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Trial record 1 of 1 for:    NCT02486302
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A Study To Evaluate The Efficacy Of Enbrel (REGISTERED) Etanercept Over A Period Of 12 Months In The Routine Treatment Of Patients With Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriatic Arthritis, Or Plaque Psoriasis. (ADEQUATE)

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ClinicalTrials.gov Identifier: NCT02486302
Recruitment Status : Completed
First Posted : July 1, 2015
Results First Posted : June 24, 2019
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date June 28, 2015
First Posted Date July 1, 2015
Results First Submitted Date November 12, 2018
Results First Posted Date June 24, 2019
Last Update Posted Date June 24, 2019
Actual Study Start Date March 24, 2015
Actual Primary Completion Date December 11, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 29, 2019)
  • Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 [ Time Frame: Week 12 ]
    Disease activity score based on 28-joints count (DAS28) calculated as weighted average of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/h]) and patient's global assessment (PtGA) of disease activity (recorded on a visual analog scale [VAS] scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28 <2.6 = remission, DAS28 less than or equal to (<=) 3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
  • Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 [ Time Frame: Week 24 ]
    DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR [mm/h] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28<2.6 = remission, DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
  • Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 and Maintained Till 52 Weeks [ Time Frame: Week 12 up to Week 52 ]
    DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR [mm/h] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28<2.6 = remission, DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
  • Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 and Maintained Till 52 Weeks [ Time Frame: Week 24 up to Week 52 ]
    DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR [mm/h] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28<2.6 = remission, DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
  • Number of Participants With PsO Who Achieved 75% Improvement From Baseline in Psoriasis Area & Severity Index(PASI75) Score or Physician's Global Assessment(PGA) of Clear or Almost Clear And Dermatology Life Quality Index(DLQI) Total Score of 0 or 1 [ Time Frame: Week 12 ]
    PASI:combined assessment of lesion severity & area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) & severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear & almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect).
  • Number of Participants With Axial Spondyloarthritis (axSpA) Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 12 [ Time Frame: Week 12 ]
    ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 <= ASDAS < 1.3; moderate disease activity: 1.3 <= ASDAS < 2.1; high disease activity: 2.1 <= ASDAS <= 3.5; very high disease activity: 3.5 < ASDAS.
  • Number of Participants With Psoriatic Arthritis (PsA) Who Achieved Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 12 [ Time Frame: Week 12 ]
    DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28<2.6 = remission, DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC <=1; 2) SJC =<1; 3) PASI <= 1 or body surface area (BSA) <=3; 4) Participant pain on VAS <= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain [best] and 100 mm = maximum possible pain [worst]; 5) PtGA on VAS <= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) Health assessment questionnaire disability index (HAQ-DI) <= 0.5(HAQ=3.16-[0.028* hannover functional questionnaire [FFbH]); 7) Tender enthesial points <= 1.
  • Number of Participants With Plaque Psoriasis (PsO) Who Achieved 75% Improvement in Psoriasis Area and Severity Index (PASI75) Score or a Physician's Global Assessment (PGA) of "Clear" or "Almost Clear" and DLQI Total Score of 0 or 1 at Week 24 [ Time Frame: Week 24 ]
    PASI:combined assessment of lesion severity & area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) & severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear & almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect).
  • Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 24 [ Time Frame: Week 24 ]
    ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 <= ASDAS < 1.3; moderate disease activity: 1.3 <= ASDAS < 2.1; high disease activity: 2.1 <= ASDAS <= 3.5; very high disease activity: 3.5 < ASDAS.
  • Number of Participants With Psoriatic Arthritis (PsA) Achieving Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 24 [ Time Frame: Week 24 ]
    DAS28 calculated as average of SJC and TJC using the 28 joints count, ESR (mm/h) and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28<2.6 = remission, DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC t<=1; 2) SJC =<1; 3) PASI <= 1 or BSA <=3; 4) Participant pain on VAS <= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain [best] and 100 mm = maximum possible pain [worst]; 5) PtGA on VAS <= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) HAQ-DI <= 0.5(HAQ=3.16-[0.028*FFbH); 7) Tender enthesial points <= 1.
Original Primary Outcome Measures
 (submitted: June 30, 2015)
  • Psoriasis Arthritis: Percentage of patients who have either a disease activity score based on 28-joints count (DAS28) <2.6 or meet Minimal Disease Activity (MDA) criteria [ Time Frame: Week 12 ]
    Change from Baseline in Disease Activity Score Based on 28-joints Count (DAS28) or Minimal Disease activity (MDA), i.e. Patient meets 5 of 7 of the following criteria:
    1. Tender Joint Count=<1
    2. Swollen Joint Count =<1
    3. Psoriasis Area and Severity Index =< 1 or Body surface area =< 3
    4. Patient pain on visual analog scale =< 15
    5. Patient global activity measured on visual analog scale =< 20
    6. Health Assessement Questionnaire (HAQ) =< 0.5
    7. Tender Enthesial Points =< 1
  • Axial Spondyloarthritis: Percentage of Patients with Ankylosing Spondylitis Disease Activity Score (ASDAS) < 1.3 [ Time Frame: Week 12 ]
    Ankylosing Spondylitis Disease Activity Score (ASDAS) is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, patient global assessment of disease activity (all assessed on a visual analogue scale [0-10cm] or a numerical rating scale [0-10]) and C-Reactive Protein (milligrams per liter [mg/l]) with ASDAS scores ranging from 0 to 10. ASDAS <1.3 = inactive disease, ASDAS 1.3-2.0 = moderate, ASDAS 2.1-3.4 = high and ASDAS >= 3.5 = very high disease activity.
  • Rheumatoid Arthritis: Percentage of patients with Disease Activity Score Based on 28-joints Count (DAS28)<2.6 [ Time Frame: Week 12 ]
    DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
  • Plaque Psoriasis: Percentage of patients achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI75) Score or a Physician's Global Assessment of "clear" or "almost clear" or a Dermatology Life Quality Index (DLQI) Total Score of 0 or 1 [ Time Frame: Week 12 ]
    The Psoriasis Area and Severity Index (PASI) ranges from 0(no disease)-72(maximal disease). The Body is divided into 4 sections; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved (0=0%] - 6=90-100% and severity (ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked) are estimated. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PGA is an average assessment of all psoriatic lesions based on erythema, scale, and Induration. DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).
  • Rheumatoid Arthritis: Percentage of patients with Disease Activity Score Based on 28-joints Count (DAS28)<2.6 [ Time Frame: Week 24 ]
    DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
  • Rheumatoid Arthritis: Percentage of patients with Disease Activity Score Based on 28-joints Count (DAS28)<2.6 [ Time Frame: Week 52 ]
    DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
  • Psoriasis Arthritis: Percentage of patients who have either a disease activity score based on 28-joints count (DAS28) <2.6 or meet Minimal Disease Activity (MDA) criteria [ Time Frame: Week 24 ]
    Change from Baseline in Disease Activity Score Based on 28-joints Count (DAS28) or Minimal Disease activity (MDA), i.e. Patient meets 5 of 7 of the following criteria: 1)Tender Joint Count=<1 2) Swollen Joint Count =<1 3) Psoriasis Area and Severity Index =< 1 or Body surface area =< 3 4) Patient pain on visual analog scale =< 15 5) Patient global activity measured on visual analog scale =< 20 6) Health Assessement Questionnaire (HAQ) =< 0.5 7) Tender Enthesial Points =< 1
  • Axial Spondyloarthritis: Percentage of Patients with Ankylosing Spondylitis Disease Activity Score (ASDAS) < 1.3 [ Time Frame: Week 24 ]
    Ankylosing Spondylitis Disease Activity Score (ASDAS) is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, patient global assessment of disease activity (all assessed on a visual analogue scale [0-10cm] or a numerical rating scale [0-10]) and C-Reactive Protein (milligrams per liter [mg/l]) with ASDAS scores ranging from 0 to 10. ASDAS <1.3 = inactive disease, ASDAS 1.3-2.0 = moderate, ASDAS 2.1-3.4 = high and ASDAS >= 3.5 = very high disease activity.
  • Plaque Psoriasis: Percentage of patients achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI75) Score or a Physician's Global Assessment of "clear" or "almost clear" or a Dermatology Life Quality Index (DLQI) Total Score of 0 or 1 [ Time Frame: Week 24 ]
    The Psoriasis Area and Severity Index (PASI) ranges from 0(no disease)-72(maximal disease). The Body is divided into 4 sections; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved (0=0%] - 6=90-100% and severity (ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked) are estimated. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PGA is an average assessment of all psoriatic lesions based on erythema, scale, and Induration. DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).
Change History
Current Secondary Outcome Measures
 (submitted: March 29, 2019)
  • Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Treated Set (TS) [ Time Frame: Baseline up to Weeks 12, 24, 36, 52 ]
  • Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set [ Time Frame: Baseline up to Weeks 12, 24, 36, 52 ]
  • Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to Weeks 12, 24, 36 and 52: Treated Set [ Time Frame: Baseline up to Weeks 12, 24, 36, 52 ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (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. TEAEs were measured up to Week 12, 24, 36 and 52 of exposure with study drug that were absent before treatment or that worsened relative to pretreatment state. TEAEs included both SAEs and non-SAEs.
  • Number of Participants With Treatment Emergent Adverse Events up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set [ Time Frame: Baseline up to Weeks 12, 24, 36, 52 ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A 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. TEAEs were measured up to Week 12, 24, 36 and 52 of exposure with study drug that were absent before treatment or that worsened relative to pretreatment state. TEAEs included both SAEs and non-SAEs.
  • Number of Participants Achieving 28 Joint Disease Activity Score (DAS28) Remission at Weeks 12, 24, 36 and 52 [ Time Frame: Weeks 12, 24, 36, 52 ]
    DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28<2.6 = remission, DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. Participants who had DAS28 <= 2.6 were considered in remission.
  • Patient Global Assessment of Disease Activity (PtGA) Scores at Weeks 12, 24, 36 and 52 [ Time Frame: Weeks 12, 24, 36, 52 ]
    Participants answered question: "How do you assess your current disease activity?" Participants responded by using a 0 - 100 mm visual analog scale where 0 mm = no activity and 100 mm = highest possible activity.
  • Mean Visual Analogue Scale (VAS) Fatigue Scores at Weeks 12, 24, 36 and 52 [ Time Frame: Weeks 12, 24, 36, 52 ]
    Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.
  • Mean Visual Analogue Scale (VAS) Pain Scores at Weeks 12, 24, 36 and 52 [ Time Frame: Weeks 12, 24, 36, 52 ]
    Participants assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst).
  • Physician Global Assessment (PGA) of Disease Activity Scores at Weeks 12, 24, 36 and 52 [ Time Frame: Weeks 12, 24, 36, 52 ]
    PGA of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity; 100 mm= high disease activity.
  • Patient Health Quessionare-2 (PHQ-2) Scores at Weeks 12, 24, 36 and 52 [ Time Frame: Weeks 12, 24, 36, 52 ]
    The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia (inability to feel pleasure in normally pleasurable activities) over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 score ranged from 0-6 (0 indicate not at all: depression/anhedonia can be ruled out; 6 indicate nearly every day: worsening of depression/anhedonia).
  • Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 [ Time Frame: Weeks 12, 24, 36, 52 ]
    The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported.
  • Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 [ Time Frame: Weeks 12, 24, 36, 52 ]
    The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported.
  • Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 [ Time Frame: Weeks 12, 24, 36, 52 ]
    The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported.
  • Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 [ Time Frame: Weeks 12, 24, 36, 52 ]
    The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 ("not at all") to 3 ("nearly every day"). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported.
  • Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 [ Time Frame: Weeks 12, 24, 36, 52 ]
    FFbH consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores * 100% [percent]) / (2 * number of answered questions) ranged between 0-100; higher score indicates better daily activities. Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes [24 hours*60 minutes] was recorded).
  • Psoriatic Arthritis(PsA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 [ Time Frame: Weeks 12, 24, 36, 52 ]
    FFbH consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores * 100% [percent]) / (2 * number of answered questions) ranged between 0-100; higher score indicates better daily activities. Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes [24 hours*60 minutes] was recorded).
  • Ankylosing Spondylitis(axSpA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 [ Time Frame: Weeks 12, 24, 36, 52 ]
    FFbH consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores * 100% [percent]) / (2 * number of answered questions) ranged between 0-100; higher score indicates better daily activities. Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes [24 hours*60 minutes] was recorded).
  • Percentage of Participants Who Discontinued Treatment Due to Lack of Efficacy or Adverse Events [ Time Frame: Baseline up to Week 52 ]
    Percentage of participants who discontinued etanercept before completing the study, was reported.
  • Number of Participants Who Switched to Other Therapy After Treatment Discontinuation [ Time Frame: Baseline up to Week 52 ]
    Participants who switched from etanercept to either disease-modifying antirheumatic drugs (DMARDs) or alternative biologic drug were reported.
  • Hannover Functional Questionnaire (FFbH) Functional Capacity Score of Participants With Rheumatoid Arthritis (RA), Axial Spondyloarthritis (axSpA), Psoriasis Arthritis (PsA) at Weeks 12, 24, 36, 52 [ Time Frame: Weeks 12, 24, 36, 52 ]
    FFbH consisted 18 questions to assess daily activities in last 7 days. Each question was answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores * 100% [percent]) / (2 * number of answered questions) ranged between 0-100; higher score indicated better daily activities.
  • Clinical Disease Activity Index (CDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52 [ Time Frame: Weeks 12, 24, 36, 52 ]
    The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.
  • Simplified Disease Activity Index (SDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52 [ Time Frame: Weeks 12, 24, 36, 52 ]
    The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity, and C-reactive protein (CRP) (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.
  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52 [ Time Frame: Weeks 12, 24, 36, 52 ]
    BASDAI is a validated self-assessment tool used to determine disease activity in participant with ankylosing spondylitis. Utilizing a VAS of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0(no symptoms)-10(very severe symptoms).
  • Number of Affected Enthesis in Participants With Axial Spondyloarthritis (axSpA) and Psoriatic Arthritis(PsA) at Weeks 12, 24, 36 and 52 [ Time Frame: Weeks 12, 24, 36, 52 ]
    An enthesis is the site where the joint capsules, ligaments or tendons attach to the bone. Enthesitis is the inflammation of the entheses. This inflammation can lead to severe pain and discomfort.
  • Occiput-to-wall Distance of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52 [ Time Frame: Weeks 12, 24, 36, 52 ]
    Occiput-to-wall distance was the distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.
  • Mean Percentage of Total Body Surface Area (BSA) for Participants With Plaque Psoriasis (PsO) and Psoriasis Arthritis (PsA) at Weeks 12, 24, 36 and 52 [ Time Frame: Weeks 12, 24, 36, 52 ]
    Percentage of BSA affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb = 1 percent (%) of total BSA. Regions of the body were assigned specific number of palms with percentage [Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)]. The total BSA affected was the summation of individual regions affected.
  • Mean of Total Number of Affected Fingers or Toes by Dactylitis in Participants With Psoriatic Arthritis (PsA) at Weeks 12, 24, 36 and 52 [ Time Frame: Weeks 12, 24, 36, 52 ]
    Each of the 10 fingers and 10 toes was evaluated for dactylitis. Score ranged from 0 to 20, where affected numbers of fingers and toes were evaluated.
  • Change From Baseline in Psoriasis Area and Severity Index (PASI) in Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 [ Time Frame: Baseline, Weeks 12, 24, 36, 52 ]
    Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% involvement to 6= 90-100% involvement. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease.
  • Median Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response in Participants With Plaque Psoriasis (PsO) [ Time Frame: Baseline up to Week 24 ]
    PASI: combined assessment of lesion severity & area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%) - 6(90-100%) & severity estimated by clinical signs of erythema, induration, desquamation; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI75: at least a 75 % reduction in PASI relative to Baseline.
  • Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO) [ Time Frame: Weeks 12, 24, 36, 52 ]
    PASI: combined assessment of lesion severity & area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%) - 6(90-100%) & severity estimated by component score of erythema, induration, desquamation; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).
  • Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) [ Time Frame: Weeks 12, 24, 36, 52 ]
    PASI: combined assessment of lesion severity & area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%) - 6(90-100%) & severity estimated by clinical signs of erythema, induration, desquamation; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).
  • Dermatology Life Quality Index (DLQI) Total Score for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 [ Time Frame: Weeks 12, 24, 36, 52 ]
    The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): no effect at DLQI < 2; small effect at 2 <=DLQI <= 5; moderate effect at 6 <=DLQI <= 10; very large effect at 11<=DLQI <= 20; extremely large effect at 21 <= DLQI <= 30.
  • Patient Assessment of Pruritus for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 [ Time Frame: Weeks 12, 24, 36, 52 ]
    Participant's assessment of pruritus measured on a 100 mm VAS ranging from 0 as "no Pruritus" to 100 as "most severe pruritus".
Original Secondary Outcome Measures
 (submitted: June 30, 2015)
  • Proportion of patients who continue treatment with etanercept [ Time Frame: Week 12 ]
  • Patient global assessment of disease activity [ Time Frame: Week 12 ]
    Participant rated Instrument to measure particpant's global assessment of disease activity on a 10 cm visual analogue scale, ranging from no activity to highest possible activity.
  • Physician Global Assessment of Disease Activity [ Time Frame: Week 12 ]
    Physciain Global Assessment of Disease Activity on a 10cm visual analogue scale ranging from no activity to highest possible activity
  • Patient assessment of Fatigue [ Time Frame: Week 12 ]
    Patient assessment of Fatigue measured on a 10cm visual analogue scale ranging from "not at all" to "greatly fatigued"
  • Patient Assessment of Pain [ Time Frame: Week 12 ]
    Patient assessment of pain measured on a 10cm visual analogue scale ranging from "no pain" to "very severe pain"
  • Patient Health Questionnaire-2 [ Time Frame: Week 12 ]
    The Patient Health Questionnaire-2 (PHQ-2) is a Brief Depression Screening Instrument. It inquires about the frequency of depressed mood and anhedonia over the past 2 weeks, scoring each as 0 ("not at all") to 3 ("nearly every day"). It ranges from 0-6.
  • Rheumatoid Arthritis, axial Spondyloarthritis, Psoriasis Arthritis: Hannover functional status questionnaire (FFbH) Score [ Time Frame: Week 12 ]
    The Hannover Functional Status Questionnaire (Funktionsfragebogen Hannover, FFbH) measures limitations in activities of daily living. Scores are given in percent of full function (range 0 to 100).
  • Rheumatoid Arthritis: Clinical Disease Activity Index (CDAI) [ Time Frame: Week 12 ]
    The CDAI is the numerical sum of 4 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.
  • Rheumatoid Arthritis: Simplified Disease Activity Index (SDAI) [ Time Frame: Week 12 ]
    The SDAI is the numerical sum of five outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity, and C-reactive protein (CRP) (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.
  • Plaque Psoriasis: Body Surface Area (BSA) [ Time Frame: Week 12 ]
    Percentage of the Body surface affected by lesions, range 0-100%
  • Axial Spondyloarthritis: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: Week 12 ]
    BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10.
  • Axial Spondyloarthritis: Occiput-to-wall distance [ Time Frame: Baseline, Week 12 ]
    Occiput-to-wall distance: distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.
  • Plaque Psoriasis: Dermatology Life Quality Index (DLQI) [ Time Frame: Week 12 ]
    DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).
  • Axial Spondyloarthritis, Psoriasis Arthritis: Number of tendons affected by enthesitis [ Time Frame: Week 12 ]
  • Psoriasis Arthritis: Number of fingers or toes affected by Dactylitis [ Time Frame: Week 12 ]
  • Rheumatoid Arthritis: Percentage of patients with Disease Activity Score Based on 28-joints Count (DAS28)<2.6 [ Time Frame: Week 36 ]
    DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
  • Correlation between visual analogue scale measures "patient global assessment", "fatigue", "pain", "physician global assessment" and "Patient Health Questionnaire-2 (PHQ-2)" across all indications [ Time Frame: Week 12 ]
  • Correlation between Hannover functional status questionnaire (FFbH) and duration of morning stiffness [ Time Frame: Week 12 ]
  • Plaque Psoriasis: Patient Assessment of Pruritus [ Time Frame: Week 12 ]
    Patient Assessment of Pruritus measured on a visual analogue scale ranging from "no Pruritus" to "most severe Pruritus"
  • Axial Spondyloarthritis: Percentage of Patients with Ankylosing Spondylitis Disease Activity Score (ASDAS) < 1.3 [ Time Frame: Week 36 ]
    Ankylosing Spondylitis Disease Activity Score (ASDAS) is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, patient global assessment of disease activity (all assessed on a visual analogue scale [0-10cm] or a numerical rating scale [0-10]) and C-Reactive Protein (milligrams per liter [mg/l]) with ASDAS scores ranging from 0 to 10. ASDAS <1.3 = inactive disease, ASDAS 1.3-2.0 = moderate, ASDAS 2.1-3.4 = high and ASDAS >= 3.5 = very high disease activity.
  • Psoriasis Arthritis: Percentage of patients who have either a disease activity score based on 28-joints count (DAS28) <2.6 or meet Minimal Disease Activity (MDA) criteria [ Time Frame: Week 36 ]
    Change from Baseline in Disease Activity Score Based on 28-joints Count (DAS28) or Minimal Disease activity (MDA), i.e. Patient meets 5 of 7 of the following criteria: 1)Tender Joint Count=<1 2) Swollen Joint Count =<1 3) Psoriasis Area and Severity Index =< 1 or Body surface area =< 3 4) Patient pain on visual analog scale =< 15 5) Patient global activity measured on visual analog scale =< 20 6) Health Assessement Questionnaire (HAQ) =< 0.5 7) Tender Enthesial Points =< 1 No
  • Plaque Psoriasis: Percentage of patients achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI75) Score or a Physician's Global Assessment of "clear" or "almost clear" or a Dermatology Life Quality Index (DLQI) Total Score of 0 or 1 [ Time Frame: Week 36 ]
    The Psoriasis Area and Severity Index (PASI) ranges from 0(no disease)-72(maximal disease). The Body is divided into 4 sections; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved (0=0%] - 6=90-100% and severity (ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked) are estimated. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PGA is an average assessment of all psoriatic lesions based on erythema, scale, and Induration. DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).
  • Plaque Psoriasis: Change in Psoriasis Area and Severity Index (PASI) Score [ Time Frame: Baseline, 24 weeks ]
    Percentage Change in the Psoriasis Area and Severity Index (PASI). PASI ranges from 0(no disease)-72(maximal disease). The Body is divided into 4 sections; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved (0=0%] - 6=90-100% and severity (ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked) are estimated. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).
  • Plaque Psoriasis: Median time until 75% improvement in Psoriasis Area and Severity Index (PASI75) Score is achieved [ Time Frame: 24 weeks ]
    Psoriasis Area and Severity Index (PASI) ranges from 0(no disease)-72(maximal disease). The Body is divided into 4 sections; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved (0=0%] - 6=90-100% and severity (ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked) are estimated. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).
  • Proportion of patients who continue treatment with etanercept [ Time Frame: Week 24 ]
  • Proportion of patients who continue treatment with etanercept [ Time Frame: Week 36 ]
  • Proportion of patients who continue treatment with etanercept [ Time Frame: Week 52 ]
  • Incidence of Adverse Events and Serious Adverse Events per Participant-Year [ Time Frame: Week 24 ]
    Participant-Year estimated by calculating all of the years that participants in a study were followed (mean study drug exposure duration multiplied by safety set population). Incidence calculated as AEs or SAEs divided by Participant-Year multiplied by 100.
  • Incidence of Adverse Events and Serious Adverse Events per Participant-Year [ Time Frame: Week 36 ]
    Participant-Year estimated by calculating all of the years that participants in a study were followed (mean study drug exposure duration multiplied by safety set population). Incidence calculated as AEs or SAEs divided by Participant-Year multiplied by 100.
  • Incidence of Adverse Events and Serious Adverse Events per Participant-Year [ Time Frame: Week 52 ]
    Participant-Year estimated by calculating all of the years that participants in a study were followed (mean study drug exposure duration multiplied by safety set population). Incidence calculated as AEs or SAEs divided by Participant-Year multiplied by 100.
  • Patient global assessment of disease activity [ Time Frame: Week 24 ]
    Participant rated Instrument to measure particpant's global assessment of disease activity on a 10 cm visual analogue scale, ranging from no activity to highest possible activity.
  • Patient global assessment of disease activity [ Time Frame: Week 36 ]
    Participant rated Instrument to measure particpant's global assessment of disease activity on a 10 cm visual analogue scale, ranging from no activity to highest possible activity.
  • Patient global assessment of disease activity [ Time Frame: Week 52 ]
    Participant rated Instrument to measure particpant's global assessment of disease activity on a 10 cm visual analogue scale, ranging from no activity to highest possible activity.
  • Physician Global Assessment of Disease Activity [ Time Frame: Week 24 ]
    Physciain Global Assessment of Disease Activity on a 10cm visual analogue scale ranging from no activity to highest possible activity
  • Physician Global Assessment of Disease Activity [ Time Frame: Week 36 ]
    Physciain Global Assessment of Disease Activity on a 10cm visual analogue scale ranging from no activity to highest possible activity
  • Physician Global Assessment of Disease Activity [ Time Frame: Week 52 ]
    Physciain Global Assessment of Disease Activity on a 10cm visual analogue scale ranging from no activity to highest possible activity
  • Patient assessment of Fatigue [ Time Frame: Week 24 ]
    Patient assessment of Fatigue measured on a 10cm visual analogue scale ranging from "not at all" to "greatly fatigued"
  • Patient assessment of Fatigue [ Time Frame: Week 36 ]
    Patient assessment of Fatigue measured on a 10cm visual analogue scale ranging from "not at all" to "greatly fatigued"
  • Patient assessment of Fatigue [ Time Frame: Week 52 ]
    Patient assessment of Fatigue measured on a 10cm visual analogue scale ranging from "not at all" to "greatly fatigued"
  • Patient Assessment of Pain [ Time Frame: Week 24 ]
    Patient assessment of pain measured on a 10cm visual analogue scale ranging from "no pain" to "very severe pain"
  • Patient Assessment of Pain [ Time Frame: Week 36 ]
    Patient assessment of pain measured on a 10cm visual analogue scale ranging from "no pain" to "very severe pain"
  • Patient Assessment of Pain [ Time Frame: Week 52 ]
    Patient assessment of pain measured on a 10cm visual analogue scale ranging from "no pain" to "very severe pain"
  • Patient Health Questionnaire-2 [ Time Frame: Week 24 ]
    The Patient Health Questionnaire-2 (PHQ-2) is a Brief Depression Screening Instrument. It inquires about the frequency of depressed mood and anhedonia over the past 2 weeks, scoring each as 0 ("not at all") to 3 ("nearly every day"). It ranges from 0-6.
  • Patient Health Questionnaire-2 [ Time Frame: Week 36 ]
    The Patient Health Questionnaire-2 (PHQ-2) is a Brief Depression Screening Instrument. It inquires about the frequency of depressed mood and anhedonia over the past 2 weeks, scoring each as 0 ("not at all") to 3 ("nearly every day"). It ranges from 0-6.
  • Patient Health Questionnaire-2 [ Time Frame: Week 52 ]
    The Patient Health Questionnaire-2 (PHQ-2) is a Brief Depression Screening Instrument. It inquires about the frequency of depressed mood and anhedonia over the past 2 weeks, scoring each as 0 ("not at all") to 3 ("nearly every day"). It ranges from 0-6.
  • Rheumatoid Arthritis, axial Spondyloarthritis, Psoriasis Arthritis: Hannover functional status questionnaire (FFbH) Score [ Time Frame: Week 24 ]
    The Hannover Functional Status Questionnaire (Funktionsfragebogen Hannover, FFbH) measures limitations in activities of daily living. Scores are given in percent of full function (range 0 to 100).
  • Rheumatoid Arthritis, axial Spondyloarthritis, Psoriasis Arthritis: Hannover functional status questionnaire (FFbH) Score [ Time Frame: Week 36 ]
    The Hannover Functional Status Questionnaire (Funktionsfragebogen Hannover, FFbH) measures limitations in activities of daily living. Scores are given in percent of full function (range 0 to 100).
  • Rheumatoid Arthritis, axial Spondyloarthritis, Psoriasis Arthritis: Hannover functional status questionnaire (FFbH) Score [ Time Frame: Week 52 ]
    The Hannover Functional Status Questionnaire (Funktionsfragebogen Hannover, FFbH) measures limitations in activities of daily living. Scores are given in percent of full function (range 0 to 100).
  • Rheumatoid Arthritis: Clinical Disease Activity Index (CDAI) [ Time Frame: Week 24 ]
    The CDAI is the numerical sum of 4 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.
  • Rheumatoid Arthritis: Clinical Disease Activity Index (CDAI) [ Time Frame: Week 36 ]
    The CDAI is the numerical sum of 4 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.
  • Rheumatoid Arthritis: Clinical Disease Activity Index (CDAI) [ Time Frame: Week 52 ]
    The CDAI is the numerical sum of 4 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.
  • Rheumatoid Arthritis: Simplified Disease Activity Index (SDAI) [ Time Frame: Week 24 ]
    The SDAI is the numerical sum of five outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity, and C-reactive protein (CRP) (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.
  • Rheumatoid Arthritis: Simplified Disease Activity Index (SDAI) [ Time Frame: Week 36 ]
    The SDAI is the numerical sum of five outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity, and C-reactive protein (CRP) (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.
  • Rheumatoid Arthritis: Simplified Disease Activity Index (SDAI) [ Time Frame: Week 52 ]
    The SDAI is the numerical sum of five outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity, and C-reactive protein (CRP) (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.
  • Plaque Psoriasis: Body Surface Area (BSA) [ Time Frame: Week 24 ]
    Percentage of the Body surface affected by lesions, range 0-100%
  • Plaque Psoriasis: Body Surface Area (BSA) [ Time Frame: Week 36 ]
    Percentage of the Body surface affected by lesions, range 0-100%
  • Plaque Psoriasis: Body Surface Area (BSA) [ Time Frame: Week 52 ]
    Percentage of the Body surface affected by lesions, range 0-100%
  • Axial Spondyloarthritis: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: Week 24 ]
    BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10.
  • Axial Spondyloarthritis: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: Week 36 ]
    BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10.
  • Axial Spondyloarthritis: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: Week 52 ]
    BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0-10.
  • Axial Spondyloarthritis: Occiput-to-wall distance [ Time Frame: Baseline, Week 24 ]
    Occiput-to-wall distance: distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.
  • Axial Spondyloarthritis: Occiput-to-wall distance [ Time Frame: Baseline, Week 36 ]
    Occiput-to-wall distance: distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.
  • Axial Spondyloarthritis: Occiput-to-wall distance [ Time Frame: Baseline, Week 52 ]
    Occiput-to-wall distance: distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.
  • Plaque Psoriasis: Dermatology Life Quality Index (DLQI) [ Time Frame: Week 24 ]
    DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).
  • Plaque Psoriasis: Dermatology Life Quality Index (DLQI) [ Time Frame: Week 36 ]
    DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).
  • Plaque Psoriasis: Dermatology Life Quality Index (DLQI) [ Time Frame: Week 52 ]
    DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).
  • Axial Spondyloarthritis, Psoriasis Arthritis: Number of tendons affected by enthesitis [ Time Frame: Week 24 ]
  • Axial Spondyloarthritis, Psoriasis Arthritis: Number of tendons affected by enthesitis [ Time Frame: Week 36 ]
  • Axial Spondyloarthritis, Psoriasis Arthritis: Number of tendons affected by enthesitis [ Time Frame: Week 52 ]
  • Psoriasis Arthritis: Number of fingers or toes affected by Dactylitis [ Time Frame: Week 24 ]
  • Psoriasis Arthritis: Number of fingers or toes affected by Dactylitis [ Time Frame: Week 36 ]
  • Psoriasis Arthritis: Number of fingers or toes affected by Dactylitis [ Time Frame: Week 52 ]
  • Correlation between visual analogue scale measures "patient global assessment", "fatigue", "pain", "physician global assessment" and "Patient Health Questionnaire-2 (PHQ-2)" across all indications [ Time Frame: Week 24 ]
  • Correlation between visual analogue scale measures "patient global assessment", "fatigue", "pain", "physician global assessment" and "Patient Health Questionnaire-2 (PHQ-2)" across all indications [ Time Frame: Week 36 ]
  • Correlation between visual analogue scale measures "patient global assessment", "fatigue", "pain", "physician global assessment" and "Patient Health Questionnaire-2 (PHQ-2)" across all indications [ Time Frame: Week 52 ]
  • Correlation between Hannover functional status questionnaire (FFbH) and duration of morning stiffness [ Time Frame: Week 24 ]
  • Correlation between Hannover functional status questionnaire (FFbH) and duration of morning stiffness [ Time Frame: Week 36 ]
  • Correlation between Hannover functional status questionnaire (FFbH) and duration of morning stiffness [ Time Frame: Week 52 ]
  • Percentage of participants who discontinued treatment due to adverse events [ Time Frame: Week 24 ]
  • Percentage of participants who discontinued treatment due to adverse events [ Time Frame: Week 36 ]
  • Percentage of participants who discontinued treatment due to adverse events [ Time Frame: Week 52 ]
  • Plaque Psoriasis: Patient Assessment of Pruritus [ Time Frame: Week 24 ]
    Patient Assessment of Pruritus measured on a visual analogue scale ranging from "no Pruritus" to "most severe Pruritus"
  • Plaque Psoriasis: Patient Assessment of Pruritus [ Time Frame: Week 36 ]
    Patient Assessment of Pruritus measured on a visual analogue scale ranging from "no Pruritus" to "most severe Pruritus"
  • Plaque Psoriasis: Patient Assessment of Pruritus [ Time Frame: Week 52 ]
    Patient Assessment of Pruritus measured on a visual analogue scale ranging from "no Pruritus" to "most severe Pruritus"
  • Axial Spondyloarthritis: Percentage of Patients with Ankylosing Spondylitis Disease Activity Score (ASDAS) < 1.3 [ Time Frame: Week 52 ]
    Ankylosing Spondylitis Disease Activity Score (ASDAS) is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, patient global assessment of disease activity (all assessed on a visual analogue scale [0-10cm] or a numerical rating scale [0-10]) and C-Reactive Protein (milligrams per liter [mg/l]) with ASDAS scores ranging from 0 to 10. ASDAS <1.3 = inactive disease, ASDAS 1.3-2.0 = moderate, ASDAS 2.1-3.4 = high and ASDAS >= 3.5 = very high disease activity.
  • Psoriasis Arthritis: Percentage of patients who have either a disease activity score based on 28-joints count (DAS28) <2.6 or meet Minimal Disease Activity (MDA) criteria [ Time Frame: Week 52 ]
    Change from Baseline in Disease Activity Score Based on 28-joints Count (DAS28) or Minimal Disease activity (MDA), i.e. Patient meets 5 of 7 of the following criteria: 1)Tender Joint Count=<1 2) Swollen Joint Count =<1 3) Psoriasis Area and Severity Index =< 1 or Body surface area =< 3 4) Patient pain on visual analog scale =< 15 5) Patient global activity measured on visual analog scale =< 20 6) Health Assessement Questionnaire (HAQ) =< 0.5 7) Tender Enthesial Points =< 1 No
  • Plaque Psoriasis: Percentage of patients achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI75) Score or a Physician's Global Assessment of "clear" or "almost clear" or a Dermatology Life Quality Index (DLQI) Total Score of 0 or 1 [ Time Frame: Week 52 ]
    The Psoriasis Area and Severity Index (PASI) ranges from 0(no disease)-72(maximal disease). The Body is divided into 4 sections; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved (0=0%] - 6=90-100% and severity (ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked) are estimated. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PGA is an average assessment of all psoriatic lesions based on erythema, scale, and Induration. DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire has a score range of 0 to 30 with higher scores indicating poor quality of life. An estimate of the minimal clinically important difference of the DLQI total score is a 5 point improvement. Total score range: 0 (best) to 30 (worst).
Current Other Pre-specified Outcome Measures
 (submitted: March 29, 2019)
  • Erythrocyte Sedimentation Rate (ESR) at Weeks 12, 24, 36 and 52 [ Time Frame: Weeks 12, 24, 36, 52 ]
    ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.
  • C-Reactive Protein (CRP) Levels at Weeks 12, 24, 36 and 52 [ Time Frame: Weeks 12, 24, 36, 52 ]
    The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
  • Number of Participants With Rheumatoid Factor (RF) at Weeks 12, 24, 36 and 52 [ Time Frame: Weeks 12, 24, 36, 52 ]
    RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter (U/mL) is considered positive.
  • Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies at Weeks 12, 24, 36 and 52 [ Time Frame: Weeks 12, 24, 36, 52 ]
    To assess the pharmacodynamics effect of etanercept on serum levels of autoantibodies, Anti-CCP antibodies levels were measured.
  • Number of Participants With Positive Human Leukocyte Antigen B27(HLA-B27) at Baseline for Participants With Axial Spondyloarthritis(axSpA) [ Time Frame: Baseline ]
    Participants with Axial Spondyloarthritis with Positive Human Leukocyte Antigen (HLA-B27) were reported.
  • Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than < 1.3 at Weeks 36 and 52 [ Time Frame: Weeks 36, 52 ]
    ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 <= ASDAS < 1.3; moderate disease activity: 1.3 <= ASDAS < 2.1; high disease activity: 2.1 <= ASDAS <= 3.5; very high disease activity: 3.5 < ASDAS.
  • Number of Participants With Psoriatic Arthritis (PsA) Achieving Either 28 Joint Disease Activity Score (DAS28) Less Than < 2.6 or Meet Minimal Disease Activity (MDA) Criteria at Weeks 36 and 52 [ Time Frame: Weeks 36, 52 ]
    DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28<2.6 = remission, DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC <=1; 2) SJC =<1; 3) PASI <= 1 or body surface area (BSA) <=3; 4) Participant pain on VAS <= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain [best] and 100 mm = maximum possible pain [worst]; 5) PtGA on VAS <= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) Health assessment questionnaire disability index (HAQ-DI) <= 0.5(HAQ=3.16-[0.028* hannover functional questionnaire [FFbH]); 7) Tender enthesial points <= 1.
  • Number of Participants With Plaque Psoriasis (PsO) Achieving PASI75 Score or a PGA of "Clear" or "Almost Clear" And DLQI Total Score of 0 or 1 at Weeks 36 and 52 [ Time Frame: Weeks 36, 52 ]
    PASI:combined assessment of lesion severity & area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) & severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear & almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect).
  • Number of Participants With Rheumatoid Arthritis (RA) Achieving 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Weeks 36 and 52 [ Time Frame: Weeks 36, 52 ]
    DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28<2.6 = remission, DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. Participants who had DAS28 <= 2.6 were considered in remission.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study To Evaluate The Efficacy Of Enbrel (REGISTERED) Etanercept Over A Period Of 12 Months In The Routine Treatment Of Patients With Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriatic Arthritis, Or Plaque Psoriasis.
Official Title A PROSPECTIVE, MULTICENTER NON-INTERVENTIONAL STUDY TO EVALUATE THE EFFICACY OF ENBREL (REGISTERED) (ETANERCEPT) OVER A PERIOD OF 12 MONTHS IN THE ROUTINE TREATMENT OF PATIENTS WITH RHEUMATOID ARTHRITIS, AXIAL SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, OR PLAQUE PSORIASIS WITH PARTICULAR FOCUS ON THE CLINICAL STATUS IMPROVEMENTS STILL OBSERVABLE AFTER 12 WEEKS OF TREATMENT
Brief Summary The purpose of this non-interventional study is to evaluate the efficacy of etanercept during routine clinical use over a maximum of 12 months in patients with rheumatoid arthritis (RA), psoriatic arthritis(PsA), axial spondyloarthritis(axSpA) or plaque psoriasis (PsO). In so doing, particular attention will be paid to the proportion of those patients who only attain the desired treatment goal after 12 weeks of treatment. The primary efficacy end point for the study is the proportion of patients who attain the desired treatment goal after 12 and 24 weeks,
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Ambulatory and Hospital care patients treated for Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriasis Arthritis or Plaque Psoriasis in Germany
Condition
  • Rheumatoid Arthritis
  • Psoriatic Arthritis
  • Axial Spondyloarthritis
  • Plaque Psoriasis
Intervention Drug: Etanercept
Etanercept shall be used according to clinical practice and in line with the summary of product characteristics.
Study Groups/Cohorts Observation Group
Intervention: Drug: Etanercept
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 29, 2019)
1534
Original Estimated Enrollment
 (submitted: June 30, 2015)
2100
Actual Study Completion Date December 11, 2017
Actual Primary Completion Date December 11, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Confirmed diagnosis of RA, axSpA, PsA or PsO
  • No prior treatment with etanercept and eligibility for treatment with etanercept according to the summary of product characteristics.

Exclusion Criteria:

  • The contraindications, special warnings, and precautions according to the summary of product characteristics for etanercept shall apply.
  • The additional documentation of the patient in another post-marketing study with etanercept is not permitted.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02486302
Other Study ID Numbers B1801385
ADEQUATE ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2019