Ankylosing Spondylitis, Psoriatic Arthritis, Rheumatoid Arthritis
Conditions
Keywords
Monoclonals, Antibodies, Ankylosing Spondylitis, Antirheumatic Agents, Quality of Life, Adalimumab, rheumatoid arthritis, psoriatic arthritis
Brief summary
The aim of this post-marketing observational study is to obtain further data on the evaluation of quality of life outcomes of HUMIRA® in routine clinical use in patients with Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) or Ankylosing Spondylitis (AS) after unsustainable clinical response to disease modifying antirheumatic drugs (DMARD) and or biological disease modifying antirheumatic drugs (BDMARD). Treatment strategies in moderate to severe rheumatoid arthritis, psoriatic arthritis and in severe active ankylosing spondylitis commonly consist of introducing biologics after conventional disease modifying antirheumatic drugs or non steroidal antiinflammatory drugs fail. Although biologic disease modifying antirheumatic drugs are generally well-tolerated, intolerances may develop or efficacy may diminish, at which time another biologic disease modifying antirheumatic drug might be considered. This study shall evaluate the quality of life outcomes of HUMIRA®, given after conventional disease modifying antirheumatic drugs and or non antiinflammatory drug failures and or after biological disease modifying antirheumatic drug failures . Failure in this context means primary or secondary loss of efficacy or intolerance to the initial agent.
Interventions
None listed
Sponsors
Group Data Management Biostatistics
Abbott
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients age greater than or equal to 18 * Patients must fulfill international and national guidelines for use of a BDMARD in RA, PsA and AS (Chest X-ray and purified protein derivative (PPD) skin test negative for tuberculosis). In addition one of the following criteria must be fulfilled: * unsatisfactory DMARD response defined as failure to treatment with at least two DMARDs including Methotrexate in patients with RA or PsA * unsatisfactory NSAID response in patients with AS or * unsatisfactory response to prior BDMARDs (in this case patients must have received BDMARDs at least 12 weeks before visit 1) in patients with RA or PsA or AS.
Exclusion criteria
* Patients who meet contraindications as outlined in the latest version of the Humira syringe® Summary of Product Characteristics (SmPC) and Humira Pen® SmPC * Patients participating in another study or clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI | Baseline, months 3,6,9,12 | The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures a patient's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene,reach, grip, activities. Each question is evaluated according to the degree of severity on a scale ranging from 0 (without any difficulty) to 3 (unable to do). |
| SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Baseline, months 3,6,9,12 | Medical Outcomes Study Short Form 36 (MOS SF-36) is generic assessment of health status that consists of 36 questions within 8 domains including Physical Functioning (PF), Role Functioning - Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Functioning - Emotional (RE), Mental Health (MH) and Reported Health Transition (HT). Results from each domain are summarized and transformed into a scale ranging from 0 (worst) to 100 (best) with the exception of HT. The score range for HT is 0 (worst) to 5 (best). |
| EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | Baseline, months 3,6,9,12 | European Quality of Life 5 Dimensions (EQ-5D) is a self-reported health outcome which measures mobility, self care, usual activities, pain discomfort, anxiety depression. An overall score is derived that measures from -0.59 (worst) to +1 (best). In addition, health state is measured on the thermometer scale (score 0 to 100) with higher scores representing better health status. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Baseline, months 3,6,9,12 | Physician's and Patient's Global Assessment of State of Health was measured using a visual analogue scale with scores from 0 to 100 (higher scores indicate worse health state). |
| DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale | Baseline,months 3,6,9,12 | The Disease Activity Score 28 measures disease activity based on the number of swollen and tender joints (28 joints), erythrocyte sedimentation rate, and patient's global assessment of disease activity on a visual scale. DAS28 is a unit scale from 0 (best value) to 10.0 (worst value). |
| C-Reactive Protein | Baseline, months 3,6,9,12 | The test for C-Reactive Protein (CRP) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. |
| Erythrocyte Sedimentation Rate | Baseline, months 3,6,9,12 | Erythrocyte sedimentation rate (ESR) is a nonspecific lab value that measures inflammation from arthritic disease. A decrease in the level indicates reduction in inflammation and therefore improvement. |
| Changes in Bath Ankylosing Spondylitis Disease Activity Index in Patients With AS: Measures Patients Fatigue, Pain (Neck, Hip, Other Joints), Tender Sensitive Body Sites, Morning Stiffness | Baseline, months 3,6,9,12 | Bath as Disease Activity Index (BASDI) measures fatigue, pain (neck, hip, other joints), tender sensitive body sites, and morning stiffness for patients suffering from AS. Scores range from 0 to 10 with higher scores representing worse disease activity. |
| Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Baseline, months 3,6,9,12 | Physician's and Patient's Global Assessment of Disease Activity (PGA) are measured using a visual analogue scale with scores ranging from 0 to 100 (higher scores indicate worse disease activity). |
Countries
Austria
Participant flow
Pre-assignment details
A total of 162 participants were screened for this study. Of those, 161 are included in the analysis as one participant was a screen failure.
Participants by arm
| Arm | Count |
|---|---|
| Rheumatoid Arthritis (RA) Rheumatoid Arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs. | 93 |
| Psoriasis Arthritis (PsA) Psoriatic Arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs. | 28 |
| Ankylosing Spondylitis (AS) Ankylosing Spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs. | 40 |
| Total | 161 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 0 |
| Overall Study | Complete remission | 0 | 1 | 0 |
| Overall Study | Lack of effectiveness | 13 | 2 | 2 |
| Overall Study | Lost to Follow-up | 2 | 0 | 2 |
| Overall Study | Other medical condition/surgery | 1 | 1 | 0 |
| Overall Study | Patient Moved | 0 | 1 | 0 |
| Overall Study | Reason unknown | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 0 | 2 |
Baseline characteristics
| Characteristic | Rheumatoid Arthritis (RA) | Psoriasis Arthritis (PsA) | Ankylosing Spondylitis (AS) | Total |
|---|---|---|---|---|
| Age Continuous | 55.7 years STANDARD_DEVIATION 14.2 | 47.9 years STANDARD_DEVIATION 8.1 | 42.0 years STANDARD_DEVIATION 12.9 | 50.9 years STANDARD_DEVIATION 14.3 |
| Duration of underlying disease | 7.6 years STANDARD_DEVIATION 7.4 | 6.2 years STANDARD_DEVIATION 6.8 | 8.9 years STANDARD_DEVIATION 11.4 | 7.7 years STANDARD_DEVIATION 8.5 |
| Region of Enrollment Austria | 93 participants | 28 participants | 40 participants | 161 participants |
| Sex: Female, Male Female | 75 Participants | 9 Participants | 17 Participants | 101 Participants |
| Sex: Female, Male Male | 18 Participants | 19 Participants | 23 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 93 | 1 / 28 | 1 / 40 | 12 / 161 |
| serious Total, serious adverse events | 6 / 93 | 2 / 28 | 0 / 40 | 8 / 161 |
Outcome results
Primary
EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression
European Quality of Life 5 Dimensions (EQ-5D) is a self-reported health outcome which measures mobility, self care, usual activities, pain discomfort, anxiety depression. An overall score is derived that measures from -0.59 (worst) to +1 (best). In addition, health state is measured on the thermometer scale (score 0 to 100) with higher scores representing better health status.
Time frame: Baseline, months 3,6,9,12
Population: Mean (average) score is based on the number of participants included in the analysis (N=161) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination \[for participants who discontinued the study early\]) in each disease group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis (RA) | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | Thermometer Scale - 9 months | 67.5 Units on a scale | Standard Deviation 21 |
| Rheumatoid Arthritis (RA) | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | Thermometer Scale - Early Termination | 67.2 Units on a scale | Standard Deviation 29.1 |
| Rheumatoid Arthritis (RA) | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | Thermometer Scale - 3 months | 64.8 Units on a scale | Standard Deviation 22 |
| Rheumatoid Arthritis (RA) | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | EQ-5D - Baseline | 0.5 Units on a scale | Standard Deviation 0.3 |
| Rheumatoid Arthritis (RA) | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | Thermometer Scale - 6 months | 59.5 Units on a scale | Standard Deviation 22 |
| Rheumatoid Arthritis (RA) | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | EQ-5D - 6 months | 0.7 Units on a scale | Standard Deviation 0.2 |
| Rheumatoid Arthritis (RA) | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | EQ-5D - 9 months | 0.7 Units on a scale | Standard Deviation 0.2 |
| Rheumatoid Arthritis (RA) | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | EQ-5D - 3 months | 0.7 Units on a scale | Standard Deviation 0.2 |
| Rheumatoid Arthritis (RA) | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | Thermometer Scale - 12 months | 73.2 Units on a scale | Standard Deviation 18.5 |
| Rheumatoid Arthritis (RA) | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | EQ-5D - 12 months | 0.8 Units on a scale | Standard Deviation 0.2 |
| Rheumatoid Arthritis (RA) | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | EQ-5D - Early Termination | 0.3 Units on a scale | Standard Deviation 0.5 |
| Rheumatoid Arthritis (RA) | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | Thermometer Scale - Baseline | 49.0 Units on a scale | Standard Deviation 21.5 |
| Psoriasis Arthritis (PsA) | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | EQ-5D - 3 months | 0.8 Units on a scale | Standard Deviation 0.2 |
| Psoriasis Arthritis (PsA) | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | Thermometer Scale - Baseline | 52.5 Units on a scale | Standard Deviation 24.8 |
| Psoriasis Arthritis (PsA) | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | EQ-5D - 9 months | 0.8 Units on a scale | Standard Deviation 0.2 |
| Psoriasis Arthritis (PsA) | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | Thermometer Scale - 6 months | 68.9 Units on a scale | Standard Deviation 23.3 |
| Psoriasis Arthritis (PsA) | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | Thermometer Scale - 9 months | 67.8 Units on a scale | Standard Deviation 25.2 |
| Psoriasis Arthritis (PsA) | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | Thermometer Scale - 3 months | 68.7 Units on a scale | Standard Deviation 21 |
| Psoriasis Arthritis (PsA) | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | EQ-5D - Baseline | 0.5 Units on a scale | Standard Deviation 0.3 |
| Psoriasis Arthritis (PsA) | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | EQ-5D - Early Termination | 1.0 Units on a scale | — |
| Psoriasis Arthritis (PsA) | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | EQ-5D - 12 months | 0.8 Units on a scale | Standard Deviation 0.1 |
| Psoriasis Arthritis (PsA) | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | EQ-5D - 6 months | 0.8 Units on a scale | Standard Deviation 0.1 |
| Psoriasis Arthritis (PsA) | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | Thermometer Scale - Early Termination | 100.0 Units on a scale | — |
| Psoriasis Arthritis (PsA) | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | Thermometer Scale - 12 months | 79.2 Units on a scale | Standard Deviation 16 |
| Total | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | Thermometer Scale - 3 months | 64.9 Units on a scale | Standard Deviation 25.6 |
| Total | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | EQ-5D - Baseline | 0.4 Units on a scale | Standard Deviation 0.3 |
| Total | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | EQ-5D - 3 months | 0.8 Units on a scale | Standard Deviation 0.2 |
| Total | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | EQ-5D - 6 months | 0.8 Units on a scale | Standard Deviation 0.3 |
| Total | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | EQ-5D - 9 months | 0.8 Units on a scale | Standard Deviation 0.2 |
| Total | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | EQ-5D - 12 months | 0.8 Units on a scale | Standard Deviation 0.3 |
| Total | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | EQ-5D - Early Termination | NA Units on a scale | — |
| Total | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | Thermometer Scale - Baseline | 40.2 Units on a scale | Standard Deviation 22.6 |
| Total | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | Thermometer Scale - 6 months | 68.7 Units on a scale | Standard Deviation 29 |
| Total | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | Thermometer Scale - 9 months | 69.2 Units on a scale | Standard Deviation 25 |
| Total | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | Thermometer Scale - 12 months | 71.5 Units on a scale | Standard Deviation 28.5 |
| Total | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | Thermometer Scale - Early Termination | NA Units on a scale | — |
| Total | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | EQ-5D - Early Termination | 0.4 Units on a scale | Standard Deviation 0.5 |
| Total | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | EQ-5D - 12 months | 0.8 Units on a scale | Standard Deviation 0.2 |
| Total | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | EQ-5D - Baseline | 0.5 Units on a scale | Standard Deviation 0.3 |
| Total | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | Thermometer Scale - 9 months | 68.0 Units on a scale | Standard Deviation 22.8 |
| Total | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | EQ-5D - 9 months | 0.8 Units on a scale | Standard Deviation 0.2 |
| Total | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | EQ-5D - 6 months | 0.8 Units on a scale | Standard Deviation 0.2 |
| Total | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | Thermometer Scale - Early Termination | 71.9 Units on a scale | Standard Deviation 29.3 |
| Total | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | Thermometer Scale - 12 months | 73.9 Units on a scale | Standard Deviation 21.2 |
| Total | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | Thermometer Scale - 3 months | 65.5 Units on a scale | Standard Deviation 22.7 |
| Total | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | Thermometer Scale - Baseline | 47.4 Units on a scale | Standard Deviation 22.7 |
| Total | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | EQ-5D - 3 months | 0.7 Units on a scale | Standard Deviation 0.2 |
| Total | EQ-5D for RA,PsA,AS, as Measure of Health Outcome. Self Reported Health Status: Measures Mobility, Self Care, Usual Activities, Pain Discomfort, Anxiety Depression | Thermometer Scale - 6 months | 63.7 Units on a scale | Standard Deviation 24.5 |
Primary
RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI
The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures a patient's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene,reach, grip, activities. Each question is evaluated according to the degree of severity on a scale ranging from 0 (without any difficulty) to 3 (unable to do).
Time frame: Baseline, months 3,6,9,12
Population: Mean (average) score is based on the number of participants included in the analysis (N =121) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination \[for participants who discontinued the study early\]) in each disease group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis (RA) | RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI | Baseline | 1.2 Units on a scale | Standard Deviation 0.7 |
| Rheumatoid Arthritis (RA) | RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI | 3 months | 0.9 Units on a scale | Standard Deviation 0.7 |
| Rheumatoid Arthritis (RA) | RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI | 6 months | 0.8 Units on a scale | Standard Deviation 0.6 |
| Rheumatoid Arthritis (RA) | RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI | 9 months | 0.8 Units on a scale | Standard Deviation 0.6 |
| Rheumatoid Arthritis (RA) | RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI | 12 months | 0.7 Units on a scale | Standard Deviation 0.6 |
| Rheumatoid Arthritis (RA) | RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI | Early Termination | 1.4 Units on a scale | Standard Deviation 0.9 |
| Psoriasis Arthritis (PsA) | RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI | Early Termination | 0.0 Units on a scale | Standard Deviation 0 |
| Psoriasis Arthritis (PsA) | RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI | Baseline | 0.9 Units on a scale | Standard Deviation 0.7 |
| Psoriasis Arthritis (PsA) | RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI | 9 months | 0.3 Units on a scale | Standard Deviation 0.5 |
| Psoriasis Arthritis (PsA) | RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI | 12 months | 0.2 Units on a scale | Standard Deviation 0.3 |
| Psoriasis Arthritis (PsA) | RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI | 3 months | 0.4 Units on a scale | Standard Deviation 0.4 |
| Psoriasis Arthritis (PsA) | RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI | 6 months | 0.4 Units on a scale | Standard Deviation 0.5 |
| Total | RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI | 3 months | 0.8 Units on a scale | Standard Deviation 0.7 |
| Total | RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI | 6 months | 0.7 Units on a scale | Standard Deviation 0.6 |
| Total | RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI | Early Termination | 1.2 Units on a scale | Standard Deviation 1 |
| Total | RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI | 9 months | 0.7 Units on a scale | Standard Deviation 0.6 |
| Total | RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI | Baseline | 1.1 Units on a scale | Standard Deviation 0.7 |
| Total | RA and if Reasonable for PsA Patients Health Assessment Questionnaire Disability Index HAQ-DI | 12 months | 0.6 Units on a scale | Standard Deviation 0.6 |
Primary
SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain
Medical Outcomes Study Short Form 36 (MOS SF-36) is generic assessment of health status that consists of 36 questions within 8 domains including Physical Functioning (PF), Role Functioning - Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Functioning - Emotional (RE), Mental Health (MH) and Reported Health Transition (HT). Results from each domain are summarized and transformed into a scale ranging from 0 (worst) to 100 (best) with the exception of HT. The score range for HT is 0 (worst) to 5 (best).
Time frame: Baseline, months 3,6,9,12
Population: Mean (average) score is based on the number of participants included in the analysis (N=161) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination \[participants who discontinued the study early\]) in each disease group. No participants in the PsA or the AS group attended an early termination visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Physical Functioning - 9 months | 67.4 Units on a scale | Standard Deviation 24.6 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Mental Health - 6 months | 67.9 Units on a scale | Standard Deviation 16.3 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | General Health - Early Termination | 39.0 Units on a scale | Standard Deviation 26.2 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Physical Functioning - 6 months | 65.3 Units on a scale | Standard Deviation 24.4 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Physical Functioning - 3 months | 67.4 Units on a scale | Standard Deviation 24.3 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Mental Health - 9 months | 70.7 Units on a scale | Standard Deviation 17.5 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Social Functioning - 12 months | 82.3 Units on a scale | Standard Deviation 20.4 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Physical Functioning -Baseline | 51.4 Units on a scale | Standard Deviation 26.4 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Reported Health Transition - Early Termination | 3.5 Units on a scale | Standard Deviation 2 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Mental Health - 12 months | 73.2 Units on a scale | Standard Deviation 14.8 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Social Functioning - Baseline | 59.5 Units on a scale | Standard Deviation 30 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Reported Health Transition - 12 months | 1.7 Units on a scale | Standard Deviation 0.9 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Reported Health Transition - 9 months | 1.9 Units on a scale | Standard Deviation 0.8 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Mental Health - Early Termination | 41.3 Units on a scale | Standard Deviation 23.8 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | General Health - 12 months | 59.5 Units on a scale | Standard Deviation 20.2 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Reported Health Transition - 6 months | 2.1 Units on a scale | Standard Deviation 1 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Reported Health Transition - 3 months | 2.0 Units on a scale | Standard Deviation 1.1 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Reported Health Transition - Baseline | 3.5 Units on a scale | Standard Deviation 1.2 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | General Health - 9 months | 54.9 Units on a scale | Standard Deviation 19 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Social Functioning - Early Termination | 47.9 Units on a scale | Standard Deviation 31 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Vitality - 12 months | 56.9 Units on a scale | Standard Deviation 17.7 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | General Health - 6 months | 54.0 Units on a scale | Standard Deviation 16.6 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | General Health - 3 months | 51.7 Units on a scale | Standard Deviation 17.9 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning -Emotional - Baseline | 45.1 Units on a scale | Standard Deviation 44.7 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Vitality - 9 months | 52.3 Units on a scale | Standard Deviation 19.1 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | General Health - Baseline | 42.9 Units on a scale | Standard Deviation 19.4 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Bodily Pain- Early Termination | 25.7 Units on a scale | Standard Deviation 37.6 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning -Emotional - 3 months | 66.2 Units on a scale | Standard Deviation 42.3 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Social Functioning - 6 months | 78.4 Units on a scale | Standard Deviation 20.5 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Bodily Pain- 12 months | 62.5 Units on a scale | Standard Deviation 19.1 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Bodily Pain- 9 months | 59.5 Units on a scale | Standard Deviation 21.6 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning -Emotional - 6 months | 69.7 Units on a scale | Standard Deviation 41.2 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Vitality - Early Termination | 23.3 Units on a scale | Standard Deviation 16.3 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Bodily Pain- 6 months | 53.9 Units on a scale | Standard Deviation 19.9 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Bodily Pain- 3 months | 56.5 Units on a scale | Standard Deviation 24.3 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning -Emotional - 9 months | 72.4 Units on a scale | Standard Deviation 40.5 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Vitality - 6 months | 52.6 Units on a scale | Standard Deviation 16 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Bodily Pain - Baseline | 33.6 Units on a scale | Standard Deviation 19.2 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning - Physical - Early Termination | 29.2 Units on a scale | Standard Deviation 40.1 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning -Emotional - 12 months | 78.2 Units on a scale | Standard Deviation 37 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Vitality - 3 months | 53.6 Units on a scale | Standard Deviation 19.3 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning - Physical - 12 months | 59.8 Units on a scale | Standard Deviation 42.3 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning - Physical - 9 months | 55.4 Units on a scale | Standard Deviation 43.7 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning - Emotional - Early Termination | 33.3 Units on a scale | Standard Deviation 51.6 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Social Functioning - 9 months | 79.0 Units on a scale | Standard Deviation 19.7 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning - Physical - 6 months | 55.3 Units on a scale | Standard Deviation 44 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning - Physical - 3 months | 57.3 Units on a scale | Standard Deviation 43.5 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Mental Health - Baseline | 55.6 Units on a scale | Standard Deviation 21.5 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Social Functioning - 3 months | 75.3 Units on a scale | Standard Deviation 20.9 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning -Physical - Baseline | 29.8 Units on a scale | Standard Deviation 40.5 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Physical Functioning - Early Termination | 33.3 Units on a scale | Standard Deviation 28.6 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Mental Health - 3 months | 66.1 Units on a scale | Standard Deviation 18.8 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Vitality - Baseline | 39.3 Units on a scale | Standard Deviation 19 |
| Rheumatoid Arthritis (RA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Physical Functioning -12 months | 70.3 Units on a scale | Standard Deviation 23.8 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | General Health - Early Termination | NA Units on a scale | — |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Social Functioning - 3 months | 79.3 Units on a scale | Standard Deviation 18.7 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Social Functioning - 6 months | 85.7 Units on a scale | Standard Deviation 19.1 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Social Functioning - 9 months | 86.9 Units on a scale | Standard Deviation 20.1 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Social Functioning - 12 months | 93.1 Units on a scale | Standard Deviation 14.3 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Social Functioning - Early Termination | NA Units on a scale | — |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning -Emotional - Baseline | 55.6 Units on a scale | Standard Deviation 43.4 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning -Emotional - 3 months | 75.4 Units on a scale | Standard Deviation 41.7 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning -Emotional - 6 months | 82.5 Units on a scale | Standard Deviation 35.9 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning -Emotional - 9 months | 78.3 Units on a scale | Standard Deviation 39.4 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning -Emotional - 12 months | 91.7 Units on a scale | Standard Deviation 26.2 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning - Emotional - Early Termination | NA Units on a scale | — |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Mental Health - Baseline | 63.1 Units on a scale | Standard Deviation 22.1 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Mental Health - 3 months | 70.1 Units on a scale | Standard Deviation 19 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Mental Health - 6 months | 75.8 Units on a scale | Standard Deviation 16.6 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Mental Health - 9 months | 74.6 Units on a scale | Standard Deviation 21.1 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Mental Health - 12 months | 81.8 Units on a scale | Standard Deviation 13.9 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Mental Health - Early Termination | NA Units on a scale | — |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Reported Health Transition - Baseline | 3.5 Units on a scale | Standard Deviation 1.1 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Reported Health Transition - 3 months | 2.1 Units on a scale | Standard Deviation 1.1 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Reported Health Transition - 6 months | 1.8 Units on a scale | Standard Deviation 1 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Reported Health Transition - 9 months | 1.8 Units on a scale | Standard Deviation 1 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Reported Health Transition - 12 months | 1.4 Units on a scale | Standard Deviation 0.6 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Reported Health Transition - Early Termination | NA Units on a scale | — |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Physical Functioning -Baseline | 58.1 Units on a scale | Standard Deviation 26.2 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Physical Functioning - 3 months | 74.3 Units on a scale | Standard Deviation 21.3 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Physical Functioning - 6 months | 76.0 Units on a scale | Standard Deviation 21.9 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Physical Functioning - 9 months | 79.8 Units on a scale | Standard Deviation 19.5 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Physical Functioning -12 months | 85.9 Units on a scale | Standard Deviation 13.2 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Physical Functioning - Early Termination | NA Units on a scale | — |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning -Physical - Baseline | 38.9 Units on a scale | Standard Deviation 43.5 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning - Physical - 3 months | 58.7 Units on a scale | Standard Deviation 41 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning - Physical - 6 months | 70.2 Units on a scale | Standard Deviation 36.8 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning - Physical - 9 months | 72.5 Units on a scale | Standard Deviation 40.5 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning - Physical - 12 months | 85.0 Units on a scale | Standard Deviation 28.6 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning - Physical - Early Termination | NA Units on a scale | — |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Bodily Pain - Baseline | 36.6 Units on a scale | Standard Deviation 23.9 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Bodily Pain- 3 months | 61.0 Units on a scale | Standard Deviation 23.5 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Bodily Pain- 6 months | 64.9 Units on a scale | Standard Deviation 23.7 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Bodily Pain- 9 months | 69.3 Units on a scale | Standard Deviation 25.9 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Bodily Pain- 12 months | 74.0 Units on a scale | Standard Deviation 23.2 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Bodily Pain- Early Termination | NA Units on a scale | — |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | General Health - Baseline | 41.9 Units on a scale | Standard Deviation 18.9 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | General Health - 3 months | 53.0 Units on a scale | Standard Deviation 20.8 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | General Health - 6 months | 61.6 Units on a scale | Standard Deviation 18 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | General Health - 9 months | 59.8 Units on a scale | Standard Deviation 19.1 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | General Health - 12 months | 65.0 Units on a scale | Standard Deviation 18.1 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Social Functioning - Baseline | 66.2 Units on a scale | Standard Deviation 31.2 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Vitality - Baseline | 39.8 Units on a scale | Standard Deviation 21.1 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Vitality - 3 months | 53.3 Units on a scale | Standard Deviation 19.7 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Vitality - 6 months | 56.8 Units on a scale | Standard Deviation 19.4 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Vitality - 9 months | 56.3 Units on a scale | Standard Deviation 16 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Vitality - 12 months | 65.0 Units on a scale | Standard Deviation 14.9 |
| Psoriasis Arthritis (PsA) | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Vitality - Early Termination | NA Units on a scale | — |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | General Health - Early Termination | NA Units on a scale | — |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Physical Functioning - 9 months | 81.4 Units on a scale | Standard Deviation 18.7 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Mental Health - 3 months | 70.4 Units on a scale | Standard Deviation 18.9 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Physical Functioning -12 months | 80.4 Units on a scale | Standard Deviation 24.5 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Social Functioning - 9 months | 83.2 Units on a scale | Standard Deviation 23.2 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Physical Functioning - Early Termination | NA Units on a scale | — |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Mental Health - Baseline | 53.9 Units on a scale | Standard Deviation 21 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning -Physical - Baseline | 25.0 Units on a scale | Standard Deviation 32.2 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Vitality - Baseline | 32.4 Units on a scale | Standard Deviation 18.7 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning - Physical - 3 months | 67.4 Units on a scale | Standard Deviation 38.8 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning - Emotional - Early Termination | NA Units on a scale | — |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning - Physical - 6 months | 73.4 Units on a scale | Standard Deviation 37.6 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning - Physical - 9 months | 75.0 Units on a scale | Standard Deviation 37.2 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning -Emotional - 12 months | 75.0 Units on a scale | Standard Deviation 38.1 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning - Physical - 12 months | 75.9 Units on a scale | Standard Deviation 38.9 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Vitality - 3 months | 54.5 Units on a scale | Standard Deviation 20.4 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning - Physical - Early Termination | NA Units on a scale | — |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning -Emotional - 9 months | 81.6 Units on a scale | Standard Deviation 31.6 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Bodily Pain - Baseline | 27.7 Units on a scale | Standard Deviation 19.1 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Social Functioning - 6 months | 81.0 Units on a scale | Standard Deviation 23 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Bodily Pain- 3 months | 66.1 Units on a scale | Standard Deviation 24.9 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning -Emotional - 6 months | 76.3 Units on a scale | Standard Deviation 36.7 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Social Functioning - Baseline | 52.8 Units on a scale | Standard Deviation 25 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Bodily Pain- 6 months | 67.7 Units on a scale | Standard Deviation 25.2 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Vitality - 6 months | 57.9 Units on a scale | Standard Deviation 19.4 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Bodily Pain- 9 months | 69.8 Units on a scale | Standard Deviation 22.5 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning -Emotional - 3 months | 74.0 Units on a scale | Standard Deviation 35.7 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Bodily Pain- 12 months | 71.2 Units on a scale | Standard Deviation 27.9 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Bodily Pain- Early Termination | NA Units on a scale | — |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning -Emotional - Baseline | 40.7 Units on a scale | Standard Deviation 42.2 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Vitality - Early Termination | NA Units on a scale | — |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | General Health - Baseline | 39.1 Units on a scale | Standard Deviation 16.4 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Vitality - 9 months | 59.2 Units on a scale | Standard Deviation 20.1 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | General Health - 3 months | 59.0 Units on a scale | Standard Deviation 21.7 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Social Functioning - Early Termination | NA Units on a scale | — |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | General Health - 6 months | 60.1 Units on a scale | Standard Deviation 23.7 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Social Functioning - 3 months | 78.0 Units on a scale | Standard Deviation 21.4 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Reported Health Transition - Baseline | 3.9 Units on a scale | Standard Deviation 1.1 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | General Health - 9 months | 65.7 Units on a scale | Standard Deviation 22.1 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Reported Health Transition - 3 months | 1.8 Units on a scale | Standard Deviation 1.1 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Mental Health - Early Termination | NA Units on a scale | — |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Reported Health Transition - 6 months | 1.5 Units on a scale | Standard Deviation 0.8 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Social Functioning - 12 months | 80.4 Units on a scale | Standard Deviation 25.1 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Reported Health Transition - 9 months | 1.4 Units on a scale | Standard Deviation 0.6 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Mental Health - 12 months | 76.7 Units on a scale | Standard Deviation 17.2 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Reported Health Transition - 12 months | 1.7 Units on a scale | Standard Deviation 0.9 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | General Health - 12 months | 66.3 Units on a scale | Standard Deviation 23 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Reported Health Transition - Early Termination | NA Units on a scale | — |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Mental Health - 9 months | 76.1 Units on a scale | Standard Deviation 18.8 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Physical Functioning -Baseline | 53.3 Units on a scale | Standard Deviation 23.4 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Physical Functioning - 3 months | 76.5 Units on a scale | Standard Deviation 21.9 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Mental Health - 6 months | 73.6 Units on a scale | Standard Deviation 18.9 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Vitality - 12 months | 58.0 Units on a scale | Standard Deviation 21.5 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Physical Functioning - 6 months | 79.4 Units on a scale | Standard Deviation 22.2 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Bodily Pain- 12 months | 67.0 Units on a scale | Standard Deviation 22.8 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning -Emotional - Baseline | 46.0 Units on a scale | Standard Deviation 43.8 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Physical Functioning - 9 months | 73.4 Units on a scale | Standard Deviation 23.1 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Social Functioning - 3 months | 76.8 Units on a scale | Standard Deviation 20.6 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | General Health - Early Termination | 39.0 Units on a scale | Standard Deviation 26.2 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Reported Health Transition - 6 months | 1.9 Units on a scale | Standard Deviation 1 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Physical Functioning -12 months | 75.9 Units on a scale | Standard Deviation 23.1 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Mental Health - Baseline | 56.6 Units on a scale | Standard Deviation 21.6 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Bodily Pain- Early Termination | 25.7 Units on a scale | Standard Deviation 37.6 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Mental Health - 12 months | 75.8 Units on a scale | Standard Deviation 15.5 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Physical Functioning - Early Termination | 33.3 Units on a scale | Standard Deviation 28.6 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | General Health - 12 months | 62.3 Units on a scale | Standard Deviation 20.7 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Vitality - 12 months | 58.7 Units on a scale | Standard Deviation 18.4 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Mental Health - 3 months | 67.9 Units on a scale | Standard Deviation 18.9 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning -Physical - Baseline | 30.3 Units on a scale | Standard Deviation 39.2 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning - Emotional - Early Termination | 33.3 Units on a scale | Standard Deviation 51.6 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | General Health - Baseline | 41.8 Units on a scale | Standard Deviation 18.6 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Social Functioning - Early Termination | 47.9 Units on a scale | Standard Deviation 31 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning - Physical - 3 months | 60.2 Units on a scale | Standard Deviation 41.8 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Reported Health Transition - 9 months | 1.7 Units on a scale | Standard Deviation 0.8 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Vitality - Baseline | 37.7 Units on a scale | Standard Deviation 19.5 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Physical Functioning -Baseline | 53.1 Units on a scale | Standard Deviation 25.6 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning - Physical - 6 months | 62.7 Units on a scale | Standard Deviation 41.7 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning -Emotional - 12 months | 79.9 Units on a scale | Standard Deviation 35.7 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Social Functioning - 6 months | 80.4 Units on a scale | Standard Deviation 21 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | General Health - 3 months | 53.8 Units on a scale | Standard Deviation 19.5 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning - Physical - 9 months | 63.8 Units on a scale | Standard Deviation 42.1 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Vitality - Early Termination | 23.3 Units on a scale | Standard Deviation 16.3 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Social Functioning - Baseline | 59.1 Units on a scale | Standard Deviation 29.2 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Vitality - 9 months | 54.9 Units on a scale | Standard Deviation 19 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning - Physical - 12 months | 68.9 Units on a scale | Standard Deviation 40.1 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning -Emotional - 9 months | 76.0 Units on a scale | Standard Deviation 38 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Mental Health - 6 months | 70.8 Units on a scale | Standard Deviation 17.3 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | General Health - 6 months | 57.0 Units on a scale | Standard Deviation 19.1 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning - Physical - Early Termination | 29.2 Units on a scale | Standard Deviation 40.1 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Social Functioning - 12 months | 83.8 Units on a scale | Standard Deviation 21.1 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Vitality - 3 months | 53.8 Units on a scale | Standard Deviation 19.5 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Reported Health Transition - 12 months | 1.6 Units on a scale | Standard Deviation 0.9 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Bodily Pain - Baseline | 32.7 Units on a scale | Standard Deviation 20.2 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning -Emotional - 6 months | 73.7 Units on a scale | Standard Deviation 39.2 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Mental Health - 9 months | 72.9 Units on a scale | Standard Deviation 18.6 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Reported Health Transition - Baseline | 3.6 Units on a scale | Standard Deviation 1.2 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Bodily Pain- 3 months | 59.8 Units on a scale | Standard Deviation 24.5 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Mental Health - Early Termination | 41.3 Units on a scale | Standard Deviation 23.8 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Social Functioning - 9 months | 81.5 Units on a scale | Standard Deviation 20.8 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Physical Functioning - 6 months | 70.9 Units on a scale | Standard Deviation 24.1 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Bodily Pain- 6 months | 59.5 Units on a scale | Standard Deviation 22.8 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Role Functioning -Emotional - 3 months | 69.8 Units on a scale | Standard Deviation 40.5 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Reported Health Transition - 3 months | 2.0 Units on a scale | Standard Deviation 1.1 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Reported Health Transition - Early Termination | 3.5 Units on a scale | Standard Deviation 2 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Bodily Pain- 9 months | 64.0 Units on a scale | Standard Deviation 23 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | General Health - 9 months | 58.7 Units on a scale | Standard Deviation 20.3 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Vitality - 6 months | 54.7 Units on a scale | Standard Deviation 17.5 |
| Total | SF-36 as Generic Measure of Health Status for RA, PsA, AS Physical Score Measures How Decrements in Physical Function Affect Day-to-day Activities Impact of Physical Impairment/Disability on QoL ,Mental Score: Impact of Mental Effect, Symptoms of Pain | Physical Functioning - 3 months | 71.0 Units on a scale | Standard Deviation 23.4 |
Secondary
Changes in Bath Ankylosing Spondylitis Disease Activity Index in Patients With AS: Measures Patients Fatigue, Pain (Neck, Hip, Other Joints), Tender Sensitive Body Sites, Morning Stiffness
Bath as Disease Activity Index (BASDI) measures fatigue, pain (neck, hip, other joints), tender sensitive body sites, and morning stiffness for patients suffering from AS. Scores range from 0 to 10 with higher scores representing worse disease activity.
Time frame: Baseline, months 3,6,9,12
Population: Mean (average) score is based on the number of participants included in the analysis (N=40) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination \[for participants who discontinued the study early\]).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis (RA) | Changes in Bath Ankylosing Spondylitis Disease Activity Index in Patients With AS: Measures Patients Fatigue, Pain (Neck, Hip, Other Joints), Tender Sensitive Body Sites, Morning Stiffness | Baseline | 6.0 Units on a scale | Standard Deviation 1.6 |
| Rheumatoid Arthritis (RA) | Changes in Bath Ankylosing Spondylitis Disease Activity Index in Patients With AS: Measures Patients Fatigue, Pain (Neck, Hip, Other Joints), Tender Sensitive Body Sites, Morning Stiffness | 3 months | 2.8 Units on a scale | Standard Deviation 2.1 |
| Rheumatoid Arthritis (RA) | Changes in Bath Ankylosing Spondylitis Disease Activity Index in Patients With AS: Measures Patients Fatigue, Pain (Neck, Hip, Other Joints), Tender Sensitive Body Sites, Morning Stiffness | 6 months | 2.0 Units on a scale | Standard Deviation 1.5 |
| Rheumatoid Arthritis (RA) | Changes in Bath Ankylosing Spondylitis Disease Activity Index in Patients With AS: Measures Patients Fatigue, Pain (Neck, Hip, Other Joints), Tender Sensitive Body Sites, Morning Stiffness | 9 months | 2.4 Units on a scale | Standard Deviation 2 |
| Rheumatoid Arthritis (RA) | Changes in Bath Ankylosing Spondylitis Disease Activity Index in Patients With AS: Measures Patients Fatigue, Pain (Neck, Hip, Other Joints), Tender Sensitive Body Sites, Morning Stiffness | 12 months | 2.5 Units on a scale | Standard Deviation 2.3 |
| Rheumatoid Arthritis (RA) | Changes in Bath Ankylosing Spondylitis Disease Activity Index in Patients With AS: Measures Patients Fatigue, Pain (Neck, Hip, Other Joints), Tender Sensitive Body Sites, Morning Stiffness | Early Termination | 4.6 Units on a scale | Standard Deviation 3.3 |
Secondary
C-Reactive Protein
The test for C-Reactive Protein (CRP) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time frame: Baseline, months 3,6,9,12
Population: Mean (average) value is based on the number of participants included in the analysis (N =161) who completed the lab assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination \[for participants who discontinued the study early\]) in each disease group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis (RA) | C-Reactive Protein | Baseline | 1.9 milligrams per deciliter (mg/dL) | Standard Deviation 2.5 |
| Rheumatoid Arthritis (RA) | C-Reactive Protein | 3 months | 1.2 milligrams per deciliter (mg/dL) | Standard Deviation 2.5 |
| Rheumatoid Arthritis (RA) | C-Reactive Protein | 6 months | 1.0 milligrams per deciliter (mg/dL) | Standard Deviation 2.2 |
| Rheumatoid Arthritis (RA) | C-Reactive Protein | 9 months | 1.0 milligrams per deciliter (mg/dL) | Standard Deviation 2.6 |
| Rheumatoid Arthritis (RA) | C-Reactive Protein | 12 months | 0.4 milligrams per deciliter (mg/dL) | Standard Deviation 0.4 |
| Rheumatoid Arthritis (RA) | C-Reactive Protein | Early Termination | 3.5 milligrams per deciliter (mg/dL) | Standard Deviation 4.7 |
| Psoriasis Arthritis (PsA) | C-Reactive Protein | Early Termination | 1.1 milligrams per deciliter (mg/dL) | Standard Deviation 2.1 |
| Psoriasis Arthritis (PsA) | C-Reactive Protein | 9 months | 0.2 milligrams per deciliter (mg/dL) | Standard Deviation 0.2 |
| Psoriasis Arthritis (PsA) | C-Reactive Protein | Baseline | 1.1 milligrams per deciliter (mg/dL) | Standard Deviation 1 |
| Psoriasis Arthritis (PsA) | C-Reactive Protein | 6 months | 0.4 milligrams per deciliter (mg/dL) | Standard Deviation 1 |
| Psoriasis Arthritis (PsA) | C-Reactive Protein | 3 months | 0.7 milligrams per deciliter (mg/dL) | Standard Deviation 1.4 |
| Psoriasis Arthritis (PsA) | C-Reactive Protein | 12 months | 0.2 milligrams per deciliter (mg/dL) | Standard Deviation 0.2 |
| Total | C-Reactive Protein | 3 months | 0.5 milligrams per deciliter (mg/dL) | Standard Deviation 0.6 |
| Total | C-Reactive Protein | 6 months | 0.4 milligrams per deciliter (mg/dL) | Standard Deviation 0.6 |
| Total | C-Reactive Protein | 9 months | 0.4 milligrams per deciliter (mg/dL) | Standard Deviation 0.3 |
| Total | C-Reactive Protein | Early Termination | 0.4 milligrams per deciliter (mg/dL) | Standard Deviation 0.3 |
| Total | C-Reactive Protein | 12 months | 0.7 milligrams per deciliter (mg/dL) | Standard Deviation 1.6 |
| Total | C-Reactive Protein | Baseline | 1.4 milligrams per deciliter (mg/dL) | Standard Deviation 1.4 |
| Total | C-Reactive Protein | 12 months | 0.4 milligrams per deciliter (mg/dL) | Standard Deviation 0.9 |
| Total | C-Reactive Protein | Early Termination | 2.6 milligrams per deciliter (mg/dL) | Standard Deviation 4.1 |
| Total | C-Reactive Protein | 3 months | 0.9 milligrams per deciliter (mg/dL) | Standard Deviation 2 |
| Total | C-Reactive Protein | 9 months | 0.7 milligrams per deciliter (mg/dL) | Standard Deviation 2.1 |
| Total | C-Reactive Protein | Baseline | 1.7 milligrams per deciliter (mg/dL) | Standard Deviation 2.1 |
| Total | C-Reactive Protein | 6 months | 0.8 milligrams per deciliter (mg/dL) | Standard Deviation 1.8 |
Secondary
DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale
The Disease Activity Score 28 measures disease activity based on the number of swollen and tender joints (28 joints), erythrocyte sedimentation rate, and patient's global assessment of disease activity on a visual scale. DAS28 is a unit scale from 0 (best value) to 10.0 (worst value).
Time frame: Baseline,months 3,6,9,12
Population: Mean (average) score is based on the number of participants included in the analysis (N=121) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination \[for participants who discontinued the study early\]) in each disease group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis (RA) | DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale | Baseline | 5.4 Units on a scale | Standard Deviation 1.2 |
| Rheumatoid Arthritis (RA) | DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale | 3 months | 3.8 Units on a scale | Standard Deviation 1.5 |
| Rheumatoid Arthritis (RA) | DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale | 6 months | 3.4 Units on a scale | Standard Deviation 1.2 |
| Rheumatoid Arthritis (RA) | DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale | 9 months | 3.7 Units on a scale | Standard Deviation 1.5 |
| Rheumatoid Arthritis (RA) | DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale | 12 months | 3.4 Units on a scale | Standard Deviation 1.3 |
| Rheumatoid Arthritis (RA) | DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale | Early Termination | 5.3 Units on a scale | Standard Deviation 1.8 |
| Psoriasis Arthritis (PsA) | DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale | Early Termination | 2.1 Units on a scale | Standard Deviation 0.8 |
| Psoriasis Arthritis (PsA) | DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale | Baseline | 4.9 Units on a scale | Standard Deviation 1.1 |
| Psoriasis Arthritis (PsA) | DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale | 9 months | 2.5 Units on a scale | Standard Deviation 1 |
| Psoriasis Arthritis (PsA) | DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale | 12 months | 2.5 Units on a scale | Standard Deviation 1 |
| Psoriasis Arthritis (PsA) | DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale | 3 months | 3.0 Units on a scale | Standard Deviation 1.1 |
| Psoriasis Arthritis (PsA) | DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale | 6 months | 2.4 Units on a scale | Standard Deviation 1 |
| Total | DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale | 3 months | 3.7 Units on a scale | Standard Deviation 1.5 |
| Total | DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale | 6 months | 3.2 Units on a scale | Standard Deviation 1.2 |
| Total | DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale | Early Termination | 4.5 Units on a scale | Standard Deviation 2.2 |
| Total | DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale | 9 months | 3.4 Units on a scale | Standard Deviation 1.5 |
| Total | DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale | Baseline | 5.3 Units on a scale | Standard Deviation 1.2 |
| Total | DAS28: Changes in Disease Activity Score 28 in Patients With RA and if Reasonable in PsA: Measures the no. of Swollen and Tender Joints (28 Joints), Erythrocyte Sedimentation Rate, Patients Global Assessment of Disease Activity on a Visual Scale | 12 months | 3.2 Units on a scale | Standard Deviation 1.3 |
Secondary
Erythrocyte Sedimentation Rate
Erythrocyte sedimentation rate (ESR) is a nonspecific lab value that measures inflammation from arthritic disease. A decrease in the level indicates reduction in inflammation and therefore improvement.
Time frame: Baseline, months 3,6,9,12
Population: Mean (average) value is based on the number of participants included in the analysis (N=161) who completed the lab assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination \[for participants who discontinued the study early\]) in each disease group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis (RA) | Erythrocyte Sedimentation Rate | Baseline | 35.8 milligrams per deciliter (mg/dL) | Standard Deviation 22.9 |
| Rheumatoid Arthritis (RA) | Erythrocyte Sedimentation Rate | 3 months | 25.3 milligrams per deciliter (mg/dL) | Standard Deviation 20.8 |
| Rheumatoid Arthritis (RA) | Erythrocyte Sedimentation Rate | 6 months | 23.9 milligrams per deciliter (mg/dL) | Standard Deviation 21.9 |
| Rheumatoid Arthritis (RA) | Erythrocyte Sedimentation Rate | 9 months | 24.2 milligrams per deciliter (mg/dL) | Standard Deviation 22.8 |
| Rheumatoid Arthritis (RA) | Erythrocyte Sedimentation Rate | 12 months | 18.3 milligrams per deciliter (mg/dL) | Standard Deviation 13.4 |
| Rheumatoid Arthritis (RA) | Erythrocyte Sedimentation Rate | Early termination | 47.3 milligrams per deciliter (mg/dL) | Standard Deviation 29.1 |
| Psoriasis Arthritis (PsA) | Erythrocyte Sedimentation Rate | Early termination | 18.0 milligrams per deciliter (mg/dL) | Standard Deviation 26.5 |
| Psoriasis Arthritis (PsA) | Erythrocyte Sedimentation Rate | 9 months | 11.6 milligrams per deciliter (mg/dL) | Standard Deviation 10.2 |
| Psoriasis Arthritis (PsA) | Erythrocyte Sedimentation Rate | Baseline | 31.7 milligrams per deciliter (mg/dL) | Standard Deviation 19.9 |
| Psoriasis Arthritis (PsA) | Erythrocyte Sedimentation Rate | 6 months | 12.3 milligrams per deciliter (mg/dL) | Standard Deviation 13.6 |
| Psoriasis Arthritis (PsA) | Erythrocyte Sedimentation Rate | 3 months | 16.0 milligrams per deciliter (mg/dL) | Standard Deviation 13.9 |
| Psoriasis Arthritis (PsA) | Erythrocyte Sedimentation Rate | 12 months | 10.5 milligrams per deciliter (mg/dL) | Standard Deviation 7.7 |
| Total | Erythrocyte Sedimentation Rate | 3 months | 12.4 milligrams per deciliter (mg/dL) | Standard Deviation 12.3 |
| Total | Erythrocyte Sedimentation Rate | 6 months | 11.9 milligrams per deciliter (mg/dL) | Standard Deviation 10.2 |
| Total | Erythrocyte Sedimentation Rate | 9 months | 11.9 milligrams per deciliter (mg/dL) | Standard Deviation 8.4 |
| Total | Erythrocyte Sedimentation Rate | Early termination | 10.5 milligrams per deciliter (mg/dL) | Standard Deviation 2.1 |
| Total | Erythrocyte Sedimentation Rate | 12 months | 14.0 milligrams per deciliter (mg/dL) | Standard Deviation 12.8 |
| Total | Erythrocyte Sedimentation Rate | Baseline | 25.2 milligrams per deciliter (mg/dL) | Standard Deviation 15.7 |
| Total | Erythrocyte Sedimentation Rate | 12 months | 15.9 milligrams per deciliter (mg/dL) | Standard Deviation 12.7 |
| Total | Erythrocyte Sedimentation Rate | Early termination | 37.3 milligrams per deciliter (mg/dL) | Standard Deviation 30.5 |
| Total | Erythrocyte Sedimentation Rate | 3 months | 20.6 milligrams per deciliter (mg/dL) | Standard Deviation 18.8 |
| Total | Erythrocyte Sedimentation Rate | 9 months | 19.1 milligrams per deciliter (mg/dL) | Standard Deviation 19.4 |
| Total | Erythrocyte Sedimentation Rate | Baseline | 32.4 milligrams per deciliter (mg/dL) | Standard Deviation 21.2 |
| Total | Erythrocyte Sedimentation Rate | 6 months | 19.0 milligrams per deciliter (mg/dL) | Standard Deviation 19.2 |
Secondary
Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only
Physician's and Patient's Global Assessment of State of Health was measured using a visual analogue scale with scores from 0 to 100 (higher scores indicate worse health state).
Time frame: Baseline, months 3,6,9,12
Population: Mean (average) score is based on the number of participants included in the analysis (N =121) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination \[for participants who discontinued the study early\]) in each disease group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis (RA) | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's GH - Baseline | 51.4 Units on a scale | Standard Deviation 21 |
| Rheumatoid Arthritis (RA) | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's GH -3 months | 29.9 Units on a scale | Standard Deviation 22.3 |
| Rheumatoid Arthritis (RA) | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's GH - 6 months | 31.5 Units on a scale | Standard Deviation 21.4 |
| Rheumatoid Arthritis (RA) | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's GH - 9 months | 31.3 Units on a scale | Standard Deviation 22.4 |
| Rheumatoid Arthritis (RA) | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's GH - 12 months | 29.0 Units on a scale | Standard Deviation 24.1 |
| Rheumatoid Arthritis (RA) | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's GH - Early Termination | 56.2 Units on a scale | Standard Deviation 28.6 |
| Rheumatoid Arthritis (RA) | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's GH - Baseline | 55.3 Units on a scale | Standard Deviation 25.4 |
| Rheumatoid Arthritis (RA) | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's GH -3 months | 33.6 Units on a scale | Standard Deviation 23.2 |
| Rheumatoid Arthritis (RA) | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's GH - 6 months | 32.9 Units on a scale | Standard Deviation 22.3 |
| Rheumatoid Arthritis (RA) | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's GH -9 months | 35.0 Units on a scale | Standard Deviation 22.7 |
| Rheumatoid Arthritis (RA) | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's GH -12 months | 30.4 Units on a scale | Standard Deviation 23.7 |
| Rheumatoid Arthritis (RA) | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's GH - Early Termination | 62.5 Units on a scale | Standard Deviation 32.1 |
| Psoriasis Arthritis (PsA) | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's GH - Early Termination | 21.7 Units on a scale | Standard Deviation 29.3 |
| Psoriasis Arthritis (PsA) | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's GH - Baseline | 46.8 Units on a scale | Standard Deviation 23.7 |
| Psoriasis Arthritis (PsA) | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's GH - Baseline | 59.0 Units on a scale | Standard Deviation 24.8 |
| Psoriasis Arthritis (PsA) | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's GH - 6 months | 29.4 Units on a scale | Standard Deviation 26.6 |
| Psoriasis Arthritis (PsA) | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's GH -3 months | 25.3 Units on a scale | Standard Deviation 19.3 |
| Psoriasis Arthritis (PsA) | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's GH - Early Termination | 11.7 Units on a scale | Standard Deviation 12.6 |
| Psoriasis Arthritis (PsA) | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's GH -12 months | 30.6 Units on a scale | Standard Deviation 25.7 |
| Psoriasis Arthritis (PsA) | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's GH - 6 months | 26.2 Units on a scale | Standard Deviation 23.9 |
| Psoriasis Arthritis (PsA) | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's GH -3 months | 31.4 Units on a scale | Standard Deviation 23.4 |
| Psoriasis Arthritis (PsA) | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's GH - 12 months | 26.2 Units on a scale | Standard Deviation 26.7 |
| Psoriasis Arthritis (PsA) | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's GH - 9 months | 26.5 Units on a scale | Standard Deviation 24.5 |
| Psoriasis Arthritis (PsA) | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's GH -9 months | 26.9 Units on a scale | Standard Deviation 23.4 |
| Total | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's GH - 9 months | 30.2 Units on a scale | Standard Deviation 22.8 |
| Total | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's GH - 12 months | 28.3 Units on a scale | Standard Deviation 24.6 |
| Total | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's GH -9 months | 33.2 Units on a scale | Standard Deviation 23 |
| Total | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's GH - Early Termination | 46.6 Units on a scale | Standard Deviation 31.8 |
| Total | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's GH - Baseline | 56.1 Units on a scale | Standard Deviation 25.2 |
| Total | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's GH -3 months | 33.1 Units on a scale | Standard Deviation 23.2 |
| Total | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's GH -12 months | 30.4 Units on a scale | Standard Deviation 24 |
| Total | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's GH - Baseline | 50.4 Units on a scale | Standard Deviation 21.6 |
| Total | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's GH -3 months | 28.9 Units on a scale | Standard Deviation 21.6 |
| Total | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's GH - 6 months | 32.1 Units on a scale | Standard Deviation 23.2 |
| Total | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's GH - 6 months | 30.4 Units on a scale | Standard Deviation 21.9 |
| Total | Physician´s / Patient's Global Assessment of State of Health (GH) Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's GH - Early Termination | 53.8 Units on a scale | Standard Deviation 35 |
Secondary
Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only
Physician's and Patient's Global Assessment of Disease Activity (PGA) are measured using a visual analogue scale with scores ranging from 0 to 100 (higher scores indicate worse disease activity).
Time frame: Baseline, months 3,6,9,12
Population: Mean (average) score is based on the number of participants included in the analysis (N=121) who completed the assessment at each timepoint (Baseline, 3, 6, 9 and 12 months and early termination \[for participants who discontinued the study early\]) in each disease group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis (RA) | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's PGA - Baseline | 55.1 Units on a scale | Standard Deviation 19.6 |
| Rheumatoid Arthritis (RA) | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's PGA - 3 months | 28.8 Units on a scale | Standard Deviation 21.1 |
| Rheumatoid Arthritis (RA) | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's PGA - 6 months | 29.5 Units on a scale | Standard Deviation 20.2 |
| Rheumatoid Arthritis (RA) | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's PGA - 9 months | 28.6 Units on a scale | Standard Deviation 19.5 |
| Rheumatoid Arthritis (RA) | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's PGA - 12 months | 22.9 Units on a scale | Standard Deviation 16.8 |
| Rheumatoid Arthritis (RA) | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's PGA - Early Termination | 57.0 Units on a scale | Standard Deviation 30.5 |
| Rheumatoid Arthritis (RA) | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's PGA - Baseline | 60.0 Units on a scale | Standard Deviation 23.3 |
| Rheumatoid Arthritis (RA) | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's PGA - 3 months | 32.4 Units on a scale | Standard Deviation 22.9 |
| Rheumatoid Arthritis (RA) | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's PGA - 6 months | 32.1 Units on a scale | Standard Deviation 21.1 |
| Rheumatoid Arthritis (RA) | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's PGA - 9 months | 32.2 Units on a scale | Standard Deviation 21.1 |
| Rheumatoid Arthritis (RA) | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's PGA - 12 months | 26.1 Units on a scale | Standard Deviation 18.4 |
| Rheumatoid Arthritis (RA) | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's PGA - Early Termination | 63.2 Units on a scale | Standard Deviation 29.5 |
| Psoriasis Arthritis (PsA) | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's PGA - Early Termination | 21.7 Units on a scale | Standard Deviation 29.3 |
| Psoriasis Arthritis (PsA) | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's PGA - Baseline | 52.0 Units on a scale | Standard Deviation 26.9 |
| Psoriasis Arthritis (PsA) | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's PGA - Baseline | 58.3 Units on a scale | Standard Deviation 27.6 |
| Psoriasis Arthritis (PsA) | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's PGA - 6 months | 27.7 Units on a scale | Standard Deviation 21.9 |
| Psoriasis Arthritis (PsA) | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's PGA - 3 months | 29.0 Units on a scale | Standard Deviation 20.1 |
| Psoriasis Arthritis (PsA) | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's PGA - Early Termination | 11.7 Units on a scale | Standard Deviation 12.6 |
| Psoriasis Arthritis (PsA) | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's PGA - 12 months | 23.9 Units on a scale | Standard Deviation 15.9 |
| Psoriasis Arthritis (PsA) | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's PGA - 6 months | 23.1 Units on a scale | Standard Deviation 19.7 |
| Psoriasis Arthritis (PsA) | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's PGA - 3 months | 34.3 Units on a scale | Standard Deviation 22.3 |
| Psoriasis Arthritis (PsA) | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's PGA - 12 months | 19.4 Units on a scale | Standard Deviation 14.7 |
| Psoriasis Arthritis (PsA) | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's PGA - 9 months | 17.9 Units on a scale | Standard Deviation 13.1 |
| Psoriasis Arthritis (PsA) | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's PGA - 9 months | 22.0 Units on a scale | Standard Deviation 16.9 |
| Total | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's PGA - 9 months | 26.1 Units on a scale | Standard Deviation 18.7 |
| Total | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's PGA - 12 months | 22.1 Units on a scale | Standard Deviation 16.3 |
| Total | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's PGA - 9 months | 29.9 Units on a scale | Standard Deviation 20.6 |
| Total | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's PGA - Early Termination | 47.3 Units on a scale | Standard Deviation 33.4 |
| Total | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's PGA - Baseline | 59.6 Units on a scale | Standard Deviation 24.3 |
| Total | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's PGA - 3 months | 32.8 Units on a scale | Standard Deviation 22.7 |
| Total | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's PGA - 12 months | 25.6 Units on a scale | Standard Deviation 17.8 |
| Total | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's PGA - Baseline | 54.4 Units on a scale | Standard Deviation 21.4 |
| Total | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's PGA - 3 months | 28.9 Units on a scale | Standard Deviation 20.8 |
| Total | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's PGA - 6 months | 31.1 Units on a scale | Standard Deviation 21.2 |
| Total | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Physician's PGA - 6 months | 28.1 Units on a scale | Standard Deviation 20.2 |
| Total | Physician´s /Patient's Global Assessment on Disease Activity Measured on a Visual Analogue Scale, for RA and PsA Patients Only | Patient's PGA - Early Termination | 54.9 Units on a scale | Standard Deviation 33.2 |