Psoriasis Arthritis, Rheumatoid Arthritis
Conditions
Brief summary
It is known from the COMET-trial that patients who start Enbrel treatment early have a great chance of reaching clinical remission and radiographic nonprogression. It is still unclear, however, how many patients with early arthritis achieve remission and radiographic nonprogression under the conditions of routine rheumatologic care and the local recommendations of Enbrel treatment (pre-treatment of at least 2 DMARDs, one of them MTX). Therefore, no robust x-ray data are available to show/demonstrate * the average extent of x-ray damage in routine patients on Enbrel outside clinical studies. * if the outstanding effect on structural damage of Enbrel can be reproduced in routine practice. * that the 'Silent Progressor' is an issue relevant not only in clinical trials, but also for day-to-day decision making. * the optimal onset of Enbrel treatment in the course of the disease to prevent radiographic damage
Detailed description
Non-interventional study: subjects to be selected according to the usual clinical practice of their physician
Interventions
The patients will be treated in accordance with the requirements of the labelling of Enbrel® in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.
Sponsors
Study design
Eligibility
Inclusion criteria
* Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator's study team before subjects are included in the study. * Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study is a requirement for inclusion into this study. Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: * Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. * Definitive diagnosis of RA or PsA. * Eligible for Etanercept treatment according to Summary of Product Characteristics (SmPC). * Inclusion of subjects pretreated with other biologics other than Etanercept is possible * One plain radiograph of hands and feet (Anteroposterior) within 3 month prior to initiation of treatment with Etanercept and one planned consecutive radiograph of hand and feet taken over 12 to 18 months according to German recommendations for patients treated with biologics.
Exclusion criteria
* Receipt of any investigational drug within 3 months of study inclusion. *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 2 (Week 156): CAS | Baseline, Week 156 | To assess radiological damage, mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively. |
| Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at the End of Phase 2 (Week 156): EAS | Baseline, Week 156 | To assess radiological damage, mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively. |
| Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 1 (Week 78): Completer Analysis Set (CAS) | Baseline, Week 78 | To assess radiological damage, mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively. |
| Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at the End of Phase 2 (Week 156): CAS | Pre-treatment, Week 156 | The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (\>0.5), no change (-0.5 to 0.5) and decrease (\<-0.5). Participants with no change or a decrease were considered to be in radiographic remission. |
| Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 2 (Week 156): EAS | Pre-treatment, Week 156 | The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (\>0.5), no change (-0.5 to 0.5) and decrease (\<-0.5). Participants with no change or a decrease were considered to be in radiographic remission. |
| Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): CAS | Pre-treatment, Week 78 | The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (\>0.5), no change (-0.5 to 0.5) and decrease (\<-0.5). Participants with no change or a decrease were considered to be in radiographic remission. |
| Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): EAS | Pre-treatment, Week 78 | The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (greater than \[\>\] 0.5), no change (-0.5 to 0.5) and decrease (less than \[\<\] -0.5). Participants with no change or a decrease were considered to be in radiographic remission. |
| Change From Baseline in Van Der Heijde Total Modified Total Sharp Score (mTSS) or Adapted mTSS at End of Phase 1 (Week 78): Efficacy Analysis Set (EAS) | Baseline, Week 78 | To assess radiological damage mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hannover Functional Ability Questionnaire (FFbH) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 | FFbH is a self-administered patient questionnaire composed by 18 questions on functional ability in activities of daily living. Each question was answered by the participant as Yes, I can perform the activity without difficulty (score assigned =2), Yes, but with difficulties (score assigned =1) and No or only with external help (score assigned =0). Final FFbH score (%) was then computed according to formula: (Sum of scores\*100) divided by (2\*number of valid answers), ranging between 0 (no functional capacity) to 100 (full functional capacity); higher scores indicate better daily activities. FFbH functional remission was defined as FFbH functional capacity of \>= 83%. |
| Change From Baseline in Disease Activity Score-28 (DAS-28) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 | DAS28 was calculated from swollen joint count and tender joint count using 28 joint count, C-reactive protein (CRP) in milligram per liter (mg/L) and participant global assessment (PtGA) of disease activity measured on a 100 mm visual analog scale (VAS) ranging from 0 (good condition) to 100 (worst condition), where higher scores indicate worse health condition). DAS28 total score range: 0 (no disease activity) to 9.4 (maximum disease activity), higher score indicates more disease activity. DAS-28 score of 2.6 to 3.2= low, 3.2 to 5.1= moderate and \>5.1= high disease activity. DAS-28 score of \<2.6= disease remission. DAS28-4(CRP) = (0.56\*sqrt\[TJC28\] + 0.28\*sqrt\[SJC28\] + 0.36\*ln\[CRP+1\]) + 0.014\*GH + 0.96) and DAS28-4(ESR) = (0.56\*sqrt\[TJC28\] + 0.28\*sqrt\[SJC28\] + 0.70\*ln\[ESR\] + 0.014\*GH), where sqrt = square root, ln = natural logarithm. |
| Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 | CDAI was calculated from tender and swollen joints using 28 joint count, participant global assessment (PtGA) and physician global assessment (PhyGA). PtGA and PhyGA both were assessed on 0-100 mm VAS scale, where higher scores indicated greater affection due to disease activity. CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of \<=10 indicates low disease activity and a score of \<= 2.8 indicates remission. |
| Change From Baseline in Simple Disease Activity Index (SDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 | SDAI was calculated from tender and swollen joints using 28 joint count, participant global assessment (PtGA), physician global assessment and (PhyGA) and CRP (in mg/L). PtGA and PhyGA both were assessed on 0-100 mm VAS scale, where higher scores indicated greater affection due to disease activity. SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of \<=11 indicates low disease activity and a score of \<=3.3 indicates remission. |
| Percentage of Participants With Rheumatoid Arthritis, With Low Disease Activity Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 | CDAI was calculated from tender and swollen joints using 28 joint count, PtGA and PhyGA. CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of \<=10 indicates low disease activity and a score of \<= 2.8 indicates remission. SDAI was calculated from tender and swollen joints using 28 joint count, PtGA, PhyGA and CRP (in mg/L). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of \<=11 indicates low disease activity and a score of \<=3.3 indicates remission. PtGA and PhyGA both were assessed on 0-100 mm VAS scale, where higher scores indicated greater affection due to disease activity. |
| Change From Baseline in Participant Pain Visual Analogue Scale (VAS) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 | VAS: participants placed a mark indicating the intensity of their pain on a scale of 0 (no pain) to 100 mm (worst possible pain). Higher scores indicate greater level of pain. |
| Change From Baseline in Physician Global Assessment (PhyGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 | PhyGA: physician marked intensity of participants' pain on a visual analogue scale of 0 (no disease activity) to 100 mm (worst possible condition). Higher scores indicate greater level of disease activity. |
| Change From Baseline in Participant Global Assessment (PtGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 | PtGA: participant assessed their disease activity using a 100 mm visual analog scale ranging from 0 = very good to 100 = worst. Higher scores indicate worse health status. |
| Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 | EQ-5D: participant rated questionnaire to assess generic health status in two parts: single utility score and visual analog scale. For utility score, participants rated their current health state on 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression with each dimension having three levels of function: 1 indicates no problem; 2 indicates some problem; 3 indicates extreme problem. |
| Duration of Morning Stiffness in Participants With Temporary Rigidity | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 | Rigidity was temporary when 'Yes' was given for the question if daily activities could be done without stiffness; rigidity was permanent when 'No' was given for the question if daily activities could be done without stiffness. |
| Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 | Participants with psoriatic arthritis were distributed in following different classes depending upon percentage (%) of BSA affected: 1) less than (\<) 3 %, 2) 3-10%, 3) 11-20% and 4) \>20%. Psoriatic arthritis affecting \<3% BSA was considered as mild, 3 to 10 % as moderate and \>10 percent as severe. |
| Change From Baseline in Nail Involvement at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 | In this outcome measure change in number of nails affected by psoriatic arthritis at specified week compared to baseline is reported. Nails included both finger nails and toe nails. |
| Change From Baseline in Inflamed Dactylitic Digits at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 | In this outcome measure change in number of inflamed dactylitic digits at specified week compared to baseline is reported. Dactylitis is inflammation of dactylitic digits (fingers and toes). |
| Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | Baseline, Week 78, 156 | In this outcome measure number of participants with use of glucocorticoids and DMARDs at baseline and specified weeks are reported. If participants used glucocorticoids and DMARDs, it was denoted by Yes and if they did not use, it was denoted by No. Data have been reported separately for glucocorticoids and DMARDs at specified weeks respectively, in 4 categories as: 1) Baseline: No and Specified Week: No, 2) Baseline: Yes and Specified Week: No, 3) Baseline: No and Specified Week: Yes, 4) Baseline: Yes and Specified Week: Yes. |
| Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Continuation of Treatment With Etanercept | Baseline up to Week 156 | In this outcome number of participants who participated or not participated in RUDI and PIT and impact of their participation in continuation or termination of treatment with Etanercept is reported. For participants whom data was not recorded is reported under category No Data. |
| Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline up to Week 156 | In this outcome number of participants who participated or not participated in RUDI and PIT and impact of their participation in quality of life parameters using EQ-5D health questionnaire is reported. For participants whom data was not recorded is reported under category No Data. EQ-5D: participant rated questionnaire to assess generic health status in two parts: single utility score and visual analog scale. For utility score, participants rated their current health state on 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression with each dimension having three levels of function: 1 indicates no problem; 2 indicates some problem; 3 indicates extreme problem. |
| Percentage of Participants With Rheumatoid Arthritis, With Remission Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156 | CDAI was calculated from tender and swollen joints using 28 joint count, PtGA and PhyGA. CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of \<=10 indicates low disease activity and a score of \<= 2.8 indicates remission. SDAI was calculated from tender and swollen joints using 28 joint count, PtGA, PhyGA and CRP (in mg/L). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of \<=11 indicates low disease activity and a score of \<=3.3 indicates remission. PtGA and PhyGA both were assessed on 0-100 mm VAS scale, where higher scores indicated greater affection due to disease activity. |
| Linear Relationship Between Normalized Radiographic Progression and Disease Duration | Baseline up to Week 78 | Linear relationship between radiographic progression and disease duration was evaluated using a linear regression model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was disease duration. |
| Effect on Normalized Radiographic Progression With Respect to Baseline Positivity of Anti-citrullinated Protein Antibody (ACPA) - Rheumatoid Factor (RF) | Baseline up to Week 78 | Effect on normalized radiographic progression with respect to ACPA-RF was evaluated using an analysis of variance (ANOVA) model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was groups of positive testing of ACPA and RF at baseline. |
| Effect on Normalized Radiographic Progression With Respect to Baseline Usage of Concomitant Medication | Baseline up to Week 78 | Effect on normalized radiographic progression with respect to use of concomitant medication at baseline was evaluated using an ANOVA model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was groups of concomitant medication as found among the medication given concomitantly during study that is recorded at baseline. |
| Effect on Normalized Radiographic Progression With Respect to Previous Treatment With Biologics | Baseline up to Week 78 | Effect on normalized radiographic progression of previous treatment with biologics was evaluated using an ANOVA model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was previous treatment with biologics. |
| Effect on Normalized Radiographic Progression With Respect to Baseline Disease Activity Score-28 (DAS-28) | Baseline up to Week 78 | Effect on radiographic progression with respect to baseline DAS-28 was evaluated using ANOVA model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was baseline DAS-28. Baseline DAS-28 is less than or equal to (\<=) 5.1 or \>5.1. DAS28: score range from 0 (none) to 9.4 (extreme disease activity); low =2.6 to 3.2, moderate =3.2 to 5.1, and high disease activity \>5.1. DAS28 score of \<2.6 indicates disease remission. |
| Change From Baseline in Total Erosion Score at End of Phase 1 (Week 78) and Phase 2 (Week 156) | Baseline, Week 78, 156 | Total erosion score as per van der Hejde method consisted of 2 dimensions: a) hands (32 erosion locations, each location graded from 0 \[no erosion\] to 5 \[maximum severity\], sum of grading of each location resulted in score of 0 to 160); and b) feet (12 erosion locations, each location graded from 0 \[no erosion\] to 10 \[maximum severity\], sum of grading of each location resulted in score of 0 to 120). Sum of erosion scores of hand (0 to 160) and feet (0 to 120) gave a total erosion score as 0 to 280, where 0 was no erosion at all and 280 was worst possible condition, higher scores indicated severe joint destruction. |
| Change From Baseline in Total Joint Space Narrow Score at End of Phase 1 (Week 78) and Phase 2 (Week 156) | Baseline, Week 78, 156 | Total joint space narrow score as per van der Hejde method consisted of 2 dimensions: a) hands (30 joint space locations, each location graded from 0 \[normal joint space\] to 4 \[bony ankylosis\], sum of grading of each location resulted in score of 0 to 120); and b) feet (12 erosion locations, each location graded from 0 \[no erosion\] to 4 \[bony ankylosis\], sum of grading of each location resulted in score of 0 to 48). Sum of joint space narrow scores of hand (0 to 120) and feet (0 to 48) gave a total joint space narrow score as 0 to 168, where 0 was normal joint space and 168 was maximum narrowing in joints, higher scores indicated severe joint destruction. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs) | Baseline up to Week 156 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events. |
| Number of Participants Who Used Concomitant Medication | Baseline up to Week 156 | Number of participants who used medication other than Etanercept for relief of pain. It was determined by the treating physician. |
| Number of Participants With Pregnancy, Puerperium and Perinatal Conditions | Baseline up to Week 156 | In this outcome measure total number of participants with pregnancy, puerperium and perinatal conditions are reported. Pregnancy, puerperium and perinatal conditions included pregnancy, abortion, abortion spontaneous or premature baby. |
| Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 78, 156 | Physicians and participants rated the tolerability of Etanercept treatment by means of a 4-point scale as: 1) very good, 2) good, 3) moderate and 4) insufficient. |
| Number of Participants With Treatment-Emergent Treatment Related Adverse Events | Baseline up to Week 156 | Treatment-related AE was any untoward medical occurrence in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events. Relatedness to study treatment was assessed by the investigator. |
| Number of Participants With Discontinuation of Etanercept Treatment | Week 78, 156 | Number of participants those who discontinued Etanercept treatment at Week 78 and 156 are reported in this outcome measure. |
| Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity | Baseline up to Week 156 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events. AEs were classified according to the severity in 3 categories a)mild: AEs not interfered with participant's usual function b)moderate: AEs interfered to some extent with participant's usual function c)severe: AEs interfered significantly with participant's usual function. Participants may be counted in more than 1 category. |
Participant flow
Recruitment details
Participants those who were recruited despite of an unknown or unclear disease diagnosis, were only included in safety analysis for the study, not for efficacy evaluation.
Participants by arm
| Arm | Count |
|---|---|
| Participants With Rheumatoid Arthritis Participants with rheumatoid arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156. | 1,378 |
| Participants With Psoriatic Arthritis Participants with psoriatic arthritis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156. | 440 |
| Participants With Unclear Diagnosis Participants with unclear diagnosis, who were on Etanercept routine treatment (as per the requirements of the labelling of Enbrel in Germany; dosage and duration of therapy was determined by the physician to meet the participants' individual needs for treatment), were observed for safety and radiological efficacy up to Week 156. During Phase 1 participants were followed up after every 13 weeks up to Week 78 and during Phase 2 participants were followed up after every 16 weeks from Week 78 till Week 156. | 3 |
| Total | 1,821 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Phase 1 (78 Weeks) | Adverse Event | 122 | 39 | 0 |
| Phase 1 (78 Weeks) | Lack of Efficacy | 227 | 82 | 0 |
| Phase 1 (78 Weeks) | No Data | 249 | 66 | 2 |
| Phase 1 (78 Weeks) | Other | 33 | 20 | 0 |
| Phase 2 (78 Weeks) | Adverse Event | 4 | 4 | 0 |
| Phase 2 (78 Weeks) | Lack of Efficacy | 14 | 2 | 0 |
| Phase 2 (78 Weeks) | No Data | 43 | 11 | 0 |
| Phase 2 (78 Weeks) | Other | 5 | 1 | 0 |
Baseline characteristics
| Characteristic | Participants With Rheumatoid Arthritis | Total | Participants With Unclear Diagnosis | Participants With Psoriatic Arthritis |
|---|---|---|---|---|
| Age, Customized 18 to 64 years | 976 Participants | 1365 Participants | 2 Participants | 387 Participants |
| Age, Customized 65 years or more | 395 Participants | 444 Participants | 0 Participants | 49 Participants |
| Age, Customized Less than 18 years | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Age, Customized No data | 6 Participants | 11 Participants | 1 Participants | 4 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — | — |
| Sex/Gender, Customized Female | 1062 Participants | 1323 Participants | 2 Participants | 259 Participants |
| Sex/Gender, Customized Male | 316 Participants | 497 Participants | 0 Participants | 181 Participants |
| Sex/Gender, Customized No Data | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 6 / 1,378 | 0 / 440 | 0 / 3 |
| other Total, other adverse events | 579 / 1,378 | 167 / 440 | 1 / 3 |
| serious Total, serious adverse events | 159 / 1,378 | 47 / 440 | 0 / 3 |
Outcome results
Change From Baseline in Van Der Heijde Total Modified Total Sharp Score (mTSS) or Adapted mTSS at End of Phase 1 (Week 78): Efficacy Analysis Set (EAS)
To assess radiological damage mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively.
Time frame: Baseline, Week 78
Population: Efficacy analysis set for Phase 1= all participants who had received at least 1 dose of Etanercept and had baseline X-ray (Rx1) and end of phase 1 X-ray (Rx2). Here, Overall Number of Participants Analyzed =number of participants evaluable for this outcome measure; Number Analyzed=number of participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Rheumatoid Arthritis | Change From Baseline in Van Der Heijde Total Modified Total Sharp Score (mTSS) or Adapted mTSS at End of Phase 1 (Week 78): Efficacy Analysis Set (EAS) | Baseline | 25.1 Units on a scale | Standard Deviation 42.4 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Van Der Heijde Total Modified Total Sharp Score (mTSS) or Adapted mTSS at End of Phase 1 (Week 78): Efficacy Analysis Set (EAS) | Change at Week 78 | 0.6 Units on a scale | Standard Deviation 7.2 |
| Participants With Psoriatic Arthritis | Change From Baseline in Van Der Heijde Total Modified Total Sharp Score (mTSS) or Adapted mTSS at End of Phase 1 (Week 78): Efficacy Analysis Set (EAS) | Baseline | 14.7 Units on a scale | Standard Deviation 25.7 |
| Participants With Psoriatic Arthritis | Change From Baseline in Van Der Heijde Total Modified Total Sharp Score (mTSS) or Adapted mTSS at End of Phase 1 (Week 78): Efficacy Analysis Set (EAS) | Change at Week 78 | -0.4 Units on a scale | Standard Deviation 5.9 |
Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 1 (Week 78): Completer Analysis Set (CAS)
To assess radiological damage, mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively.
Time frame: Baseline, Week 78
Population: Completer analysis set for Phase 1: all participants who had received at least 1 dose of Etanercept and had clinical data for Rx1 and Rx2 and provided data for end of Phase 1 of study. Overall Number of Participants Analyzed = participants evaluable for this outcome measure. Number Analyzed= participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Rheumatoid Arthritis | Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 1 (Week 78): Completer Analysis Set (CAS) | Baseline | 25.3 Units on a scale | Standard Deviation 42.5 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 1 (Week 78): Completer Analysis Set (CAS) | Change at Week 78 | 0.6 Units on a scale | Standard Deviation 7.2 |
| Participants With Psoriatic Arthritis | Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 1 (Week 78): Completer Analysis Set (CAS) | Baseline | 14.7 Units on a scale | Standard Deviation 25.8 |
| Participants With Psoriatic Arthritis | Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 1 (Week 78): Completer Analysis Set (CAS) | Change at Week 78 | -0.5 Units on a scale | Standard Deviation 5.8 |
Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 2 (Week 156): CAS
To assess radiological damage, mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively.
Time frame: Baseline, Week 156
Population: Completer analysis set for Phase 2 included all participants who had received at least 1 dose of Etanercept, and had clinical data for the obligatory X-ray (Rx1) and Rx3, and completed Phase 2 of the study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Rheumatoid Arthritis | Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 2 (Week 156): CAS | 1.4 Units on a scale | Standard Deviation 9.9 |
| Participants With Psoriatic Arthritis | Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 2 (Week 156): CAS | 0.7 Units on a scale | Standard Deviation 8.2 |
Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at the End of Phase 2 (Week 156): EAS
To assess radiological damage, mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively.
Time frame: Baseline, Week 156
Population: Efficacy analysis set for Phase 2 included all participants who had received at least 1 dose of Etanercept and had Rx1 and end of Phase 2 X-ray (Rx3). Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Rheumatoid Arthritis | Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at the End of Phase 2 (Week 156): EAS | 1.4 Units on a scale | Standard Deviation 9.9 |
| Participants With Psoriatic Arthritis | Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at the End of Phase 2 (Week 156): EAS | 0.7 Units on a scale | Standard Deviation 8.2 |
Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): CAS
The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (\>0.5), no change (-0.5 to 0.5) and decrease (\<-0.5). Participants with no change or a decrease were considered to be in radiographic remission.
Time frame: Pre-treatment, Week 78
Population: CAS for phase 1 included all participants who had received at least 1 dose of Etanercept, and had Rx1 and Rx2, and provided data for end of Phase 1 of study. Here, Overall Number of Participants Analyzed=number of participants evaluable for this outcome measure and Number Analyzed=number of participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Rheumatoid Arthritis | Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): CAS | Change at Week 78 | -0.306 Scores per year | Standard Deviation 6.002 |
| Participants With Rheumatoid Arthritis | Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): CAS | Pre-treatment | 0.981 Scores per year | Standard Deviation 4.413 |
| Participants With Psoriatic Arthritis | Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): CAS | Pre-treatment | 1.080 Scores per year | Standard Deviation 5.182 |
| Participants With Psoriatic Arthritis | Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): CAS | Change at Week 78 | -1.033 Scores per year | Standard Deviation 8.724 |
Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): EAS
The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (greater than \[\>\] 0.5), no change (-0.5 to 0.5) and decrease (less than \[\<\] -0.5). Participants with no change or a decrease were considered to be in radiographic remission.
Time frame: Pre-treatment, Week 78
Population: Efficacy analysis set for Phase 1 included all participants who had received at least 1 dose of Etanercept and had Rx1 and Rx2. Here, Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure and Number Analyzed = number of participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Rheumatoid Arthritis | Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): EAS | Change at Week 78 | -0.267 Scores per year | Standard Deviation 5.989 |
| Participants With Rheumatoid Arthritis | Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): EAS | Pre-treatment | 0.959 Scores per year | Standard Deviation 4.396 |
| Participants With Psoriatic Arthritis | Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): EAS | Pre-treatment | 1.056 Scores per year | Standard Deviation 5.127 |
| Participants With Psoriatic Arthritis | Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): EAS | Change at Week 78 | -0.995 Scores per year | Standard Deviation 8.628 |
Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 2 (Week 156): EAS
The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (\>0.5), no change (-0.5 to 0.5) and decrease (\<-0.5). Participants with no change or a decrease were considered to be in radiographic remission.
Time frame: Pre-treatment, Week 156
Population: Efficacy analysis set for Phase 2 included all participants who had received at least 1 dose of Etanercept and had Rx1 and Rx3. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Rheumatoid Arthritis | Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 2 (Week 156): EAS | -0.473 Scores per year | Standard Deviation 5.94 |
| Participants With Psoriatic Arthritis | Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 2 (Week 156): EAS | -0.348 Scores per year | Standard Deviation 3.985 |
Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at the End of Phase 2 (Week 156): CAS
The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (\>0.5), no change (-0.5 to 0.5) and decrease (\<-0.5). Participants with no change or a decrease were considered to be in radiographic remission.
Time frame: Pre-treatment, Week 156
Population: CAS for phase 2 included all participants who had received at least 1 dose of Etanercept, and had Rx1 and Rx2, and completed phase 2 of the study. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Rheumatoid Arthritis | Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at the End of Phase 2 (Week 156): CAS | -0.473 Scores per year | Standard Deviation 5.94 |
| Participants With Psoriatic Arthritis | Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at the End of Phase 2 (Week 156): CAS | -0.348 Scores per year | Standard Deviation 3.985 |
Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis
CDAI was calculated from tender and swollen joints using 28 joint count, participant global assessment (PtGA) and physician global assessment (PhyGA). PtGA and PhyGA both were assessed on 0-100 mm VAS scale, where higher scores indicated greater affection due to disease activity. CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of \<=10 indicates low disease activity and a score of \<= 2.8 indicates remission.
Time frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Population: Full analysis set: all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Number Analyzed = number of participants evaluable for the specified time points. Data for this outcome measure was to be collected and evaluated only for participants with rheumatoid arthritis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Rheumatoid Arthritis | Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis | Change at Week 104 | -17.53 Units on a scale | Standard Deviation 11.99 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis | Baseline | 25.64 Units on a scale | Standard Deviation 12.14 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis | Change at Week 13 | -11.51 Units on a scale | Standard Deviation 12.13 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis | Change at Week 26 | -13.49 Units on a scale | Standard Deviation 12.53 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis | Change at Week 39 | -13.98 Units on a scale | Standard Deviation 12.78 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis | Change at Week 52 | -14.32 Units on a scale | Standard Deviation 12.29 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis | Change at Week 65 | -15.28 Units on a scale | Standard Deviation 12.66 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis | Change at Week 78 | -15.54 Units on a scale | Standard Deviation 12.28 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis | Change at Week 130 | -17.37 Units on a scale | Standard Deviation 12.18 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis | Change at Week 156 | -18.38 Units on a scale | Standard Deviation 11.99 |
Change From Baseline in Disease Activity Score-28 (DAS-28) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156
DAS28 was calculated from swollen joint count and tender joint count using 28 joint count, C-reactive protein (CRP) in milligram per liter (mg/L) and participant global assessment (PtGA) of disease activity measured on a 100 mm visual analog scale (VAS) ranging from 0 (good condition) to 100 (worst condition), where higher scores indicate worse health condition). DAS28 total score range: 0 (no disease activity) to 9.4 (maximum disease activity), higher score indicates more disease activity. DAS-28 score of 2.6 to 3.2= low, 3.2 to 5.1= moderate and \>5.1= high disease activity. DAS-28 score of \<2.6= disease remission. DAS28-4(CRP) = (0.56\*sqrt\[TJC28\] + 0.28\*sqrt\[SJC28\] + 0.36\*ln\[CRP+1\]) + 0.014\*GH + 0.96) and DAS28-4(ESR) = (0.56\*sqrt\[TJC28\] + 0.28\*sqrt\[SJC28\] + 0.70\*ln\[ESR\] + 0.014\*GH), where sqrt = square root, ln = natural logarithm.
Time frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Population: Full analysis set included all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Here, Number Analyzed signifies number of participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Rheumatoid Arthritis | Change From Baseline in Disease Activity Score-28 (DAS-28) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Baseline | 4.63 Units on a scale | Standard Deviation 1.24 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Disease Activity Score-28 (DAS-28) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 13 | -1.26 Units on a scale | Standard Deviation 1.38 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Disease Activity Score-28 (DAS-28) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 26 | -1.52 Units on a scale | Standard Deviation 1.38 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Disease Activity Score-28 (DAS-28) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 39 | -1.57 Units on a scale | Standard Deviation 1.41 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Disease Activity Score-28 (DAS-28) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 52 | -1.64 Units on a scale | Standard Deviation 1.41 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Disease Activity Score-28 (DAS-28) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 65 | -1.76 Units on a scale | Standard Deviation 1.47 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Disease Activity Score-28 (DAS-28) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 78 | -1.73 Units on a scale | Standard Deviation 1.38 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Disease Activity Score-28 (DAS-28) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 104 | -1.94 Units on a scale | Standard Deviation 1.33 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Disease Activity Score-28 (DAS-28) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 130 | -1.96 Units on a scale | Standard Deviation 1.36 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Disease Activity Score-28 (DAS-28) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 156 | -2.10 Units on a scale | Standard Deviation 1.42 |
| Participants With Psoriatic Arthritis | Change From Baseline in Disease Activity Score-28 (DAS-28) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 104 | -1.67 Units on a scale | Standard Deviation 1.37 |
| Participants With Psoriatic Arthritis | Change From Baseline in Disease Activity Score-28 (DAS-28) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Baseline | 4.18 Units on a scale | Standard Deviation 1.11 |
| Participants With Psoriatic Arthritis | Change From Baseline in Disease Activity Score-28 (DAS-28) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 65 | -1.54 Units on a scale | Standard Deviation 1.26 |
| Participants With Psoriatic Arthritis | Change From Baseline in Disease Activity Score-28 (DAS-28) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 13 | -1.23 Units on a scale | Standard Deviation 1.31 |
| Participants With Psoriatic Arthritis | Change From Baseline in Disease Activity Score-28 (DAS-28) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 156 | -1.54 Units on a scale | Standard Deviation 1.39 |
| Participants With Psoriatic Arthritis | Change From Baseline in Disease Activity Score-28 (DAS-28) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 26 | -1.37 Units on a scale | Standard Deviation 1.28 |
| Participants With Psoriatic Arthritis | Change From Baseline in Disease Activity Score-28 (DAS-28) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 78 | -1.62 Units on a scale | Standard Deviation 1.31 |
| Participants With Psoriatic Arthritis | Change From Baseline in Disease Activity Score-28 (DAS-28) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 39 | -1.52 Units on a scale | Standard Deviation 1.27 |
| Participants With Psoriatic Arthritis | Change From Baseline in Disease Activity Score-28 (DAS-28) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 130 | -1.66 Units on a scale | Standard Deviation 1.27 |
| Participants With Psoriatic Arthritis | Change From Baseline in Disease Activity Score-28 (DAS-28) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 52 | -1.69 Units on a scale | Standard Deviation 1.2 |
Change From Baseline in Hannover Functional Ability Questionnaire (FFbH) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156
FFbH is a self-administered patient questionnaire composed by 18 questions on functional ability in activities of daily living. Each question was answered by the participant as Yes, I can perform the activity without difficulty (score assigned =2), Yes, but with difficulties (score assigned =1) and No or only with external help (score assigned =0). Final FFbH score (%) was then computed according to formula: (Sum of scores\*100) divided by (2\*number of valid answers), ranging between 0 (no functional capacity) to 100 (full functional capacity); higher scores indicate better daily activities. FFbH functional remission was defined as FFbH functional capacity of \>= 83%.
Time frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Population: Full analysis set included all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Here, Number Analyzed signifies number of participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Rheumatoid Arthritis | Change From Baseline in Hannover Functional Ability Questionnaire (FFbH) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 13 | 4.38 Units on a scale | Standard Deviation 12.94 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Hannover Functional Ability Questionnaire (FFbH) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 52 | 5.78 Units on a scale | Standard Deviation 15.27 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Hannover Functional Ability Questionnaire (FFbH) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 130 | 6.22 Units on a scale | Standard Deviation 15.46 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Hannover Functional Ability Questionnaire (FFbH) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 65 | 6.15 Units on a scale | Standard Deviation 15.96 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Hannover Functional Ability Questionnaire (FFbH) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 26 | 5.63 Units on a scale | Standard Deviation 15.25 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Hannover Functional Ability Questionnaire (FFbH) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 104 | 6.10 Units on a scale | Standard Deviation 14.98 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Hannover Functional Ability Questionnaire (FFbH) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 78 | 6.59 Units on a scale | Standard Deviation 16.16 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Hannover Functional Ability Questionnaire (FFbH) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 39 | 6.20 Units on a scale | Standard Deviation 15.43 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Hannover Functional Ability Questionnaire (FFbH) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 156 | 5.54 Units on a scale | Standard Deviation 16.42 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Hannover Functional Ability Questionnaire (FFbH) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Baseline | 64.99 Units on a scale | Standard Deviation 22.71 |
| Participants With Psoriatic Arthritis | Change From Baseline in Hannover Functional Ability Questionnaire (FFbH) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 156 | 3.56 Units on a scale | Standard Deviation 15.78 |
| Participants With Psoriatic Arthritis | Change From Baseline in Hannover Functional Ability Questionnaire (FFbH) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Baseline | 68.67 Units on a scale | Standard Deviation 22.09 |
| Participants With Psoriatic Arthritis | Change From Baseline in Hannover Functional Ability Questionnaire (FFbH) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 13 | 3.45 Units on a scale | Standard Deviation 13.44 |
| Participants With Psoriatic Arthritis | Change From Baseline in Hannover Functional Ability Questionnaire (FFbH) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 78 | 3.62 Units on a scale | Standard Deviation 16.37 |
| Participants With Psoriatic Arthritis | Change From Baseline in Hannover Functional Ability Questionnaire (FFbH) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 26 | 3.99 Units on a scale | Standard Deviation 15.11 |
| Participants With Psoriatic Arthritis | Change From Baseline in Hannover Functional Ability Questionnaire (FFbH) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 39 | 4.90 Units on a scale | Standard Deviation 14.46 |
| Participants With Psoriatic Arthritis | Change From Baseline in Hannover Functional Ability Questionnaire (FFbH) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 52 | 4.43 Units on a scale | Standard Deviation 16.47 |
| Participants With Psoriatic Arthritis | Change From Baseline in Hannover Functional Ability Questionnaire (FFbH) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 65 | 4.83 Units on a scale | Standard Deviation 16.52 |
| Participants With Psoriatic Arthritis | Change From Baseline in Hannover Functional Ability Questionnaire (FFbH) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 104 | 5.09 Units on a scale | Standard Deviation 14.54 |
| Participants With Psoriatic Arthritis | Change From Baseline in Hannover Functional Ability Questionnaire (FFbH) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 130 | 4.66 Units on a scale | Standard Deviation 15.03 |
Change From Baseline in Inflamed Dactylitic Digits at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis
In this outcome measure change in number of inflamed dactylitic digits at specified week compared to baseline is reported. Dactylitis is inflammation of dactylitic digits (fingers and toes).
Time frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Population: Full analysis set. Here, Number Analyzed signifies number of participants evaluable for the specified time points. Data for this outcome measure was to be collected and evaluated only for participants with psoriatic arthritis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Rheumatoid Arthritis | Change From Baseline in Inflamed Dactylitic Digits at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis | Baseline | 0.72 Dactylitic digits | Standard Deviation 1.64 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Inflamed Dactylitic Digits at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis | Change at Week 13 | -0.39 Dactylitic digits | Standard Deviation 1.36 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Inflamed Dactylitic Digits at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis | Change at Week 26 | -0.54 Dactylitic digits | Standard Deviation 1.77 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Inflamed Dactylitic Digits at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis | Change at Week 39 | -0.61 Dactylitic digits | Standard Deviation 1.53 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Inflamed Dactylitic Digits at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis | Change at Week 52 | -0.69 Dactylitic digits | Standard Deviation 1.58 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Inflamed Dactylitic Digits at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis | Change at Week 65 | -0.50 Dactylitic digits | Standard Deviation 2.08 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Inflamed Dactylitic Digits at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis | Change at Week 78 | -0.38 Dactylitic digits | Standard Deviation 1.4 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Inflamed Dactylitic Digits at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis | Change at Week 104 | -0.61 Dactylitic digits | Standard Deviation 1.47 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Inflamed Dactylitic Digits at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis | Change at Week 130 | -0.63 Dactylitic digits | Standard Deviation 1.96 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Inflamed Dactylitic Digits at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis | Change at Week 156 | -0.63 Dactylitic digits | Standard Deviation 1.72 |
Change From Baseline in Nail Involvement at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis
In this outcome measure change in number of nails affected by psoriatic arthritis at specified week compared to baseline is reported. Nails included both finger nails and toe nails.
Time frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Population: Full analysis set. Here, Number Analyzed signifies number of participants evaluable for the specified time points. Data for this outcome measure was to be collected and evaluated only for participants with psoriatic arthritis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Rheumatoid Arthritis | Change From Baseline in Nail Involvement at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis | Baseline | 3.18 Nails | Standard Deviation 4.99 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Nail Involvement at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis | Change at Week 13 | -0.98 Nails | Standard Deviation 3.58 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Nail Involvement at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis | Change at Week 26 | -1.64 Nails | Standard Deviation 4.38 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Nail Involvement at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis | Change at Week 39 | -1.75 Nails | Standard Deviation 4.55 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Nail Involvement at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis | Change at Week 52 | -2.09 Nails | Standard Deviation 5.04 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Nail Involvement at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis | Change at Week 65 | -2.38 Nails | Standard Deviation 4.89 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Nail Involvement at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis | Change at Week 78 | -1.79 Nails | Standard Deviation 4.3 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Nail Involvement at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis | Change at Week 104 | -1.98 Nails | Standard Deviation 5.81 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Nail Involvement at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis | Change at Week 130 | -1.12 Nails | Standard Deviation 4.75 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Nail Involvement at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis | Change at Week 156 | -1.38 Nails | Standard Deviation 5.11 |
Change From Baseline in Participant Global Assessment (PtGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156
PtGA: participant assessed their disease activity using a 100 mm visual analog scale ranging from 0 = very good to 100 = worst. Higher scores indicate worse health status.
Time frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Population: Full analysis set included all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Here, Number Analyzed signifies number of participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Rheumatoid Arthritis | Change From Baseline in Participant Global Assessment (PtGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Baseline | 54.69 millimeter | Standard Deviation 24.91 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Participant Global Assessment (PtGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 13 | -13.55 millimeter | Standard Deviation 27.17 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Participant Global Assessment (PtGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 26 | -17.30 millimeter | Standard Deviation 29.43 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Participant Global Assessment (PtGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 39 | -18.09 millimeter | Standard Deviation 28.13 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Participant Global Assessment (PtGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 52 | -19.38 millimeter | Standard Deviation 28.84 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Participant Global Assessment (PtGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 65 | -22.52 millimeter | Standard Deviation 29.15 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Participant Global Assessment (PtGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 104 | -22.68 millimeter | Standard Deviation 26.87 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Participant Global Assessment (PtGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 130 | -23.75 millimeter | Standard Deviation 27.23 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Participant Global Assessment (PtGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 156 | -26.30 millimeter | Standard Deviation 27.39 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Participant Global Assessment (PtGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 78 | -22.24 millimeter | Standard Deviation 30.34 |
| Participants With Psoriatic Arthritis | Change From Baseline in Participant Global Assessment (PtGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 130 | -23.10 millimeter | Standard Deviation 29.21 |
| Participants With Psoriatic Arthritis | Change From Baseline in Participant Global Assessment (PtGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Baseline | 56.99 millimeter | Standard Deviation 24.57 |
| Participants With Psoriatic Arthritis | Change From Baseline in Participant Global Assessment (PtGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 65 | -22.74 millimeter | Standard Deviation 28.75 |
| Participants With Psoriatic Arthritis | Change From Baseline in Participant Global Assessment (PtGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 13 | -17.13 millimeter | Standard Deviation 28.34 |
| Participants With Psoriatic Arthritis | Change From Baseline in Participant Global Assessment (PtGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 78 | -24.59 millimeter | Standard Deviation 31.73 |
| Participants With Psoriatic Arthritis | Change From Baseline in Participant Global Assessment (PtGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 26 | -19.32 millimeter | Standard Deviation 27.37 |
| Participants With Psoriatic Arthritis | Change From Baseline in Participant Global Assessment (PtGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 104 | -20.59 millimeter | Standard Deviation 31.57 |
| Participants With Psoriatic Arthritis | Change From Baseline in Participant Global Assessment (PtGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 39 | -21.58 millimeter | Standard Deviation 28.74 |
| Participants With Psoriatic Arthritis | Change From Baseline in Participant Global Assessment (PtGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 156 | -21.24 millimeter | Standard Deviation 30.14 |
| Participants With Psoriatic Arthritis | Change From Baseline in Participant Global Assessment (PtGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 52 | -22.55 millimeter | Standard Deviation 30.03 |
Change From Baseline in Participant Pain Visual Analogue Scale (VAS) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156
VAS: participants placed a mark indicating the intensity of their pain on a scale of 0 (no pain) to 100 mm (worst possible pain). Higher scores indicate greater level of pain.
Time frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Population: Full analysis set included all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Here, Number Analyzed signifies number of participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Rheumatoid Arthritis | Change From Baseline in Participant Pain Visual Analogue Scale (VAS) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 104 | -23.46 millimeter | Standard Deviation 29.01 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Participant Pain Visual Analogue Scale (VAS) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 78 | -22.58 millimeter | Standard Deviation 32.12 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Participant Pain Visual Analogue Scale (VAS) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 39 | -18.38 millimeter | Standard Deviation 29.91 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Participant Pain Visual Analogue Scale (VAS) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Baseline | 55.93 millimeter | Standard Deviation 26.26 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Participant Pain Visual Analogue Scale (VAS) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 130 | -24.67 millimeter | Standard Deviation 28.75 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Participant Pain Visual Analogue Scale (VAS) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 13 | -15.03 millimeter | Standard Deviation 28.5 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Participant Pain Visual Analogue Scale (VAS) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 65 | -22.83 millimeter | Standard Deviation 30.95 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Participant Pain Visual Analogue Scale (VAS) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 26 | -18.56 millimeter | Standard Deviation 29.83 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Participant Pain Visual Analogue Scale (VAS) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 156 | -26.88 millimeter | Standard Deviation 28.77 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Participant Pain Visual Analogue Scale (VAS) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 52 | -19.73 millimeter | Standard Deviation 31.02 |
| Participants With Psoriatic Arthritis | Change From Baseline in Participant Pain Visual Analogue Scale (VAS) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 156 | -18.33 millimeter | Standard Deviation 31.13 |
| Participants With Psoriatic Arthritis | Change From Baseline in Participant Pain Visual Analogue Scale (VAS) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 65 | -22.40 millimeter | Standard Deviation 29.74 |
| Participants With Psoriatic Arthritis | Change From Baseline in Participant Pain Visual Analogue Scale (VAS) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 78 | -24.91 millimeter | Standard Deviation 31.69 |
| Participants With Psoriatic Arthritis | Change From Baseline in Participant Pain Visual Analogue Scale (VAS) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 104 | -21.09 millimeter | Standard Deviation 32.67 |
| Participants With Psoriatic Arthritis | Change From Baseline in Participant Pain Visual Analogue Scale (VAS) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 130 | -21.67 millimeter | Standard Deviation 29.18 |
| Participants With Psoriatic Arthritis | Change From Baseline in Participant Pain Visual Analogue Scale (VAS) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 52 | -22.24 millimeter | Standard Deviation 30.57 |
| Participants With Psoriatic Arthritis | Change From Baseline in Participant Pain Visual Analogue Scale (VAS) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 26 | -19.01 millimeter | Standard Deviation 27.51 |
| Participants With Psoriatic Arthritis | Change From Baseline in Participant Pain Visual Analogue Scale (VAS) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Baseline | 57.69 millimeter | Standard Deviation 25.14 |
| Participants With Psoriatic Arthritis | Change From Baseline in Participant Pain Visual Analogue Scale (VAS) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 13 | -18.20 millimeter | Standard Deviation 27.96 |
| Participants With Psoriatic Arthritis | Change From Baseline in Participant Pain Visual Analogue Scale (VAS) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 39 | -21.84 millimeter | Standard Deviation 29.62 |
Change From Baseline in Physician Global Assessment (PhyGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156
PhyGA: physician marked intensity of participants' pain on a visual analogue scale of 0 (no disease activity) to 100 mm (worst possible condition). Higher scores indicate greater level of disease activity.
Time frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Population: Full analysis set included all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Here, Number Analyzed signifies number of participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Rheumatoid Arthritis | Change From Baseline in Physician Global Assessment (PhyGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 104 | -37.10 millimeter | Standard Deviation 23.18 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Physician Global Assessment (PhyGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 13 | -24.49 millimeter | Standard Deviation 22.98 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Physician Global Assessment (PhyGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 26 | -29.22 millimeter | Standard Deviation 24.42 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Physician Global Assessment (PhyGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 39 | -30.67 millimeter | Standard Deviation 23.92 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Physician Global Assessment (PhyGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 52 | -31.78 millimeter | Standard Deviation 24.74 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Physician Global Assessment (PhyGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 65 | -34.07 millimeter | Standard Deviation 24.83 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Physician Global Assessment (PhyGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 78 | -35.88 millimeter | Standard Deviation 25.29 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Physician Global Assessment (PhyGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 130 | -37.11 millimeter | Standard Deviation 22.96 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Physician Global Assessment (PhyGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 156 | -40.09 millimeter | Standard Deviation 22.39 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Physician Global Assessment (PhyGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Baseline | 57.28 millimeter | Standard Deviation 19.38 |
| Participants With Psoriatic Arthritis | Change From Baseline in Physician Global Assessment (PhyGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 130 | -33.98 millimeter | Standard Deviation 22.19 |
| Participants With Psoriatic Arthritis | Change From Baseline in Physician Global Assessment (PhyGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Baseline | 55.73 millimeter | Standard Deviation 19.9 |
| Participants With Psoriatic Arthritis | Change From Baseline in Physician Global Assessment (PhyGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 65 | -34.37 millimeter | Standard Deviation 24.02 |
| Participants With Psoriatic Arthritis | Change From Baseline in Physician Global Assessment (PhyGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 13 | -24.97 millimeter | Standard Deviation 23.29 |
| Participants With Psoriatic Arthritis | Change From Baseline in Physician Global Assessment (PhyGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 78 | -35.87 millimeter | Standard Deviation 23.66 |
| Participants With Psoriatic Arthritis | Change From Baseline in Physician Global Assessment (PhyGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 26 | -28.54 millimeter | Standard Deviation 24.28 |
| Participants With Psoriatic Arthritis | Change From Baseline in Physician Global Assessment (PhyGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 104 | -34.87 millimeter | Standard Deviation 21.22 |
| Participants With Psoriatic Arthritis | Change From Baseline in Physician Global Assessment (PhyGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 39 | -32.06 millimeter | Standard Deviation 24.46 |
| Participants With Psoriatic Arthritis | Change From Baseline in Physician Global Assessment (PhyGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 156 | -34.75 millimeter | Standard Deviation 22.55 |
| Participants With Psoriatic Arthritis | Change From Baseline in Physician Global Assessment (PhyGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 | Change at Week 52 | -34.36 millimeter | Standard Deviation 22.72 |
Change From Baseline in Simple Disease Activity Index (SDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis
SDAI was calculated from tender and swollen joints using 28 joint count, participant global assessment (PtGA), physician global assessment and (PhyGA) and CRP (in mg/L). PtGA and PhyGA both were assessed on 0-100 mm VAS scale, where higher scores indicated greater affection due to disease activity. SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of \<=11 indicates low disease activity and a score of \<=3.3 indicates remission.
Time frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Population: Full analysis set: all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Number Analyzed = number of participants evaluable for the specified time points. Data for this outcome measure was to be collected and evaluated only for participants with rheumatoid arthritis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Rheumatoid Arthritis | Change From Baseline in Simple Disease Activity Index (SDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis | Change at Week 52 | -17.70 Units on a scale | Standard Deviation 47.4 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Simple Disease Activity Index (SDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis | Change at Week 65 | -18.77 Units on a scale | Standard Deviation 49.86 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Simple Disease Activity Index (SDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis | Baseline | 35.88 Units on a scale | Standard Deviation 198.26 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Simple Disease Activity Index (SDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis | Change at Week 13 | -20.62 Units on a scale | Standard Deviation 225.74 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Simple Disease Activity Index (SDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis | Change at Week 26 | -26.04 Units on a scale | Standard Deviation 248.89 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Simple Disease Activity Index (SDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis | Change at Week 39 | -16.00 Units on a scale | Standard Deviation 45.07 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Simple Disease Activity Index (SDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis | Change at Week 78 | -19.02 Units on a scale | Standard Deviation 51.83 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Simple Disease Activity Index (SDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis | Change at Week 103 | -18.08 Units on a scale | Standard Deviation 15.07 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Simple Disease Activity Index (SDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis | Change at Week 130 | -17.33 Units on a scale | Standard Deviation 17.19 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Simple Disease Activity Index (SDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis | Change at Week 156 | -18.85 Units on a scale | Standard Deviation 14.06 |
Change From Baseline in Total Erosion Score at End of Phase 1 (Week 78) and Phase 2 (Week 156)
Total erosion score as per van der Hejde method consisted of 2 dimensions: a) hands (32 erosion locations, each location graded from 0 \[no erosion\] to 5 \[maximum severity\], sum of grading of each location resulted in score of 0 to 160); and b) feet (12 erosion locations, each location graded from 0 \[no erosion\] to 10 \[maximum severity\], sum of grading of each location resulted in score of 0 to 120). Sum of erosion scores of hand (0 to 160) and feet (0 to 120) gave a total erosion score as 0 to 280, where 0 was no erosion at all and 280 was worst possible condition, higher scores indicated severe joint destruction.
Time frame: Baseline, Week 78, 156
Population: Efficacy analysis set included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2 or had Rx1 and Rx3. Here, Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure and Number Analyzed = number of participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Rheumatoid Arthritis | Change From Baseline in Total Erosion Score at End of Phase 1 (Week 78) and Phase 2 (Week 156) | Baseline | 11.1 Units on a scale | Standard Deviation 23.8 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Total Erosion Score at End of Phase 1 (Week 78) and Phase 2 (Week 156) | Change at Week 78 | -0.1 Units on a scale | Standard Deviation 4.1 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Total Erosion Score at End of Phase 1 (Week 78) and Phase 2 (Week 156) | Change at Week 156 | 0.0 Units on a scale | Standard Deviation 5.7 |
| Participants With Psoriatic Arthritis | Change From Baseline in Total Erosion Score at End of Phase 1 (Week 78) and Phase 2 (Week 156) | Baseline | 4.6 Units on a scale | Standard Deviation 11.9 |
| Participants With Psoriatic Arthritis | Change From Baseline in Total Erosion Score at End of Phase 1 (Week 78) and Phase 2 (Week 156) | Change at Week 78 | -0.3 Units on a scale | Standard Deviation 3.1 |
| Participants With Psoriatic Arthritis | Change From Baseline in Total Erosion Score at End of Phase 1 (Week 78) and Phase 2 (Week 156) | Change at Week 156 | 0.2 Units on a scale | Standard Deviation 6.5 |
Change From Baseline in Total Joint Space Narrow Score at End of Phase 1 (Week 78) and Phase 2 (Week 156)
Total joint space narrow score as per van der Hejde method consisted of 2 dimensions: a) hands (30 joint space locations, each location graded from 0 \[normal joint space\] to 4 \[bony ankylosis\], sum of grading of each location resulted in score of 0 to 120); and b) feet (12 erosion locations, each location graded from 0 \[no erosion\] to 4 \[bony ankylosis\], sum of grading of each location resulted in score of 0 to 48). Sum of joint space narrow scores of hand (0 to 120) and feet (0 to 48) gave a total joint space narrow score as 0 to 168, where 0 was normal joint space and 168 was maximum narrowing in joints, higher scores indicated severe joint destruction.
Time frame: Baseline, Week 78, 156
Population: Efficacy analysis set included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2 or have Rx1 and Rx3. Here, Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure and Number Analyzed = number of participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Rheumatoid Arthritis | Change From Baseline in Total Joint Space Narrow Score at End of Phase 1 (Week 78) and Phase 2 (Week 156) | Baseline | 14.0 Units on a scale | Standard Deviation 19.9 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Total Joint Space Narrow Score at End of Phase 1 (Week 78) and Phase 2 (Week 156) | Change at Week 78 | 0.7 Units on a scale | Standard Deviation 4.3 |
| Participants With Rheumatoid Arthritis | Change From Baseline in Total Joint Space Narrow Score at End of Phase 1 (Week 78) and Phase 2 (Week 156) | Change at Week 156 | 1.4 Units on a scale | Standard Deviation 5.9 |
| Participants With Psoriatic Arthritis | Change From Baseline in Total Joint Space Narrow Score at End of Phase 1 (Week 78) and Phase 2 (Week 156) | Baseline | 10.0 Units on a scale | Standard Deviation 15 |
| Participants With Psoriatic Arthritis | Change From Baseline in Total Joint Space Narrow Score at End of Phase 1 (Week 78) and Phase 2 (Week 156) | Change at Week 78 | -0.1 Units on a scale | Standard Deviation 3.7 |
| Participants With Psoriatic Arthritis | Change From Baseline in Total Joint Space Narrow Score at End of Phase 1 (Week 78) and Phase 2 (Week 156) | Change at Week 156 | 0.6 Units on a scale | Standard Deviation 3.1 |
Duration of Morning Stiffness in Participants With Temporary Rigidity
Rigidity was temporary when 'Yes' was given for the question if daily activities could be done without stiffness; rigidity was permanent when 'No' was given for the question if daily activities could be done without stiffness.
Time frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Population: Full analysis set included all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Here, Number Analyzed signifies number of participants evaluable for the specified time points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Participants With Rheumatoid Arthritis | Duration of Morning Stiffness in Participants With Temporary Rigidity | Week 26 | 0.50 Hours |
| Participants With Rheumatoid Arthritis | Duration of Morning Stiffness in Participants With Temporary Rigidity | Week 13 | 0.50 Hours |
| Participants With Rheumatoid Arthritis | Duration of Morning Stiffness in Participants With Temporary Rigidity | Week 78 | 0.38 Hours |
| Participants With Rheumatoid Arthritis | Duration of Morning Stiffness in Participants With Temporary Rigidity | Week 39 | 0.50 Hours |
| Participants With Rheumatoid Arthritis | Duration of Morning Stiffness in Participants With Temporary Rigidity | Week 104 | 0.25 Hours |
| Participants With Rheumatoid Arthritis | Duration of Morning Stiffness in Participants With Temporary Rigidity | Baseline | 1.00 Hours |
| Participants With Rheumatoid Arthritis | Duration of Morning Stiffness in Participants With Temporary Rigidity | Week 130 | 0.25 Hours |
| Participants With Rheumatoid Arthritis | Duration of Morning Stiffness in Participants With Temporary Rigidity | Week 52 | 0.50 Hours |
| Participants With Rheumatoid Arthritis | Duration of Morning Stiffness in Participants With Temporary Rigidity | Week 156 | 0.25 Hours |
| Participants With Rheumatoid Arthritis | Duration of Morning Stiffness in Participants With Temporary Rigidity | Week 65 | 0.50 Hours |
| Participants With Psoriatic Arthritis | Duration of Morning Stiffness in Participants With Temporary Rigidity | Week 156 | 0.33 Hours |
| Participants With Psoriatic Arthritis | Duration of Morning Stiffness in Participants With Temporary Rigidity | Baseline | 1.00 Hours |
| Participants With Psoriatic Arthritis | Duration of Morning Stiffness in Participants With Temporary Rigidity | Week 13 | 0.50 Hours |
| Participants With Psoriatic Arthritis | Duration of Morning Stiffness in Participants With Temporary Rigidity | Week 26 | 0.50 Hours |
| Participants With Psoriatic Arthritis | Duration of Morning Stiffness in Participants With Temporary Rigidity | Week 39 | 0.50 Hours |
| Participants With Psoriatic Arthritis | Duration of Morning Stiffness in Participants With Temporary Rigidity | Week 52 | 0.50 Hours |
| Participants With Psoriatic Arthritis | Duration of Morning Stiffness in Participants With Temporary Rigidity | Week 65 | 0.25 Hours |
| Participants With Psoriatic Arthritis | Duration of Morning Stiffness in Participants With Temporary Rigidity | Week 78 | 0.46 Hours |
| Participants With Psoriatic Arthritis | Duration of Morning Stiffness in Participants With Temporary Rigidity | Week 104 | 0.25 Hours |
| Participants With Psoriatic Arthritis | Duration of Morning Stiffness in Participants With Temporary Rigidity | Week 130 | 0.50 Hours |
Effect on Normalized Radiographic Progression With Respect to Baseline Disease Activity Score-28 (DAS-28)
Effect on radiographic progression with respect to baseline DAS-28 was evaluated using ANOVA model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was baseline DAS-28. Baseline DAS-28 is less than or equal to (\<=) 5.1 or \>5.1. DAS28: score range from 0 (none) to 9.4 (extreme disease activity); low =2.6 to 3.2, moderate =3.2 to 5.1, and high disease activity \>5.1. DAS28 score of \<2.6 indicates disease remission.
Time frame: Baseline up to Week 78
Population: Efficacy analysis set for Phase 1 included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2. Here, Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure and Number Analyzed = number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Participants With Rheumatoid Arthritis | Effect on Normalized Radiographic Progression With Respect to Baseline Disease Activity Score-28 (DAS-28) | Baseline DAS-28 <= 5.1 | 0.716 Scores per year |
| Participants With Rheumatoid Arthritis | Effect on Normalized Radiographic Progression With Respect to Baseline Disease Activity Score-28 (DAS-28) | Baseline DAS-28 > 5.1 | 0.170 Scores per year |
| Participants With Psoriatic Arthritis | Effect on Normalized Radiographic Progression With Respect to Baseline Disease Activity Score-28 (DAS-28) | Baseline DAS-28 <= 5.1 | -0.314 Scores per year |
| Participants With Psoriatic Arthritis | Effect on Normalized Radiographic Progression With Respect to Baseline Disease Activity Score-28 (DAS-28) | Baseline DAS-28 > 5.1 | -0.507 Scores per year |
Effect on Normalized Radiographic Progression With Respect to Baseline Positivity of Anti-citrullinated Protein Antibody (ACPA) - Rheumatoid Factor (RF)
Effect on normalized radiographic progression with respect to ACPA-RF was evaluated using an analysis of variance (ANOVA) model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was groups of positive testing of ACPA and RF at baseline.
Time frame: Baseline up to Week 78
Population: Efficacy analysis set for Phase 1 included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2. Here, Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure and Number Analyzed = number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Participants With Rheumatoid Arthritis | Effect on Normalized Radiographic Progression With Respect to Baseline Positivity of Anti-citrullinated Protein Antibody (ACPA) - Rheumatoid Factor (RF) | ACPA and RF negative | 1.326 Scores per year |
| Participants With Rheumatoid Arthritis | Effect on Normalized Radiographic Progression With Respect to Baseline Positivity of Anti-citrullinated Protein Antibody (ACPA) - Rheumatoid Factor (RF) | ACPA or RF positive | 1.075 Scores per year |
| Participants With Rheumatoid Arthritis | Effect on Normalized Radiographic Progression With Respect to Baseline Positivity of Anti-citrullinated Protein Antibody (ACPA) - Rheumatoid Factor (RF) | ACPA and RF positive | 0.087 Scores per year |
| Participants With Psoriatic Arthritis | Effect on Normalized Radiographic Progression With Respect to Baseline Positivity of Anti-citrullinated Protein Antibody (ACPA) - Rheumatoid Factor (RF) | ACPA and RF negative | -1.142 Scores per year |
| Participants With Psoriatic Arthritis | Effect on Normalized Radiographic Progression With Respect to Baseline Positivity of Anti-citrullinated Protein Antibody (ACPA) - Rheumatoid Factor (RF) | ACPA or RF positive | 2.448 Scores per year |
| Participants With Psoriatic Arthritis | Effect on Normalized Radiographic Progression With Respect to Baseline Positivity of Anti-citrullinated Protein Antibody (ACPA) - Rheumatoid Factor (RF) | ACPA and RF positive | 3.370 Scores per year |
Effect on Normalized Radiographic Progression With Respect to Baseline Usage of Concomitant Medication
Effect on normalized radiographic progression with respect to use of concomitant medication at baseline was evaluated using an ANOVA model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was groups of concomitant medication as found among the medication given concomitantly during study that is recorded at baseline.
Time frame: Baseline up to Week 78
Population: Efficacy analysis set for Phase 1 included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2. Here, Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure and Number Analyzed = number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Participants With Rheumatoid Arthritis | Effect on Normalized Radiographic Progression With Respect to Baseline Usage of Concomitant Medication | Concomitant Medication at baseline: Yes | 0.749 Scores per year |
| Participants With Rheumatoid Arthritis | Effect on Normalized Radiographic Progression With Respect to Baseline Usage of Concomitant Medication | Concomitant Medication at baseline: No | -0.978 Scores per year |
| Participants With Psoriatic Arthritis | Effect on Normalized Radiographic Progression With Respect to Baseline Usage of Concomitant Medication | Concomitant Medication at baseline: Yes | -0.339 Scores per year |
| Participants With Psoriatic Arthritis | Effect on Normalized Radiographic Progression With Respect to Baseline Usage of Concomitant Medication | Concomitant Medication at baseline: No | -0.370 Scores per year |
Effect on Normalized Radiographic Progression With Respect to Previous Treatment With Biologics
Effect on normalized radiographic progression of previous treatment with biologics was evaluated using an ANOVA model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was previous treatment with biologics.
Time frame: Baseline up to Week 78
Population: Efficacy analysis set for Phase 1 included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2. Here, Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure and Number Analyzed = number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Participants With Rheumatoid Arthritis | Effect on Normalized Radiographic Progression With Respect to Previous Treatment With Biologics | Previous treatment with biologics | 0.235 Scores per year |
| Participants With Rheumatoid Arthritis | Effect on Normalized Radiographic Progression With Respect to Previous Treatment With Biologics | No previous treatment with biologics | 0.621 Scores per year |
| Participants With Psoriatic Arthritis | Effect on Normalized Radiographic Progression With Respect to Previous Treatment With Biologics | Previous treatment with biologics | -0.986 Scores per year |
| Participants With Psoriatic Arthritis | Effect on Normalized Radiographic Progression With Respect to Previous Treatment With Biologics | No previous treatment with biologics | -0.170 Scores per year |
Linear Relationship Between Normalized Radiographic Progression and Disease Duration
Linear relationship between radiographic progression and disease duration was evaluated using a linear regression model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was disease duration.
Time frame: Baseline up to Week 78
Population: Efficacy analysis set for Phase 1 included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With Rheumatoid Arthritis | Linear Relationship Between Normalized Radiographic Progression and Disease Duration | -0.012 Regression coefficient |
| Participants With Psoriatic Arthritis | Linear Relationship Between Normalized Radiographic Progression and Disease Duration | -0.050 Regression coefficient |
Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis
Participants with psoriatic arthritis were distributed in following different classes depending upon percentage (%) of BSA affected: 1) less than (\<) 3 %, 2) 3-10%, 3) 11-20% and 4) \>20%. Psoriatic arthritis affecting \<3% BSA was considered as mild, 3 to 10 % as moderate and \>10 percent as severe.
Time frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Population: Full analysis set. Here, Number Analyzed signifies number of participants evaluable for the specified time points. Data for this outcome measure was to be collected and evaluated only for participants with psoriatic arthritis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 13 | >20% | 13 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 39 | >20% | 2 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 104 | 11-20% | 2 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Baseline | <3% | 203 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Baseline | 3-10% | 123 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Baseline | 11-20% | 41 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Baseline | >20% | 20 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 13 | <3% | 247 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 13 | 3-10% | 82 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 13 | 11-20% | 28 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 26 | <3% | 233 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 26 | 3-10% | 63 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 26 | 11-20% | 14 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 26 | >20% | 6 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 39 | <3% | 210 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 39 | 3-10% | 35 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 39 | 11-20% | 15 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 52 | <3% | 196 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 52 | 3-10% | 37 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 52 | 11-20% | 10 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 52 | >20% | 3 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 65 | <3% | 176 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 65 | 3-10% | 33 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 65 | 11-20% | 4 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 65 | >20% | 2 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 78 | <3% | 182 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 78 | 3-10% | 23 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 78 | 11-20% | 5 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 78 | >20% | 1 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 104 | <3% | 80 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 104 | 3-10% | 12 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 104 | >20% | 2 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 130 | <3% | 75 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 130 | 3-10% | 9 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 130 | 11-20% | 4 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 130 | >20% | 1 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 156 | <3% | 74 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 156 | 3-10% | 8 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 156 | 11-20% | 2 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis | Week 156 | >20% | 1 Participants |
Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D)
EQ-5D: participant rated questionnaire to assess generic health status in two parts: single utility score and visual analog scale. For utility score, participants rated their current health state on 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression with each dimension having three levels of function: 1 indicates no problem; 2 indicates some problem; 3 indicates extreme problem.
Time frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Population: Full analysis set included all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Here, Number Analyzed signifies number of participants evaluable for the specified rows.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Self-care | Some problems | 61 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Mobility | Some problems | 714 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Mobility | Extreme problems | 3 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Mobility | No data | 10 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Self-care | No problems | 798 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Self-care | Some problems | 423 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Self-care | Extreme problems | 37 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Self-care | No data | 15 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Usual Activities | No problems | 326 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Usual Activities | Some problems | 887 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Usual Activities | Extreme problems | 51 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Usual Activities | No data | 9 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Pain/Discomfort | No problems | 67 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Pain/Discomfort | Some problems | 817 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Pain/Discomfort | Extreme problems | 380 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Pain/Discomfort | No data | 9 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Anxiety/Depression | No problems | 693 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Anxiety/Depression | Some problems | 515 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Anxiety/Depression | Extreme problems | 56 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Anxiety/Depression | No data | 9 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13: Mobility | No problems | 640 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13: Mobility | Some problems | 586 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13: Mobility | Extreme problems | 4 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13: Mobility | No data | 10 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13: Self-care | No problems | 867 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13: Self-care | Some problems | 329 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13: Self-care | Extreme problems | 34 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13: Self-care | No data | 10 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13: Usual Activities | No problems | 480 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13: Usual Activities | Some problems | 699 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13: Usual Activities | Extreme problems | 50 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13: Usual Activities | No data | 11 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13: Pain/Discomfort | No problems | 162 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13: Pain/Discomfort | Some problems | 903 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13: Pain/Discomfort | Extreme problems | 164 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13: Pain/Discomfort | No data | 11 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13:Anxiety/ Depression | Some problems | 427 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13:Anxiety/ Depression | Extreme problems | 48 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13:Anxiety/ Depression | No data | 14 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Mobility | No problems | 558 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Mobility | Some problems | 461 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Mobility | No data | 9 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Self-care | No problems | 733 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Self-care | Some problems | 267 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Self-care | Extreme problems | 22 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Self-care | No data | 9 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Usual Activities | No problems | 433 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Usual Activities | Some problems | 550 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Usual Activities | Extreme problems | 38 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Usual Activities | No data | 10 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Pain/Discomfort | No problems | 181 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Pain/Discomfort | Some problems | 733 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Pain/Discomfort | Extreme problems | 105 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Pain/Discomfort | No data | 12 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Anxiety/Depression | No problems | 641 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Anxiety/Depression | Some problems | 348 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Anxiety/Depression | Extreme problems | 32 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Anxiety/Depression | No data | 10 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Mobility | Some problems | 391 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Mobility | No data | 4 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Self-care | No problems | 664 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Self-care | Some problems | 212 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Self-care | Extreme problems | 21 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Self-care | No data | 7 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Usual Activities | No problems | 402 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Usual Activities | Some problems | 474 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Usual Activities | Extreme problems | 24 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Usual Activities | No data | 4 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Pain/Discomfort | No problems | 161 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Pain/Discomfort | Some problems | 641 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Pain/Discomfort | Extreme problems | 98 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Pain/Discomfort | No data | 4 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Anxiety/ Depression | No problems | 576 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Anxiety/ Depression | Some problems | 301 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Anxiety/ Depression | Extreme problems | 22 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Anxiety/ Depression | No data | 5 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Mobility | No problems | 459 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Mobility | Some problems | 346 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Mobility | Extreme problems | 1 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Mobility | No data | 5 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Self-care | Some problems | 190 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Self-care | No data | 5 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Usual Activities | No problems | 400 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Usual Activities | Some problems | 380 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Usual Activities | Extreme problems | 26 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Usual Activities | No data | 5 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Pain/Discomfort | No problems | 153 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Pain/Discomfort | Some problems | 577 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Pain/Discomfort | Extreme problems | 73 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Anxiety/Depression | No problems | 506 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Anxiety/Depression | Some problems | 268 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Anxiety/Depression | No data | 9 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Mobility | No problems | 422 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Mobility | Some problems | 292 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Mobility | Extreme problems | 1 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Mobility | No data | 4 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Self-care | No problems | 525 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Self-care | Some problems | 177 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Self-care | Extreme problems | 11 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Self-care | No data | 6 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Usual Activities | No problems | 361 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Usual Activities | Some problems | 331 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Usual Activities | Extreme problems | 21 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Usual Activities | No data | 6 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Pain/Discomfort | No problems | 149 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Pain/Discomfort | Some problems | 505 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Pain/Discomfort | Extreme problems | 62 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Pain/Discomfort | No data | 3 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Anxiety/ Depression | No problems | 467 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Anxiety/ Depression | Extreme problems | 23 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Anxiety/ Depression | No data | 4 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Mobility | No problems | 401 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Mobility | Some problems | 286 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Mobility | Extreme problems | 0 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Mobility | No data | 5 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Self-care | No problems | 527 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Self-care | Some problems | 155 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Self-care | Extreme problems | 6 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Self-care | No data | 4 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Usual Activities | No problems | 355 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Usual Activities | Some problems | 316 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Usual Activities | Extreme problems | 16 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Usual Activities | No data | 5 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Pain/Discomfort | No problems | 152 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Pain/Discomfort | Some problems | 477 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Pain/Discomfort | Extreme problems | 58 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Pain/Discomfort | No data | 5 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Anxiety/Depression | No problems | 455 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Anxiety/Depression | Some problems | 211 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Anxiety/Depression | Extreme problems | 20 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Anxiety/Depression | No data | 6 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Mobility | No problems | 167 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Mobility | Some problems | 109 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13:Anxiety/ Depression | No problems | 751 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Mobility | Extreme problems | 3 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Mobility | No problems | 506 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Mobility | Extreme problems | 3 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Self-care | No problems | 605 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Self-care | Extreme problems | 11 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Pain/Discomfort | No data | 8 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Anxiety/Depression | Extreme problems | 28 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Anxiety/ Depression | Some problems | 225 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Anxiety/Depression | No data | 1 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Mobility | No problems | 126 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Usual Activities | No data | 1 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Pain/Discomfort | Some problems | 149 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Pain/Discomfort | No data | 2 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Anxiety/ Depression | Some problems | 65 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Mobility | Extreme problems | 2 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Mobility | No data | 0 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Self-care | No problems | 212 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Mobility | No problems | 546 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Self-care | Extreme problems | 4 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Self-care | No data | 1 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Usual Activities | No problems | 134 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Usual Activities | Some problems | 141 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Usual Activities | Extreme problems | 3 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Usual Activities | No data | 0 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Pain/Discomfort | No problems | 48 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Pain/Discomfort | Some problems | 210 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Pain/Discomfort | Extreme problems | 18 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Pain/Discomfort | No data | 2 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Anxiety/ Depression | No problems | 190 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Anxiety/ Depression | Some problems | 80 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Anxiety/ Depression | Extreme problems | 8 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Anxiety/ Depression | No data | 0 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Mobility | No problems | 144 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Mobility | Some problems | 107 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Mobility | Extreme problems | 0 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Mobility | No data | 1 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Self-care | No problems | 188 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Self-care | Some problems | 58 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Self-care | Extreme problems | 4 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Self-care | No data | 2 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Usual Activities | No problems | 126 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Usual Activities | Some problems | 115 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Usual Activities | Extreme problems | 9 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Usual Activities | No data | 2 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Pain/Discomfort | No problems | 55 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Pain/Discomfort | Some problems | 174 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Pain/Discomfort | Extreme problems | 22 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Pain/Discomfort | No data | 1 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Anxiety/Depression | No problems | 176 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Anxiety/Depression | Some problems | 66 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Anxiety/Depression | Extreme problems | 9 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Mobility | Some problems | 86 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Mobility | Extreme problems | 2 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Mobility | No data | 1 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Self-care | No problems | 156 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Self-care | Some problems | 51 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Self-care | Extreme problems | 7 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Self-care | No data | 1 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Usual Activities | No problems | 114 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Usual Activities | Some problems | 92 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Usual Activities | Extreme problems | 8 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Pain/Discomfort | No problems | 49 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Pain/Discomfort | Extreme problems | 15 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Anxiety/ Depression | No problems | 143 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Anxiety/ Depression | Extreme problems | 6 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Anxiety/ Depression | No data | 1 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Self-care | Some problems | 12 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Mobility | No problems | 177 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Self-care | No data | 2 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Mobility | Some problems | 230 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Self-care | Some problems | 12 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Mobility | Extreme problems | 0 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Usual Activities | No problems | 119 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Mobility | No data | 4 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Usual Activities | No data | 0 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Self-care | No problems | 294 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Usual Activities | Some problems | 100 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Self-care | Some problems | 107 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Self-care | Extreme problems | 1 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Self-care | Extreme problems | 5 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Usual Activities | Extreme problems | 3 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Self-care | No data | 5 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Pain/Discomfort | Some problems | 61 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Usual Activities | No problems | 115 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Usual Activities | No data | 2 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Usual Activities | Some problems | 278 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Self-care | No data | 3 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Pain/Discomfort | No problems | 50 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Usual Activities | No data | 3 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Pain/Discomfort | No problems | 30 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Pain/Discomfort | No problems | 19 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Pain/Discomfort | Some problems | 147 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Pain/Discomfort | Some problems | 264 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Usual Activities | No problems | 68 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Pain/Discomfort | Extreme problems | 125 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Pain/Discomfort | Extreme problems | 23 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Pain/Discomfort | No data | 3 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Self-care | Extreme problems | 3 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Anxiety/Depression | No problems | 218 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Pain/Discomfort | No data | 4 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Anxiety/Depression | Some problems | 167 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Usual Activities | Some problems | 40 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Anxiety/Depression | Extreme problems | 22 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Anxiety/ Depression | Some problems | 62 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Anxiety/Depression | No data | 4 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Pain/Discomfort | Some problems | 71 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13: Mobility | No problems | 213 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Anxiety/ Depression | Extreme problems | 4 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13: Mobility | Some problems | 183 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Usual Activities | Extreme problems | 2 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13: Mobility | Extreme problems | 1 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Anxiety/ Depression | No data | 2 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13: Mobility | No data | 5 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Anxiety/ Depression | No data | 2 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13: Self-care | No problems | 304 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Mobility | No problems | 132 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13: Self-care | Some problems | 85 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Usual Activities | No data | 2 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13: Self-care | Extreme problems | 7 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Mobility | Some problems | 78 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13: Self-care | No data | 6 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Pain/Discomfort | Extreme problems | 6 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13: Usual Activities | No problems | 166 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Mobility | Extreme problems | 0 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13: Usual Activities | Some problems | 222 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Pain/Discomfort | No problems | 28 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13: Usual Activities | Extreme problems | 10 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Mobility | No data | 2 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13: Usual Activities | No data | 4 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Self-care | No data | 2 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13: Pain/Discomfort | No problems | 59 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Self-care | No problems | 178 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Pain/Discomfort | Some problems | 77 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13: Pain/Discomfort | Extreme problems | 69 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Self-care | Some problems | 31 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13: Pain/Discomfort | No data | 4 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13:Anxiety/ Depression | No problems | 242 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Pain/Discomfort | No data | 0 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13:Anxiety/ Depression | Some problems | 142 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Self-care | Extreme problems | 1 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Pain/Discomfort | Extreme problems | 4 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13:Anxiety/ Depression | No data | 4 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Self-care | No data | 2 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Mobility | No problems | 200 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Pain/Discomfort | Extreme problems | 10 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Mobility | Some problems | 137 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Mobility | Extreme problems | 0 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Usual Activities | No problems | 115 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Mobility | No data | 7 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Pain/Discomfort | No data | 3 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Self-care | No problems | 267 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Usual Activities | Some problems | 91 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Self-care | Some problems | 66 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Anxiety/Depression | No problems | 75 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Self-care | Extreme problems | 5 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Usual Activities | Extreme problems | 4 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Self-care | No data | 6 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Anxiety/ Depression | No problems | 86 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Usual Activities | No problems | 156 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Usual Activities | No data | 2 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Usual Activities | Some problems | 171 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Usual Activities | No problems | 55 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Usual Activities | Extreme problems | 9 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Pain/Discomfort | No problems | 55 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Usual Activities | No data | 8 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Anxiety/ Depression | Some problems | 21 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Pain/Discomfort | No problems | 66 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Pain/Discomfort | Some problems | 135 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Pain/Discomfort | Some problems | 234 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Anxiety/Depression | Some problems | 31 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Pain/Discomfort | Extreme problems | 36 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Pain/Discomfort | Extreme problems | 18 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Pain/Discomfort | No data | 8 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Anxiety/ Depression | Extreme problems | 3 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Anxiety/Depression | No problems | 227 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Pain/Discomfort | No data | 4 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Anxiety/Depression | Some problems | 99 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Pain/Discomfort | No data | 3 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Anxiety/Depression | Extreme problems | 12 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Anxiety/Depression | No problems | 152 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 26: Anxiety/Depression | No data | 6 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Mobility | No problems | 168 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Anxiety/ Depression | No data | 2 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Mobility | Some problems | 108 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Mobility | Extreme problems | 0 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Anxiety/Depression | Some problems | 50 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Mobility | No data | 3 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Anxiety/Depression | Extreme problems | 0 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Self-care | No problems | 222 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Anxiety/Depression | Extreme problems | 7 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Self-care | Some problems | 49 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Mobility | No problems | 69 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Self-care | Extreme problems | 5 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 78: Anxiety/Depression | No data | 3 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Self-care | No data | 3 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Mobility | No problems | 58 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Usual Activities | No problems | 143 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Mobility | No problems | 76 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Usual Activities | Some problems | 131 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Mobility | Some problems | 38 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Usual Activities | Extreme problems | 3 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Baseline: Usual Activities | Extreme problems | 15 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Usual Activities | No data | 2 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13: Pain/Discomfort | Some problems | 270 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Pain/Discomfort | No problems | 67 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Usual Activities | Some problems | 35 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Pain/Discomfort | Some problems | 186 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 13:Anxiety/ Depression | Extreme problems | 14 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Pain/Discomfort | Extreme problems | 24 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Mobility | Extreme problems | 0 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Pain/Discomfort | No data | 2 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Mobility | Some problems | 35 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Anxiety/ Depression | No problems | 183 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Mobility | No data | 0 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Anxiety/ Depression | Some problems | 83 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Mobility | Some problems | 92 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Anxiety/ Depression | Extreme problems | 11 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Anxiety/ Depression | Extreme problems | 4 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 39: Anxiety/ Depression | No data | 2 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Self-care | No problems | 86 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Mobility | No problems | 158 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Mobility | Extreme problems | 0 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Pain/Discomfort | No data | 3 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Mobility | Extreme problems | 0 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Anxiety/Depression | Some problems | 73 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Mobility | No data | 3 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Self-care | No problems | 210 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Self-care | Some problems | 20 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Self-care | Some problems | 35 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Self-care | Extreme problems | 5 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Anxiety/ Depression | No problems | 156 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Self-care | No data | 3 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Usual Activities | Extreme problems | 3 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Usual Activities | No problems | 130 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Self-care | Extreme problems | 1 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Usual Activities | Some problems | 115 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Anxiety/Depression | No data | 1 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Usual Activities | Extreme problems | 5 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Mobility | No data | 2 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Usual Activities | No data | 3 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Self-care | No data | 0 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Pain/Discomfort | No problems | 48 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Usual Activities | No data | 2 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Pain/Discomfort | Some problems | 185 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Anxiety/ Depression | No problems | 68 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Pain/Discomfort | Extreme problems | 17 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Usual Activities | No problems | 63 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Anxiety/Depression | No problems | 168 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Self-care | No problems | 78 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Anxiety/Depression | Extreme problems | 9 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Anxiety/ Depression | Some problems | 21 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 52: Anxiety/Depression | No data | 3 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Mobility | Some problems | 34 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Mobility | No problems | 141 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Usual Activities | Some problems | 43 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Mobility | Some problems | 81 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Mobility | Extreme problems | 0 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Mobility | Extreme problems | 0 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 156: Pain/Discomfort | No problems | 21 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Mobility | No data | 2 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Mobility | No data | 2 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Self-care | No problems | 183 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 130: Usual Activities | Extreme problems | 1 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Self-care | Some problems | 37 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 104: Self-care | No problems | 96 Participants |
| Participants With Psoriatic Arthritis | Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) | Week 65: Self-care | Extreme problems | 2 Participants |
Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156)
In this outcome measure number of participants with use of glucocorticoids and DMARDs at baseline and specified weeks are reported. If participants used glucocorticoids and DMARDs, it was denoted by Yes and if they did not use, it was denoted by No. Data have been reported separately for glucocorticoids and DMARDs at specified weeks respectively, in 4 categories as: 1) Baseline: No and Specified Week: No, 2) Baseline: Yes and Specified Week: No, 3) Baseline: No and Specified Week: Yes, 4) Baseline: Yes and Specified Week: Yes.
Time frame: Baseline, Week 78, 156
Population: Full analysis set included all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Here, Number Analyzed = number of participants evaluable for the specified rows.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Participants With Rheumatoid Arthritis | Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | Glucocorticoids Usage Baseline Versus Week 156 | Baseline: No and Specified Week: No | 168 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | DMARDs Usage Baseline Versus Week 78 | Baseline: No and Specified Week: No | 124 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | Glucocorticoids Usage Baseline Versus Week 156 | Baseline: Yes and Specified Week: No | 91 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | Glucocorticoids Usage Baseline Versus Week 78 | Baseline: No and Specified Week: No | 499 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | Glucocorticoids Usage Baseline Versus Week 156 | Baseline: No and Specified Week: Yes | 20 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | DMARDs Usage Baseline Versus Week 78 | Baseline: Yes and Specified Week: No | 655 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | Glucocorticoids Usage Baseline Versus Week 156 | Baseline: Yes and Specified Week: Yes | 12 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | Glucocorticoids Usage Baseline Versus Week 78 | Baseline: No and Specified Week: Yes | 312 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | DMARDs Usage Baseline Versus Week 156 | Baseline: No and Specified Week: No | 33 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | DMARDs Usage Baseline Versus Week 78 | Baseline: No and Specified Week: Yes | 24 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | DMARDs Usage Baseline Versus Week 156 | Baseline: Yes and Specified Week: No | 234 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | Glucocorticoids Usage Baseline Versus Week 78 | Baseline: Yes and Specified Week: Yes | 293 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | DMARDs Usage Baseline Versus Week 156 | Baseline: No and Specified Week: Yes | 1 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | DMARDs Usage Baseline Versus Week 78 | Baseline: Yes and Specified Week: Yes | 478 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | DMARDs Usage Baseline Versus Week 156 | Baseline: Yes and Specified Week: Yes | 23 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | Glucocorticoids Usage Baseline Versus Week 78 | Baseline: Yes and Specified Week: No | 177 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | DMARDs Usage Baseline Versus Week 156 | Baseline: Yes and Specified Week: Yes | 5 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | Glucocorticoids Usage Baseline Versus Week 78 | Baseline: No and Specified Week: No | 258 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | Glucocorticoids Usage Baseline Versus Week 78 | Baseline: Yes and Specified Week: No | 28 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | Glucocorticoids Usage Baseline Versus Week 78 | Baseline: Yes and Specified Week: Yes | 58 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | DMARDs Usage Baseline Versus Week 78 | Baseline: No and Specified Week: No | 133 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | DMARDs Usage Baseline Versus Week 78 | Baseline: Yes and Specified Week: No | 139 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | DMARDs Usage Baseline Versus Week 78 | Baseline: No and Specified Week: Yes | 17 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | DMARDs Usage Baseline Versus Week 78 | Baseline: Yes and Specified Week: Yes | 124 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | Glucocorticoids Usage Baseline Versus Week 156 | Baseline: No and Specified Week: No | 86 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | Glucocorticoids Usage Baseline Versus Week 156 | Baseline: Yes and Specified Week: No | 18 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | Glucocorticoids Usage Baseline Versus Week 156 | Baseline: No and Specified Week: Yes | 6 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | Glucocorticoids Usage Baseline Versus Week 156 | Baseline: Yes and Specified Week: Yes | 6 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | DMARDs Usage Baseline Versus Week 156 | Baseline: No and Specified Week: No | 39 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | DMARDs Usage Baseline Versus Week 156 | Baseline: Yes and Specified Week: No | 71 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | DMARDs Usage Baseline Versus Week 156 | Baseline: No and Specified Week: Yes | 1 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156) | Glucocorticoids Usage Baseline Versus Week 78 | Baseline: No and Specified Week: Yes | 69 Participants |
Percentage of Participants With Rheumatoid Arthritis, With Low Disease Activity Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI)
CDAI was calculated from tender and swollen joints using 28 joint count, PtGA and PhyGA. CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of \<=10 indicates low disease activity and a score of \<= 2.8 indicates remission. SDAI was calculated from tender and swollen joints using 28 joint count, PtGA, PhyGA and CRP (in mg/L). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of \<=11 indicates low disease activity and a score of \<=3.3 indicates remission. PtGA and PhyGA both were assessed on 0-100 mm VAS scale, where higher scores indicated greater affection due to disease activity.
Time frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Population: Full analysis set: all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Number Analyzed = number of participants evaluable for the specified time points. Data for this outcome measure was to be collected and evaluated only for participants with rheumatoid arthritis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Low Disease Activity Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 103: CDAI | 44.4 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Low Disease Activity Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 130: CDAI | 41.5 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Low Disease Activity Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Baseline: SDAI | 7.0 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Low Disease Activity Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Baseline: CDAI | 7.0 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Low Disease Activity Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 13: CDAI | 36.1 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Low Disease Activity Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 26: CDAI | 41.2 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Low Disease Activity Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 39: CDAI | 37.8 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Low Disease Activity Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 52: CDAI | 38.0 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Low Disease Activity Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 65: CDAI | 43.7 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Low Disease Activity Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 78: CDAI | 40.3 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Low Disease Activity Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 165: CDAI | 43.0 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Low Disease Activity Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 13: SDAI | 35.2 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Low Disease Activity Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 26: SDAI | 41.1 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Low Disease Activity Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 39: SDAI | 38.7 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Low Disease Activity Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 52: SDAI | 39.2 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Low Disease Activity Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 65: SDAI | 45.8 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Low Disease Activity Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 78: SDAI | 43.2 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Low Disease Activity Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 103: SDAI | 43.5 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Low Disease Activity Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 130: SDAI | 44.0 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Low Disease Activity Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 165: SDAI | 38.0 Percentage of participants |
Percentage of Participants With Rheumatoid Arthritis, With Remission Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI)
CDAI was calculated from tender and swollen joints using 28 joint count, PtGA and PhyGA. CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of \<=10 indicates low disease activity and a score of \<= 2.8 indicates remission. SDAI was calculated from tender and swollen joints using 28 joint count, PtGA, PhyGA and CRP (in mg/L). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of \<=11 indicates low disease activity and a score of \<=3.3 indicates remission. PtGA and PhyGA both were assessed on 0-100 mm VAS scale, where higher scores indicated greater affection due to disease activity.
Time frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156
Population: Full analysis set. Here, Overall Number of Participants Analyzed = number of participants evaluable for this outcome measure and Number Analyzed = number of participants evaluable for the specified time points. Data for this outcome measure was to be collected and evaluated only for participants with rheumatoid arthritis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Remission Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Baseline: CDAI | 0.6 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Remission Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 13: CDAI | 11.2 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Remission Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 26: CDAI | 16.0 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Remission Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 39: CDAI | 19.8 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Remission Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 52: CDAI | 21.3 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Remission Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 65: CDAI | 22.8 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Remission Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 78: CDAI | 25.3 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Remission Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 103: CDAI | 24.7 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Remission Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 130: CDAI | 27.0 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Remission Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 165: CDAI | 31.9 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Remission Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Baseline: SDAI | 0.4 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Remission Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 13: SDAI | 11.1 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Remission Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 26: SDAI | 13.6 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Remission Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 39: SDAI | 17.3 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Remission Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 52: SDAI | 19.3 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Remission Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 65: SDAI | 19.8 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Remission Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 78: SDAI | 22.3 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Remission Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 103: SDAI | 23.3 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Remission Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 130: SDAI | 25.1 Percentage of participants |
| Participants With Rheumatoid Arthritis | Percentage of Participants With Rheumatoid Arthritis, With Remission Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) | Week 165: SDAI | 35.5 Percentage of participants |
Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Continuation of Treatment With Etanercept
In this outcome number of participants who participated or not participated in RUDI and PIT and impact of their participation in continuation or termination of treatment with Etanercept is reported. For participants whom data was not recorded is reported under category No Data.
Time frame: Baseline up to Week 156
Population: Full analysis set included all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Here, Overall Number of participants analyzed = number of participants evaluable for this measure and Number Analyzed = number of participants evaluable for the specified rows.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Continuation of Treatment With Etanercept | Rudi and PIT= Yes | Treatment Continued | 207 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Continuation of Treatment With Etanercept | Rudi and PIT= Yes | Treatment Terminated | 139 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Continuation of Treatment With Etanercept | Rudi and PIT= Yes | No Data | 1 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Continuation of Treatment With Etanercept | Rudi and PIT= No | Treatment Continued | 555 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Continuation of Treatment With Etanercept | Rudi and PIT= No | Treatment Terminated | 335 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Continuation of Treatment With Etanercept | Rudi and PIT= No | No Data | 4 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Continuation of Treatment With Etanercept | Rudi and PIT= No | Treatment Terminated | 116 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Continuation of Treatment With Etanercept | Rudi and PIT= Yes | Treatment Continued | 58 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Continuation of Treatment With Etanercept | Rudi and PIT= No | Treatment Continued | 178 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Continuation of Treatment With Etanercept | Rudi and PIT= Yes | Treatment Terminated | 48 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Continuation of Treatment With Etanercept | Rudi and PIT= No | No Data | 0 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Continuation of Treatment With Etanercept | Rudi and PIT= Yes | No Data | 0 Participants |
Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D)
In this outcome number of participants who participated or not participated in RUDI and PIT and impact of their participation in quality of life parameters using EQ-5D health questionnaire is reported. For participants whom data was not recorded is reported under category No Data. EQ-5D: participant rated questionnaire to assess generic health status in two parts: single utility score and visual analog scale. For utility score, participants rated their current health state on 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression with each dimension having three levels of function: 1 indicates no problem; 2 indicates some problem; 3 indicates extreme problem.
Time frame: Baseline up to Week 156
Population: Full analysis set included all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Here, Overall Number of participants analyzed = number of participants evaluable for this measure and Number Analyzed = number of participants evaluable for the specified rows.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Self-care | Extreme problem | 13 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Mobility | No problems | 143 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Mobility | Extreme problem | 2 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Mobility | No data | 9 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Mobility | No problems | 483 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Mobility | Some problems | 394 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Mobility | Extreme problem | 1 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Mobility | No data | 9 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Self-care | No problems | 213 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Self-care | Some problems | 111 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Mobility | Some problems | 191 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Self-care | No data | 8 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Self-care | No problems | 618 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Self-care | Some problems | 244 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Self-care | Extreme problem | 16 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Self-care | No data | 9 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Usual Activities | No problems | 113 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Usual Activities | Some problems | 204 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Usual Activities | Extreme problem | 19 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Usual Activities | No data | 9 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Usual Activities | No problems | 392 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Usual Activities | Some problems | 456 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Usual Activities | Extreme problem | 30 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Usual Activities | No data | 9 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Pain/Discomfort | No problems | 38 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Pain/Discomfort | Some problems | 230 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Pain/Discomfort | Extreme problem | 68 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Pain/Discomfort | No data | 9 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Pain/Discomfort | No problems | 155 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Pain/Discomfort | Some problems | 611 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Pain/Discomfort | Extreme problem | 112 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Pain/Discomfort | No data | 9 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Anxiety/Depression | No problems | 188 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Anxiety/Depression | Some problems | 138 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Anxiety/Depression | Extreme problem | 11 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Anxiety/Depression | No data | 8 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Anxiety/Depression | No problems | 544 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Anxiety/Depression | Some problems | 300 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Anxiety/Depression | Extreme problem | 34 Participants |
| Participants With Rheumatoid Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Anxiety/Depression | No data | 9 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Anxiety/Depression | Some problems | 88 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Usual Activities | No problems | 142 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Mobility | No problems | 50 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Mobility | Some problems | 54 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Pain/Discomfort | Extreme problem | 35 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Mobility | Extreme problem | 0 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Usual Activities | Some problems | 136 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Mobility | No data | 2 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Anxiety/Depression | No data | 3 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Mobility | No problems | 167 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Usual Activities | Extreme problem | 6 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Mobility | Some problems | 117 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Pain/Discomfort | No data | 8 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Mobility | Extreme problem | 0 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Usual Activities | No data | 8 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Mobility | No data | 8 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Anxiety/Depression | No data | 8 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Self-care | No problems | 72 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Pain/Discomfort | No problems | 17 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Self-care | Some problems | 25 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Anxiety/Depression | No problems | 63 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Self-care | Extreme problem | 6 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Pain/Discomfort | Some problems | 62 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Self-care | No data | 3 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Anxiety/Depression | No problems | 188 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Self-care | No problems | 233 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Pain/Discomfort | Extreme problem | 25 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Self-care | Some problems | 47 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Anxiety/Depression | Some problems | 34 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Self-care | Extreme problem | 4 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Pain/Discomfort | No data | 2 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Self-care | No data | 8 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Anxiety/Depression | Extreme problem | 8 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Usual Activities | No problems | 39 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Pain/Discomfort | No problems | 60 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Usual Activities | Some problems | 58 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Anxiety/Depression | Extreme problem | 6 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Usual Activities | Extreme problem | 8 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= No: Pain/Discomfort | Some problems | 189 Participants |
| Participants With Psoriatic Arthritis | Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) | Rudi and PIT= Yes: Usual Activities | No data | 1 Participants |
Number of Participants Who Used Concomitant Medication
Number of participants who used medication other than Etanercept for relief of pain. It was determined by the treating physician.
Time frame: Baseline up to Week 156
Population: Safety analysis set included all patients who received at least 1 dose of Etanercept.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With Rheumatoid Arthritis | Number of Participants Who Used Concomitant Medication | 1284 Participants |
| Participants With Psoriatic Arthritis | Number of Participants Who Used Concomitant Medication | 376 Participants |
| Participants With Unclear Diagnosis | Number of Participants Who Used Concomitant Medication | 2 Participants |
Number of Participants With Discontinuation of Etanercept Treatment
Number of participants those who discontinued Etanercept treatment at Week 78 and 156 are reported in this outcome measure.
Time frame: Week 78, 156
Population: Safety analysis set included all patients who received at least 1 dose of Etanercept. Here, Number Analyzed signifies number of participants evaluable for specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With Rheumatoid Arthritis | Number of Participants With Discontinuation of Etanercept Treatment | Week 78 | 57 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Discontinuation of Etanercept Treatment | Week 156 | 8 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Discontinuation of Etanercept Treatment | Week 78 | 18 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Discontinuation of Etanercept Treatment | Week 156 | 4 Participants |
| Participants With Unclear Diagnosis | Number of Participants With Discontinuation of Etanercept Treatment | Week 78 | 1 Participants |
Number of Participants With Pregnancy, Puerperium and Perinatal Conditions
In this outcome measure total number of participants with pregnancy, puerperium and perinatal conditions are reported. Pregnancy, puerperium and perinatal conditions included pregnancy, abortion, abortion spontaneous or premature baby.
Time frame: Baseline up to Week 156
Population: Safety analysis set included all patients who received at least 1 dose of Etanercept.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With Rheumatoid Arthritis | Number of Participants With Pregnancy, Puerperium and Perinatal Conditions | 4 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Pregnancy, Puerperium and Perinatal Conditions | 1 Participants |
| Participants With Unclear Diagnosis | Number of Participants With Pregnancy, Puerperium and Perinatal Conditions | 0 Participants |
Number of Participants With Results of Tolerability Assessment by Physician and Participant
Physicians and participants rated the tolerability of Etanercept treatment by means of a 4-point scale as: 1) very good, 2) good, 3) moderate and 4) insufficient.
Time frame: Week 78, 156
Population: Safety analysis set included all patients who received at least 1 dose of Etanercept. Here, Number Analyzed signifies number of participants evaluable for specified rows.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Participants With Rheumatoid Arthritis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 78: Physician Assessment | Moderate | 4 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 156: Physician Assessment | Insufficient | 0 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 78: Participant Assessment | Moderate | 33 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 78: Physician Assessment | Good | 252 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 156: Physician Assessment | Moderate | 1 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 78: Participant Assessment | Insufficient | 9 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 156: Participant Assessment | Moderate | 4 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 156: Physician Assessment | Good | 70 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 156: Physician Assessment | Very good | 149 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 78: Physician Assessment | Insufficient | 4 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 78: Physician Assessment | Very good | 439 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 156: Participant Assessment | Good | 89 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 78: Participant Assessment | Very good | 284 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 156: Participant Assessment | Insufficient | 2 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 156: Participant Assessment | Very good | 115 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 78: Participant Assessment | Good | 281 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 156: Participant Assessment | Insufficient | 0 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 78: Physician Assessment | Very good | 146 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 78: Physician Assessment | Good | 70 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 78: Physician Assessment | Moderate | 2 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 78: Physician Assessment | Insufficient | 2 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 78: Participant Assessment | Very good | 96 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 78: Participant Assessment | Good | 75 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 78: Participant Assessment | Moderate | 12 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 78: Participant Assessment | Insufficient | 0 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 156: Physician Assessment | Very good | 67 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 156: Physician Assessment | Good | 30 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 156: Physician Assessment | Moderate | 0 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 156: Physician Assessment | Insufficient | 0 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 156: Participant Assessment | Very good | 55 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 156: Participant Assessment | Good | 38 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 156: Participant Assessment | Moderate | 1 Participants |
| Participants With Unclear Diagnosis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 78: Participant Assessment | Very good | 1 Participants |
| Participants With Unclear Diagnosis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 78: Physician Assessment | Very good | 1 Participants |
| Participants With Unclear Diagnosis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 78: Participant Assessment | Insufficient | 0 Participants |
| Participants With Unclear Diagnosis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 78: Physician Assessment | Insufficient | 0 Participants |
| Participants With Unclear Diagnosis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 78: Participant Assessment | Moderate | 0 Participants |
| Participants With Unclear Diagnosis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 78: Physician Assessment | Good | 0 Participants |
| Participants With Unclear Diagnosis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 78: Participant Assessment | Good | 0 Participants |
| Participants With Unclear Diagnosis | Number of Participants With Results of Tolerability Assessment by Physician and Participant | Week 78: Physician Assessment | Moderate | 0 Participants |
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.
Time frame: Baseline up to Week 156
Population: Safety analysis set included all patients who received at least 1 dose of Etanercept.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With Rheumatoid Arthritis | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs) | AEs | 658 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs) | SAEs | 159 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs) | AEs | 190 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs) | SAEs | 47 Participants |
| Participants With Unclear Diagnosis | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs) | AEs | 1 Participants |
| Participants With Unclear Diagnosis | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs) | SAEs | 0 Participants |
Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events. AEs were classified according to the severity in 3 categories a)mild: AEs not interfered with participant's usual function b)moderate: AEs interfered to some extent with participant's usual function c)severe: AEs interfered significantly with participant's usual function. Participants may be counted in more than 1 category.
Time frame: Baseline up to Week 156
Population: Safety analysis set included all patients who received at least 1 dose of Etanercept. Here, Overall Number of Participants Analyzed signifies number of participants who had at least 1 treatment AE.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With Rheumatoid Arthritis | Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity | Severe | 172 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity | Mild | 292 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity | No Data | 36 Participants |
| Participants With Rheumatoid Arthritis | Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity | Moderate | 377 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity | Severe | 52 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity | Moderate | 104 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity | No Data | 7 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity | Mild | 85 Participants |
| Participants With Unclear Diagnosis | Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity | No Data | 1 Participants |
| Participants With Unclear Diagnosis | Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity | Mild | 0 Participants |
| Participants With Unclear Diagnosis | Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity | Moderate | 0 Participants |
| Participants With Unclear Diagnosis | Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity | Severe | 0 Participants |
Number of Participants With Treatment-Emergent Treatment Related Adverse Events
Treatment-related AE was any untoward medical occurrence in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events. Relatedness to study treatment was assessed by the investigator.
Time frame: Baseline up to Week 156
Population: Safety analysis set included all patients who received at least 1 dose of Etanercept. Here, Overall Number of Participants Analyzed signifies number of participants who had at least 1 treatment AE.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With Rheumatoid Arthritis | Number of Participants With Treatment-Emergent Treatment Related Adverse Events | 345 Participants |
| Participants With Psoriatic Arthritis | Number of Participants With Treatment-Emergent Treatment Related Adverse Events | 100 Participants |
| Participants With Unclear Diagnosis | Number of Participants With Treatment-Emergent Treatment Related Adverse Events | 1 Participants |