PRERA: Prospective Evaluation of the Radiographic Efficacy of Enbrel

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01623752
• Collaborator: (none)
• Enrollment: 1,821
• Actual Duration (Months): 72.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis; Psoriasis Arthritis	Drug: Etanercept; Drug: Etanercept

Detailed Description

Non-interventional study: subjects to be selected according to the usual clinical practice of their physician

Study Design

• Study Type: Observational
• Actual Enrollment: 1821 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A PROSPECTIVE EVALUATION OF THE RADIOGRAPHIC EFFICACY OF ETANERCEPT IN PATIENTS WITH RHEUMATOID ARTHRITIS OR PSORIATIC ARTHRITIS.
• Actual Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Mar 1, 2018
• Actual Study Completion Date: Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Patients with Rheumatoid Arthritis	Drug: Etanercept; 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.; Other Names: Enbrel
Patients with Psoriasis Arthritis	Drug: Etanercept; 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.; Other Names: Enbrel

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

Secondary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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%.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

16. 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.

17. 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.

18. 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.

19. 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.

20. 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.

21. 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).

22. 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.

23. 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".

24. 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.

Other Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

• Exclusion Criteria according to the Enbrel® SmPC, with particular attention to:

• Hypersensitivity to the active substance (etanercept) or to any of the excipients.

• Sepsis or risk of sepsis.

• Active infections, including chronic or localised infections.

• Subjects who have received any previous treatment with etanercept

• Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 20, 2011

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01623752
• Other Study ID Numbers: B1801317
• First Posted: Jun 20, 2012
• Last Update Posted: Aug 16, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Psoriasis; Etanercept

Study Results

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.

Arm/Group Title	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis	Participants With Unclear Diagnosis
Arm/Group Description	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.	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.	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.
Period Title: Phase 1 (78 Weeks)
STARTED	1378	440	3
COMPLETED	747	233	1
NOT COMPLETED	631	207	2
Period Title: Phase 1 (78 Weeks)
STARTED	291	116	0
COMPLETED	225	98	0
NOT COMPLETED	66	18	0

Baseline Characteristics

Arm/Group Title	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis	Participants With Unclear Diagnosis	Total
Arm/Group Description	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.	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.	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.	Total of all reporting groups
Overall Participants	1378	440	3	1821
Age, Customized (Count of Participants)
Less than 18 years	1 0.1%	0 0%	0 0%	1 0.1%
18 to 64 years	976 70.8%	387 88%	2 66.7%	1365 75%
65 years or more	395 28.7%	49 11.1%	0 0%	444 24.4%
No data	6 0.4%	4 0.9%	1 33.3%	11 0.6%
Sex/Gender, Customized (Count of Participants)
Female	1062 77.1%	259 58.9%	2 66.7%	1323 72.7%
Male	316 22.9%	181 41.1%	0 0%	497 27.3%
No Data	0 0%	0 0%	1 33.3%	1 0.1%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

Title	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)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis
Arm/Group Description	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.	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.
Measure Participants	504	166
Baseline	25.1 (42.4)	14.7 (25.7)
Change at Week 78	0.6 (7.2)	-0.4 (5.9)

2. Primary Outcome

Title	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)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis
Arm/Group Description	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.	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.
Measure Participants	500	164
Baseline	25.3 (42.5)	14.7 (25.8)
Change at Week 78	0.6 (7.2)	-0.5 (5.8)

3. Primary Outcome

Title	Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at the End of Phase 2 (Week 156): EAS
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis
Arm/Group Description	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.	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.
Measure Participants	97	48
Mean (Standard Deviation) [Units on a scale]	1.4 (9.9)	0.7 (8.2)

4. Primary Outcome

Title	Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 2 (Week 156): CAS
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis
Arm/Group Description	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.	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.
Measure Participants	96	48
Mean (Standard Deviation) [Units on a scale]	1.4 (9.9)	0.7 (8.2)

5. Primary Outcome

Title	Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): EAS
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis
Arm/Group Description	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.	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.
Measure Participants	189	46
Pre-treatment	0.959 (4.396)	1.056 (5.127)
Change at Week 78	-0.267 (5.989)	-0.995 (8.628)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Participants With Rheumatoid Arthritis
	Comments	P-value was calculated using Paired t-test for the change in normalized progression.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.278
	Comments
	Method	Paired t-test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Participants With Psoriatic Arthritis
	Comments	P-value was calculated using Paired t-test for the change in normalized progression.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.222
	Comments
	Method	Paired t-test
	Comments

6. Primary Outcome

Title	Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): CAS
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis
Arm/Group Description	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.	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.
Measure Participants	187	45
Pre-treatment	0.981 (4.413)	1.080 (5.182)
Change at Week 78	-0.306 (6.002)	-1.033 (8.724)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Participants With Rheumatoid Arthritis
	Comments	P-value was calculated using Paired t-test for the change in normalized progression.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.251
	Comments
	Method	Paired t-test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Participants With Psoriatic Arthritis
	Comments	P-value was calculated using Paired t-test for the change in normalized progression.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.218
	Comments
	Method	Paired t-test
	Comments

7. Primary Outcome

Title	Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 2 (Week 156): EAS
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis
Arm/Group Description	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.	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.
Measure Participants	40	15
Mean (Standard Deviation) [Scores per year]	-0.473 (5.940)	-0.348 (3.985)

8. Primary Outcome

Title	Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at the End of Phase 2 (Week 156): CAS
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis
Arm/Group Description	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.	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.
Measure Participants	40	15
Mean (Standard Deviation) [Scores per year]	-0.473 (5.940)	-0.348 (3.985)

9. Secondary Outcome

Title	Linear Relationship Between Normalized Radiographic Progression and Disease Duration
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis
Arm/Group Description	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.	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.
Measure Participants	466	157
Number [Regression coefficient]	-0.012	-0.050

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Participants With Rheumatoid Arthritis
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.675
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Participants With Psoriatic Arthritis
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.357
	Comments
	Method	Regression, Linear
	Comments

10. Secondary Outcome

Title	Effect on Normalized Radiographic Progression With Respect to Baseline Positivity of Anti-citrullinated Protein Antibody (ACPA) - Rheumatoid Factor (RF)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis
Arm/Group Description	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.	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.
Measure Participants	387	87
ACPA and RF negative	1.326	-1.142
ACPA or RF positive	1.075	2.448
ACPA and RF positive	0.087	3.370

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Participants With Rheumatoid Arthritis
	Comments	Statistical analysis (P value) composite for all categories.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.106
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Participants With Psoriatic Arthritis
	Comments	Statistical analysis (P value) composite for all categories.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.181
	Comments
	Method	ANOVA
	Comments

11. Secondary Outcome

Title	Effect on Normalized Radiographic Progression With Respect to Baseline Usage of Concomitant Medication
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis
Arm/Group Description	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.	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.
Measure Participants	471	157
Concomitant Medication at baseline: Yes	0.749	-0.339
Concomitant Medication at baseline: No	-0.978	-0.370

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Participants With Rheumatoid Arthritis
	Comments	Statistical analysis (P value) composite for all categories.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.015
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Participants With Psoriatic Arthritis
	Comments	Statistical analysis (P value) composite for all categories.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.969
	Comments
	Method	ANOVA
	Comments

12. Secondary Outcome

Title	Effect on Normalized Radiographic Progression With Respect to Previous Treatment With Biologics
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis
Arm/Group Description	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.	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.
Measure Participants	471	157
Previous treatment with biologics	0.235	-0.986
No previous treatment with biologics	0.621	-0.170

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Participants With Rheumatoid Arthritis
	Comments	Statistical analysis (P value) composite for all categories.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.489
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Participants With Psoriatic Arthritis
	Comments	Statistical analysis (P value) composite for all categories.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.386
	Comments
	Method	ANOVA
	Comments

13. Secondary Outcome

Title	Effect on Normalized Radiographic Progression With Respect to Baseline Disease Activity Score-28 (DAS-28)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis
Arm/Group Description	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.	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.
Measure Participants	367	126
Baseline DAS-28 <= 5.1	0.716	-0.314
Baseline DAS-28 > 5.1	0.170	-0.507

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Participants With Rheumatoid Arthritis
	Comments	Statistical analysis (P value) composite for all categories.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.364
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Participants With Psoriatic Arthritis
	Comments	Statistical analysis (P value) composite for all categories.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.849
	Comments
	Method	ANOVA
	Comments

14. Secondary Outcome

Title	Change From Baseline in Total Erosion Score at End of Phase 1 (Week 78) and Phase 2 (Week 156)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis
Arm/Group Description	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.	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.
Measure Participants	505	166
Baseline	11.1 (23.8)	4.6 (11.9)
Change at Week 78	-0.1 (4.1)	-0.3 (3.1)
Change at Week 156	0.0 (5.7)	0.2 (6.5)

15. Secondary Outcome

Title	Change From Baseline in Total Joint Space Narrow Score at End of Phase 1 (Week 78) and Phase 2 (Week 156)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis
Arm/Group Description	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.	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.
Measure Participants	507	166
Baseline	14.0 (19.9)	10.0 (15.0)
Change at Week 78	0.7 (4.3)	-0.1 (3.7)
Change at Week 156	1.4 (5.9)	0.6 (3.1)

16. Secondary Outcome

Title	Change From Baseline in Hannover Functional Ability Questionnaire (FFbH) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis
Arm/Group Description	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.	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.
Measure Participants	1281	413
Baseline	64.99 (22.71)	68.67 (22.09)
Change at Week 13	4.38 (12.94)	3.45 (13.44)
Change at Week 26	5.63 (15.25)	3.99 (15.11)
Change at Week 39	6.20 (15.43)	4.90 (14.46)
Change at Week 52	5.78 (15.27)	4.43 (16.47)
Change at Week 65	6.15 (15.96)	4.83 (16.52)
Change at Week 78	6.59 (16.16)	3.62 (16.37)
Change at Week 104	6.10 (14.98)	5.09 (14.54)
Change at Week 130	6.22 (15.46)	4.66 (15.03)
Change at Week 156	5.54 (16.42)	3.56 (15.78)

17. Secondary Outcome

Title	Change From Baseline in Disease Activity Score-28 (DAS-28) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis
Arm/Group Description	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.	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.
Measure Participants	1281	431
Baseline	4.63 (1.24)	4.18 (1.11)
Change at Week 13	-1.26 (1.38)	-1.23 (1.31)
Change at Week 26	-1.52 (1.38)	-1.37 (1.28)
Change at Week 39	-1.57 (1.41)	-1.52 (1.27)
Change at Week 52	-1.64 (1.41)	-1.69 (1.20)
Change at Week 65	-1.76 (1.47)	-1.54 (1.26)
Change at Week 78	-1.73 (1.38)	-1.62 (1.31)
Change at Week 104	-1.94 (1.33)	-1.67 (1.37)
Change at Week 130	-1.96 (1.36)	-1.66 (1.27)
Change at Week 156	-2.10 (1.42)	-1.54 (1.39)

18. Secondary Outcome

Title	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
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Rheumatoid Arthritis
Arm/Group Description	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.
Measure Participants	1281
Baseline	25.64 (12.14)
Change at Week 13	-11.51 (12.13)
Change at Week 26	-13.49 (12.53)
Change at Week 39	-13.98 (12.78)
Change at Week 52	-14.32 (12.29)
Change at Week 65	-15.28 (12.66)
Change at Week 78	-15.54 (12.28)
Change at Week 104	-17.53 (11.99)
Change at Week 130	-17.37 (12.18)
Change at Week 156	-18.38 (11.99)

19. Secondary Outcome

Title	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
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Rheumatoid Arthritis
Arm/Group Description	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.
Measure Participants	1281
Baseline	35.88 (198.26)
Change at Week 13	-20.62 (225.74)
Change at Week 26	-26.04 (248.89)
Change at Week 39	-16.00 (45.07)
Change at Week 52	-17.70 (47.40)
Change at Week 65	-18.77 (49.86)
Change at Week 78	-19.02 (51.83)
Change at Week 103	-18.08 (15.07)
Change at Week 130	-17.33 (17.19)
Change at Week 156	-18.85 (14.06)

20. Secondary Outcome

Title	Percentage of Participants With Rheumatoid Arthritis, With Low Disease Activity Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Rheumatoid Arthritis
Arm/Group Description	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.
Measure Participants	1281
Baseline: CDAI	7.0 0.5%
Week 13: CDAI	36.1 2.6%
Week 26: CDAI	41.2 3%
Week 39: CDAI	37.8 2.7%
Week 52: CDAI	38.0 2.8%
Week 65: CDAI	43.7 3.2%
Week 78: CDAI	40.3 2.9%
Week 103: CDAI	44.4 3.2%
Week 130: CDAI	41.5 3%
Week 165: CDAI	43.0 3.1%
Baseline: SDAI	7.0 0.5%
Week 13: SDAI	35.2 2.6%
Week 26: SDAI	41.1 3%
Week 39: SDAI	38.7 2.8%
Week 52: SDAI	39.2 2.8%
Week 65: SDAI	45.8 3.3%
Week 78: SDAI	43.2 3.1%
Week 103: SDAI	43.5 3.2%
Week 130: SDAI	44.0 3.2%
Week 165: SDAI	38.0 2.8%

21. Secondary Outcome

Title	Percentage of Participants With Rheumatoid Arthritis, With Remission Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Rheumatoid Arthritis
Arm/Group Description	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.
Measure Participants	1281
Baseline: CDAI	0.6 0%
Week 13: CDAI	11.2 0.8%
Week 26: CDAI	16.0 1.2%
Week 39: CDAI	19.8 1.4%
Week 52: CDAI	21.3 1.5%
Week 65: CDAI	22.8 1.7%
Week 78: CDAI	25.3 1.8%
Week 103: CDAI	24.7 1.8%
Week 130: CDAI	27.0 2%
Week 165: CDAI	31.9 2.3%
Baseline: SDAI	0.4 0%
Week 13: SDAI	11.1 0.8%
Week 26: SDAI	13.6 1%
Week 39: SDAI	17.3 1.3%
Week 52: SDAI	19.3 1.4%
Week 65: SDAI	19.8 1.4%
Week 78: SDAI	22.3 1.6%
Week 103: SDAI	23.3 1.7%
Week 130: SDAI	25.1 1.8%
Week 165: SDAI	35.5 2.6%

22. Secondary Outcome

Title	Change From Baseline in Participant Pain Visual Analogue Scale (VAS) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis
Arm/Group Description	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.	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.
Measure Participants	1281	413
Baseline	55.93 (26.26)	57.69 (25.14)
Change at Week 13	-15.03 (28.50)	-18.20 (27.96)
Change at Week 26	-18.56 (29.83)	-19.01 (27.51)
Change at Week 39	-18.38 (29.91)	-21.84 (29.62)
Change at Week 52	-19.73 (31.02)	-22.24 (30.57)
Change at Week 65	-22.83 (30.95)	-22.40 (29.74)
Change at Week 78	-22.58 (32.12)	-24.91 (31.69)
Change at Week 104	-23.46 (29.01)	-21.09 (32.67)
Change at Week 130	-24.67 (28.75)	-21.67 (29.18)
Change at Week 156	-26.88 (28.77)	-18.33 (31.13)

23. Secondary Outcome

Title	Change From Baseline in Physician Global Assessment (PhyGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis
Arm/Group Description	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.	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.
Measure Participants	1281	413
Baseline	57.28 (19.38)	55.73 (19.90)
Change at Week 13	-24.49 (22.98)	-24.97 (23.29)
Change at Week 26	-29.22 (24.42)	-28.54 (24.28)
Change at Week 39	-30.67 (23.92)	-32.06 (24.46)
Change at Week 52	-31.78 (24.74)	-34.36 (22.72)
Change at Week 65	-34.07 (24.83)	-34.37 (24.02)
Change at Week 78	-35.88 (25.29)	-35.87 (23.66)
Change at Week 104	-37.10 (23.18)	-34.87 (21.22)
Change at Week 130	-37.11 (22.96)	-33.98 (22.19)
Change at Week 156	-40.09 (22.39)	-34.75 (22.55)

24. Secondary Outcome

Title	Change From Baseline in Participant Global Assessment (PtGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis
Arm/Group Description	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.	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.
Measure Participants	1281	413
Baseline	54.69 (24.91)	56.99 (24.57)
Change at Week 13	-13.55 (27.17)	-17.13 (28.34)
Change at Week 26	-17.30 (29.43)	-19.32 (27.37)
Change at Week 39	-18.09 (28.13)	-21.58 (28.74)
Change at Week 52	-19.38 (28.84)	-22.55 (30.03)
Change at Week 65	-22.52 (29.15)	-22.74 (28.75)
Change at Week 78	-22.24 (30.34)	-24.59 (31.73)
Change at Week 104	-22.68 (26.87)	-20.59 (31.57)
Change at Week 130	-23.75 (27.23)	-23.10 (29.21)
Change at Week 156	-26.30 (27.39)	-21.24 (30.14)

25. Secondary Outcome

Title	Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis
Arm/Group Description	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.	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.
Measure Participants	1281	413
No problems	546 39.6%	177 40.2%
Some problems	714 51.8%	230 52.3%
Extreme problems	3 0.2%	0 0%
No data	10 0.7%	4 0.9%
No problems	798 57.9%	294 66.8%
Some problems	423 30.7%	107 24.3%
Extreme problems	37 2.7%	5 1.1%
No data	15 1.1%	5 1.1%
No problems	326 23.7%	115 26.1%
Some problems	887 64.4%	278 63.2%
Extreme problems	51 3.7%	15 3.4%
No data	9 0.7%	3 0.7%
No problems	67 4.9%	19 4.3%
Some problems	817 59.3%	264 60%
Extreme problems	380 27.6%	125 28.4%
No data	9 0.7%	3 0.7%
No problems	693 50.3%	218 49.5%
Some problems	515 37.4%	167 38%
Extreme problems	56 4.1%	22 5%
No data	9 0.7%	4 0.9%
No problems	640 46.4%	213 48.4%
Some problems	586 42.5%	183 41.6%
Extreme problems	4 0.3%	1 0.2%
No data	10 0.7%	5 1.1%
No problems	867 62.9%	304 69.1%
Some problems	329 23.9%	85 19.3%
Extreme problems	34 2.5%	7 1.6%
No data	10 0.7%	6 1.4%
No problems	480 34.8%	166 37.7%
Some problems	699 50.7%	222 50.5%
Extreme problems	50 3.6%	10 2.3%
No data	11 0.8%	4 0.9%
No problems	162 11.8%	59 13.4%
Some problems	903 65.5%	270 61.4%
Extreme problems	164 11.9%	69 15.7%
No data	11 0.8%	4 0.9%
No problems	751 54.5%	242 55%
Some problems	427 31%	142 32.3%
Extreme problems	48 3.5%	14 3.2%
No data	14 1%	4 0.9%
No problems	558 40.5%	200 45.5%
Some problems	461 33.5%	137 31.1%
Extreme problems	3 0.2%	0 0%
No data	9 0.7%	7 1.6%
No problems	733 53.2%	267 60.7%
Some problems	267 19.4%	66 15%
Extreme problems	22 1.6%	5 1.1%
No data	9 0.7%	6 1.4%
No problems	433 31.4%	156 35.5%
Some problems	550 39.9%	171 38.9%
Extreme problems	38 2.8%	9 2%
No data	10 0.7%	8 1.8%
No problems	181 13.1%	66 15%
Some problems	733 53.2%	234 53.2%
Extreme problems	105 7.6%	36 8.2%
No data	12 0.9%	8 1.8%
No problems	641 46.5%	227 51.6%
Some problems	348 25.3%	99 22.5%
Extreme problems	32 2.3%	12 2.7%
No data	10 0.7%	6 1.4%
No problems	506 36.7%	168 38.2%
Some problems	391 28.4%	108 24.5%
Extreme problems	3 0.2%	0 0%
No data	4 0.3%	3 0.7%
No problems	664 48.2%	222 50.5%
Some problems	212 15.4%	49 11.1%
Extreme problems	21 1.5%	5 1.1%
No data	7 0.5%	3 0.7%
No problems	402 29.2%	143 32.5%
Some problems	474 34.4%	131 29.8%
Extreme problems	24 1.7%	3 0.7%
No data	4 0.3%	2 0.5%
No problems	161 11.7%	67 15.2%
Some problems	641 46.5%	186 42.3%
Extreme problems	98 7.1%	24 5.5%
No data	4 0.3%	2 0.5%
No problems	576 41.8%	183 41.6%
Some problems	301 21.8%	83 18.9%
Extreme problems	22 1.6%	11 2.5%
No data	5 0.4%	2 0.5%
No problems	459 33.3%	158 35.9%
Some problems	346 25.1%	92 20.9%
Extreme problems	1 0.1%	0 0%
No data	5 0.4%	3 0.7%
No problems	605 43.9%	210 47.7%
Some problems	190 13.8%	35 8%
Extreme problems	11 0.8%	5 1.1%
No data	5 0.4%	3 0.7%
No problems	400 29%	130 29.5%
Some problems	380 27.6%	115 26.1%
Extreme problems	26 1.9%	5 1.1%
No data	5 0.4%	3 0.7%
No problems	153 11.1%	48 10.9%
Some problems	577 41.9%	185 42%
Extreme problems	73 5.3%	17 3.9%
No data	8 0.6%	3 0.7%
No problems	506 36.7%	168 38.2%
Some problems	268 19.4%	73 16.6%
Extreme problems	28 2%	9 2%
No data	9 0.7%	3 0.7%
No problems	422 30.6%	141 32%
Some problems	292 21.2%	81 18.4%
Extreme problems	1 0.1%	0 0%
No data	4 0.3%	2 0.5%
No problems	525 38.1%	183 41.6%
Some problems	177 12.8%	37 8.4%
Extreme problems	11 0.8%	2 0.5%
No data	6 0.4%	2 0.5%
No problems	361 26.2%	119 27%
Some problems	331 24%	100 22.7%
Extreme problems	21 1.5%	3 0.7%
No data	6 0.4%	2 0.5%
No problems	149 10.8%	50 11.4%
Some problems	505 36.6%	147 33.4%
Extreme problems	62 4.5%	23 5.2%
No data	3 0.2%	4 0.9%
No problems	467 33.9%	156 35.5%
Some problems	225 16.3%	62 14.1%
Extreme problems	23 1.7%	4 0.9%
No data	4 0.3%	2 0.5%
No problems	401 29.1%	132 30%
Some problems	286 20.8%	78 17.7%
Extreme problems	0 0%	0 0%
No data	5 0.4%	2 0.5%
No problems	527 38.2%	178 40.5%
Some problems	155 11.2%	31 7%
Extreme problems	6 0.4%	1 0.2%
No data	4 0.3%	2 0.5%
No problems	355 25.8%	115 26.1%
Some problems	316 22.9%	91 20.7%
Extreme problems	16 1.2%	4 0.9%
No data	5 0.4%	2 0.5%
No problems	152 11%	55 12.5%
Some problems	477 34.6%	135 30.7%
Extreme problems	58 4.2%	18 4.1%
No data	5 0.4%	4 0.9%
No problems	455 33%	152 34.5%
Some problems	211 15.3%	50 11.4%
Extreme problems	20 1.5%	7 1.6%
No data	6 0.4%	3 0.7%
No problems	167 12.1%	76 17.3%
Some problems	109 7.9%	34 7.7%
Extreme problems	2 0.1%	0 0%
No data	0 0%	2 0.5%
No problems	212 15.4%	96 21.8%
Some problems	61 4.4%	12 2.7%
Extreme problems	4 0.3%	1 0.2%
No data	1 0.1%	3 0.7%
No problems	134 9.7%	68 15.5%
Some problems	141 10.2%	40 9.1%
Extreme problems	3 0.2%	2 0.5%
No data	0 0%	2 0.5%
No problems	48 3.5%	28 6.4%
Some problems	210 15.2%	77 17.5%
Extreme problems	18 1.3%	4 0.9%
No data	2 0.1%	3 0.7%
No problems	190 13.8%	86 19.5%
Some problems	80 5.8%	21 4.8%
Extreme problems	8 0.6%	3 0.7%
No data	0 0%	2 0.5%
No problems	144 10.4%	69 15.7%
Some problems	107 7.8%	38 8.6%
Extreme problems	0 0%	0 0%
No data	1 0.1%	0 0%
No problems	188 13.6%	86 19.5%
Some problems	58 4.2%	20 4.5%
Extreme problems	4 0.3%	1 0.2%
No data	2 0.1%	0 0%
No problems	126 9.1%	63 14.3%
Some problems	115 8.3%	43 9.8%
Extreme problems	9 0.7%	1 0.2%
No data	2 0.1%	0 0%
No problems	55 4%	30 6.8%
Some problems	174 12.6%	71 16.1%
Extreme problems	22 1.6%	6 1.4%
No data	1 0.1%	0 0%
No problems	176 12.8%	75 17%
Some problems	66 4.8%	31 7%
Extreme problems	9 0.7%	0 0%
No data	1 0.1%	1 0.2%
No problems	126 9.1%	58 13.2%
Some problems	86 6.2%	35 8%
Extreme problems	2 0.1%	0 0%
No data	1 0.1%	2 0.5%
No problems	156 11.3%	78 17.7%
Some problems	51 3.7%	12 2.7%
Extreme problems	7 0.5%	3 0.7%
No data	1 0.1%	2 0.5%
No problems	114 8.3%	55 12.5%
Some problems	92 6.7%	35 8%
Extreme problems	8 0.6%	3 0.7%
No data	1 0.1%	2 0.5%
No problems	49 3.6%	21 4.8%
Some problems	149 10.8%	61 13.9%
Extreme problems	15 1.1%	10 2.3%
No data	2 0.1%	3 0.7%
No problems	143 10.4%	68 15.5%
Some problems	65 4.7%	21 4.8%
Extreme problems	6 0.4%	4 0.9%
No data	1 0.1%	2 0.5%

26. Secondary Outcome

Title	Duration of Morning Stiffness in Participants With Temporary Rigidity
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis
Arm/Group Description	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.	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.
Measure Participants	1281	413
Baseline	1.00	1.00
Week 13	0.50	0.50
Week 26	0.50	0.50
Week 39	0.50	0.50
Week 52	0.50	0.50
Week 65	0.50	0.25
Week 78	0.38	0.46
Week 104	0.25	0.25
Week 130	0.25	0.50
Week 156	0.25	0.33

27. Secondary Outcome

Title	Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Psoriatic Arthritis
Arm/Group Description	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.
Measure Participants	413
<3%	203 14.7%
3-10%	123 8.9%
11-20%	41 3%
>20%	20 1.5%
<3%	247 17.9%
3-10%	82 6%
11-20%	28 2%
>20%	13 0.9%
<3%	233 16.9%
3-10%	63 4.6%
11-20%	14 1%
>20%	6 0.4%
<3%	210 15.2%
3-10%	35 2.5%
11-20%	15 1.1%
>20%	2 0.1%
<3%	196 14.2%
3-10%	37 2.7%
11-20%	10 0.7%
>20%	3 0.2%
<3%	176 12.8%
3-10%	33 2.4%
11-20%	4 0.3%
>20%	2 0.1%
<3%	182 13.2%
3-10%	23 1.7%
11-20%	5 0.4%
>20%	1 0.1%
<3%	80 5.8%
3-10%	12 0.9%
11-20%	2 0.1%
>20%	2 0.1%
<3%	75 5.4%
3-10%	9 0.7%
11-20%	4 0.3%
>20%	1 0.1%
<3%	74 5.4%
3-10%	8 0.6%
11-20%	2 0.1%
>20%	1 0.1%

28. Secondary Outcome

Title	Change From Baseline in Nail Involvement at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Psoriatic Arthritis
Arm/Group Description	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.
Measure Participants	413
Baseline	3.18 (4.99)
Change at Week 13	-0.98 (3.58)
Change at Week 26	-1.64 (4.38)
Change at Week 39	-1.75 (4.55)
Change at Week 52	-2.09 (5.04)
Change at Week 65	-2.38 (4.89)
Change at Week 78	-1.79 (4.30)
Change at Week 104	-1.98 (5.81)
Change at Week 130	-1.12 (4.75)
Change at Week 156	-1.38 (5.11)

29. Secondary Outcome

Title	Change From Baseline in Inflamed Dactylitic Digits at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Psoriatic Arthritis
Arm/Group Description	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.
Measure Participants	413
Baseline	0.72 (1.64)
Change at Week 13	-0.39 (1.36)
Change at Week 26	-0.54 (1.77)
Change at Week 39	-0.61 (1.53)
Change at Week 52	-0.69 (1.58)
Change at Week 65	-0.50 (2.08)
Change at Week 78	-0.38 (1.40)
Change at Week 104	-0.61 (1.47)
Change at Week 130	-0.63 (1.96)
Change at Week 156	-0.63 (1.72)

30. Secondary Outcome

Title	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)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis
Arm/Group Description	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.	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.
Measure Participants	1281	413
Baseline: No and Specified Week: No	499 36.2%	258 58.6%
Baseline: Yes and Specified Week: No	177 12.8%	28 6.4%
Baseline: No and Specified Week: Yes	312 22.6%	69 15.7%
Baseline: Yes and Specified Week: Yes	293 21.3%	58 13.2%
Baseline: No and Specified Week: No	124 9%	133 30.2%
Baseline: Yes and Specified Week: No	655 47.5%	139 31.6%
Baseline: No and Specified Week: Yes	24 1.7%	17 3.9%
Baseline: Yes and Specified Week: Yes	478 34.7%	124 28.2%
Baseline: No and Specified Week: No	168 12.2%	86 19.5%
Baseline: Yes and Specified Week: No	91 6.6%	18 4.1%
Baseline: No and Specified Week: Yes	20 1.5%	6 1.4%
Baseline: Yes and Specified Week: Yes	12 0.9%	6 1.4%
Baseline: No and Specified Week: No	33 2.4%	39 8.9%
Baseline: Yes and Specified Week: No	234 17%	71 16.1%
Baseline: No and Specified Week: Yes	1 0.1%	1 0.2%
Baseline: Yes and Specified Week: Yes	23 1.7%	5 1.1%

31. Secondary Outcome

Title	Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Continuation of Treatment With Etanercept
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis
Arm/Group Description	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.	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.
Measure Participants	1241	400
Treatment Continued	207 15%	58 13.2%
Treatment Terminated	139 10.1%	48 10.9%
No Data	1 0.1%	0 0%
Treatment Continued	555 40.3%	178 40.5%
Treatment Terminated	335 24.3%	116 26.4%
No Data	4 0.3%	0 0%

32. Secondary Outcome

Title	Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis
Arm/Group Description	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.	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.
Measure Participants	1232	398
No problems	143 10.4%	50 11.4%
Some problems	191 13.9%	54 12.3%
Extreme problem	2 0.1%	0 0%
No data	9 0.7%	2 0.5%
No problems	483 35.1%	167 38%
Some problems	394 28.6%	117 26.6%
Extreme problem	1 0.1%	0 0%
No data	9 0.7%	8 1.8%
No problems	213 15.5%	72 16.4%
Some problems	111 8.1%	25 5.7%
Extreme problem	13 0.9%	6 1.4%
No data	8 0.6%	3 0.7%
No problems	618 44.8%	233 53%
Some problems	244 17.7%	47 10.7%
Extreme problem	16 1.2%	4 0.9%
No data	9 0.7%	8 1.8%
No problems	113 8.2%	39 8.9%
Some problems	204 14.8%	58 13.2%
Extreme problem	19 1.4%	8 1.8%
No data	9 0.7%	1 0.2%
No problems	392 28.4%	142 32.3%
Some problems	456 33.1%	136 30.9%
Extreme problem	30 2.2%	6 1.4%
No data	9 0.7%	8 1.8%
No problems	38 2.8%	17 3.9%
Some problems	230 16.7%	62 14.1%
Extreme problem	68 4.9%	25 5.7%
No data	9 0.7%	2 0.5%
No problems	155 11.2%	60 13.6%
Some problems	611 44.3%	189 43%
Extreme problem	112 8.1%	35 8%
No data	9 0.7%	8 1.8%
No problems	188 13.6%	63 14.3%
Some problems	138 10%	34 7.7%
Extreme problem	11 0.8%	6 1.4%
No data	8 0.6%	3 0.7%
No problems	544 39.5%	188 42.7%
Some problems	300 21.8%	88 20%
Extreme problem	34 2.5%	8 1.8%
No data	9 0.7%	8 1.8%

33. Other Pre-specified Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs)
Description	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

Outcome Measure Data

Analysis Population Description

Safety analysis set included all patients who received at least 1 dose of Etanercept.

Arm/Group Title	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis	Participants With Unclear Diagnosis
Arm/Group Description	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.	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.	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.
Measure Participants	1378	440	3
AEs	658 47.8%	190 43.2%	1 33.3%
SAEs	159 11.5%	47 10.7%	0 0%

34. Other Pre-specified Outcome

Title	Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis	Participants With Unclear Diagnosis
Arm/Group Description	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.	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.	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.
Measure Participants	658	190	1
Mild	292 21.2%	85 19.3%	0 0%
Moderate	377 27.4%	104 23.6%	0 0%
Severe	172 12.5%	52 11.8%	0 0%
No Data	36 2.6%	7 1.6%	1 33.3%

35. Other Pre-specified Outcome

Title	Number of Participants With Discontinuation of Etanercept Treatment
Description	Number of participants those who discontinued Etanercept treatment at Week 78 and 156 are reported in this outcome measure.
Time Frame	Week 78, 156

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis	Participants With Unclear Diagnosis
Arm/Group Description	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.	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.	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.
Measure Participants	1378	440	3
Week 78	57 4.1%	18 4.1%	1 33.3%
Week 156	8 0.6%	4 0.9%

36. Other Pre-specified Outcome

Title	Number of Participants With Treatment-Emergent Treatment Related Adverse Events
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis	Participants With Unclear Diagnosis
Arm/Group Description	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.	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.	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.
Measure Participants	658	190	1
Count of Participants [Participants]	345 25%	100 22.7%	1 33.3%

37. Other Pre-specified Outcome

Title	Number of Participants With Results of Tolerability Assessment by Physician and Participant
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis	Participants With Unclear Diagnosis
Arm/Group Description	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.	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.	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.
Measure Participants	1378	440	3
Very good	439 31.9%	146 33.2%	1 33.3%
Good	252 18.3%	70 15.9%	0 0%
Moderate	4 0.3%	2 0.5%	0 0%
Insufficient	4 0.3%	2 0.5%	0 0%
Very good	284 20.6%	96 21.8%	1 33.3%
Good	281 20.4%	75 17%	0 0%
Moderate	33 2.4%	12 2.7%	0 0%
Insufficient	9 0.7%	0 0%	0 0%
Very good	149 10.8%	67 15.2%
Good	70 5.1%	30 6.8%
Moderate	1 0.1%	0 0%
Insufficient	0 0%	0 0%
Very good	115 8.3%	55 12.5%
Good	89 6.5%	38 8.6%
Moderate	4 0.3%	1 0.2%
Insufficient	2 0.1%	0 0%

38. Other Pre-specified Outcome

Title	Number of Participants With Pregnancy, Puerperium and Perinatal Conditions
Description	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

Outcome Measure Data

Analysis Population Description

Safety analysis set included all patients who received at least 1 dose of Etanercept.

Arm/Group Title	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis	Participants With Unclear Diagnosis
Arm/Group Description	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.	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.	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.
Measure Participants	1378	440	3
Count of Participants [Participants]	4 0.3%	1 0.2%	0 0%

39. Other Pre-specified Outcome

Title	Number of Participants Who Used Concomitant Medication
Description	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

Outcome Measure Data

Analysis Population Description

Safety analysis set included all patients who received at least 1 dose of Etanercept.

Arm/Group Title	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis	Participants With Unclear Diagnosis
Arm/Group Description	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.	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.	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.
Measure Participants	1378	440	3
Count of Participants [Participants]	1284 93.2%	376 85.5%	2 66.7%

Adverse Events

Time Frame	Baseline up to Week 156
Adverse Event Reporting Description	Same event may appear both an AE and SAE. However, what is presented are distinct events. Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE.
Arm/Group Title	Participants With Rheumatoid Arthritis		Participants With Psoriatic Arthritis		Participants With Unclear Diagnosis
Arm/Group Description	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.		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.		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.
All Cause Mortality
	Participants With Rheumatoid Arthritis		Participants With Psoriatic Arthritis		Participants With Unclear Diagnosis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/1378 (0.4%)		0/440 (0%)		0/3 (0%)
Serious Adverse Events
	Participants With Rheumatoid Arthritis		Participants With Psoriatic Arthritis		Participants With Unclear Diagnosis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	159/1378 (11.5%)		47/440 (10.7%)		0/3 (0%)
Blood and lymphatic system disorders
Lymphadenopathy	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Cardiac disorders
Acute myocardial infarction	4/1378 (0.3%)		2/440 (0.5%)		0/3 (0%)
Atrial fibrillation	2/1378 (0.1%)		3/440 (0.7%)		0/3 (0%)
Coronary artery disease	4/1378 (0.3%)		1/440 (0.2%)		0/3 (0%)
Angina pectoris	0/1378 (0%)		2/440 (0.5%)		0/3 (0%)
Cardiac failure	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Myocardial infarction	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Cardiac arrest	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Congenital, familial and genetic disorders
Trisomy 8	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Ear and labyrinth disorders
Vertigo positional	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Hearing impaired	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Hypoacusis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Vestibular disorder	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Endocrine disorders
Hyperthyroidism	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Eye disorders
Macular hole	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Gastrointestinal disorders
Inguinal hernia	0/1378 (0%)		4/440 (0.9%)		0/3 (0%)
Abdominal pain upper	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Nausea	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Vomiting	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Abdominal adhesions	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Abdominal discomfort	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Crohn's disease	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Diarrhoea	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Dry mouth	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Gastric ulcer haemorrhage	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Gastrointestinal necrosis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Haemorrhoids	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Oesophageal ulcer haemorrhage	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Rectal polyp	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Upper gastrointestinal haemorrhage	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Ileus	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
General disorders
Condition aggravated	7/1378 (0.5%)		3/440 (0.7%)		0/3 (0%)
Disease progression	2/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Injection site pruritus	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Pain	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Asthenia	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Death	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Disease recurrence	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Drug ineffective	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
General physical health deterioration	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Injection site erythema	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Injection site pain	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Injection site swelling	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Medical device complication	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Mucosal inflammation	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Necrosis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Oedema peripheral	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Pyrexia	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Hepatobiliary disorders
Cholelithiasis	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Autoimmune hepatitis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Cholangitis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Cholecystitis acute	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Drug-induced liver injury	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Hepatotoxicity	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Immune system disorders
Hypersensitivity	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Infections and infestations
Pneumonia	3/1378 (0.2%)		1/440 (0.2%)		0/3 (0%)
Abscess	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Bronchitis	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Diverticulitis	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Osteomyelitis	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Sepsis	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Staphylococcal infection	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Urosepsis	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Abscess oral	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Acute tonsillitis	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Arteriosclerotic gangrene	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Arthritis bacterial	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Bronchopneumonia	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Bursitis infective	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Endocarditis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Febrile infection	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Gastroenteritis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Herpes zoster	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Intervertebral discitis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Lobar pneumonia	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Lung infection	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Otitis media	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Pyelonephritis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Sinusitis aspergillus	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Staphylococcal skin infection	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Urinary tract infection	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Injury, poisoning and procedural complications
Femoral neck fracture	2/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Lumbar vertebral fracture	2/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Radius fracture	2/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Rib fracture	3/1378 (0.2%)		0/440 (0%)		0/3 (0%)
Clavicle fracture	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Fall	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Humerus fracture	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Animal bite	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Comminuted fracture	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Foot fracture	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Forearm fracture	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Fractured coccyx	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Hand fracture	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Impacted fracture	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Injury	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Joint dislocation	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Ligament rupture	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Meniscus injury	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Muscle strain	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Overdose	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Patella fracture	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Pneumothorax traumatic	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Poisoning	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Skull fractured base	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Sternal fracture	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Toxicity to various agents	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Venous injury	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Wrist fracture	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Investigations
Blood pressure abnormal	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Liver function test abnormal	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Transaminases increased	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Weight decreased	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Weight increased	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Metabolism and nutrition disorders
Dehydration	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Hyperkalaemia	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Obesity	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	14/1378 (1%)		1/440 (0.2%)		0/3 (0%)
Arthropathy	6/1378 (0.4%)		0/440 (0%)		0/3 (0%)
Rheumatoid arthritis	4/1378 (0.3%)		1/440 (0.2%)		0/3 (0%)
Arthralgia	2/1378 (0.1%)		2/440 (0.5%)		0/3 (0%)
Lumbar spinal stenosis	3/1378 (0.2%)		1/440 (0.2%)		0/3 (0%)
Foot deformity	3/1378 (0.2%)		0/440 (0%)		0/3 (0%)
Arthritis	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Back pain	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Bursitis	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Intervertebral disc disorder	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Intervertebral disc protrusion	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Osteonecrosis	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Psoriatic arthropathy	0/1378 (0%)		2/440 (0.5%)		0/3 (0%)
Facet joint syndrome	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Loose body in joint	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Meniscal degeneration	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Metatarsalgia	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Neuropathic arthropathy	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Osteonecrosis of jaw	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Osteopenia	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Pain in extremity	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Spinal column stenosis	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Spinal disorder	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Spinal osteoarthritis	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Synovial cyst	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Tenosynovitis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	3/1378 (0.2%)		0/440 (0%)		0/3 (0%)
Prostate cancer	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Uterine leiomyoma	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Acute myeloid leukaemia	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Benign lung neoplasm	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Breast cancer female	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Bronchial carcinoma	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Chest wall tumour	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Colon adenoma	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Lentigo maligna	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Leukaemia	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Lung neoplasm malignant	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Malignant melanoma	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Pancreatic carcinoma	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Rectal cancer	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Renal oncocytoma	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Thyroid neoplasm	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Warty dyskeratoma	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Nervous system disorders
Cerebrovascular accident	2/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Facial paresis	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Paraesthesia	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Akathisia	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Borderline mental impairment	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Carotid artery stenosis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Clinically isolated syndrome	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Cubital tunnel syndrome	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Depressed level of consciousness	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Dizziness	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Meralgia paraesthetica	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Nerve compression	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Neuralgia	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Neuritis	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Polyneuropathy	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Sciatica	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Tension headache	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Vascular encephalopathy	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Pregnancy, puerperium and perinatal conditions
Abortion	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Abortion spontaneous	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Premature baby	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Psychiatric disorders
Depression	0/1378 (0%)		3/440 (0.7%)		0/3 (0%)
Suicide attempt	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Renal and urinary disorders
Renal failure acute	3/1378 (0.2%)		0/440 (0%)		0/3 (0%)
Nephrolithiasis	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Nephritis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Prerenal failure	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Renal cyst	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Reproductive system and breast disorders
Menorrhagia	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Cervical dysplasia	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Uterine prolapse	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Chronic obstructive pulmonary disease	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Dyspnoea	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Emphysema	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Lung disorder	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Lung infiltration	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Nasal septum deviation	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Organising pneumonia	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Pneumonia aspiration	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Pneumothorax	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Pneumothorax spontaneous	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Pulmonary embolism	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Pulmonary sarcoidosis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Pulmonary vein occlusion	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Skin and subcutaneous tissue disorders
Pruritus	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Psoriasis	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Pyoderma gangrenosum	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Rash	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Skin ulcer	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Subcutaneous emphysema	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Surgical and medical procedures
Arthrodesis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Vascular disorders
Haematoma	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Hypertension	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Hypertensive crisis	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Thrombosis	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Peripheral arterial occlusive disease	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Shock haemorrhagic	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Thrombophlebitis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	Participants With Rheumatoid Arthritis		Participants With Psoriatic Arthritis		Participants With Unclear Diagnosis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	579/1378 (42%)		167/440 (38%)		1/3 (33.3%)
Blood and lymphatic system disorders
Anaemia	4/1378 (0.3%)		0/440 (0%)		0/3 (0%)
Leukopenia	1/1378 (0.1%)		2/440 (0.5%)		0/3 (0%)
Iron deficiency anaemia	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Thrombocytopenia	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Thrombocytopenic purpura	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Bicytopenia	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Cardiac disorders
Angina pectoris	3/1378 (0.2%)		0/440 (0%)		0/3 (0%)
Palpitations	3/1378 (0.2%)		0/440 (0%)		0/3 (0%)
Cardiac failure	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Tachycardia	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Arrhythmia	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Cardiovascular disorder	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Coronary artery disease	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Cyanosis	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Ear and labyrinth disorders
Vertigo	10/1378 (0.7%)		0/440 (0%)		0/3 (0%)
Tinnitus	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Vertigo positional	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Vestibular disorder	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Endocrine disorders
Goitre	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Hyperthyroidism	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Eye disorders
Visual impairment	4/1378 (0.3%)		0/440 (0%)		0/3 (0%)
Eye irritation	2/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Scleritis	2/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Dry eye	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Uveitis	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Cataract	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Chalazion	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Corneal disorder	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Episcleritis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Erythema of eyelid	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Eye inflammation	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Eye pruritus	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Vision blurred	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Glaucoma	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Iridocyclitis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Keratitis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Lacrimation increased	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Macular degeneration	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Photophobia	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Vitreous haemorrhage	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Gastrointestinal disorders
Nausea	23/1378 (1.7%)		6/440 (1.4%)		0/3 (0%)
Diarrhoea	11/1378 (0.8%)		5/440 (1.1%)		0/3 (0%)
Dry mouth	5/1378 (0.4%)		2/440 (0.5%)		0/3 (0%)
Abdominal pain upper	5/1378 (0.4%)		1/440 (0.2%)		0/3 (0%)
Vomiting	4/1378 (0.3%)		1/440 (0.2%)		0/3 (0%)
Abdominal pain	3/1378 (0.2%)		0/440 (0%)		0/3 (0%)
Gastritis	3/1378 (0.2%)		0/440 (0%)		0/3 (0%)
Abdominal discomfort	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Abdominal distension	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Aphthous stomatitis	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Cheilitis	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Colitis	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Gingival ulceration	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Stomatitis	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Abdominal pain lower	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Enteritis	3/1378 (0.2%)		1/440 (0.2%)		0/3 (0%)
Anal fissure	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Crohn's disease	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Duodenitis	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Dyspepsia	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Epigastric discomfort	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Gastrointestinal disorder	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Gastrointestinal pain	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Haematochezia	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Haemorrhoids	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Haemorrhoids thrombosed	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Irritable bowel syndrome	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Lumbar hernia	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Melaena	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Retching	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Salivary hypersecretion	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Tooth disorder	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Tooth loss	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
General disorders
Drug ineffective	60/1378 (4.4%)		24/440 (5.5%)		0/3 (0%)
Injection site reaction	55/1378 (4%)		10/440 (2.3%)		0/3 (0%)
Injection site erythema	22/1378 (1.6%)		5/440 (1.1%)		1/3 (33.3%)
Injection site pruritus	14/1378 (1%)		4/440 (0.9%)		0/3 (0%)
Injection site hypersensitivity	14/1378 (1%)		2/440 (0.5%)		0/3 (0%)
Fatigue	10/1378 (0.7%)		4/440 (0.9%)		0/3 (0%)
Pyrexia	9/1378 (0.7%)		4/440 (0.9%)		0/3 (0%)
Oedema peripheral	8/1378 (0.6%)		4/440 (0.9%)		0/3 (0%)
Condition aggravated	6/1378 (0.4%)		1/440 (0.2%)		0/3 (0%)
Chest pain	2/1378 (0.1%)		3/440 (0.7%)		0/3 (0%)
Pain	5/1378 (0.4%)		0/440 (0%)		0/3 (0%)
Chills	3/1378 (0.2%)		1/440 (0.2%)		0/3 (0%)
Injection site pain	2/1378 (0.1%)		2/440 (0.5%)		0/3 (0%)
Injection site swelling	4/1378 (0.3%)		0/440 (0%)		0/3 (0%)
Local swelling	1/1378 (0.1%)		3/440 (0.7%)		0/3 (0%)
Cyst	1/1378 (0.1%)		2/440 (0.5%)		0/3 (0%)
Injection site dermatitis	2/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Injection site rash	3/1378 (0.2%)		0/440 (0%)		0/3 (0%)
Injection site urticaria	3/1378 (0.2%)		0/440 (0%)		0/3 (0%)
Swelling	2/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Asthenia	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Feeling abnormal	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Impaired healing	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Injection site discomfort	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Local reaction	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Oedema	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Administration site reaction	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Adverse drug reaction	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Face oedema	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Feeling cold	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Gait disturbance	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Influenza like illness	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Injection site irritation	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Injection site vesicles	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Instillation site reaction	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Mucosal dryness	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Mucosal inflammation	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Performance status decreased	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Hepatobiliary disorders
Biliary colic	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Hepatitis cholestatic	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Liver disorder	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Immune system disorders
Drug hypersensitivity	4/1378 (0.3%)		2/440 (0.5%)		0/3 (0%)
Hypersensitivity	4/1378 (0.3%)		2/440 (0.5%)		0/3 (0%)
Seasonal allergy	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Atopy	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Infections and infestations
Influenza	42/1378 (3%)		16/440 (3.6%)		0/3 (0%)
Respiratory tract infection	23/1378 (1.7%)		8/440 (1.8%)		0/3 (0%)
Bronchitis	17/1378 (1.2%)		9/440 (2%)		0/3 (0%)
Nasopharyngitis	18/1378 (1.3%)		6/440 (1.4%)		0/3 (0%)
Herpes zoster	17/1378 (1.2%)		1/440 (0.2%)		0/3 (0%)
Infection	11/1378 (0.8%)		4/440 (0.9%)		0/3 (0%)
Sinusitis	9/1378 (0.7%)		5/440 (1.1%)		0/3 (0%)
Urinary tract infection	12/1378 (0.9%)		2/440 (0.5%)		0/3 (0%)
Cystitis	10/1378 (0.7%)		0/440 (0%)		0/3 (0%)
Rhinitis	5/1378 (0.4%)		3/440 (0.7%)		0/3 (0%)
Conjunctivitis	6/1378 (0.4%)		0/440 (0%)		0/3 (0%)
Gastroenteritis	4/1378 (0.3%)		2/440 (0.5%)		0/3 (0%)
Herpes simplex	5/1378 (0.4%)		1/440 (0.2%)		0/3 (0%)
Laryngitis	3/1378 (0.2%)		3/440 (0.7%)		0/3 (0%)
Pneumonia	6/1378 (0.4%)		0/440 (0%)		0/3 (0%)
Bronchopneumonia	2/1378 (0.1%)		2/440 (0.5%)		0/3 (0%)
Otitis media	3/1378 (0.2%)		1/440 (0.2%)		0/3 (0%)
Upper respiratory tract infection	20/1378 (1.5%)		4/440 (0.9%)		0/3 (0%)
Oral herpes	6/1378 (0.4%)		2/440 (0.5%)		0/3 (0%)
Tooth infection	2/1378 (0.1%)		2/440 (0.5%)		0/3 (0%)
Erysipelas	2/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Erythema migrans	3/1378 (0.2%)		0/440 (0%)		0/3 (0%)
Fungal infection	3/1378 (0.2%)		0/440 (0%)		0/3 (0%)
Gastrointestinal infection	2/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Pulpitis dental	3/1378 (0.2%)		0/440 (0%)		0/3 (0%)
Rash pustular	2/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Viral infection	2/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Abscess	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Acute tonsillitis	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Furuncle	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Gastrointestinal viral infection	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Herpes virus infection	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Periodontitis	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Tonsillitis	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Abdominal wall abscess	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Abscess limb	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Abscess neck	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Abscess oral	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Adenoviral hepatitis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Bacterial infection	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Borrelia infection	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Cellulitis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Cytomegalovirus infection	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Dental fistula	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Ear infection	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Febrile infection	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Gastric infection	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Hand-foot-and-mouth disease	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Infection susceptibility increased	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Latent tuberculosis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Mastoiditis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Oesophageal candidiasis	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Oral candidiasis	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Oral infection	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Paronychia	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Pharyngitis	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Pyelonephritis	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Pyelonephritis acute	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Respiratory tract infection viral	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Salpingo-oophoritis	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Skin infection	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Tracheobronchitis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Vaginal infection	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Vulvovaginal candidiasis	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Viral upper respiratory tract infection	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Tooth abscess	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Wound infection	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Bursitis infective	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Chronic sinusitis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Injury, poisoning and procedural complications
Arthropod bite	3/1378 (0.2%)		1/440 (0.2%)		0/3 (0%)
Epicondylitis	1/1378 (0.1%)		3/440 (0.7%)		0/3 (0%)
Wound	4/1378 (0.3%)		0/440 (0%)		0/3 (0%)
Contusion	2/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Fall	1/1378 (0.1%)		2/440 (0.5%)		0/3 (0%)
Forearm fracture	2/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Joint injury	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Meniscus injury	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Rib fracture	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Wrist fracture	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Arthropod sting	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Dislocation of vertebra	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Face injury	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Facial bones fracture	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Foot fracture	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Fracture	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Incisional hernia	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Joint dislocation	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Ligament injury	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Ligament rupture	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Ligament sprain	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Maternal exposure during pregnancy	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Patella fracture	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Pneumoconiosis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Post procedural fistula	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Procedural pain	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Radius fracture	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Skin injury	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Tendon rupture	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Thermal burn	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Vaccination complication	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Investigations
C-reactive protein increased	5/1378 (0.4%)		3/440 (0.7%)		0/3 (0%)
Liver function test abnormal	6/1378 (0.4%)		0/440 (0%)		0/3 (0%)
Red blood cell sedimentation rate increased	5/1378 (0.4%)		1/440 (0.2%)		0/3 (0%)
Alanine aminotransferase increased	3/1378 (0.2%)		2/440 (0.5%)		0/3 (0%)
Weight decreased	5/1378 (0.4%)		0/440 (0%)		0/3 (0%)
Hepatic enzyme increased	2/1378 (0.1%)		2/440 (0.5%)		0/3 (0%)
Transaminases increased	2/1378 (0.1%)		2/440 (0.5%)		0/3 (0%)
Arthroscopy	2/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Gamma-glutamyltransferase increased	3/1378 (0.2%)		0/440 (0%)		0/3 (0%)
Weight increased	2/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Blood creatinine increased	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Activated partial thromboplastin time prolonged	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Aspartate aminotransferase increased	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Biopsy liver	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Blood cholesterol increased	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Blood lactate dehydrogenase increased	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Blood pressure abnormal	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Bone scan abnormal	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
C-reactive protein	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Gamma-glutamyltransferase abnormal	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Glycosylated haemoglobin increased	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Lymphoblast morphology abnormal	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Radioisotope scan	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Respiratory rate increased	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Metabolism and nutrition disorders
Vitamin D deficiency	6/1378 (0.4%)		0/440 (0%)		0/3 (0%)
Decreased appetite	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Hyperlipidaemia	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Hyperuricaemia	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Iron deficiency	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Hypercholesterolaemia	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Hyperglycaemia	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Type 2 diabetes mellitus	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Vitamin B12 deficiency	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis	13/1378 (0.9%)		4/440 (0.9%)		0/3 (0%)
Osteoarthritis	9/1378 (0.7%)		5/440 (1.1%)		0/3 (0%)
Back pain	5/1378 (0.4%)		5/440 (1.1%)		0/3 (0%)
Pain in extremity	8/1378 (0.6%)		2/440 (0.5%)		0/3 (0%)
Arthralgia	6/1378 (0.4%)		3/440 (0.7%)		0/3 (0%)
Myalgia	4/1378 (0.3%)		3/440 (0.7%)		0/3 (0%)
Tendonitis	3/1378 (0.2%)		4/440 (0.9%)		0/3 (0%)
Bursitis	5/1378 (0.4%)		1/440 (0.2%)		0/3 (0%)
Tenosynovitis	5/1378 (0.4%)		1/440 (0.2%)		0/3 (0%)
Musculoskeletal pain	4/1378 (0.3%)		1/440 (0.2%)		0/3 (0%)
Rheumatic disorder	4/1378 (0.3%)		0/440 (0%)		0/3 (0%)
Synovial cyst	4/1378 (0.3%)		0/440 (0%)		0/3 (0%)
Fibromyalgia	2/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Joint swelling	2/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Osteoporotic fracture	3/1378 (0.2%)		0/440 (0%)		0/3 (0%)
Rotator cuff syndrome	1/1378 (0.1%)		2/440 (0.5%)		0/3 (0%)
Sjogren's syndrome	3/1378 (0.2%)		0/440 (0%)		0/3 (0%)
Spinal osteoarthritis	3/1378 (0.2%)		0/440 (0%)		0/3 (0%)
Arthritis	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Dactylitis	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Exostosis	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Intervertebral disc protrusion	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Muscle spasms	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Muscle tightness	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Musculoskeletal discomfort	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Neck pain	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Osteoporosis	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Polyarthritis	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Psoriatic arthropathy	0/1378 (0%)		2/440 (0.5%)		0/3 (0%)
Rheumatic fever	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Arthropathy	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Jaw cyst	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Joint effusion	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Lumbar spinal stenosis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Mobility decreased	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Muscular weakness	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Musculoskeletal stiffness	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Osteopenia	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Pathological fracture	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Rheumatoid nodule	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Sacroiliitis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Seronegative arthritis	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Soft tissue disorder	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Spinal pain	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Spondylitis	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Spondylolisthesis	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Trigger finger	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Benign neoplasm of prostate	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Chronic lymphocytic leukaemia	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Fibroma	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Leiomyoma	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Squamous cell carcinoma	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Uterine leiomyoma	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Nervous system disorders
Headache	12/1378 (0.9%)		2/440 (0.5%)		0/3 (0%)
Restless legs syndrome	5/1378 (0.4%)		0/440 (0%)		0/3 (0%)
Sciatica	3/1378 (0.2%)		2/440 (0.5%)		0/3 (0%)
Hypertonia	1/1378 (0.1%)		2/440 (0.5%)		0/3 (0%)
Cervicobrachial syndrome	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Dizziness	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Dysgeusia	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Memory impairment	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Disturbance in attention	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Hypoaesthesia	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Migraine	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Morton's neuralgia	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Neuropathy peripheral	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Polyneuropathy	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Radiculopathy	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Somnolence	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Tension headache	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Carpal tunnel syndrome	5/1378 (0.4%)		0/440 (0%)		0/3 (0%)
Pregnancy, puerperium and perinatal conditions
Pregnancy	3/1378 (0.2%)		1/440 (0.2%)		0/3 (0%)
Psychiatric disorders
Depression	9/1378 (0.7%)		6/440 (1.4%)		0/3 (0%)
Restlessness	4/1378 (0.3%)		1/440 (0.2%)		0/3 (0%)
Sleep disorder	3/1378 (0.2%)		0/440 (0%)		0/3 (0%)
Aggression	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Anxiety	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Bipolar I disorder	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Depressed mood	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Disorientation	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Emotional distress	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Insomnia	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Irritability	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Listless	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Panic attack	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Renal and urinary disorders
Haematuria	3/1378 (0.2%)		0/440 (0%)		0/3 (0%)
Nephrolithiasis	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Cystitis noninfective	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Nocturia	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Obstructive uropathy	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Pollakiuria	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Proteinuria	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Renal failure	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Reproductive system and breast disorders
Benign prostatic hyperplasia	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Breast cyst	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Breast pain	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Erectile dysfunction	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Menstrual discomfort	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Vaginal inflammation	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	6/1378 (0.4%)		4/440 (0.9%)		0/3 (0%)
Dyspnoea	10/1378 (0.7%)		0/440 (0%)		0/3 (0%)
Asthma	6/1378 (0.4%)		0/440 (0%)		0/3 (0%)
Dyspnoea exertional	4/1378 (0.3%)		0/440 (0%)		0/3 (0%)
Oropharyngeal pain	3/1378 (0.2%)		0/440 (0%)		0/3 (0%)
Epistaxis	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Lung disorder	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Pleural effusion	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Alveolitis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Chronic obstructive pulmonary disease	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Dysphonia	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Nasal congestion	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Nasal disorder	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Nasal inflammation	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Pneumonitis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Pulmonary fibrosis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Pulmonary infarction	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Pulmonary mass	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Respiratory distress	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Sinus disorder	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Sleep apnoea syndrome	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Throat irritation	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Skin and subcutaneous tissue disorders
Erythema	13/1378 (0.9%)		4/440 (0.9%)		0/3 (0%)
Alopecia	10/1378 (0.7%)		2/440 (0.5%)		0/3 (0%)
Pruritus	10/1378 (0.7%)		2/440 (0.5%)		0/3 (0%)
Rash	9/1378 (0.7%)		1/440 (0.2%)		0/3 (0%)
Psoriasis	3/1378 (0.2%)		6/440 (1.4%)		0/3 (0%)
Eczema	5/1378 (0.4%)		3/440 (0.7%)		0/3 (0%)
Rash pruritic	6/1378 (0.4%)		0/440 (0%)		0/3 (0%)
Hyperhidrosis	3/1378 (0.2%)		1/440 (0.2%)		0/3 (0%)
Pustular psoriasis	3/1378 (0.2%)		1/440 (0.2%)		0/3 (0%)
Skin reaction	3/1378 (0.2%)		1/440 (0.2%)		0/3 (0%)
Urticaria	4/1378 (0.3%)		0/440 (0%)		0/3 (0%)
Acne	2/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Skin disorder	1/1378 (0.1%)		2/440 (0.5%)		0/3 (0%)
Skin ulcer	2/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Dermatitis	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Dermatitis allergic	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Dry skin	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Pruritus generalised	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Actinic keratosis	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Blister	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Cutaneous vasculitis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Dermal cyst	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Drug eruption	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Ecchymosis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Erythema nodosum	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Hyperkeratosis	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Leukoplakia	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Nail disorder	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Night sweats	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Onycholysis	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Petechiae	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Pigmentation disorder	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Rash generalised	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Rosacea	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Skin burning sensation	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Skin exfoliation	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Skin hyperpigmentation	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Skin lesion	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Swelling face	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Surgical and medical procedures
Cataract operation	4/1378 (0.3%)		0/440 (0%)		0/3 (0%)
Dental operation	0/1378 (0%)		4/440 (0.9%)		0/3 (0%)
Joint injection	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Surgery	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Synovectomy	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Tooth extraction	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Wound treatment	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Bunion operation	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Carpal tunnel decompression	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Cyst removal	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Dental implantation	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Elbow operation	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Endodontic procedure	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Glaucoma surgery	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Hernia repair	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Hip arthroplasty	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Inguinal hernia repair	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Joint surgery	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Knee arthroplasty	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Lens extraction	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Polypectomy	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Rehabilitation therapy	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Removal of internal fixation	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Rheumatoid nodule removal	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Skin neoplasm excision	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Synoviorthesis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Tendon operation	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Tonsillectomy	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Wisdom teeth removal	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Vascular disorders
Hypertension	5/1378 (0.4%)		3/440 (0.7%)		0/3 (0%)
Thrombosis	3/1378 (0.2%)		0/440 (0%)		0/3 (0%)
Deep vein thrombosis	1/1378 (0.1%)		1/440 (0.2%)		0/3 (0%)
Haematoma	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Peripheral arterial occlusive disease	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Venous thrombosis	2/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Arterial stenosis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Flushing	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Haemorrhage	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Hot flush	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Hypertensive crisis	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Hypotension	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Intra-abdominal haematoma	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Labile hypertension	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Lymphoedema	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Peripheral vascular disorder	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Thrombophlebitis	1/1378 (0.1%)		0/440 (0%)		0/3 (0%)
Varicose vein	0/1378 (0%)		1/440 (0.2%)		0/3 (0%)
Essential hypertension	1/1378 (0.1%)		2/440 (0.5%)		0/3 (0%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.