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| ID | Type | Description | Link |
|---|---|---|---|
| B1801047 | Other Identifier | Alias Study Number |
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It can be assumed that there is a link between what the patient feels and thinks about his medication and objective measures of disease activity and safety.
A total of 500 subjects will provide 80% power to test the hypothesis that the absolute value of the correlation between two measures (e.g., BMQ Necessity and DAS28) is ≤ 0.3 (i.e., H0:│r│ ≤ 0.3 ) versus the alternative that it is > 0.3 (i.e., H1:│r │ > 0.3 ) assuming the absolute value of the true correlation is 0.40. A total of 500 will be enrolled to allow for approximately 5% being lost from analysis due to lack of post baseline data.
The Pearson method will be used for correlation between the BMQ total score for Necessity and the DAS28 and between the BMQ total score for Concern and DAS28. The Spearman rank method will be used for correlation between the BMQ total scores and Safety. For these latter analyses, subjects will be classified into one of 3 safety categories: (1) No AEs, (2) Non-serious AEs, (3) Serious AEs. 95% confidence intervals for the correlations will be provided.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rheumatoid arthritis patients treated with SC anti-TNF |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SC anti-TNF | Other | Subcutaneous (SC) anti-TNF |
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| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between Beliefs About Medicines Questionnaire (BMQ) Necessity Score and Disease Activity Score Based on 28 Joints Count (DAS28) at Month 12 | Correlation between BMQ necessity and DAS28 was assessed by using Pearson correlation coefficient. BMQ necessity: 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicate degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of swollen joint count (SJC); tender joint count (TJC) using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hour]) and participant's assessment of disease activity (DA) on visual analog scale (VAS) (range 0 [very well] to 100 millimeter (mm) [extremely bad]). DAS28 less than or equal to (<=) 3.2=low DA; greater than (>) 3.2 to <=5.1=moderate DA; >5.1=high DA; <2.6=remission. | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between Beliefs About Medicines Questionnaire Necessity Score and Safety at Month 12 | Correlation between BMQ necessity score and safety was assessed by using Spearman correlation coefficient. BMQ necessity: 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported adverse events (AEs) considered related to anti-TNF- alpha therapy. |
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Inclusion Criteria:
Patients with RA on stable therapy defined as:
Etanercept: 1x50 mg/week or 2x25mg/week for at least 1 consecutive year. Adalimumab: 1x40 mg every other week for at least 1 consecutive year. Oral corticosteroids: stable doses for ≥ 12 weeks before baseline Methotrexate: stable doses for ≥ 12 weeks before baseline Other DMARD's: stable doses for ≥ 12 weeks before baseline
Exclusion Criteria:
Participation in other clinical or observational trials.
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rheumatoid arthritis patients treated with SC anti-TNF capable of completing some questionnaires
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Algemeen Ziekenhuis St Jan | Bruges | 8000 | Belgium |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) | Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline analysis set (BAS) included all participants who were enrolled in the study and seen at baseline.
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| ID | Title | Description |
|---|---|---|
| BG000 | Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) | Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Correlation Between Beliefs About Medicines Questionnaire (BMQ) Necessity Score and Disease Activity Score Based on 28 Joints Count (DAS28) at Month 12 | Correlation between BMQ necessity and DAS28 was assessed by using Pearson correlation coefficient. BMQ necessity: 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicate degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of swollen joint count (SJC); tender joint count (TJC) using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hour]) and participant's assessment of disease activity (DA) on visual analog scale (VAS) (range 0 [very well] to 100 millimeter (mm) [extremely bad]). DAS28 less than or equal to (<=) 3.2=low DA; greater than (>) 3.2 to <=5.1=moderate DA; >5.1=high DA; <2.6=remission. | Full Analysis Set (FAS) included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | correlation coefficient | Month 12 |
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The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha) | Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician's discretion based on summary of product characteristics, were followed up for 1 year. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDra v18.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDra v18.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Month 12 |
| Correlation Between Beliefs About Medicines Questionnaire Concerns Score and Disease Activity Score Based on 28 Joints Count at Month 12 | Correlation between BMQ concerns score and DAS28 score was assessed by using Pearson correlation coefficient. BMQ concerns is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of SJC; TJC using 28 joints count, ESR (mm/hour) and participant's assessment of DA on VAS (range 0 [very well] to 100 mm [extremely bad]). DAS28 <=3.2= low DA; >3.2 to <=5.1= moderate DA; >5.1=high DA; <2.6=remission. | Month 12 |
| Correlation Between Beliefs About Medicines Questionnaire Concerns Score and Safety at Month 12 | Correlation between BMQ concerns score and safety was assessed by using Spearman correlation coefficient. BMQ Concerns is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported AEs considered related to anti-TNF- alpha therapy. | Month 12 |
| Correlation Between Evolution of Beliefs About Medicines Questionnaire Necessity Score and Disease Activity Score Based on 28 Joints Count | Correlation between evolution of BMQ necessity score and DAS28 score was assessed by calculating Pearson correlation coefficient between change from baseline in DAS28 score and BMQ necessity score at Month 6 and 12. BMQ necessity: 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of SJC; TJC using 28 joints count, ESR (mm/hour) and participant's assessment of DA on VAS (range 0 [very well] to 100 mm [extremely bad]). DAS28 <=3.2= low DA; >3.2 to <=5.1= moderate DA; >5.1=high DA; <2.6=remission. | Month 6, 12 |
| Correlation Between Evolution of Beliefs About Medicines Questionnaire Necessity Score and Safety | Correlation between evolution of BMQ necessity score and safety was assessed by calculating Spearman correlation coefficient between change from baseline in safety score and BMQ necessity score at Month 6 and 12. BMQ necessity: 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported AEs considered related to anti-TNF- alpha therapy. | Month 6, 12 |
| Correlation Between Evolution of Beliefs About Medicines Questionnaire Concerns and Disease Activity Score Based on 28 Joints Count | Correlation between evolution of BMQ concerns score and DAS28 score was assessed by calculating Pearson correlation coefficient between change from baseline in DAS28 score and BMQ concerns score at Month 6 and 12. BMQ concerns is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of SJC; TJC using 28 joints count, ESR (mm/hour) and participant's assessment of DA on VAS (range 0 [very well] to 100 mm [extremely bad]). DAS28 <=3.2= low DA; >3.2 to <=5.1= moderate DA; >5.1=high DA; <2.6=remission. | Month 6, 12 |
| Correlation Between Evolution of Beliefs About Medicines Questionnaire Concerns and Safety | Correlation between evolution of BMQ concerns score and safety was assessed by calculating Spearman correlation coefficient between change from baseline in BMQ concerns score and safety score at Month 6 and 12. BMQ concerns is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported AEs considered related to anti-TNF- alpha therapy. | Month 6, 12 |
| Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Baseline | BMQ consists of two 5-item scales assessing participants' agreement or strong agreement with beliefs about BMQ necessity and BMQ concerns. The items were: BMQ1: Necessity (my health at present depends on my medicines); BMQ2: Concern (having to take medications worries me); BMQ3: Necessity (my life would be impossible without my medications); BMQ4: Concern (I sometimes worry about the long term effects of my medications); BMQ5: Necessity (without my medications I would be very ill); BMQ6: Concern (my medications are mystery to me); BMQ7: Necessity (my health in the future will depend on my medications); BMQ8:Concern (my medications disrupt my life); BMQ9: Necessity (I sometimes worry about becoming too dependent on my medications); BMQ10: Concern (my medications protect me from becoming worse); BMQ11: Necessity (these medicines cause to me unpleasant adverse events). | Baseline |
| Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12 | BMQ consists of two 5-item scales assessing participants' agreement or strong agreement with beliefs about BMQ necessity and BMQ concerns. The items were: BMQ1: Necessity (my health at present depends on my medicines); BMQ2: Concern (having to take medications worries me); BMQ3: Necessity (my life would be impossible without my medications); BMQ4: Concern (I sometimes worry about the long term effects of my medications); BMQ5: Necessity (without my medications I would be very ill); BMQ6: Concern (my medications are mystery to me); BMQ7: Necessity (my health in the future will depend on my medications); BMQ8:Concern (my medications disrupt my life); BMQ9: Necessity (I sometimes worry about becoming too dependent on my medications); BMQ10: Concern (my medications protect me from becoming worse); BMQ11: Necessity (these medicines cause to me unpleasant adverse events). | Month 6, 12 |
| Change From Baseline in Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 12 | BMQ consists of two 5-item scales assessing participants' agreement or strong agreement with beliefs about BMQ necessity and BMQ concerns. The items were: BMQ1: Necessity (my health at present depends on my medicines); BMQ2: Concern (having to take medications worries me); BMQ3: Necessity (my life would be impossible without my medications); BMQ4: Concern (I sometimes worry about the long term effects of my medications); BMQ5: Necessity (without my medications I would be very ill); BMQ6: Concern (my medications are mystery to me); BMQ7: Necessity (my health in the future will depend on my medications); BMQ8:Concern (my medications disrupt my life); BMQ9: Necessity (I sometimes worry about becoming too dependent on my medications); BMQ10: Concern (my medications protect me from becoming worse); BMQ11: Necessity (these medicines cause to me unpleasant adverse events). | Baseline, Month 12 |
| Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale (MARS) at Baseline | BMQ Necessity and BMQ Concerns are described in outcome measure 1 and 2 respectively. BMQ necessity-concerns: difference between necessity and concerns scales (ranges from -20 to +20, where higher score=better cost-benefit). BMQ Harm scale assesses the degree to which medicines are perceived as harmful. BMQ over use scale assesses beliefs about use of medicines and if they are overprescribed by clinicians. BMQ Harm and overuse scales comprise of 4 items, each item assessed on a 5-point scale (1=strongly disagree to 5=strongly agree). Total BMQ Harm and overuse scores were calculated as the sum of individual items and ranges from 4 to 20. Higher scores =more negative orientation towards medicines. MARS consists of a 5-item scale assessing the frequency of non-adherent behavior of participants for taking medication (5=never, 4=rarely, 3=sometimes, 2=often, 1=very often). Scores for each of the 5 items were summed; ranging from 5 to 25. Higher scores=higher levels of adherence. | Baseline |
| Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale at Month 6 and 12 | BMQ Necessity and BMQ Concerns are described in outcome measure 1 and 2 respectively. BMQ necessity-concerns: difference between necessity and concerns scales (ranges from -20 to +20, where higher score=better cost-benefit). BMQ Harm scale assesses the degree to which medicines are perceived as harmful. BMQ over use scale assesses beliefs about use of medicines and if they are overprescribed by clinicians. BMQ Harm and overuse scales comprise of 4 items, each item assessed on a 5-point scale (1=strongly disagree to 5=strongly agree). Total BMQ Harm and overuse scores were calculated as the sum of individual items and ranges from 4 to 20. Higher scores =more negative orientation towards medicines. MARS consists of a 5-item scale assessing the frequency of non-adherent behavior of participants for taking medication (5=never, 4=rarely, 3=sometimes, 2=often, 1=very often). Scores for each of the 5 items were summed; ranging from 5 to 25. Higher scores=higher levels of adherence. | Month 6, 12 |
| Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Necessity Score at Baseline | Correlation between BMQ necessity score and participant's characteristics (demography and clinical factors) was assessed by using Pearson correlation coefficient. BMQ consists of two 5-item scales assessing participants' beliefs about necessity of prescribed medication for controlling disease (BMQ necessity) and their concerns about potential adverse consequences of taking it (BMQ concerns). Respondents indicate their degree of agreement with each statement on five-point Likert scale, ranging from 1=strongly disagree to 5=strongly agree. Total scores for necessity and concerns scales were summed; range from 5 to 25. Higher scores = stronger beliefs. Participant's characteristics included age, height, weight, body mass index (BMI), time since first RA symptoms, diagnosis, number of comorbidities and number of joint replacement or surgery. | Baseline |
| Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Concerns Score at Baseline | Correlation between BMQ concerns score and participant's characteristics (demography and clinical factors) was assessed by using Pearson correlation coefficient. BMQ consists of two 5-item scales assessing participants' beliefs about necessity of prescribed medication for controlling disease (BMQ necessity) and their concerns about potential adverse consequences of taking it (BMQ concerns). Respondents indicate their degree of agreement with each statement on five-point Likert scale, ranging from 1=strongly disagree to 5=strongly agree. Total scores for necessity and concerns scales were summed; range from 5 to 25. Higher scores = stronger beliefs. Participant's characteristics included age, height, weight, BMI, time since first RA symptoms, diagnosis, number of comorbidities and number of joint replacement or surgery. | Baseline |
| Pregnancy |
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| Lost to Follow-up |
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| Lack of Efficacy |
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| Site Closed |
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| Investigator Forget to Complete Visits |
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| Other |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Secondary | Correlation Between Beliefs About Medicines Questionnaire Necessity Score and Safety at Month 12 | Correlation between BMQ necessity score and safety was assessed by using Spearman correlation coefficient. BMQ necessity: 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported adverse events (AEs) considered related to anti-TNF- alpha therapy. | FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | correlation coefficient | Month 12 |
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| Secondary | Correlation Between Beliefs About Medicines Questionnaire Concerns Score and Disease Activity Score Based on 28 Joints Count at Month 12 | Correlation between BMQ concerns score and DAS28 score was assessed by using Pearson correlation coefficient. BMQ concerns is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of SJC; TJC using 28 joints count, ESR (mm/hour) and participant's assessment of DA on VAS (range 0 [very well] to 100 mm [extremely bad]). DAS28 <=3.2= low DA; >3.2 to <=5.1= moderate DA; >5.1=high DA; <2.6=remission. | FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | correlation coefficient | Month 12 |
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| Secondary | Correlation Between Beliefs About Medicines Questionnaire Concerns Score and Safety at Month 12 | Correlation between BMQ concerns score and safety was assessed by using Spearman correlation coefficient. BMQ Concerns is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported AEs considered related to anti-TNF- alpha therapy. | FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | correlation coefficient | Month 12 |
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| Secondary | Correlation Between Evolution of Beliefs About Medicines Questionnaire Necessity Score and Disease Activity Score Based on 28 Joints Count | Correlation between evolution of BMQ necessity score and DAS28 score was assessed by calculating Pearson correlation coefficient between change from baseline in DAS28 score and BMQ necessity score at Month 6 and 12. BMQ necessity: 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of SJC; TJC using 28 joints count, ESR (mm/hour) and participant's assessment of DA on VAS (range 0 [very well] to 100 mm [extremely bad]). DAS28 <=3.2= low DA; >3.2 to <=5.1= moderate DA; >5.1=high DA; <2.6=remission. | FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'n' signifies those participants who were evaluable at specified time point. | Posted | Number | 95% Confidence Interval | correlation coefficient | Month 6, 12 |
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| Secondary | Correlation Between Evolution of Beliefs About Medicines Questionnaire Necessity Score and Safety | Correlation between evolution of BMQ necessity score and safety was assessed by calculating Spearman correlation coefficient between change from baseline in safety score and BMQ necessity score at Month 6 and 12. BMQ necessity: 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported AEs considered related to anti-TNF- alpha therapy. | FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'n' signifies those participants who were evaluable at specified time point. | Posted | Number | 95% Confidence Interval | correlation coefficient | Month 6, 12 |
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| Secondary | Correlation Between Evolution of Beliefs About Medicines Questionnaire Concerns and Disease Activity Score Based on 28 Joints Count | Correlation between evolution of BMQ concerns score and DAS28 score was assessed by calculating Pearson correlation coefficient between change from baseline in DAS28 score and BMQ concerns score at Month 6 and 12. BMQ concerns is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of SJC; TJC using 28 joints count, ESR (mm/hour) and participant's assessment of DA on VAS (range 0 [very well] to 100 mm [extremely bad]). DAS28 <=3.2= low DA; >3.2 to <=5.1= moderate DA; >5.1=high DA; <2.6=remission. | FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'n' signifies those participants who were evaluable at specified time point. | Posted | Number | 95% Confidence Interval | correlation coefficient | Month 6, 12 |
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| Secondary | Correlation Between Evolution of Beliefs About Medicines Questionnaire Concerns and Safety | Correlation between evolution of BMQ concerns score and safety was assessed by calculating Spearman correlation coefficient between change from baseline in BMQ concerns score and safety score at Month 6 and 12. BMQ concerns is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported AEs considered related to anti-TNF- alpha therapy. | FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'n' signifies those participants who were evaluable at each specified time point. | Posted | Number | 95% Confidence Interval | correlation coefficient | Month 6, 12 |
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| Secondary | Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Baseline | BMQ consists of two 5-item scales assessing participants' agreement or strong agreement with beliefs about BMQ necessity and BMQ concerns. The items were: BMQ1: Necessity (my health at present depends on my medicines); BMQ2: Concern (having to take medications worries me); BMQ3: Necessity (my life would be impossible without my medications); BMQ4: Concern (I sometimes worry about the long term effects of my medications); BMQ5: Necessity (without my medications I would be very ill); BMQ6: Concern (my medications are mystery to me); BMQ7: Necessity (my health in the future will depend on my medications); BMQ8:Concern (my medications disrupt my life); BMQ9: Necessity (I sometimes worry about becoming too dependent on my medications); BMQ10: Concern (my medications protect me from becoming worse); BMQ11: Necessity (these medicines cause to me unpleasant adverse events). | BAS included all participants who were enrolled in the study and seen at baseline. Here 'n' signifies those participants who were evaluable for the given sub-scale items. | Posted | Number | percentage of participants | Baseline |
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| Secondary | Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12 | BMQ consists of two 5-item scales assessing participants' agreement or strong agreement with beliefs about BMQ necessity and BMQ concerns. The items were: BMQ1: Necessity (my health at present depends on my medicines); BMQ2: Concern (having to take medications worries me); BMQ3: Necessity (my life would be impossible without my medications); BMQ4: Concern (I sometimes worry about the long term effects of my medications); BMQ5: Necessity (without my medications I would be very ill); BMQ6: Concern (my medications are mystery to me); BMQ7: Necessity (my health in the future will depend on my medications); BMQ8:Concern (my medications disrupt my life); BMQ9: Necessity (I sometimes worry about becoming too dependent on my medications); BMQ10: Concern (my medications protect me from becoming worse); BMQ11: Necessity (these medicines cause to me unpleasant adverse events). | FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items. | Posted | Number | percentage of participants | Month 6, 12 |
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| Secondary | Change From Baseline in Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 12 | BMQ consists of two 5-item scales assessing participants' agreement or strong agreement with beliefs about BMQ necessity and BMQ concerns. The items were: BMQ1: Necessity (my health at present depends on my medicines); BMQ2: Concern (having to take medications worries me); BMQ3: Necessity (my life would be impossible without my medications); BMQ4: Concern (I sometimes worry about the long term effects of my medications); BMQ5: Necessity (without my medications I would be very ill); BMQ6: Concern (my medications are mystery to me); BMQ7: Necessity (my health in the future will depend on my medications); BMQ8:Concern (my medications disrupt my life); BMQ9: Necessity (I sometimes worry about becoming too dependent on my medications); BMQ10: Concern (my medications protect me from becoming worse); BMQ11: Necessity (these medicines cause to me unpleasant adverse events). | FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items. | Posted | Number | percentage of participants | Baseline, Month 12 |
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|
| Secondary | Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale (MARS) at Baseline | BMQ Necessity and BMQ Concerns are described in outcome measure 1 and 2 respectively. BMQ necessity-concerns: difference between necessity and concerns scales (ranges from -20 to +20, where higher score=better cost-benefit). BMQ Harm scale assesses the degree to which medicines are perceived as harmful. BMQ over use scale assesses beliefs about use of medicines and if they are overprescribed by clinicians. BMQ Harm and overuse scales comprise of 4 items, each item assessed on a 5-point scale (1=strongly disagree to 5=strongly agree). Total BMQ Harm and overuse scores were calculated as the sum of individual items and ranges from 4 to 20. Higher scores =more negative orientation towards medicines. MARS consists of a 5-item scale assessing the frequency of non-adherent behavior of participants for taking medication (5=never, 4=rarely, 3=sometimes, 2=often, 1=very often). Scores for each of the 5 items were summed; ranging from 5 to 25. Higher scores=higher levels of adherence. | BAS included all participants who were enrolled in the study and seen at baseline. Here, 'n' signifies those participants who were evaluable for each specified subscales. | Posted | Number | 95% Confidence Interval | correlation coefficient | Baseline |
|
|
|
| Secondary | Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale at Month 6 and 12 | BMQ Necessity and BMQ Concerns are described in outcome measure 1 and 2 respectively. BMQ necessity-concerns: difference between necessity and concerns scales (ranges from -20 to +20, where higher score=better cost-benefit). BMQ Harm scale assesses the degree to which medicines are perceived as harmful. BMQ over use scale assesses beliefs about use of medicines and if they are overprescribed by clinicians. BMQ Harm and overuse scales comprise of 4 items, each item assessed on a 5-point scale (1=strongly disagree to 5=strongly agree). Total BMQ Harm and overuse scores were calculated as the sum of individual items and ranges from 4 to 20. Higher scores =more negative orientation towards medicines. MARS consists of a 5-item scale assessing the frequency of non-adherent behavior of participants for taking medication (5=never, 4=rarely, 3=sometimes, 2=often, 1=very often). Scores for each of the 5 items were summed; ranging from 5 to 25. Higher scores=higher levels of adherence. | FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, 'n' signifies those participants who were evaluable for each specified subscales. | Posted | Number | 95% Confidence Interval | correlation coefficient | Month 6, 12 |
|
|
|
| Secondary | Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Necessity Score at Baseline | Correlation between BMQ necessity score and participant's characteristics (demography and clinical factors) was assessed by using Pearson correlation coefficient. BMQ consists of two 5-item scales assessing participants' beliefs about necessity of prescribed medication for controlling disease (BMQ necessity) and their concerns about potential adverse consequences of taking it (BMQ concerns). Respondents indicate their degree of agreement with each statement on five-point Likert scale, ranging from 1=strongly disagree to 5=strongly agree. Total scores for necessity and concerns scales were summed; range from 5 to 25. Higher scores = stronger beliefs. Participant's characteristics included age, height, weight, body mass index (BMI), time since first RA symptoms, diagnosis, number of comorbidities and number of joint replacement or surgery. | BAS included all participants who were enrolled in the study and seen at baseline. Here, 'n' signifies those participants who were evaluable for the specified characteristics. | Posted | Number | 95% Confidence Interval | correlation coefficient | Baseline |
|
|
|
| Secondary | Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Concerns Score at Baseline | Correlation between BMQ concerns score and participant's characteristics (demography and clinical factors) was assessed by using Pearson correlation coefficient. BMQ consists of two 5-item scales assessing participants' beliefs about necessity of prescribed medication for controlling disease (BMQ necessity) and their concerns about potential adverse consequences of taking it (BMQ concerns). Respondents indicate their degree of agreement with each statement on five-point Likert scale, ranging from 1=strongly disagree to 5=strongly agree. Total scores for necessity and concerns scales were summed; range from 5 to 25. Higher scores = stronger beliefs. Participant's characteristics included age, height, weight, BMI, time since first RA symptoms, diagnosis, number of comorbidities and number of joint replacement or surgery. | BAS included all participants who were enrolled in the study and seen at baseline. Here, 'n' signifies those participants who were evaluable for the specified characteristics. | Posted | Number | 95% Confidence Interval | correlation coefficient | Baseline |
|
|
|
| 33 |
| 460 |
| 82 |
| 460 |
| Myocardial infarction | Cardiac disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Intestinal perforation | Gastrointestinal disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDra v18.0 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDra v18.0 | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDra v18.0 | Non-systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDra v18.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDra v18.0 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDra v18.0 | Non-systematic Assessment |
|
| Tuberculosis | Infections and infestations | MedDra v18.0 | Non-systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDra v18.0 | Non-systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDra v18.0 | Non-systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDra v18.0 | Non-systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | MedDra v18.0 | Non-systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDra v18.0 | Non-systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDra v18.0 | Non-systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDra v18.0 | Non-systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Benign salivary gland neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra v18.0 | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra v18.0 | Non-systematic Assessment |
|
| Endometrial adeocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra v18.0 | Non-systematic Assessment |
|
| Leiomyosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra v18.0 | Non-systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra v18.0 | Non-systematic Assessment |
|
| Aphonia | Nervous system disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Nephrotic syndrome | Renal and urinary disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Cholecystectomy | Surgical and medical procedures | MedDra v18.0 | Non-systematic Assessment |
|
| Colon operation | Surgical and medical procedures | MedDra v18.0 | Non-systematic Assessment |
|
| Coronary artery bypass | Surgical and medical procedures | MedDra v18.0 | Non-systematic Assessment |
|
| Hip arthroplasty | Surgical and medical procedures | MedDra v18.0 | Non-systematic Assessment |
|
| Osteosynthesis | Surgical and medical procedures | MedDra v18.0 | Non-systematic Assessment |
|
| Peripheral endarterectomy | Surgical and medical procedures | MedDra v18.0 | Non-systematic Assessment |
|
| Prolapse repair | Surgical and medical procedures | MedDra v18.0 | Non-systematic Assessment |
|
| Salivary gland operation | Surgical and medical procedures | MedDra v18.0 | Non-systematic Assessment |
|
| Sinus antrostomy | Surgical and medical procedures | MedDra v18.0 | Non-systematic Assessment |
|
| Stent placement | Surgical and medical procedures | MedDra v18.0 | Non-systematic Assessment |
|
| Surgery | Surgical and medical procedures | MedDra v18.0 | Non-systematic Assessment |
|
| Aortic stenosis | Vascular disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Peripheral ischaemia | Vascular disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Anal erosion | Gastrointestinal disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Anal ulcer | Gastrointestinal disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Hernia | General disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Swelling | General disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Temperature intolerance | General disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Sarcoidosis | Immune system disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDra v18.0 | Non-systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDra v18.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDra v18.0 | Non-systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDra v18.0 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDra v18.0 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDra v18.0 | Non-systematic Assessment |
|
| Infective exacerbation of bronchiectasis | Infections and infestations | MedDra v18.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDra v18.0 | Non-systematic Assessment |
|
| Localised infection | Infections and infestations | MedDra v18.0 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDra v18.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDra v18.0 | Non-systematic Assessment |
|
| Post procedural infection | Infections and infestations | MedDra v18.0 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDra v18.0 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDra v18.0 | Non-systematic Assessment |
|
| Sinusitis aspergillus | Infections and infestations | MedDra v18.0 | Non-systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDra v18.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDra v18.0 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDra v18.0 | Non-systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDra v18.0 | Non-systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDra v18.0 | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDra v18.0 | Non-systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDra v18.0 | Non-systematic Assessment |
|
| Suture rupture | Injury, poisoning and procedural complications | MedDra v18.0 | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDra v18.0 | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDra v18.0 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDra v18.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Plasma cell myelomas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra v18.0 | Non-systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Morton's neuralgia | Nervous system disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Renal artery stenosis | Renal and urinary disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Menopausal symptom | Reproductive system and breast disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Alopecia areata | Skin and subcutaneous tissue disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Bunion operation | Surgical and medical procedures | MedDra v18.0 | Non-systematic Assessment |
|
| Cyst removal | Surgical and medical procedures | MedDra v18.0 | Non-systematic Assessment |
|
| Ear operation | Surgical and medical procedures | MedDra v18.0 | Non-systematic Assessment |
|
| Foot operation | Surgical and medical procedures | MedDra v18.0 | Non-systematic Assessment |
|
| Injection | Surgical and medical procedures | MedDra v18.0 | Non-systematic Assessment |
|
| Renal artery stent placement | Surgical and medical procedures | MedDra v18.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDra v18.0 | Non-systematic Assessment |
|
| Raynaud's phenomenon | Vascular disorders | MedDra v18.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
| BMQ2: Concern (Totally Agree) (n=422) |
|
| BMQ3: Necessity (Agree) (n=424) |
|
| BMQ3: Necessity (Totally Agree) (n=424) |
|
| BMQ4: Concern (Agree) (n=424) |
|
| BMQ4: Concern (Totally Agree) (n=424) |
|
| BMQ5: Necessity (Agree) (n=427) |
|
| BMQ5: Necessity (Totally Agree) (n=427) |
|
| BMQ6: Concern (Agree) (n=419) |
|
| BMQ6: Concern (Totally Agree) (n=419) |
|
| BMQ7: Necessity (Agree) (n=426) |
|
| BMQ7: Necessity (Totally Agree) (n=426) |
|
| BMQ8: Concern (Agree) (n=426) |
|
| BMQ8: Concern (Totally Agree) (n=426) |
|
| BMQ9: Concern (Agree) (n=424) |
|
| BMQ9: Concern (Totally Agree) (n=424) |
|
| BMQ10: Necessity (Agree) (n=427) |
|
| BMQ10: Necessity (Totally Agree (n=427) |
|
| BMQ11: Concern (Agree) (n=428) |
|
| BMQ11: Concern (Totally Agree) (n=428) |
|
| Title | Measurements |
|---|---|
|
| BMQ1: Necessity (Totally Agree)- Month 12 (n=363) |
|
| BMQ2: Concern (Agree)- Month 6 (n=374) |
|
| BMQ2: Concern (Agree)- Month 12 (n=360) |
|
| BMQ2: Concern (Totally Agree)- Month 6 (n=374) |
|
| BMQ2: Concern (Totally Agree)- Month 12 (n=360) |
|
| BMQ3: Necessity (Agree)- Month 6 (n=376) |
|
| BMQ3: Necessity (Agree)- Month 12 (n=363) |
|
| BMQ3: Necessity (Totally Agree)- Month 6 (n=376) |
|
| BMQ3: Necessity (Totally Agree)- Month 12 (n=363) |
|
| BMQ4: Concern (Agree)- Month 6 (n=376) |
|
| BMQ4: Concern (Agree)- Month 12 (n=361) |
|
| BMQ4: Concern (Totally Agree)- Month 6 (n=376) |
|
| BMQ4: Concern (Totally Agree)- Month 12 (n=361) |
|
| BMQ5: Necessity (Agree)- Month 6 (n=375) |
|
| BMQ5: Necessity (Agree)- Month 12 (n=362) |
|
| BMQ5: Necessity (Totally Agree)- Month 6 (n=375) |
|
| BMQ5: Necessity (Totally Agree)- Month 12 (n=362) |
|
| BMQ6: Concern (Agree)- Month 6 (n=373) |
|
| BMQ6: Concern (Agree)- Month 12 (n=359) |
|
| BMQ6: Concern (Totally Agree)- Month 6 (n=373) |
|
| BMQ6: Concern (Totally Agree)- Month 12 (n=359) |
|
| BMQ7: Necessity (Agree)- Month 6 (n=376) |
|
| BMQ7: Necessity (Agree)- Month 12 (n=361) |
|
| BMQ7: Necessity (Totally Agree)- Month 6 (n=376) |
|
| BMQ7: Necessity (Totally Agree)- Month 12 (n=361) |
|
| BMQ8: Concern (Agree)- Month 6 (n=373) |
|
| BMQ8: Concern (Agree)- Month 12 (n=361) |
|
| BMQ8: Concern (Totally Agree)- Month 6 (n=373) |
|
| BMQ8: Concern (Totally Agree)- Month 12 (n=361) |
|
| BMQ9: Concern (Agree)- Month 6 (n=375) |
|
| BMQ9: Concern (Agree)- Month 12 (n=361) |
|
| BMQ9: Concern (Totally Agree)- Month 6 (n=375) |
|
| BMQ9: Concern (Totally Agree)- Month 12 (n=361) |
|
| BMQ10: Necessity (Agree)- Month 6 (n=380) |
|
| BMQ10: Necessity (Agree)- Month 12 (n=363) |
|
| BMQ10: Necessity (Totally Agree)- Month 6 (n=380) |
|
| BMQ10: Necessity (Totally Agree)- Month 12 (n=363) |
|
| BMQ11: Concern (Agree)- Month 6 (n=378) |
|
| BMQ11: Concern (Agree)- Month 12 (n=363) |
|
| BMQ11: Concern (Totally Agree)- Month 6 (n=378) |
|
| BMQ11: Concern (Totally Agree)- Month 12 (n=363) |
|
| Title | Measurements |
|---|---|
|
| BMQ2: Concern-Change at Month 12 (n=336) |
|
| BMQ3: Necessity- Baseline (n=341) |
|
| BMQ3: Necessity-Change at Month 12 (n=341) |
|
| BMQ4: Concern- Baseline (n=340) |
|
| BMQ4: Concern-Change at Month 12 (n=340) |
|
| BMQ5: Necessity- Baseline (n=344) |
|
| BMQ5: Necessity-Change at Month 12 (n=344) |
|
| BMQ6: Concern- Baseline (n=339) |
|
| BMQ6: Concern-Change at Month 12 (n=339) |
|
| BMQ7: Necessity- Baseline (n=341) |
|
| BMQ7: Necessity-Change at Month 12 (n=341) |
|
| BMQ8: Concern- Baseline (n=342) |
|
| BMQ8: Concern-Change at Month 12 (n=342) |
|
| BMQ9: Concern- Baseline (n=339) |
|
| BMQ9: Concern-Change at Month 12 (n=339) |
|
| BMQ10: Necessity (n=344)- Baseline (n=344) |
|
| BMQ10: Necessity-Change at Month 12 (n=344) |
|
| BMQ11: Concern- Baseline (n=344) |
|
| BMQ11: Concern-Change at Month 12 (n=344) |
|
|
| BMQ Overuse (n=405) |
|
| BMQ Harm (n=408) |
|
|
| BMQ -Concerns: Month 12 (n=348) |
|
| BMQ (Necessity-Concerns): Month 6 (n=356) |
|
| BMQ (Necessity-Concerns): Month 12 (n=344) |
|
| BMQ Overuse: Month 6 (n=364) |
|
| BMQ Overuse: Month 12 (n=349) |
|
| BMQ Harm: Month 6 (n=366) |
|
| BMQ Harm: Month 12 (n=350) |
|
| Title | Measurements |
|---|---|
|
| BMI (n=402) |
|
| Time since first RA symptoms (n=409) |
|
| Time since first RA diagnosis (n= 422) |
|
| Number (No.) of comorbidities (n=422) |
|
| No. of joint replacement/surgery (n= 422) |
|
| Title | Measurements |
|---|---|
|
| BMI (n=389) |
|
| Time since first RA symptoms (n=396) |
|
| Time since first RA diagnosis (n=409) |
|
| No. of comorbidities (n=409) |
|
| No. of joint replacement/surgery (n=409) |
|