 24 | Month 18 | 4.2 units on a scale | Standard Error 0.16 |
| Early Adalimumab | Likert Scale for Participant's Satisfaction With Care at Months 3, 6, 9, 12, 18 and 24 | Month 9 | 4.1 units on a scale | Standard Error 0.17 |
| Early Adalimumab | Likert Scale for Participant's Satisfaction With Care at Months 3, 6, 9, 12, 18 and 24 | Month 3 | 4.1 units on a scale | Standard Error 0.19 |
| Early Adalimumab | Likert Scale for Participant's Satisfaction With Care at Months 3, 6, 9, 12, 18 and 24 | Month 12 | 4.2 units on a scale | Standard Error 0.15 |
Comparison: Month 3p-value: 0.04695% CI: [0, 1.1]ANCOVA
Comparison: Month 6p-value: 0.00395% CI: [0.3, 1.3]ANCOVA
Comparison: Month 9p-value: 0.20495% CI: [-0.2, 0.8]ANCOVA
Comparison: Month 12p-value: 0.22795% CI: [-0.2, 0.7]ANCOVA
Comparison: Month 18p-value: 0.8695% CI: [-0.4, 0.5]ANCOVA
Comparison: Month 24p-value: 0.47695% CI: [-0.3, 0.6]ANCOVA
Secondary
Percentage of Participants Achieving HAQ < 0.5 at Months 3, 6, 9, 12, 18 and 24
The percentage of participants achieving HAQ \< 0.5. HAQ is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI \< 0.5. A lower HAQ-DI score is better.
Time frame: Months 3, 6, 9, 12, 18, 24
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care | Percentage of Participants Achieving HAQ < 0.5 at Months 3, 6, 9, 12, 18 and 24 | Month 18 | 28.6 percentage of participants |
| Standard of Care | Percentage of Participants Achieving HAQ < 0.5 at Months 3, 6, 9, 12, 18 and 24 | Month 24 | 28.6 percentage of participants |
| Standard of Care | Percentage of Participants Achieving HAQ < 0.5 at Months 3, 6, 9, 12, 18 and 24 | Month 3 | 31.4 percentage of participants |
| Standard of Care | Percentage of Participants Achieving HAQ < 0.5 at Months 3, 6, 9, 12, 18 and 24 | Month 6 | 22.9 percentage of participants |
| Standard of Care | Percentage of Participants Achieving HAQ < 0.5 at Months 3, 6, 9, 12, 18 and 24 | Month 9 | 34.3 percentage of participants |
| Standard of Care | Percentage of Participants Achieving HAQ < 0.5 at Months 3, 6, 9, 12, 18 and 24 | Month 12 | 34.3 percentage of participants |
| Early Adalimumab | Percentage of Participants Achieving HAQ < 0.5 at Months 3, 6, 9, 12, 18 and 24 | Month 9 | 35.9 percentage of participants |
| Early Adalimumab | Percentage of Participants Achieving HAQ < 0.5 at Months 3, 6, 9, 12, 18 and 24 | Month 18 | 30.8 percentage of participants |
| Early Adalimumab | Percentage of Participants Achieving HAQ < 0.5 at Months 3, 6, 9, 12, 18 and 24 | Month 6 | 30.8 percentage of participants |
| Early Adalimumab | Percentage of Participants Achieving HAQ < 0.5 at Months 3, 6, 9, 12, 18 and 24 | Month 24 | 30.8 percentage of participants |
| Early Adalimumab | Percentage of Participants Achieving HAQ < 0.5 at Months 3, 6, 9, 12, 18 and 24 | Month 12 | 33.3 percentage of participants |
| Early Adalimumab | Percentage of Participants Achieving HAQ < 0.5 at Months 3, 6, 9, 12, 18 and 24 | Month 3 | 20.5 percentage of participants |
Comparison: Month 3p-value: 0.28395% CI: [-30.84, 9.01]Chi-squared
Comparison: Month 6p-value: 0.44495% CI: [-12.17, 28]Chi-squared
Comparison: Month 9p-value: 0.88595% CI: [-20.16, 23.38]Chi-squared
Comparison: Month 12p-value: 0.93195% CI: [-22.54, 20.64]Chi-squared
Comparison: Month 18p-value: 0.83695% CI: [-18.63, 23.03]Chi-squared
Comparison: Month 24p-value: 0.83695% CI: [-18.63, 23.03]Chi-squared
Secondary
Percentage of Participants Achieving MCID in FACIT-Fatigue Scale at Months 3, 6, 9, 12, 18 and 24
The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions on a scale from 'not at all' (0) to 'very much' (4). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue. The MCID was defined as a 3.56-unit decrease in FACIT-Fatigue Scale.
Time frame: Months 3, 6, 9, 12, 18, 24
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care | Percentage of Participants Achieving MCID in FACIT-Fatigue Scale at Months 3, 6, 9, 12, 18 and 24 | Month 3 | 14.3 percentage of participants |
| Standard of Care | Percentage of Participants Achieving MCID in FACIT-Fatigue Scale at Months 3, 6, 9, 12, 18 and 24 | Month 6 | 14.3 percentage of participants |
| Standard of Care | Percentage of Participants Achieving MCID in FACIT-Fatigue Scale at Months 3, 6, 9, 12, 18 and 24 | Month 9 | 17.1 percentage of participants |
| Standard of Care | Percentage of Participants Achieving MCID in FACIT-Fatigue Scale at Months 3, 6, 9, 12, 18 and 24 | Month 12 | 8.6 percentage of participants |
| Standard of Care | Percentage of Participants Achieving MCID in FACIT-Fatigue Scale at Months 3, 6, 9, 12, 18 and 24 | Month 18 | 8.6 percentage of participants |
| Standard of Care | Percentage of Participants Achieving MCID in FACIT-Fatigue Scale at Months 3, 6, 9, 12, 18 and 24 | Month 24 | 11.4 percentage of participants |
| Early Adalimumab | Percentage of Participants Achieving MCID in FACIT-Fatigue Scale at Months 3, 6, 9, 12, 18 and 24 | Month 18 | 15.8 percentage of participants |
| Early Adalimumab | Percentage of Participants Achieving MCID in FACIT-Fatigue Scale at Months 3, 6, 9, 12, 18 and 24 | Month 3 | 13.2 percentage of participants |
| Early Adalimumab | Percentage of Participants Achieving MCID in FACIT-Fatigue Scale at Months 3, 6, 9, 12, 18 and 24 | Month 12 | 13.2 percentage of participants |
| Early Adalimumab | Percentage of Participants Achieving MCID in FACIT-Fatigue Scale at Months 3, 6, 9, 12, 18 and 24 | Month 6 | 7.9 percentage of participants |
| Early Adalimumab | Percentage of Participants Achieving MCID in FACIT-Fatigue Scale at Months 3, 6, 9, 12, 18 and 24 | Month 24 | 5.3 percentage of participants |
| Early Adalimumab | Percentage of Participants Achieving MCID in FACIT-Fatigue Scale at Months 3, 6, 9, 12, 18 and 24 | Month 9 | 5.3 percentage of participants |
Comparison: Month 3p-value: 195% CI: [-17.94, 15.16]Fisher Exact
Comparison: Month 6p-value: 0.46895% CI: [-22.34, 8.81]Fisher Exact
Comparison: Month 9p-value: 0.14295% CI: [-27.88, 3.16]Fisher Exact
Comparison: Month 12p-value: 0.71295% CI: [-11.08, 19.83]Fisher Exact
Comparison: Month 18p-value: 0.48295% CI: [-8.92, 22.89]Fisher Exact
Comparison: Month 24p-value: 0.41895% CI: [-21.18, 7.69]Fisher Exact
Secondary
Percentage of Participants Achieving Minimal Clinical Important Difference (MCID) in HAQ at Months 3, 6, 9, 12, 18 and 24
The percentage of participants achieving MCID in HAQ, defined as a 0.22 unit decrease in HAQ. HAQ is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A lower HAQ-DI score is better.
Time frame: Months 3, 6, 9, 12, 18, 24
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care | Percentage of Participants Achieving Minimal Clinical Important Difference (MCID) in HAQ at Months 3, 6, 9, 12, 18 and 24 | Month 9 | 57.1 percentage of participants |
| Standard of Care | Percentage of Participants Achieving Minimal Clinical Important Difference (MCID) in HAQ at Months 3, 6, 9, 12, 18 and 24 | Month 18 | 57.1 percentage of participants |
| Standard of Care | Percentage of Participants Achieving Minimal Clinical Important Difference (MCID) in HAQ at Months 3, 6, 9, 12, 18 and 24 | Month 6 | 54.3 percentage of participants |
| Standard of Care | Percentage of Participants Achieving Minimal Clinical Important Difference (MCID) in HAQ at Months 3, 6, 9, 12, 18 and 24 | Month 24 | 57.1 percentage of participants |
| Standard of Care | Percentage of Participants Achieving Minimal Clinical Important Difference (MCID) in HAQ at Months 3, 6, 9, 12, 18 and 24 | Month 12 | 68.6 percentage of participants |
| Standard of Care | Percentage of Participants Achieving Minimal Clinical Important Difference (MCID) in HAQ at Months 3, 6, 9, 12, 18 and 24 | Month 3 | 65.7 percentage of participants |
| Early Adalimumab | Percentage of Participants Achieving Minimal Clinical Important Difference (MCID) in HAQ at Months 3, 6, 9, 12, 18 and 24 | Month 12 | 59.0 percentage of participants |
| Early Adalimumab | Percentage of Participants Achieving Minimal Clinical Important Difference (MCID) in HAQ at Months 3, 6, 9, 12, 18 and 24 | Month 6 | 51.3 percentage of participants |
| Early Adalimumab | Percentage of Participants Achieving Minimal Clinical Important Difference (MCID) in HAQ at Months 3, 6, 9, 12, 18 and 24 | Month 9 | 64.1 percentage of participants |
| Early Adalimumab | Percentage of Participants Achieving Minimal Clinical Important Difference (MCID) in HAQ at Months 3, 6, 9, 12, 18 and 24 | Month 3 | 53.8 percentage of participants |
| Early Adalimumab | Percentage of Participants Achieving Minimal Clinical Important Difference (MCID) in HAQ at Months 3, 6, 9, 12, 18 and 24 | Month 18 | 53.8 percentage of participants |
| Early Adalimumab | Percentage of Participants Achieving Minimal Clinical Important Difference (MCID) in HAQ at Months 3, 6, 9, 12, 18 and 24 | Month 24 | 41.0 percentage of participants |
Comparison: Month 3p-value: 0.29995% CI: [-34.05, 10.31]Chi-squared
Comparison: Month 6p-value: 0.79695% CI: [-25.77, 19.77]Chi-squared
Comparison: Month 9p-value: 0.5495% CI: [-15.3, 29.22]Chi-squared
Comparison: Month 12p-value: 0.39295% CI: [-31.39, 12.19]Chi-squared
Comparison: Month 18p-value: 0.77695% CI: [-25.96, 19.37]Chi-squared
Comparison: Month 24p-value: 0.16695% CI: [-38.64, 6.4]Chi-squared
Secondary
Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Months 3, 6, 9, 12, 18 and 24
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
Population: Intent-to-treat population: all participants who were randomized and received at least one dose of study drug (nonresponder imputation).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care | Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Months 3, 6, 9, 12, 18 and 24 | Month 3 | 57.1 percentage of participants |
| Standard of Care | Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Months 3, 6, 9, 12, 18 and 24 | Month 6 | 37.1 percentage of participants |
| Standard of Care | Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Months 3, 6, 9, 12, 18 and 24 | Month 9 | 60.0 percentage of participants |
| Standard of Care | Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Months 3, 6, 9, 12, 18 and 24 | Month 12 | 68.6 percentage of participants |
| Standard of Care | Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Months 3, 6, 9, 12, 18 and 24 | Month 18 | 65.7 percentage of participants |
| Standard of Care | Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Months 3, 6, 9, 12, 18 and 24 | Month 24 | 65.7 percentage of participants |
| Early Adalimumab | Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Months 3, 6, 9, 12, 18 and 24 | Month 18 | 51.3 percentage of participants |
| Early Adalimumab | Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Months 3, 6, 9, 12, 18 and 24 | Month 3 | 69.2 percentage of participants |
| Early Adalimumab | Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Months 3, 6, 9, 12, 18 and 24 | Month 12 | 56.4 percentage of participants |
| Early Adalimumab | Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Months 3, 6, 9, 12, 18 and 24 | Month 6 | 64.1 percentage of participants |
| Early Adalimumab | Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Months 3, 6, 9, 12, 18 and 24 | Month 24 | 46.2 percentage of participants |
| Early Adalimumab | Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Months 3, 6, 9, 12, 18 and 24 | Month 9 | 66.7 percentage of participants |
Comparison: Month 3p-value: 0.28195% CI: [-9.79, 33.97]Chi-squared
Comparison: Month 6p-value: 0.02195% CI: [4.98, 48.93]Chi-squared
Comparison: Month 9p-value: 0.55295% CI: [-15.29, 28.63]Chi-squared
Comparison: Month 12p-value: 0.28195% CI: [-34.04, 9.72]Chi-squared
Comparison: Month 18p-value: 0.20995% CI: [-36.64, 7.78]Chi-squared
Comparison: Month 24p-value: 0.09195% CI: [-41.74, 2.62]Chi-squared
Secondary
Percentage of Participants With American College of Rheumatology 50% (ACR50) Response at Months 3, 6, 9, 12, 18 and 24
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
Population: Intent-to-treat population: all participants who were randomized and received at least one dose of study drug (nonresponder imputation).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care | Percentage of Participants With American College of Rheumatology 50% (ACR50) Response at Months 3, 6, 9, 12, 18 and 24 | Month 24 | 42.9 percentage of participants |
| Standard of Care | Percentage of Participants With American College of Rheumatology 50% (ACR50) Response at Months 3, 6, 9, 12, 18 and 24 | Month 3 | 22.9 percentage of participants |
| Standard of Care | Percentage of Participants With American College of Rheumatology 50% (ACR50) Response at Months 3, 6, 9, 12, 18 and 24 | Month 6 | 22.9 percentage of participants |
| Standard of Care | Percentage of Participants With American College of Rheumatology 50% (ACR50) Response at Months 3, 6, 9, 12, 18 and 24 | Month 9 | 40.0 percentage of participants |
| Standard of Care | Percentage of Participants With American College of Rheumatology 50% (ACR50) Response at Months 3, 6, 9, 12, 18 and 24 | Month 12 | 34.3 percentage of participants |
| Standard of Care | Percentage of Participants With American College of Rheumatology 50% (ACR50) Response at Months 3, 6, 9, 12, 18 and 24 | Month 18 | 45.7 percentage of participants |
| Early Adalimumab | Percentage of Participants With American College of Rheumatology 50% (ACR50) Response at Months 3, 6, 9, 12, 18 and 24 | Month 12 | 43.6 percentage of participants |
| Early Adalimumab | Percentage of Participants With American College of Rheumatology 50% (ACR50) Response at Months 3, 6, 9, 12, 18 and 24 | Month 24 | 33.3 percentage of participants |
| Early Adalimumab | Percentage of Participants With American College of Rheumatology 50% (ACR50) Response at Months 3, 6, 9, 12, 18 and 24 | Month 9 | 48.7 percentage of participants |
| Early Adalimumab | Percentage of Participants With American College of Rheumatology 50% (ACR50) Response at Months 3, 6, 9, 12, 18 and 24 | Month 3 | 38.5 percentage of participants |
| Early Adalimumab | Percentage of Participants With American College of Rheumatology 50% (ACR50) Response at Months 3, 6, 9, 12, 18 and 24 | Month 18 | 38.5 percentage of participants |
| Early Adalimumab | Percentage of Participants With American College of Rheumatology 50% (ACR50) Response at Months 3, 6, 9, 12, 18 and 24 | Month 6 | 43.6 percentage of participants |
Comparison: Month 3p-value: 0.14895% CI: [-5.05, 36.26]Chi-squared
Comparison: Month 6p-value: 0.0695% CI: [-0.14, 41.61]Chi-squared
Comparison: Month 9p-value: 0.45195% CI: [-13.85, 31.29]Chi-squared
Comparison: Month 12p-value: 0.41395% CI: [-12.82, 31.43]Chi-squared
Comparison: Month 18p-value: 0.52895% CI: [-29.74, 15.23]Chi-squared
Comparison: Month 24p-value: 0.39995% CI: [-31.61, 12.56]Chi-squared
Secondary
Percentage of Participants With American College of Rheumatology 70% (ACR70) Response at Months 3, 6, 9, 12, 18 and 24
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
Population: Intent-to-treat population: all participants who were randomized and received at least one dose of study drug (nonresponder imputation).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care | Percentage of Participants With American College of Rheumatology 70% (ACR70) Response at Months 3, 6, 9, 12, 18 and 24 | Month 3 | 2.9 percentage of participants |
| Standard of Care | Percentage of Participants With American College of Rheumatology 70% (ACR70) Response at Months 3, 6, 9, 12, 18 and 24 | Month 6 | 8.6 percentage of participants |
| Standard of Care | Percentage of Participants With American College of Rheumatology 70% (ACR70) Response at Months 3, 6, 9, 12, 18 and 24 | Month 9 | 22.9 percentage of participants |
| Standard of Care | Percentage of Participants With American College of Rheumatology 70% (ACR70) Response at Months 3, 6, 9, 12, 18 and 24 | Month 12 | 14.3 percentage of participants |
| Standard of Care | Percentage of Participants With American College of Rheumatology 70% (ACR70) Response at Months 3, 6, 9, 12, 18 and 24 | Month 18 | 20.0 percentage of participants |
| Standard of Care | Percentage of Participants With American College of Rheumatology 70% (ACR70) Response at Months 3, 6, 9, 12, 18 and 24 | Month 24 | 40.0 percentage of participants |
| Early Adalimumab | Percentage of Participants With American College of Rheumatology 70% (ACR70) Response at Months 3, 6, 9, 12, 18 and 24 | Month 18 | 30.8 percentage of participants |
| Early Adalimumab | Percentage of Participants With American College of Rheumatology 70% (ACR70) Response at Months 3, 6, 9, 12, 18 and 24 | Month 3 | 15.4 percentage of participants |
| Early Adalimumab | Percentage of Participants With American College of Rheumatology 70% (ACR70) Response at Months 3, 6, 9, 12, 18 and 24 | Month 12 | 30.8 percentage of participants |
| Early Adalimumab | Percentage of Participants With American College of Rheumatology 70% (ACR70) Response at Months 3, 6, 9, 12, 18 and 24 | Month 6 | 28.2 percentage of participants |
| Early Adalimumab | Percentage of Participants With American College of Rheumatology 70% (ACR70) Response at Months 3, 6, 9, 12, 18 and 24 | Month 24 | 23.1 percentage of participants |
| Early Adalimumab | Percentage of Participants With American College of Rheumatology 70% (ACR70) Response at Months 3, 6, 9, 12, 18 and 24 | Month 9 | 25.6 percentage of participants |
Comparison: Month 3p-value: 0.11195% CI: [-1.7, 27.06]Fisher Exact
Comparison: Month 6p-value: 0.03195% CI: [2.74, 36.53]Chi-squared
Comparison: Month 9p-value: 0.7895% CI: [-16.74, 22.31]Chi-squared
Comparison: Month 12p-value: 0.09295% CI: [-2.07, 35.04]Chi-squared
Comparison: Month 18p-value: 0.2995% CI: [-8.86, 30.4]Chi-squared
Comparison: Month 24p-value: 0.11695% CI: [-37.86, 4.01]Chi-squared
Secondary
Percentage of Participants With DAS28(CRP) Low Disease Activity at Months 3, 6, 9, 12, 18 and 24
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care | Percentage of Participants With DAS28(CRP) Low Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 3 | 22.9 percentage of participants |
| Standard of Care | Percentage of Participants With DAS28(CRP) Low Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 6 | 28.6 percentage of participants |
| Standard of Care | Percentage of Participants With DAS28(CRP) Low Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 9 | 51.4 percentage of participants |
| Standard of Care | Percentage of Participants With DAS28(CRP) Low Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 12 | 48.6 percentage of participants |
| Standard of Care | Percentage of Participants With DAS28(CRP) Low Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 18 | 51.4 percentage of participants |
| Standard of Care | Percentage of Participants With DAS28(CRP) Low Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 24 | 54.3 percentage of participants |
| Early Adalimumab | Percentage of Participants With DAS28(CRP) Low Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 18 | 48.7 percentage of participants |
| Early Adalimumab | Percentage of Participants With DAS28(CRP) Low Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 3 | 33.3 percentage of participants |
| Early Adalimumab | Percentage of Participants With DAS28(CRP) Low Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 12 | 56.4 percentage of participants |
| Early Adalimumab | Percentage of Participants With DAS28(CRP) Low Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 6 | 51.3 percentage of participants |
| Early Adalimumab | Percentage of Participants With DAS28(CRP) Low Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 24 | 43.6 percentage of participants |
| Early Adalimumab | Percentage of Participants With DAS28(CRP) Low Disease Activity at Months 3, 6, 9, 12, 18 and 24 | Month 9 | 56.4 percentage of participants |
Comparison: Month 3p-value: 0.31895% CI: [-9.83, 30.78]Chi-squared
Comparison: Month 6p-value: 0.04795% CI: [1.03, 44.39]Chi-squared
Comparison: Month 9p-value: 0.66895% CI: [-17.74, 27.71]Chi-squared
Comparison: Month 12p-value: 0.595% CI: [-14.88, 30.56]Chi-squared
Comparison: Month 18p-value: 0.81695% CI: [-25.52, 20.1]Chi-squared
Comparison: Month 24p-value: 0.35895% CI: [-33.38, 11.99]Chi-squared
Secondary
Percentage of Participants With DAS28(CRP) Remission at Months 3, 6, 9, 12, 18 and 24
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care | Percentage of Participants With DAS28(CRP) Remission at Months 3, 6, 9, 12, 18 and 24 | Month 6 | 11.4 percentage of participants |
| Standard of Care | Percentage of Participants With DAS28(CRP) Remission at Months 3, 6, 9, 12, 18 and 24 | Month 12 | 22.9 percentage of participants |
| Standard of Care | Percentage of Participants With DAS28(CRP) Remission at Months 3, 6, 9, 12, 18 and 24 | Month 3 | 8.6 percentage of participants |
| Standard of Care | Percentage of Participants With DAS28(CRP) Remission at Months 3, 6, 9, 12, 18 and 24 | Month 18 | 34.3 percentage of participants |
| Standard of Care | Percentage of Participants With DAS28(CRP) Remission at Months 3, 6, 9, 12, 18 and 24 | Month 9 | 31.4 percentage of participants |
| Standard of Care | Percentage of Participants With DAS28(CRP) Remission at Months 3, 6, 9, 12, 18 and 24 | Month 24 | 42.9 percentage of participants |
| Early Adalimumab | Percentage of Participants With DAS28(CRP) Remission at Months 3, 6, 9, 12, 18 and 24 | Month 9 | 28.2 percentage of participants |
| Early Adalimumab | Percentage of Participants With DAS28(CRP) Remission at Months 3, 6, 9, 12, 18 and 24 | Month 3 | 17.9 percentage of participants |
| Early Adalimumab | Percentage of Participants With DAS28(CRP) Remission at Months 3, 6, 9, 12, 18 and 24 | Month 6 | 35.9 percentage of participants |
| Early Adalimumab | Percentage of Participants With DAS28(CRP) Remission at Months 3, 6, 9, 12, 18 and 24 | Month 24 | 38.5 percentage of participants |
| Early Adalimumab | Percentage of Participants With DAS28(CRP) Remission at Months 3, 6, 9, 12, 18 and 24 | Month 12 | 35.9 percentage of participants |
| Early Adalimumab | Percentage of Participants With DAS28(CRP) Remission at Months 3, 6, 9, 12, 18 and 24 | Month 18 | 30.8 percentage of participants |
Comparison: Month 3p-value: 0.31695% CI: [-7.09, 25.13]Fisher Exact
Comparison: Month 6p-value: 0.01495% CI: [6.09, 42.85]Chi-squared
Comparison: Month 9p-value: 0.76295% CI: [-24.1, 17.66]Chi-squared
Comparison: Month 12p-value: 0.2295% CI: [-7.46, 33.54]Chi-squared
Comparison: Month 18p-value: 0.74795% CI: [-24.9, 17.86]Chi-squared
Comparison: Month 24p-value: 0.70195% CI: [-26.8, 18.01]Chi-squared
Secondary
Percentage of Participants With EULAR Moderate Response at Months 3, 6, 9, 12, 18 and 24
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care | Percentage of Participants With EULAR Moderate Response at Months 3, 6, 9, 12, 18 and 24 | Month 3 | 37.1 percentage of participants |
| Standard of Care | Percentage of Participants With EULAR Moderate Response at Months 3, 6, 9, 12, 18 and 24 | Month 6 | 25.7 percentage of participants |
| Standard of Care | Percentage of Participants With EULAR Moderate Response at Months 3, 6, 9, 12, 18 and 24 | Month 9 | 28.6 percentage of participants |
| Standard of Care | Percentage of Participants With EULAR Moderate Response at Months 3, 6, 9, 12, 18 and 24 | Month 12 | 37.1 percentage of participants |
| Standard of Care | Percentage of Participants With EULAR Moderate Response at Months 3, 6, 9, 12, 18 and 24 | Month 18 | 22.9 percentage of participants |
| Standard of Care | Percentage of Participants With EULAR Moderate Response at Months 3, 6, 9, 12, 18 and 24 | Month 24 | 14.3 percentage of participants |
| Early Adalimumab | Percentage of Participants With EULAR Moderate Response at Months 3, 6, 9, 12, 18 and 24 | Month 18 | 10.3 percentage of participants |
| Early Adalimumab | Percentage of Participants With EULAR Moderate Response at Months 3, 6, 9, 12, 18 and 24 | Month 3 | 48.7 percentage of participants |
| Early Adalimumab | Percentage of Participants With EULAR Moderate Response at Months 3, 6, 9, 12, 18 and 24 | Month 12 | 23.1 percentage of participants |
| Early Adalimumab | Percentage of Participants With EULAR Moderate Response at Months 3, 6, 9, 12, 18 and 24 | Month 6 | 30.8 percentage of participants |
| Early Adalimumab | Percentage of Participants With EULAR Moderate Response at Months 3, 6, 9, 12, 18 and 24 | Month 24 | 10.3 percentage of participants |
| Early Adalimumab | Percentage of Participants With EULAR Moderate Response at Months 3, 6, 9, 12, 18 and 24 | Month 9 | 28.2 percentage of participants |
Comparison: Month 3p-value: 0.31695% CI: [-10.84, 33.99]Chi-squared
Comparison: Month 6p-value: 0.6395% CI: [-15.43, 25.54]Chi-squared
Comparison: Month 9p-value: 0.97295% CI: [-20.94, 20.21]Chi-squared
Comparison: Month 12p-value: 0.18695% CI: [-34.83, 6.7]Chi-squared
Comparison: Month 18p-value: 0.14295% CI: [-29.46, 4.26]Chi-squared
Comparison: Month 24p-value: 0.72795% CI: [-20.34, 11.52]Chi-squared
Secondary
Percentage of Participants With European League Against Rheumatism (EULAR) Good Response at Months 3, 6, 9, 12, 18 and 24
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care | Percentage of Participants With European League Against Rheumatism (EULAR) Good Response at Months 3, 6, 9, 12, 18 and 24 | Month 3 | 22.9 percentage of participants |
| Standard of Care | Percentage of Participants With European League Against Rheumatism (EULAR) Good Response at Months 3, 6, 9, 12, 18 and 24 | Month 6 | 28.6 percentage of participants |
| Standard of Care | Percentage of Participants With European League Against Rheumatism (EULAR) Good Response at Months 3, 6, 9, 12, 18 and 24 | Month 9 | 48.6 percentage of participants |
| Standard of Care | Percentage of Participants With European League Against Rheumatism (EULAR) Good Response at Months 3, 6, 9, 12, 18 and 24 | Month 12 | 45.7 percentage of participants |
| Standard of Care | Percentage of Participants With European League Against Rheumatism (EULAR) Good Response at Months 3, 6, 9, 12, 18 and 24 | Month 18 | 51.4 percentage of participants |
| Standard of Care | Percentage of Participants With European League Against Rheumatism (EULAR) Good Response at Months 3, 6, 9, 12, 18 and 24 | Month 24 | 54.3 percentage of participants |
| Early Adalimumab | Percentage of Participants With European League Against Rheumatism (EULAR) Good Response at Months 3, 6, 9, 12, 18 and 24 | Month 18 | 48.7 percentage of participants |
| Early Adalimumab | Percentage of Participants With European League Against Rheumatism (EULAR) Good Response at Months 3, 6, 9, 12, 18 and 24 | Month 3 | 30.8 percentage of participants |
| Early Adalimumab | Percentage of Participants With European League Against Rheumatism (EULAR) Good Response at Months 3, 6, 9, 12, 18 and 24 | Month 12 | 53.8 percentage of participants |
| Early Adalimumab | Percentage of Participants With European League Against Rheumatism (EULAR) Good Response at Months 3, 6, 9, 12, 18 and 24 | Month 6 | 48.7 percentage of participants |
| Early Adalimumab | Percentage of Participants With European League Against Rheumatism (EULAR) Good Response at Months 3, 6, 9, 12, 18 and 24 | Month 24 | 43.6 percentage of participants |
| Early Adalimumab | Percentage of Participants With European League Against Rheumatism (EULAR) Good Response at Months 3, 6, 9, 12, 18 and 24 | Month 9 | 51.3 percentage of participants |
Comparison: Month 3p-value: 0.44495% CI: [-12.17, 28]Chi-squared
Comparison: Month 6p-value: 0.07695% CI: [-1.53, 41.83]Chi-squared
Comparison: Month 9p-value: 0.81695% CI: [-20.1, 25.52]Chi-squared
Comparison: Month 12p-value: 0.48595% CI: [-14.61, 30.87]Chi-squared
Comparison: Month 18p-value: 0.81695% CI: [-25.52, 20.1]Chi-squared
Comparison: Month 24p-value: 0.35895% CI: [-33.38, 11.99]Chi-squared
Secondary
Percentage of Participants With Flare-Up After Remission by Month 24
Percentage of participants with a flare-up after remission by Month 24, defined as participants who reached remission (DAS28 \< 2.6) but later had two consecutive visits with DAS28 ≥ 2.6 (based on observed cases only). 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: Month 24
Population: Intent-to-treat population: all participants who were randomized and received at least one dose of study drug and had an assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care | Percentage of Participants With Flare-Up After Remission by Month 24 | 8.6 percentage of participants |
| Early Adalimumab | Percentage of Participants With Flare-Up After Remission by Month 24 | 15.4 percentage of participants |
p-value: 0.48695% CI: [-9.21, 22.22]Fisher Exact
Secondary
Percentage of Participants With No Radiographic Progression at Month 6 and Month 24
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
Population: Intent-to-treat population: all participants who were randomized and received at least one dose of study drug (nonresponder imputation).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care | Percentage of Participants With No Radiographic Progression at Month 6 and Month 24 | Month 6 | 68.6 percentage of participants |
| Standard of Care | Percentage of Participants With No Radiographic Progression at Month 6 and Month 24 | Month 24 | 51.4 percentage of participants |
| Early Adalimumab | Percentage of Participants With No Radiographic Progression at Month 6 and Month 24 | Month 6 | 71.8 percentage of participants |
| Early Adalimumab | Percentage of Participants With No Radiographic Progression at Month 6 and Month 24 | Month 24 | 46.2 percentage of participants |
Comparison: Month 6p-value: 0.76295% CI: [-17.7, 24.1]Chi-squared
Comparison: Month 24p-value: 0.6595% CI: [-28.1, 17.5]Chi-squared
Secondary
Percentage of Participants With Rapid Radiographic Progression at Month 12
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
Population: Intent-to-treat population: all participants who were randomized and received at least one dose of study drug ith an assessment (nonresponder imputation).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care | Percentage of Participants With Rapid Radiographic Progression at Month 12 | 14.3 percentage of participants |
| Early Adalimumab | Percentage of Participants With Rapid Radiographic Progression at Month 12 | 2.6 percentage of participants |
p-value: 0.09595% CI: [-27, 1.6]Fisher Exact