Ankylosing Spondylitis, Psoriatic Arthritis, Rheumatoid Arthritis
Conditions
Keywords
Ankylosing, Rheumatoid, Antibodies, Arthritis, Pain, Antirheumatic Agents, Psoriatic, Spondylitis, Monoclonals
Brief summary
The purpose of this study is to assess whether or not adalimumab (Humira®) can influence pain medication in participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) with or without comorbidities, which do not constitute a contraindication for adalimumab as stated in the released summary of product characteristics. Therefore it shall be evaluated if pain medication which is used in these participants is changed, reduced or stopped due to adalimumab treatment.
Detailed description
This is a non-interventional, observational study in which Humira (adalimumab) is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. The assignment of the patient to a Humira-containing regimen has to be decided in advance and has to be current practice. The prescription of Humira is clearly separated from the decision to include the participant in this study.
Interventions
None listed
Sponsors
Raffeiner GmbH
AbbVie (prior sponsor, Abbott)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients aged ≥ 18 years for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis * Patients must fulfill international and national guidelines for the use of a biological disease modifying antirheumatic drug in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis (chest x-ray and interferon gamma release assay or purified protein derivative-skin test negative for tuberculosis). In addition one of the following criteria must be fulfilled: * unsatisfactory disease modifying antirheumatic drug response defined as failure to treatment with at least two disease modifying antirheumatic drugs including Methotrexate in patients with rheumatoid arthritis or psoriatic arthritis * unsatisfactory non steroidal antiinflammatory drug response in patients with ankylosing spondylitis or unsatisfactory response to prior biological disease modifying antirheumatic drugs in patients with rheumatoid arthritis or psoriatic arthritis or ankylosing spondylitis
Exclusion criteria
* Patients who meet contraindications as outlined in the latest version of the Humira syringe® summary of product characteristics and Humira Pen® summary of product characteristics * Patients participating in another study program or clinical trial * Patients who have been treated with Humira before
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Assessment of the Presence of Distress Caused by Pain in the Last 3 Months Recorded on a Likert Scale at Baseline and Month 12 | Baseline, Month 12 | Participants indicated their perception of average distress caused by pain in the past 3 months on a 5-point Likert scale, where; 0 = no pain, 1 = not distressed, 2 = slightly distressed, 3 = moderately distressed, 4 = greatly distressed by pains. |
| Physician Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12 | Baseline, Months 3, 6, 9, 12 | Physicians measured participants' present pain intensity on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable). |
| Participant Assessment of Present Pain Intensity Recorded on a Likert Scale at Baseline and Month 12 | Baseline, Month 12 | Participants measured their present pain intensity by specifying their level of pain in response to the question How intensive is your pain at present? on a 4-point Likert scale, where 0 = no pain; 1 = mild pain, 2 = moderate pain, 3 = severe pain. |
| Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12 | Baseline, Months 3, 6, 9, 12 | Participants measured their pain intensity in the past 3 months on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable). |
| Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Likert Scale at Baseline and Month 12 | Baseline, Month 12 | Participants measured their pain intensity in the past 3 months by specifying their level of pain in response to the question How intensive was your pain on average in the past 3 months? on a 4-point Likert scale, where 0 = no pain; 1 = mild pain, 2 = moderate pain, 3 = severe pain. |
| Participant Assessment of the Pattern of Pain Progression (Daytime/Nocturnal) in the Past 3 Months at Baseline and Month 12 | Baseline, Month 12 | Participants assessed the pattern of their pain progression in the past 3 months according to the following descriptors: intermittent (daytime and/or nocturnal); mostly daytime; mostly nocturnal; continuous (daytime and nocturnal). |
| Participant Assessment of the Pattern of Pain Progression (Sudden/Creeping) in the Past 3 Months at Baseline and Month 12 | Baseline, Month 12 | Participants assessed the pattern of their pain progression in the past 3 months according to the following descriptors: the type of beginning of pain was mostly sudden; the type of beginning of pain was mostly creeping. |
| Participant Assessment of the Presence of Nocturnal Pain Progression in the Past 3 Months at Baseline and Month 12 | Baseline, Month 12 | Participants assessed how often on average they noted the presence of nocturnal pain in the past 3 month according to the following descriptors: never; rarely (not exceeding once a week), every night (awake from sleep at least once a night), more than once a night per week. |
| Participant Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12 | Baseline, Months 3, 6, 9, 12 | Participants measured their present pain intensity on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline, and Months 3, 6, 9, and 12 | Baseline, Months 3, 6, 9, 12 | The HAQ-DI is a participant-reported questionnaire. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. The minimal clinically important difference defined for the HAQ-DI is ≥0.22. HAQ remission, indicating normal physical function, is defined as HAQ-DI \< 0.5. |
| Mean Rheumatoid Arthritis Disease Activity Index (RADAI) at Baseline, and Months 3, 6, 9, and 12 | Baseline, Months 3, 6, 9, 12 | The RADAI is a questionnaire for patients used for measuring disease activity. The index consists of 6 questions. The items ask the participants about (1) global disease activity in the last 6 months, (2) disease activity in terms of current swollen and tender joints, (3) arthritis pain, (4) the current status of health, (5) duration of morning stiffness and (6) tender joints to be rated in a joint list. The joint list asks about pain in the left and right shoulders, elbows, wrists, fingers, hips, knees, ankles and toes. The first 4 items are all rated on a numeric rating scale from 0 to 10, where higher scores indicate more disease activity. The scores on the last 2 items range from 0 to 6 and 0 to 48, respectively, but are transformed on the same scale of 0 to 10. The RADAI total score is the sum of individual items divided by 5 (range 0-10), with a higher score signifying more disease activity. |
| Mean Bath Ankylosing Spondylitis Functional Index (BASFI) Scores at Baseline, and Months 3, 6, 9, and 12 | Baseline, Months 3, 6, 9, 12 | The BASFI is a set of 10 questions designed to determine the degree of functional limitation in those with AS. The 10 questions were chosen with a major input from patients with AS. The first 8 questions consider activities related to functional anatomy. The final 2 questions assess the participants' ability to cope with everyday life. A visual analogue scale (with 0 being easy and 10 impossible) is used to answer the questions on the test. |
| Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for Participants With Ankylosing Spondylitis (AS) at Baseline, and Months 3, 6, 9, and 12 | Baseline, Months 3, 6, 9, 12 | The BASDAI is used for measuring and evaluating disease activity in AS. This index consists of 6 questions pertaining to the 5 major symptoms of AS: fatigue, spinal pain, joint pain/swelling, areas of localized tenderness (or enthesitis, defined as inflammation of tendons and ligaments), duration of morning stiffness, severity of morning stiffness. A visual analogue scale ranging from 0 (none) to 10 (very severe) is used to answer the questions. The final BASDAI score averages the individual assessments for a final score range of 0-10 (0 being no problem and 10 being the worst problem). |
| Mean Erythrocyte Sedimentation Rate (ESR) at Baseline, and Months 3, 6, 9, and 12 | Baseline, Months 3, 6, 9, 12 | The ESR is a practicable and sensitive but not specific parameter for measuring disease progression. By means of the ESR it can be generally distinguished between an active and nonactive rheumatic disease. The normal reference range is, as a rule, 0 to 10 mm/h for men and 0 to 15 mm/h for women. The higher the ESR value out of the normal range, the higher is the disease activity. |
| Mean C-reactive Protein (CRP) at Baseline, and Months 3, 6, 9, and 12 | Baseline, Months 3, 6, 9, 12 | The CRP is an acute phase reactant plasma protein, normally produced by the liver, which is commonly used as an indirect measure of the extent and activity of an inflammation. The CRP normal reference range in the blood is, as a rule, from 0 to 1.0 mg/dL. |
| Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Baseline, Months 3, 6, 9, 12 | The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1 to 4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5 to 8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 \[worst\] to 100 \[best \]). The standard recall period is 4 weeks. Increases from Baseline indicate improvement. |
Countries
Austria
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rheumatoid Arthiritis (RA) Participants with rheumatoid arthritis (RA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication. | 78 |
| Psoriatic Arthritis (PsA) Participants with psoriatic arthritis (PsA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication. | 30 |
| Ankylosing Spondylitis (AS) Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication. | 47 |
| Total | 155 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 | 0 |
| Overall Study | Lack of Efficacy | 8 | 3 | 4 |
| Overall Study | Lost to Follow-up | 2 | 1 | 3 |
| Overall Study | Other | 6 | 1 | 1 |
Baseline characteristics
| Characteristic | Rheumatoid Arthiritis (RA) | Psoriatic Arthritis (PsA) | Ankylosing Spondylitis (AS) | Total |
|---|---|---|---|---|
| Age, Continuous | 54.76 years STANDARD_DEVIATION 13.11 | 48.07 years STANDARD_DEVIATION 12.71 | 42.02 years STANDARD_DEVIATION 10.97 | 49.6 years STANDARD_DEVIATION 13.56 |
| Sex: Female, Male Female | 67 Participants | 9 Participants | 18 Participants | 94 Participants |
| Sex: Female, Male Male | 11 Participants | 21 Participants | 29 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 21 / 155 |
| serious Total, serious adverse events | 3 / 155 |
Outcome results
Primary
Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Likert Scale at Baseline and Month 12
Participants measured their pain intensity in the past 3 months by specifying their level of pain in response to the question How intensive was your pain on average in the past 3 months? on a 4-point Likert scale, where 0 = no pain; 1 = mild pain, 2 = moderate pain, 3 = severe pain.
Time frame: Baseline, Month 12
Population: All participants with an assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RA, PsA, AS | Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Likert Scale at Baseline and Month 12 | No pain | 0 participants |
| RA, PsA, AS | Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Likert Scale at Baseline and Month 12 | Mild | 10 participants |
| RA, PsA, AS | Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Likert Scale at Baseline and Month 12 | Moderate | 71 participants |
| RA, PsA, AS | Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Likert Scale at Baseline and Month 12 | Severe | 69 participants |
| RA, PsA, AS: Month 12 | Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Likert Scale at Baseline and Month 12 | Severe | 2 participants |
| RA, PsA, AS: Month 12 | Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Likert Scale at Baseline and Month 12 | No pain | 40 participants |
| RA, PsA, AS: Month 12 | Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Likert Scale at Baseline and Month 12 | Moderate | 19 participants |
| RA, PsA, AS: Month 12 | Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Likert Scale at Baseline and Month 12 | Mild | 44 participants |
Primary
Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12
Participants measured their pain intensity in the past 3 months on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable).
Time frame: Baseline, Months 3, 6, 9, 12
Population: All participants with an assessment. n=number of participants with an assessment at time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RA, PsA, AS | Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12 | Baseline, n=150 | 64.31 units on a scale | Standard Deviation 19.79 |
| RA, PsA, AS | Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12 | Month 3, n=142 | 38.24 units on a scale | Standard Deviation 25.12 |
| RA, PsA, AS | Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12 | Month 6, n=114 | 30.89 units on a scale | Standard Deviation 21.5 |
| RA, PsA, AS | Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12 | Month 9, n=109 | 24.74 units on a scale | Standard Deviation 20.3 |
| RA, PsA, AS | Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12 | Month 12, n=105 | 17.36 units on a scale | Standard Deviation 17.57 |
Primary
Participant Assessment of Present Pain Intensity Recorded on a Likert Scale at Baseline and Month 12
Participants measured their present pain intensity by specifying their level of pain in response to the question How intensive is your pain at present? on a 4-point Likert scale, where 0 = no pain; 1 = mild pain, 2 = moderate pain, 3 = severe pain.
Time frame: Baseline, Month 12
Population: All participants with an assessment at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RA, PsA, AS | Participant Assessment of Present Pain Intensity Recorded on a Likert Scale at Baseline and Month 12 | No Pain | 4 participants |
| RA, PsA, AS | Participant Assessment of Present Pain Intensity Recorded on a Likert Scale at Baseline and Month 12 | Mild Pain | 22 participants |
| RA, PsA, AS | Participant Assessment of Present Pain Intensity Recorded on a Likert Scale at Baseline and Month 12 | Moderate Pain | 61 participants |
| RA, PsA, AS | Participant Assessment of Present Pain Intensity Recorded on a Likert Scale at Baseline and Month 12 | Severe Pain | 63 participants |
| RA, PsA, AS: Month 12 | Participant Assessment of Present Pain Intensity Recorded on a Likert Scale at Baseline and Month 12 | Severe Pain | 2 participants |
| RA, PsA, AS: Month 12 | Participant Assessment of Present Pain Intensity Recorded on a Likert Scale at Baseline and Month 12 | No Pain | 49 participants |
| RA, PsA, AS: Month 12 | Participant Assessment of Present Pain Intensity Recorded on a Likert Scale at Baseline and Month 12 | Moderate Pain | 14 participants |
| RA, PsA, AS: Month 12 | Participant Assessment of Present Pain Intensity Recorded on a Likert Scale at Baseline and Month 12 | Mild Pain | 40 participants |
Primary
Participant Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12
Participants measured their present pain intensity on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable).
Time frame: Baseline, Months 3, 6, 9, 12
Population: All participants with an assessment. n=number of participants with an assessment at time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RA, PsA, AS | Participant Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12 | Baseline, n=152 | 58.32 units on a scale | Standard Deviation 22.01 |
| RA, PsA, AS | Participant Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12 | Month 3, n=143 | 34.28 units on a scale | Standard Deviation 24.74 |
| RA, PsA, AS | Participant Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12 | Month 6, n=116 | 27.14 units on a scale | Standard Deviation 22.69 |
| RA, PsA, AS | Participant Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12 | Month 9, n=112 | 21.71 units on a scale | Standard Deviation 20.21 |
| RA, PsA, AS | Participant Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12 | Month 12, n=105 | 14.62 units on a scale | Standard Deviation 16.88 |
Primary
Participant Assessment of the Pattern of Pain Progression (Daytime/Nocturnal) in the Past 3 Months at Baseline and Month 12
Participants assessed the pattern of their pain progression in the past 3 months according to the following descriptors: intermittent (daytime and/or nocturnal); mostly daytime; mostly nocturnal; continuous (daytime and nocturnal).
Time frame: Baseline, Month 12
Population: All participants with an assessment. n=number of participants with an assessment at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RA, PsA, AS | Participant Assessment of the Pattern of Pain Progression (Daytime/Nocturnal) in the Past 3 Months at Baseline and Month 12 | Intermittent | 41 participants |
| RA, PsA, AS | Participant Assessment of the Pattern of Pain Progression (Daytime/Nocturnal) in the Past 3 Months at Baseline and Month 12 | Mostly daytime | 18 participants |
| RA, PsA, AS | Participant Assessment of the Pattern of Pain Progression (Daytime/Nocturnal) in the Past 3 Months at Baseline and Month 12 | Mostly nocturnal | 26 participants |
| RA, PsA, AS | Participant Assessment of the Pattern of Pain Progression (Daytime/Nocturnal) in the Past 3 Months at Baseline and Month 12 | Continuous | 65 participants |
| RA, PsA, AS: Month 12 | Participant Assessment of the Pattern of Pain Progression (Daytime/Nocturnal) in the Past 3 Months at Baseline and Month 12 | Continuous | 10 participants |
| RA, PsA, AS: Month 12 | Participant Assessment of the Pattern of Pain Progression (Daytime/Nocturnal) in the Past 3 Months at Baseline and Month 12 | Intermittent | 42 participants |
| RA, PsA, AS: Month 12 | Participant Assessment of the Pattern of Pain Progression (Daytime/Nocturnal) in the Past 3 Months at Baseline and Month 12 | Mostly nocturnal | 13 participants |
| RA, PsA, AS: Month 12 | Participant Assessment of the Pattern of Pain Progression (Daytime/Nocturnal) in the Past 3 Months at Baseline and Month 12 | Mostly daytime | 22 participants |
Primary
Participant Assessment of the Pattern of Pain Progression (Sudden/Creeping) in the Past 3 Months at Baseline and Month 12
Participants assessed the pattern of their pain progression in the past 3 months according to the following descriptors: the type of beginning of pain was mostly sudden; the type of beginning of pain was mostly creeping.
Time frame: Baseline, Month 12
Population: All participants with an assessment. n=number of participants with an assessment at time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RA, PsA, AS | Participant Assessment of the Pattern of Pain Progression (Sudden/Creeping) in the Past 3 Months at Baseline and Month 12 | Sudden | 40 participants |
| RA, PsA, AS | Participant Assessment of the Pattern of Pain Progression (Sudden/Creeping) in the Past 3 Months at Baseline and Month 12 | Creeping | 101 participants |
| RA, PsA, AS: Month 12 | Participant Assessment of the Pattern of Pain Progression (Sudden/Creeping) in the Past 3 Months at Baseline and Month 12 | Creeping | 56 participants |
| RA, PsA, AS: Month 12 | Participant Assessment of the Pattern of Pain Progression (Sudden/Creeping) in the Past 3 Months at Baseline and Month 12 | Sudden | 30 participants |
Primary
Participant Assessment of the Presence of Distress Caused by Pain in the Last 3 Months Recorded on a Likert Scale at Baseline and Month 12
Participants indicated their perception of average distress caused by pain in the past 3 months on a 5-point Likert scale, where; 0 = no pain, 1 = not distressed, 2 = slightly distressed, 3 = moderately distressed, 4 = greatly distressed by pains.
Time frame: Baseline, Month 12
Population: All participants with an assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RA, PsA, AS | Participant Assessment of the Presence of Distress Caused by Pain in the Last 3 Months Recorded on a Likert Scale at Baseline and Month 12 | Not distressed by pain | 0 participants |
| RA, PsA, AS | Participant Assessment of the Presence of Distress Caused by Pain in the Last 3 Months Recorded on a Likert Scale at Baseline and Month 12 | Moderately distressed by pain | 71 participants |
| RA, PsA, AS | Participant Assessment of the Presence of Distress Caused by Pain in the Last 3 Months Recorded on a Likert Scale at Baseline and Month 12 | Slightly distressed by pain | 10 participants |
| RA, PsA, AS | Participant Assessment of the Presence of Distress Caused by Pain in the Last 3 Months Recorded on a Likert Scale at Baseline and Month 12 | Greatly distressed by pain | 69 participants |
| RA, PsA, AS | Participant Assessment of the Presence of Distress Caused by Pain in the Last 3 Months Recorded on a Likert Scale at Baseline and Month 12 | No pain | 0 participants |
| RA, PsA, AS: Month 12 | Participant Assessment of the Presence of Distress Caused by Pain in the Last 3 Months Recorded on a Likert Scale at Baseline and Month 12 | Greatly distressed by pain | 2 participants |
| RA, PsA, AS: Month 12 | Participant Assessment of the Presence of Distress Caused by Pain in the Last 3 Months Recorded on a Likert Scale at Baseline and Month 12 | No pain | 33 participants |
| RA, PsA, AS: Month 12 | Participant Assessment of the Presence of Distress Caused by Pain in the Last 3 Months Recorded on a Likert Scale at Baseline and Month 12 | Not distressed by pain | 23 participants |
| RA, PsA, AS: Month 12 | Participant Assessment of the Presence of Distress Caused by Pain in the Last 3 Months Recorded on a Likert Scale at Baseline and Month 12 | Slightly distressed by pain | 28 participants |
| RA, PsA, AS: Month 12 | Participant Assessment of the Presence of Distress Caused by Pain in the Last 3 Months Recorded on a Likert Scale at Baseline and Month 12 | Moderately distressed by pain | 18 participants |
Primary
Participant Assessment of the Presence of Nocturnal Pain Progression in the Past 3 Months at Baseline and Month 12
Participants assessed how often on average they noted the presence of nocturnal pain in the past 3 month according to the following descriptors: never; rarely (not exceeding once a week), every night (awake from sleep at least once a night), more than once a night per week.
Time frame: Baseline, Month 12
Population: All participants with an assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RA, PsA, AS | Participant Assessment of the Presence of Nocturnal Pain Progression in the Past 3 Months at Baseline and Month 12 | Never | 3 participants |
| RA, PsA, AS | Participant Assessment of the Presence of Nocturnal Pain Progression in the Past 3 Months at Baseline and Month 12 | Rarely | 14 participants |
| RA, PsA, AS | Participant Assessment of the Presence of Nocturnal Pain Progression in the Past 3 Months at Baseline and Month 12 | Every night | 57 participants |
| RA, PsA, AS | Participant Assessment of the Presence of Nocturnal Pain Progression in the Past 3 Months at Baseline and Month 12 | More than once a night per week | 74 participants |
| RA, PsA, AS: Month 12 | Participant Assessment of the Presence of Nocturnal Pain Progression in the Past 3 Months at Baseline and Month 12 | More than once a night per week | 17 participants |
| RA, PsA, AS: Month 12 | Participant Assessment of the Presence of Nocturnal Pain Progression in the Past 3 Months at Baseline and Month 12 | Never | 41 participants |
| RA, PsA, AS: Month 12 | Participant Assessment of the Presence of Nocturnal Pain Progression in the Past 3 Months at Baseline and Month 12 | Every night | 3 participants |
| RA, PsA, AS: Month 12 | Participant Assessment of the Presence of Nocturnal Pain Progression in the Past 3 Months at Baseline and Month 12 | Rarely | 42 participants |
Primary
Physician Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12
Physicians measured participants' present pain intensity on a visual analogue scale (VAS), where the responses were on a continuous range from 0 (no pain) to 100 (worst pain imaginable).
Time frame: Baseline, Months 3, 6, 9, 12
Population: All participants with an assessment. n=number of participants with an assessment at time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RA, PsA, AS | Physician Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12 | Baseline, n=152 | 56.55 units on a scale | Standard Deviation 21.57 |
| RA, PsA, AS | Physician Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12 | Month 3, n=141 | 31.19 units on a scale | Standard Deviation 23.95 |
| RA, PsA, AS | Physician Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12 | Month 6, n=114 | 25.32 units on a scale | Standard Deviation 22.13 |
| RA, PsA, AS | Physician Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12 | Month 9, n=108 | 19.06 units on a scale | Standard Deviation 18.46 |
| RA, PsA, AS | Physician Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12 | Month 12, n=105 | 12.2 units on a scale | Standard Deviation 15.1 |
Secondary
Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for Participants With Ankylosing Spondylitis (AS) at Baseline, and Months 3, 6, 9, and 12
The BASDAI is used for measuring and evaluating disease activity in AS. This index consists of 6 questions pertaining to the 5 major symptoms of AS: fatigue, spinal pain, joint pain/swelling, areas of localized tenderness (or enthesitis, defined as inflammation of tendons and ligaments), duration of morning stiffness, severity of morning stiffness. A visual analogue scale ranging from 0 (none) to 10 (very severe) is used to answer the questions. The final BASDAI score averages the individual assessments for a final score range of 0-10 (0 being no problem and 10 being the worst problem).
Time frame: Baseline, Months 3, 6, 9, 12
Population: All participants with an assessment. n=number of participants with an assessment at time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RA, PsA, AS | Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for Participants With Ankylosing Spondylitis (AS) at Baseline, and Months 3, 6, 9, and 12 | Baseline, n=45 | 5.65 units on a scale | Standard Deviation 2.25 |
| RA, PsA, AS | Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for Participants With Ankylosing Spondylitis (AS) at Baseline, and Months 3, 6, 9, and 12 | Month 3, n=44 | 3.24 units on a scale | Standard Deviation 2.25 |
| RA, PsA, AS | Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for Participants With Ankylosing Spondylitis (AS) at Baseline, and Months 3, 6, 9, and 12 | Month 6, n=39 | 2.62 units on a scale | Standard Deviation 2.55 |
| RA, PsA, AS | Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for Participants With Ankylosing Spondylitis (AS) at Baseline, and Months 3, 6, 9, and 12 | Month 9, n=34 | 1.97 units on a scale | Standard Deviation 2.15 |
| RA, PsA, AS | Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for Participants With Ankylosing Spondylitis (AS) at Baseline, and Months 3, 6, 9, and 12 | Month 12, n=32 | 1.23 units on a scale | Standard Deviation 1.9 |
Secondary
Mean Bath Ankylosing Spondylitis Functional Index (BASFI) Scores at Baseline, and Months 3, 6, 9, and 12
The BASFI is a set of 10 questions designed to determine the degree of functional limitation in those with AS. The 10 questions were chosen with a major input from patients with AS. The first 8 questions consider activities related to functional anatomy. The final 2 questions assess the participants' ability to cope with everyday life. A visual analogue scale (with 0 being easy and 10 impossible) is used to answer the questions on the test.
Time frame: Baseline, Months 3, 6, 9, 12
Population: Participants with AS or PsA and an assessment. n=number of participants with an assessment at time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RA, PsA, AS | Mean Bath Ankylosing Spondylitis Functional Index (BASFI) Scores at Baseline, and Months 3, 6, 9, and 12 | Baseline, n=72 | 5.46 units on a scale | Standard Deviation 1.6 |
| RA, PsA, AS | Mean Bath Ankylosing Spondylitis Functional Index (BASFI) Scores at Baseline, and Months 3, 6, 9, and 12 | Month 3, n=67 | 3.78 units on a scale | Standard Deviation 2.14 |
| RA, PsA, AS | Mean Bath Ankylosing Spondylitis Functional Index (BASFI) Scores at Baseline, and Months 3, 6, 9, and 12 | Month 6, n=53 | 2.74 units on a scale | Standard Deviation 2.1 |
| RA, PsA, AS | Mean Bath Ankylosing Spondylitis Functional Index (BASFI) Scores at Baseline, and Months 3, 6, 9, and 12 | Month 9, n=46 | 2.19 units on a scale | Standard Deviation 1.81 |
| RA, PsA, AS | Mean Bath Ankylosing Spondylitis Functional Index (BASFI) Scores at Baseline, and Months 3, 6, 9, and 12 | Month 12, n=49 | 1.72 units on a scale | Standard Deviation 1.83 |
Secondary
Mean C-reactive Protein (CRP) at Baseline, and Months 3, 6, 9, and 12
The CRP is an acute phase reactant plasma protein, normally produced by the liver, which is commonly used as an indirect measure of the extent and activity of an inflammation. The CRP normal reference range in the blood is, as a rule, from 0 to 1.0 mg/dL.
Time frame: Baseline, Months 3, 6, 9, 12
Population: All participants with an assessment. n=number of participants with an assessment at time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RA, PsA, AS | Mean C-reactive Protein (CRP) at Baseline, and Months 3, 6, 9, and 12 | Month 9, n=44, 17, 32 | 2.16 mg/dL | Standard Deviation 3.85 |
| RA, PsA, AS | Mean C-reactive Protein (CRP) at Baseline, and Months 3, 6, 9, and 12 | Month 6, n=50, 17, 35 | 1.95 mg/dL | Standard Deviation 4.03 |
| RA, PsA, AS | Mean C-reactive Protein (CRP) at Baseline, and Months 3, 6, 9, and 12 | Baseline, n=57, 21, 39 | 1.83 mg/dL | Standard Deviation 2.65 |
| RA, PsA, AS | Mean C-reactive Protein (CRP) at Baseline, and Months 3, 6, 9, and 12 | Month 3, n=61, 22, 39 | 4.3 mg/dL | Standard Deviation 10.88 |
| RA, PsA, AS | Mean C-reactive Protein (CRP) at Baseline, and Months 3, 6, 9, and 12 | Month 12, n=45, 18, 31 | 1.73 mg/dL | Standard Deviation 3.89 |
| RA, PsA, AS: Month 12 | Mean C-reactive Protein (CRP) at Baseline, and Months 3, 6, 9, and 12 | Month 6, n=50, 17, 35 | 1.25 mg/dL | Standard Deviation 1.94 |
| RA, PsA, AS: Month 12 | Mean C-reactive Protein (CRP) at Baseline, and Months 3, 6, 9, and 12 | Baseline, n=57, 21, 39 | 1.56 mg/dL | Standard Deviation 3.25 |
| RA, PsA, AS: Month 12 | Mean C-reactive Protein (CRP) at Baseline, and Months 3, 6, 9, and 12 | Month 3, n=61, 22, 39 | 2.31 mg/dL | Standard Deviation 7.39 |
| RA, PsA, AS: Month 12 | Mean C-reactive Protein (CRP) at Baseline, and Months 3, 6, 9, and 12 | Month 9, n=44, 17, 32 | 5.33 mg/dL | Standard Deviation 12.96 |
| RA, PsA, AS: Month 12 | Mean C-reactive Protein (CRP) at Baseline, and Months 3, 6, 9, and 12 | Month 12, n=45, 18, 31 | 2.42 mg/dL | Standard Deviation 5.36 |
| Ankylosing Spondylitis (AS) | Mean C-reactive Protein (CRP) at Baseline, and Months 3, 6, 9, and 12 | Month 12, n=45, 18, 31 | 1.26 mg/dL | Standard Deviation 3.31 |
| Ankylosing Spondylitis (AS) | Mean C-reactive Protein (CRP) at Baseline, and Months 3, 6, 9, and 12 | Month 9, n=44, 17, 32 | 1.14 mg/dL | Standard Deviation 2.35 |
| Ankylosing Spondylitis (AS) | Mean C-reactive Protein (CRP) at Baseline, and Months 3, 6, 9, and 12 | Baseline, n=57, 21, 39 | 1.18 mg/dL | Standard Deviation 1.69 |
| Ankylosing Spondylitis (AS) | Mean C-reactive Protein (CRP) at Baseline, and Months 3, 6, 9, and 12 | Month 6, n=50, 17, 35 | 1.57 mg/dL | Standard Deviation 3.14 |
| Ankylosing Spondylitis (AS) | Mean C-reactive Protein (CRP) at Baseline, and Months 3, 6, 9, and 12 | Month 3, n=61, 22, 39 | 0.84 mg/dL | Standard Deviation 1.89 |
Secondary
Mean Erythrocyte Sedimentation Rate (ESR) at Baseline, and Months 3, 6, 9, and 12
The ESR is a practicable and sensitive but not specific parameter for measuring disease progression. By means of the ESR it can be generally distinguished between an active and nonactive rheumatic disease. The normal reference range is, as a rule, 0 to 10 mm/h for men and 0 to 15 mm/h for women. The higher the ESR value out of the normal range, the higher is the disease activity.
Time frame: Baseline, Months 3, 6, 9, 12
Population: All participants with an assessment. n=number of participants with an assessment at time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RA, PsA, AS | Mean Erythrocyte Sedimentation Rate (ESR) at Baseline, and Months 3, 6, 9, and 12 | Month 9, n=51, 23, 33 | 25.49 mm/h | Standard Deviation 22.45 |
| RA, PsA, AS | Mean Erythrocyte Sedimentation Rate (ESR) at Baseline, and Months 3, 6, 9, and 12 | Month 6, n=58, 21, 37 | 21.98 mm/h | Standard Deviation 19.22 |
| RA, PsA, AS | Mean Erythrocyte Sedimentation Rate (ESR) at Baseline, and Months 3, 6, 9, and 12 | Baseline, n=69, 25, 40 | 32.87 mm/h | Standard Deviation 17.89 |
| RA, PsA, AS | Mean Erythrocyte Sedimentation Rate (ESR) at Baseline, and Months 3, 6, 9, and 12 | Month 3, n=68, 25, 40 | 21.95 mm/h | Standard Deviation 18.25 |
| RA, PsA, AS | Mean Erythrocyte Sedimentation Rate (ESR) at Baseline, and Months 3, 6, 9, and 12 | Month 12, n=49, 21, 30 | 19.94 mm/h | Standard Deviation 19.63 |
| RA, PsA, AS: Month 12 | Mean Erythrocyte Sedimentation Rate (ESR) at Baseline, and Months 3, 6, 9, and 12 | Month 6, n=58, 21, 37 | 14.81 mm/h | Standard Deviation 16.62 |
| RA, PsA, AS: Month 12 | Mean Erythrocyte Sedimentation Rate (ESR) at Baseline, and Months 3, 6, 9, and 12 | Baseline, n=69, 25, 40 | 23.96 mm/h | Standard Deviation 19.41 |
| RA, PsA, AS: Month 12 | Mean Erythrocyte Sedimentation Rate (ESR) at Baseline, and Months 3, 6, 9, and 12 | Month 3, n=68, 25, 40 | 13.4 mm/h | Standard Deviation 15.05 |
| RA, PsA, AS: Month 12 | Mean Erythrocyte Sedimentation Rate (ESR) at Baseline, and Months 3, 6, 9, and 12 | Month 9, n=51, 23, 33 | 14.09 mm/h | Standard Deviation 16.9 |
| RA, PsA, AS: Month 12 | Mean Erythrocyte Sedimentation Rate (ESR) at Baseline, and Months 3, 6, 9, and 12 | Month 12, n=49, 21, 30 | 13.33 mm/h | Standard Deviation 15.32 |
| Ankylosing Spondylitis (AS) | Mean Erythrocyte Sedimentation Rate (ESR) at Baseline, and Months 3, 6, 9, and 12 | Month 12, n=49, 21, 30 | 12.0 mm/h | Standard Deviation 7.95 |
| Ankylosing Spondylitis (AS) | Mean Erythrocyte Sedimentation Rate (ESR) at Baseline, and Months 3, 6, 9, and 12 | Month 9, n=51, 23, 33 | 12.79 mm/h | Standard Deviation 7.75 |
| Ankylosing Spondylitis (AS) | Mean Erythrocyte Sedimentation Rate (ESR) at Baseline, and Months 3, 6, 9, and 12 | Baseline, n=69, 25, 40 | 28.58 mm/h | Standard Deviation 22.87 |
| Ankylosing Spondylitis (AS) | Mean Erythrocyte Sedimentation Rate (ESR) at Baseline, and Months 3, 6, 9, and 12 | Month 6, n=58, 21, 37 | 13.24 mm/h | Standard Deviation 10.29 |
| Ankylosing Spondylitis (AS) | Mean Erythrocyte Sedimentation Rate (ESR) at Baseline, and Months 3, 6, 9, and 12 | Month 3, n=68, 25, 40 | 12.45 mm/h | Standard Deviation 10.33 |
Secondary
Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline, and Months 3, 6, 9, and 12
The HAQ-DI is a participant-reported questionnaire. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. The minimal clinically important difference defined for the HAQ-DI is ≥0.22. HAQ remission, indicating normal physical function, is defined as HAQ-DI \< 0.5.
Time frame: Baseline, Months 3, 6, 9, 12
Population: All participants with an assessment. n=number of participants with an assessment at time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RA, PsA, AS | Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline, and Months 3, 6, 9, and 12 | Month 9, n=46, 21, 0 | 0.83 units on a scale | Standard Deviation 0.71 |
| RA, PsA, AS | Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline, and Months 3, 6, 9, and 12 | Month 6, n=53, 19, 0 | 0.87 units on a scale | Standard Deviation 0.78 |
| RA, PsA, AS | Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline, and Months 3, 6, 9, and 12 | Baseline, n=73, 28, 6 | 1.31 units on a scale | Standard Deviation 0.69 |
| RA, PsA, AS | Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline, and Months 3, 6, 9, and 12 | Month 3, n=66, 26, 2 | 0.94 units on a scale | Standard Deviation 0.72 |
| RA, PsA, AS | Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline, and Months 3, 6, 9, and 12 | Month 12, n=48, 22, 0 | 0.68 units on a scale | Standard Deviation 0.72 |
| RA, PsA, AS: Month 12 | Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline, and Months 3, 6, 9, and 12 | Month 6, n=53, 19, 0 | 0.77 units on a scale | Standard Deviation 0.69 |
| RA, PsA, AS: Month 12 | Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline, and Months 3, 6, 9, and 12 | Baseline, n=73, 28, 6 | 0.85 units on a scale | Standard Deviation 0.57 |
| RA, PsA, AS: Month 12 | Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline, and Months 3, 6, 9, and 12 | Month 3, n=66, 26, 2 | 0.62 units on a scale | Standard Deviation 0.64 |
| RA, PsA, AS: Month 12 | Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline, and Months 3, 6, 9, and 12 | Month 9, n=46, 21, 0 | 0.54 units on a scale | Standard Deviation 0.54 |
| RA, PsA, AS: Month 12 | Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline, and Months 3, 6, 9, and 12 | Month 12, n=48, 22, 0 | 0.51 units on a scale | Standard Deviation 0.57 |
| Ankylosing Spondylitis (AS) | Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline, and Months 3, 6, 9, and 12 | Month 12, n=48, 22, 0 | NA units on a scale | — |
| Ankylosing Spondylitis (AS) | Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline, and Months 3, 6, 9, and 12 | Month 9, n=46, 21, 0 | NA units on a scale | — |
| Ankylosing Spondylitis (AS) | Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline, and Months 3, 6, 9, and 12 | Baseline, n=73, 28, 6 | 0.88 units on a scale | Standard Deviation 0.62 |
| Ankylosing Spondylitis (AS) | Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline, and Months 3, 6, 9, and 12 | Month 6, n=53, 19, 0 | NA units on a scale | — |
| Ankylosing Spondylitis (AS) | Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline, and Months 3, 6, 9, and 12 | Month 3, n=66, 26, 2 | 0.75 units on a scale | Standard Deviation 0.35 |
Secondary
Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12
The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1 to 4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5 to 8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 \[worst\] to 100 \[best \]). The standard recall period is 4 weeks. Increases from Baseline indicate improvement.
Time frame: Baseline, Months 3, 6, 9, 12
Population: All participants with an assessment. n=number of participants with an assessment at time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Role functioning physical: Month 6, n=103 | 48.8 units on a scale | Standard Deviation 44.5 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Physical functioning: Baseline, n=143 | 46.9 units on a scale | Standard Deviation 26 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Physical functioning: Month 3, n=131 | 62.1 units on a scale | Standard Deviation 28.9 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Physical functioning: Month 6, n=104 | 66.9 units on a scale | Standard Deviation 27.4 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Physical functioning: Month 9, n=96 | 71.9 units on a scale | Standard Deviation 25.9 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Physical functioning: Month 12, n=94 | 77.1 units on a scale | Standard Deviation 25.8 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Role functioning physical: Baseline, n=142 | 16.7 units on a scale | Standard Deviation 33 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Role functioning physical: Month 3, n=129 | 42.4 units on a scale | Standard Deviation 44.9 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Role functioning physical: Month 9, n=96 | 54.7 units on a scale | Standard Deviation 44.8 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Role functioning physical: Month 12, n=93 | 63.4 units on a scale | Standard Deviation 44 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Bodily pain: Baseline, n=144 | 27.2 units on a scale | Standard Deviation 19 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Bodily pain: Month 3, n=131 | 52.1 units on a scale | Standard Deviation 25.6 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Bodily pain: Month 6, n=104 | 56.3 units on a scale | Standard Deviation 24.1 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Bodily pain: Month 9, n=96 | 62.8 units on a scale | Standard Deviation 23.8 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Bodily pain: Month 12, n=95 | 73.2 units on a scale | Standard Deviation 23.2 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | General health: Baseline, n=141 | 38.3 units on a scale | Standard Deviation 16.5 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | General health: Month 3, n=131 | 46.6 units on a scale | Standard Deviation 19.8 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | General health: Month 6, n=104 | 49.9 units on a scale | Standard Deviation 18.9 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | General health: Month 9, n=96 | 58.3 units on a scale | Standard Deviation 20.8 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | General health: Month 12, n=95 | 64.9 units on a scale | Standard Deviation 21.4 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Vitality: Baseline, n=144 | 36.6 units on a scale | Standard Deviation 18.9 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Vitality: Month 3, n=131 | 51.3 units on a scale | Standard Deviation 21.4 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Vitality: Month 6, n=104 | 56.3 units on a scale | Standard Deviation 21.6 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Vitality: Month 9, n=96 | 61.4 units on a scale | Standard Deviation 20.1 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Vitality: Month 12, n=95 | 68.0 units on a scale | Standard Deviation 18.7 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Social functioning: Baseline, n=142 | 42.5 units on a scale | Standard Deviation 23.8 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Social functioning: Month 3, n=130 | 62.6 units on a scale | Standard Deviation 25.4 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Social functioning: Month 6, n=104 | 66.7 units on a scale | Standard Deviation 25.1 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Social functioning: Month 9, n=96 | 72.7 units on a scale | Standard Deviation 23.7 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Social functioning: Month 12, n=94 | 82.4 units on a scale | Standard Deviation 19.9 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Role functioning emotional: Baseline, n=143 | 38.0 units on a scale | Standard Deviation 43.6 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Role functioning emotional: Month 3, n=128 | 60.7 units on a scale | Standard Deviation 45.7 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Role functioning emotional: Month 6, n=103 | 61.2 units on a scale | Standard Deviation 43.1 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Role functioning emotional: Month 9, n=96 | 76.0 units on a scale | Standard Deviation 39.8 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Role functioning emotional: Month 12, n=95 | 85.6 units on a scale | Standard Deviation 31.8 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Mental health: Baseline, n=143 | 48.9 units on a scale | Standard Deviation 18.5 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Mental health: Month 3, n=131 | 63.0 units on a scale | Standard Deviation 19.1 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Mental health: Month 6, n=103 | 67.5 units on a scale | Standard Deviation 19.7 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Mental health: Month 9, n=94 | 72.1 units on a scale | Standard Deviation 18.9 |
| RA, PsA, AS | Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 | Mental health: Month 12, n=95 | 77.1 units on a scale | Standard Deviation 18 |
Secondary
Mean Rheumatoid Arthritis Disease Activity Index (RADAI) at Baseline, and Months 3, 6, 9, and 12
The RADAI is a questionnaire for patients used for measuring disease activity. The index consists of 6 questions. The items ask the participants about (1) global disease activity in the last 6 months, (2) disease activity in terms of current swollen and tender joints, (3) arthritis pain, (4) the current status of health, (5) duration of morning stiffness and (6) tender joints to be rated in a joint list. The joint list asks about pain in the left and right shoulders, elbows, wrists, fingers, hips, knees, ankles and toes. The first 4 items are all rated on a numeric rating scale from 0 to 10, where higher scores indicate more disease activity. The scores on the last 2 items range from 0 to 6 and 0 to 48, respectively, but are transformed on the same scale of 0 to 10. The RADAI total score is the sum of individual items divided by 5 (range 0-10), with a higher score signifying more disease activity.
Time frame: Baseline, Months 3, 6, 9, 12
Population: All participants with an assessment. n=number of participants with an assessment at time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RA, PsA, AS | Mean Rheumatoid Arthritis Disease Activity Index (RADAI) at Baseline, and Months 3, 6, 9, and 12 | Month 9, n=46, 20, 0 | 2.19 units on a scale | Standard Deviation 1.81 |
| RA, PsA, AS | Mean Rheumatoid Arthritis Disease Activity Index (RADAI) at Baseline, and Months 3, 6, 9, and 12 | Month 3, n=67, 22, 2 | 3.78 units on a scale | Standard Deviation 2.14 |
| RA, PsA, AS | Mean Rheumatoid Arthritis Disease Activity Index (RADAI) at Baseline, and Months 3, 6, 9, and 12 | Month 6, n=53, 18, 0 | 2.74 units on a scale | Standard Deviation 2.1 |
| RA, PsA, AS | Mean Rheumatoid Arthritis Disease Activity Index (RADAI) at Baseline, and Months 3, 6, 9, and 12 | Baseline, n=72, 27, 5 | 5.46 units on a scale | Standard Deviation 1.6 |
| RA, PsA, AS | Mean Rheumatoid Arthritis Disease Activity Index (RADAI) at Baseline, and Months 3, 6, 9, and 12 | Month 12, n=49, 21, 0 | 1.72 units on a scale | Standard Deviation 1.83 |
| RA, PsA, AS: Month 12 | Mean Rheumatoid Arthritis Disease Activity Index (RADAI) at Baseline, and Months 3, 6, 9, and 12 | Month 3, n=67, 22, 2 | 2.41 units on a scale | Standard Deviation 1.63 |
| RA, PsA, AS: Month 12 | Mean Rheumatoid Arthritis Disease Activity Index (RADAI) at Baseline, and Months 3, 6, 9, and 12 | Month 9, n=46, 20, 0 | 1.81 units on a scale | Standard Deviation 1.86 |
| RA, PsA, AS: Month 12 | Mean Rheumatoid Arthritis Disease Activity Index (RADAI) at Baseline, and Months 3, 6, 9, and 12 | Baseline, n=72, 27, 5 | 4.72 units on a scale | Standard Deviation 1.69 |
| RA, PsA, AS: Month 12 | Mean Rheumatoid Arthritis Disease Activity Index (RADAI) at Baseline, and Months 3, 6, 9, and 12 | Month 6, n=53, 18, 0 | 2.34 units on a scale | Standard Deviation 2.06 |
| RA, PsA, AS: Month 12 | Mean Rheumatoid Arthritis Disease Activity Index (RADAI) at Baseline, and Months 3, 6, 9, and 12 | Month 12, n=49, 21, 0 | 1.55 units on a scale | Standard Deviation 1.91 |
| Ankylosing Spondylitis (AS) | Mean Rheumatoid Arthritis Disease Activity Index (RADAI) at Baseline, and Months 3, 6, 9, and 12 | Month 6, n=53, 18, 0 | NA units on a scale | — |
| Ankylosing Spondylitis (AS) | Mean Rheumatoid Arthritis Disease Activity Index (RADAI) at Baseline, and Months 3, 6, 9, and 12 | Baseline, n=72, 27, 5 | 4.61 units on a scale | Standard Deviation 2.57 |
| Ankylosing Spondylitis (AS) | Mean Rheumatoid Arthritis Disease Activity Index (RADAI) at Baseline, and Months 3, 6, 9, and 12 | Month 9, n=46, 20, 0 | NA units on a scale | — |
| Ankylosing Spondylitis (AS) | Mean Rheumatoid Arthritis Disease Activity Index (RADAI) at Baseline, and Months 3, 6, 9, and 12 | Month 3, n=67, 22, 2 | 4.23 units on a scale | Standard Deviation 2.15 |
| Ankylosing Spondylitis (AS) | Mean Rheumatoid Arthritis Disease Activity Index (RADAI) at Baseline, and Months 3, 6, 9, and 12 | Month 12, n=49, 21, 0 | NA units on a scale | — |