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Study Comparing Etanercept (ETN) Against a Placebo for Etanercept on a Background Nonsteroidal Anti Inflammatory Drug (NSAIDs) in the Treatment of Early Spondyloarthritis (SpA) Patients Who do Not Have X-ray Structural Changes (EMBARK)

Primary Purpose

Spondylitis, Ankylosing

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

etanercept

Background NSAID

PLACEBO

Background NSAID

About this trial

This is an interventional treatment trial for Spondylitis, Ankylosing focused on measuring Early ankylosing spondylitis (SpA) study; efficacy and safety and health out comes

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of axial spondyloarthritis as defined by Assessments in Ankylosing Spondylitis (ASAS)criteria
Active symptoms defined as Ankylosing Spondylitis Disease Activity Index{BASDAI) > or = 4
Axial symptoms of back pain with a less than favorable response to on steroidal anti inflammatory drugs at optimal dosage for greater than 4 weeks

Exclusion Criteria:

Evidence of current or recent episode of uveitis
Evidence of IBD flare within 6 months
Previous treatment with an anti Tumor necrosis factor(TNF)
Active tuberculosis
Radiographic sacroiliitis grade 3-4 unilaterally or >= 2 bilaterally

Sites / Locations

Centro Medico Privado de Reumatologia
Consultorios Reumatológicos Pampa
Universitair Ziekenhuis Gent
Reuma Instituut
AZ Groeninge
Preventive Care Ltda.
Ips Medicity S.A.S
Servimed Sas
Mediscan Group, s.r.o.
Revmatologicky ustav
Medical Plus s.r.o.
Meilahden kolmiosairaala
Kiljavan Lääketutkimus
Hopital de Bicetre
CHU Lapeyronie, Immuno-Rhumatologie
Hôpital Cochin
CHU de Tours
Charite - Campus Benjamin Franklin, Medizinische Klinik I - Rheumatologie
Studienambulanz, Medizinische Klinik 3, Universitaetsklinikum Erlangen
Schoen Klinik Hamburg-Eilbek, Abt. Rheumatologie und Klin. Immunologie
Rheumazentrum Ruhrgebiet
MEDIGREIF Verwaltungs- und Betriebsgesellschaft Fachkrankenhaus Vogelsang-Gommern mbH
Orszagos Reumatologiai es Fizioterapias Intezet/Klinikai Immunologiai es Reumatologiai Osztaly
Budai Irgalmasrendi Korhaz
Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft.
Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft.
Kenezy Gyula Korhaz es Rendelointezet
Csolnoky Ferenc Korhaz
Gachon University Gil Hospital
Chonnam National University Hospital
Hanyang University Hospital
Academic Medical Centre (AMC) / Division of Clinical Immunology and Rheumatology
Leiden University Medical Center, Reumatologie
Rheumatology Research Institute of Russian Academy of Medical Sciences
Russian Cardiology Research-and-Production Complex
Saint-Petersburg State Budgetary Healthcare Institution
Limited Liability Company NMC Tomography
Leningrad Regional Clinical Hospital
Hospital Virgen Macarena
Fundacion Hospital Alcorcon
Hospital Reina Sofia
Complexo Hospitalario Universitario A Coruña
Chung-Ho Memorial Hospital, Kaohsiung Medical University
Chung Shan Medical University Hospital
Taipei Veterans General Hospital
Rhuematology Clinical Research Unit
Hampshire Hospitals NHS Foundation Trust
Norfolk and Norwich University Hospital NHS Trust
Russells Hall Hospital
Whipps Cross University Hospital,

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

etanercept

PLACEBO

Arm Description

In Period 1 : Subjects will receive via a prefilled syringe an active dose equivalent to 1.0ml of Etanercept solution once weekly SC once weekly. Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician.

In Period 1: Subjects will receive in a prefilled syringe with a PLACEBO dose equivalent to 1.0 ml of placebo solution once weekly SC Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving Ankylosing Spondylitis (ASAS) 40 Response at Week 12

ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) in 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0 = no disease activity, 100 = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.

Secondary Outcome Measures

Percentage of Participants Achieving ASAS 40 Response at Time Points

ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement from baseline and an absolute change ≥ 20 units on a 0-100 scale (0 = no disease activity, 100 = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.

Percentage of Participants Achieving ASAS 20 Response at Time Points

ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening in remaining domain.

Percentage of Participants Achieving ASAS 5/6 Response at Time Points

ASAS 5/6 consists of 6 domains: the 4 used in ASAS 20 (participant global assessment of disease activity, pain, function, inflammation measured on a 0-100 scale, where 0 = no disease activity and 100 = high disease activity) plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). Achieving ASAS 5/6 requires a 20% improvement compared to baseline in ≥ 5 domains and no worsening in the remaining domain.

Mean Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) High Sensitivity CRP (hsCRP) Score at Time Points

ASDAS includes CRP (mg/L) or ESR (mm/hr); Apart from the value of CRP or ESR, the four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included in this index are back pain, duration of morning stiffness, peripheral pain/swelling and patient global assessment of disease activity. The ASDAS scores are then calculated as follows: ASDAS_CRP = (0.121 x total back pain) + (0.110 x subject global) + (0.073 x peripheral pain/swelling) + (0.058 x duration of morning stiffness) + (0.579 x Ln(CRP+1)). And ASDAS_ESR: (0.079 x total back pain) + (0.113 x subject global) + (0.086 x peripheral pain/swelling) + (0.069 x duration of morning stiffness) + (0.293 x √ESR). In addition, the proportion of participants who achieve inactive disease based on the ASDAS will be determined for each group. Inactive disease is defined as an ASDAS score <1.3.

Percentage of Participants Achieving ASAS Partial Remission at Time Points

Partial remission defined as a score of 20 units or less (on a scale of 0-100, where 0 = no disease activity and 100 = high disease activity) in each of the 4 Assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation. For scale, 100 = high disease activity.

Time to ASAS Partial Remission

The median time to partial remission was not reached at Week 12. Hence, we report an estimate of the percentage of participants, estimated using Kaplan-Meier approach.

Mean Change From Baseline in Visual Analogue Scale (VAS) Physician Global Assessments at Time Points

The Investigator estimated the participant's overall disease activity over the previous 48 hours (this was independent of the Subject Assessment of Disease Activity) using a scale between 0 mm (none) and 100 mm (severe).

Mean Change From Baseline in VAS Score for Subject Assessment of Disease Activity at Time Points

Participants to assess their overall disease activity over the last 48 hours using a pain scale between 0 mm (none) and 100 mm (severe), which corresponded to the magnitude of their pain.

Changes From Baseline in VAS Score for Nocturnal Back Pain at Time Points

The VAS scale was used to assess the level of nocturnal pain during the past 48 hours. For this, participants marked their level of pain on a 100 mm VAS anchored by 0 for "No pain " to 100 mm for "Most Severe Pain."

Changes From Baseline in VAS Score for Total Back Pain at Time Points

The VAS scale was used to assess the level of total back pain during the past 48 hours. For this, participants marked their level of pain on a 100 mm VAS anchored by 0 for "No pain " to 100 mm for "Most Severe Pain."

Changes From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Time Points

BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 = impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.

Mean Change From Baseline in BASFI Full Day Activities at Time Points

Mean Change From Baseline in BASFI Bending Forward at Time Points

Mean Change From Baseline in BASFI Getting Out of an Arm-less Chair at Time Points

Mean Change From Baseline in BASFI Physically Demanding Activities at Time Points

Mean Change From Baseline in BASFI Reaching up High at Time Points

Mean Change From Baseline in BASFI Climbing Steps Without Aid at Time Points

Mean Change From Baseline in BASFI Getting-up Off-floor From Back at Time Points

Mean Change From Baseline in BASFI Standing Unsupported for 10 Minutes at Time Points

Mean Change From Baseline in BASFI Looking Over Shoulder at Time Points

Mean Change From Baseline in BASFI Putting on Socks at Time Points

Changes From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Time Points

BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a VAS of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The final BASDAI score averages the individual assessments for a final score range of 0-10.

Mean Change From Baseline in BASDAI Level of Morning Stiffness at Time Points

Mean Change From Baseline in BASDAI Level of Fatigue/Tiredness at Time Points

Mean Change From Baseline in BASDAI Level of Discomfort at Time Points

Mean Change From Baseline in BASDAI Level of How Long Stiffness Lasts at Time Points

Mean Change From Baseline in BASDAI Level of Pain/Swelling at Time Points

Mean Change From Baseline in BASDAI Level of Neck/Back/Hip Pain at Time Points

Percentage of Participants With BASDAI 50 at Time Points

Response was defined as a 50% improvement of the Baseline BASDAI to 104 weeks of study treatment, respectively. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5.

Percentage of Participants With BASDAI 20 at Time Points

Response was defined as a 20% improvement of the Baseline BASDAI to 104 weeks of study treatment. The BASDAI score is obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 and 6) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5.

Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Total Score at Time Points

The BAS-G was a 2 question assessment evaluating the effect of AS on the participants well-being over the last week and last 6 months. The 2 questions were: How have you been over the last week? and How have you been over the last six months?. Each question is scored by the participant on a 100 mm scale ranging from 0 (Very Good) to 100 (Very Bad). The two values are averaged to obtain the BAS-G score.

Mean Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Time Points

BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.

Mean Change From Baseline in BASMI Lateral Side Flexion Score by Time Point

Mean Change From Baseline in BASMI Cervical Rotation Degree by Time Point

Mean Change From Baseline in BASMI Modified Schobers Test Score by Time Point

Mean Change From Baseline in BASMI Intermalleolar Distance Score by Time Point

Mean Change From Baseline in BASMI Tragus to Wall Score by Time Point

Change From Baseline in Chest Expansion at Time Points

Chest expansion, measured in cm, is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). At maximal inspiration, the chest circumference was measured at nipple line or at the 4th intercostal space (in cm to the nearest 0.1 cm).

Mean Change From Baseline in Occiput-to-wall Test at Time Points

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.

Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) - Spine 6 Discovertebral Units (DVU) Total Score at 12 Weeks

The change from baseline in the MRI score of spine was assessed using SPARCC method. The scores of the 6 most severely affected spinal levels (discovertebral units/DVUs) was selected. Each DVU was divided into 4 quadrants. Each quadrant was assigned a score of 0 = no lesion or 1 = increased signal. This was repeated for each of 3 consecutive sagittal slices resulting in a score of up to 12 per DVU. On each slice, the presence of a lesion exhibiting an intense signal in any quadrant was assigned an additional score of 1 for that slice. Additionally, on each slice the presence of a lesion exhibiting depth ≥ 1 cm in any quadrant was given an additional score of 1. The maximum score for 6 DVU Spine Total Score is 108.

Mean Change From Baseline in SPARCC Score for the Sacroiliac Joint at Time Points

The change from baseline in the MRI score of sacroiliac joints was assessed using SPARCC method. Scoring was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned a score of 0 = no lesion/1 = increased signal. For each slice, the score is increased by 1 for each joint that exhibits an intense signal in any quadrant. Also, for each slice, an additional score of 1 will be given for each joint that includes a lesion demonstrating continuous increased signal of a depth ≥1 cm from the articular surface. The maximum possible score is 72.

Mean Change From Baseline in SPARCC - Spine 6 Discovertebral Units (DVU) Total Score at Time Points

Mean Change From Baseline in Ankylosing Spondylitis Spine Magnetic Resonance Imaging-Activity (ASspiMRI-a) Total Score

ASspiMRI-a measures acute lesion scores as determined by short-tau inversion recovery (STIR) and gadolinium-enhanced T1 (Gd-DTPA). All 23 disco-vertebral units (DVU) of the spine (from C2 to S1), defined as the region between 2 virtual lines through the middle of each vertebra, are scored in a single dimension, which is representing the highest level of inflammation in that particular DVU. Enhancement and bone marrow edema are graded (0-3) for each DVU, with 3 more grades (4-6) if, in addition to the signs of acute inflammation defined for grades 1-3, erosions are visualized, leading to a maximum score of 138 for the entire spine. Acute spinal changes were assessed by using STIR sagittal views of the cervical, thoracic and lumbar spine. The total score ranges from 0 (no inflammation) to 138 (high inflammation).

Mean Change From Baseline in Number of Swollen Joints at Time Points

Forty-four (44) joints were assessed by the Investigator to determine the number of joints that were considered swollen (artificial joints were not assessed). The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done. The 44 joints to be assessed were:sternoclavicular, acromioclavicular, shoulder, elbow, wrist (includes radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (I, II, III, IV, V), thumb interphalangeal (IP), proximal IPs (II, III, IV, V), knee, ankle, metatarsophalangeals (I, II, III, IV, V).

Mean Change From Baseline in Number of Tender Joints at Time Points

Forty-four (44) joints were assessed by the Investigator to determine the number of joints that were considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be considered for artificial joints). The 44 joints to be assessed were:sternoclavicular, acromioclavicular, shoulder, elbow, wrist (includes radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (I, II, III, IV, V), thumb interphalangeal (IP), proximal IPs (II, III, IV, V), knee, ankle, metatarsophalangeals (I, II, III, IV, V).

Mean Change From Baseline in Dactylitis Score at Time Points

Each of the 10 fingers and 10 toes is evaluated for dactylitis. A score of 0, 1, 2 or 3 (where 0 = none, 1= mild, 2 = moderate, 3 = severe) is assigned to each. A total score which can range from 0 to 60 is obtained by adding the scores for the 20 digits

Changes From Baseline in Maastricht Ankylosing Spondylitis Enthesis Score (MASES) at Time Points

Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness).

Change From Baseline in C-reactive Protein (CRP) Concentration Time Points

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.

Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Time Points

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.

Change From Baseline in Euro Quality of Life (EQ)-5D VAS Score Time Points

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

Change From Baseline in EQ-5D Health State Profile Utility Score at Time Points

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

Change From Baseline in Short Form-36 (SF-36) Physical Component Summary (PCS) at Time Points

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100 = highest level of functioning).

Change From Baseline in SF-36 Mental Component Summary (MCS) at Time Points

Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Depression Score at Time Points

This outcome measure is describing the HADS subscale of depression. HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. There is no Total Score for HADS.

Change From Baseline in HADS Anxiety Score at Time Points

This outcome measure is describing the HADS subscale of anxiety. HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. There is no Total Score for HADS.

Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score at Time Points

ASQoL is a questionnaire that assesses disease-specific quality of life (QoL). It consists of 18 statements that are relevant to the physical and mental conditions for a participant with Ankylosing Spondylitis (AS): mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL).

Change From Baseline in Ankylosing Spondylitis Work Instability Index (AS-WIS) Score at Time Points

The AS-WIS is a 20 item questionnaire to assess work disability and risk of unemployment due to AS. Higher scores indicate greater work impairment and instability that results from a mismatch between an individual's ability levels given their AS and their job. Each question is assigned a score of 1 for a response of "True" and 0 for a response of "Not True". All item scores are summed to give a total score that can range from 0 to 20. If a subject has ≥ 5 missing responses (ie more than 20%), then a total score is not calculated. For subjects with ≥ 1 but ≤ 4 missing responses, the total score is calculated as follows: T=20x/(20-m) where: T is the total score, x is the total score for the items answered and n is the number of non-missing items.

Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed Due to Health Problems at Time Points

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent work time missed due to health problem: Q2/(Q2+Q4). The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.

Change From Baseline in WPAI: Percent Impairment While Working Due to Health Problems at Time Points

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent impairment while working due to health problem: Q5/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.

Changes From Baseline in WPAI - Activity Impairment Due to Health Problems at Time Points

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent activity impairment due to health problem: Q6/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.

Changes From Baseline in WPAI - Overall Work Impairment Due to Health Problems at Time Points

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent overall work impairment due to health problem: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))*(Q5/10)]. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.

Change From Baseline in Multidimensional Fatigue Inventory (MFI) Score at Time Points

The MFI is a 20-item questionnaire that evaluates several aspects of fatigue. The General Fatigue Item is disclosed here. The general fatigue item contains four items, two of which are indicative for fatigue and two items contra-indicative for fatigue. Indicative items (eg, "I tire easily") are formulated in such a way that a high score suggests a high degree of fatigue. In case of contra-indicative items (eg, "I feel fit") a high score indicates a low degree of fatigue. Each item is scored on a 5-point numeric rating scale anchored at each end by "Yes, that is true" (scored 1) to "No, that is not true" (scored 5). Scoring for the MFI is done in such a way that higher scores indicate greater fatigue. Therefore, the items indicative for fatigue need to be recoded (1=5, 2=4, 3=3, 4=2, 5=1). For each scale a total score is calculated by summation of the scores of the individual items. Scores can range from the minimum of 4 to the maximum of 20. MFI-20 scale is copyrighted.

Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale Score From Baseline to Week 104

The MOS sleep scale consists of 12 items to measure 6 sleep dimensions: initiation (time to fall asleep), quantity (hours of sleep each night), maintenance, respiratory problems, perceived adequacy, somnolence (the last 4 items reported using a 6-item Likert scale ranging from 1 [all of the time] to 6 [none of the time]). The raw scores ranging from 1 to 6 are transformed to scores ranging from 0 to 100 before the indices are calculated. Therefore the reported scores, consisting of means of converted items, also range from 0 to 100. However, two indexes can be derived: Sleep problems index I (short form) and sleep problems index II (long form). Additional subscales can be derived: sleep disturbance, snoring, awaken shortness of breath or headache, sleep adequacy, sleep somnolence, sleep quantity, and optimal sleep. However, data for two indexes and additional subscales is not reported.

Percentage of Participants With Minimally Clinically Important Improvement (MCII) at Time Points

The MCII asks participants to rate the level of improvement they have experienced in the 48 hours compared to when they started the study. Response options are "Improved - less pain", "No change", and "Worse - more pain." If the participant indicates that improvement has occurred, then they are asked to indicate how important that improvement is to them from "Not at all important" to "Very important'.

Percentage of Participants Achieving Patient Acceptable Symptom State (PASS) at Time Points

PASS is defined as a symptom state that the participants consider acceptable.

Full Information

NCT ID

NCT01258738

First Posted

December 9, 2010

Last Updated

September 14, 2015

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01258738

Brief Title

Study Comparing Etanercept (ETN) Against a Placebo for Etanercept on a Background Nonsteroidal Anti Inflammatory Drug (NSAIDs) in the Treatment of Early Spondyloarthritis (SpA) Patients Who do Not Have X-ray Structural Changes

Acronym

EMBARK

Official Title

A Multicentre, 12 Week Double Blind Placebo Controlled Randomized Study Of Etanercept On A Background Nsaid In The Treatment Of Adult Subjects With Non Radiographic Axial Spondyloarthritis With A 92 Week Open Label Extension

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a two part study. During period one there will be a comparison of Etanercept (ETN) against a placebo with both arms maintaining the background anti inflammatory drug prescribed by their Physician. The hypothesis is that Etanercept will be superior to the placebo arm as determined by the proportion of subjects achieving Assessments in Ankylosing Spondylitis (ASAS)40 improvement at 12 weeks. This will be followed by 92 weeks extension where everyone in the trial receives Etanercept (ETN) and a background non steroidal anti inflammatory drug(NSAID).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spondylitis, Ankylosing

Keywords

Early ankylosing spondylitis (SpA) study; efficacy and safety and health out comes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

225 (Actual)

8. Arms, Groups, and Interventions

Arm Title

etanercept

Arm Type

Active Comparator

Arm Description

Arm Title

PLACEBO

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

etanercept

Other Intervention Name(s)

ENBREL

Intervention Description

In Period 1, subjects will receive in a prefilled syringe with 1.0 ml (test article Etanercept (SC) once weekly . Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician.

Intervention Type

Drug

Intervention Name(s)

Background NSAID

Intervention Description

Subject will continue to take a concomitant background non steroidal anti inflammatory drug(NSAID)as prescribed by their attending physician. The name and dose of this NSAID is the decision of the attending physician.

Intervention Type

Other

Intervention Name(s)

PLACEBO

Intervention Description

In Period 1 will receive a prefilled syringe of Placebo for Etanercept Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician.

Intervention Type

Drug

Intervention Name(s)

Background NSAID

Intervention Description

Subject will continue to take a concomitant background non steroidal anti inflammatory drug(NSAID)as prescribed by attending physician (dose drug selection as tolerated and agreed upon by the attending Physician).

Primary Outcome Measure Information:

Title

Percentage of Participants Achieving Ankylosing Spondylitis (ASAS) 40 Response at Week 12

Description

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Percentage of Participants Achieving ASAS 40 Response at Time Points

Description

Time Frame

Baseline to Week 104

Title

Percentage of Participants Achieving ASAS 20 Response at Time Points

Description

Time Frame

Baseline to Week 104

Title

Percentage of Participants Achieving ASAS 5/6 Response at Time Points

Description

Time Frame

Baseline to Week 104

Title

Mean Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) High Sensitivity CRP (hsCRP) Score at Time Points

Description

Time Frame

Baseline to Week 104

Title

Percentage of Participants Achieving ASAS Partial Remission at Time Points

Description

Time Frame

Baseline to Week 104

Title

Time to ASAS Partial Remission

Description

The median time to partial remission was not reached at Week 12. Hence, we report an estimate of the percentage of participants, estimated using Kaplan-Meier approach.

Time Frame

Week 12

Title

Mean Change From Baseline in Visual Analogue Scale (VAS) Physician Global Assessments at Time Points

Description

Time Frame

Baseline to Week 104

Title

Mean Change From Baseline in VAS Score for Subject Assessment of Disease Activity at Time Points

Description

Participants to assess their overall disease activity over the last 48 hours using a pain scale between 0 mm (none) and 100 mm (severe), which corresponded to the magnitude of their pain.

Time Frame

Baseline to Week 104

Title

Changes From Baseline in VAS Score for Nocturnal Back Pain at Time Points

Description

Time Frame

Baseline to Week 104

Title

Changes From Baseline in VAS Score for Total Back Pain at Time Points

Description

Time Frame

Baseline to Week 104

Title

Changes From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Time Points

Description

Time Frame

Baseline to Week 104

Title

Mean Change From Baseline in BASFI Full Day Activities at Time Points

Description

Time Frame

Baseline to Week 104

Title

Mean Change From Baseline in BASFI Bending Forward at Time Points

Description

Time Frame

Baseline to Week 104

Title

Mean Change From Baseline in BASFI Getting Out of an Arm-less Chair at Time Points

Description

Time Frame

Baseline to Week 104

Title

Mean Change From Baseline in BASFI Physically Demanding Activities at Time Points

Description

Time Frame

Baseline to Week 104

Title

Mean Change From Baseline in BASFI Reaching up High at Time Points

Description

Time Frame

Baseline to Week 104

Title

Mean Change From Baseline in BASFI Climbing Steps Without Aid at Time Points

Description

Time Frame

Baseline to Week 104

Title

Mean Change From Baseline in BASFI Getting-up Off-floor From Back at Time Points

Description

Time Frame

Baseline to Week 104

Title

Mean Change From Baseline in BASFI Standing Unsupported for 10 Minutes at Time Points

Description

Time Frame

Baseline to Week 104

Title

Mean Change From Baseline in BASFI Looking Over Shoulder at Time Points

Description

Time Frame

Baseline to Week 104

Title

Mean Change From Baseline in BASFI Putting on Socks at Time Points

Description

Time Frame

Baseline to Week 104

Title

Changes From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Time Points

Description

Time Frame

Baseline to Week 104

Title

Mean Change From Baseline in BASDAI Level of Morning Stiffness at Time Points

Description

Time Frame

Baseline to Week 104

Title

Mean Change From Baseline in BASDAI Level of Fatigue/Tiredness at Time Points

Description

Time Frame

Baseline to Week 104

Title

Mean Change From Baseline in BASDAI Level of Discomfort at Time Points

Description

Time Frame

Baseline to Week 104

Title

Mean Change From Baseline in BASDAI Level of How Long Stiffness Lasts at Time Points

Description

Time Frame

Baseline to Week 104

Title

Mean Change From Baseline in BASDAI Level of Pain/Swelling at Time Points

Description

Time Frame

Baseline to Week 104

Title

Mean Change From Baseline in BASDAI Level of Neck/Back/Hip Pain at Time Points

Description

Time Frame

Baseline to Week 104

Title

Percentage of Participants With BASDAI 50 at Time Points

Description

Time Frame

Baseline to Week 104

Title

Percentage of Participants With BASDAI 20 at Time Points

Description

Time Frame

Baseline to Week 104

Title

Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Total Score at Time Points

Description

Time Frame

Baseline to Week 104

Title

Mean Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Time Points

Description

Time Frame

Baseline to Week 104

Title

Mean Change From Baseline in BASMI Lateral Side Flexion Score by Time Point

Description

Time Frame

Baseline to Week 104

Title

Mean Change From Baseline in BASMI Cervical Rotation Degree by Time Point

Description

Time Frame

Baseline to Week 104

Title

Mean Change From Baseline in BASMI Modified Schobers Test Score by Time Point

Description

Time Frame

Baseline to Week 104

Title

Mean Change From Baseline in BASMI Intermalleolar Distance Score by Time Point

Description

Time Frame

Baseline to Week 104

Title

Mean Change From Baseline in BASMI Tragus to Wall Score by Time Point

Description

Time Frame

Baseline to Week 104

Title

Change From Baseline in Chest Expansion at Time Points

Description

Time Frame

Baseline to Week 104

Title

Mean Change From Baseline in Occiput-to-wall Test at Time Points

Description

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.

Time Frame

Baseline to Week 104

Title

Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) - Spine 6 Discovertebral Units (DVU) Total Score at 12 Weeks

Description

Time Frame

Week 12

Title

Mean Change From Baseline in SPARCC Score for the Sacroiliac Joint at Time Points

Description

Time Frame

Weeks 12 and 104

Title

Mean Change From Baseline in SPARCC - Spine 6 Discovertebral Units (DVU) Total Score at Time Points

Description

Time Frame

Weeks 12 and 104

Title

Mean Change From Baseline in Ankylosing Spondylitis Spine Magnetic Resonance Imaging-Activity (ASspiMRI-a) Total Score

Description

Time Frame

Weeks 12 and 104

Title

Mean Change From Baseline in Number of Swollen Joints at Time Points

Description

Time Frame

Baseline to Week 104

Title

Mean Change From Baseline in Number of Tender Joints at Time Points

Description

Time Frame

Baseline to Week 104

Title

Mean Change From Baseline in Dactylitis Score at Time Points

Description

Time Frame

Baseline to Week 104

Title

Changes From Baseline in Maastricht Ankylosing Spondylitis Enthesis Score (MASES) at Time Points

Description

Time Frame

Baseline to Week 104

Title

Change From Baseline in C-reactive Protein (CRP) Concentration Time Points

Description

Time Frame

Baseline to Week 104

Title

Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Time Points

Description

Time Frame

Baseline to Week 104

Title

Change From Baseline in Euro Quality of Life (EQ)-5D VAS Score Time Points

Description

Time Frame

Baseline to Week 104

Title

Change From Baseline in EQ-5D Health State Profile Utility Score at Time Points

Description

Time Frame

Baseline to Week 104

Title

Change From Baseline in Short Form-36 (SF-36) Physical Component Summary (PCS) at Time Points

Description

Time Frame

Baseline to Week 104

Title

Change From Baseline in SF-36 Mental Component Summary (MCS) at Time Points

Description

Time Frame

Baseline to Week 104

Title

Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Depression Score at Time Points

Description

Time Frame

Baseline to Week 104

Title

Change From Baseline in HADS Anxiety Score at Time Points

Description

Time Frame

Baseline to Week 104

Title

Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score at Time Points

Description

Time Frame

Baseline to Week 104

Title

Change From Baseline in Ankylosing Spondylitis Work Instability Index (AS-WIS) Score at Time Points

Description

Time Frame

Baseline to Week 104

Title

Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed Due to Health Problems at Time Points

Description

Time Frame

Baseline to Week 104

Title

Change From Baseline in WPAI: Percent Impairment While Working Due to Health Problems at Time Points

Description

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent impairment while working due to health problem: Q5/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.

Time Frame

Baseline to Week 104

Title

Changes From Baseline in WPAI - Activity Impairment Due to Health Problems at Time Points

Description

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent activity impairment due to health problem: Q6/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.

Time Frame

Baseline to Week 104

Title

Changes From Baseline in WPAI - Overall Work Impairment Due to Health Problems at Time Points

Description

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent overall work impairment due to health problem: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))*(Q5/10)]. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.

Time Frame

Baseline to Week 104

Title

Change From Baseline in Multidimensional Fatigue Inventory (MFI) Score at Time Points

Description

Time Frame

Baseline to Week 104

Title

Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale Score From Baseline to Week 104

Description

Time Frame

Baseline to Week 104

Title

Percentage of Participants With Minimally Clinically Important Improvement (MCII) at Time Points

Description

Time Frame

Weeks 12 and 104

Title

Percentage of Participants Achieving Patient Acceptable Symptom State (PASS) at Time Points

Description

PASS is defined as a symptom state that the participants consider acceptable.

Time Frame

Weeks 12 and 104

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of axial spondyloarthritis as defined by Assessments in Ankylosing Spondylitis (ASAS)criteria Active symptoms defined as Ankylosing Spondylitis Disease Activity Index{BASDAI) > or = 4 Axial symptoms of back pain with a less than favorable response to on steroidal anti inflammatory drugs at optimal dosage for greater than 4 weeks Exclusion Criteria: Evidence of current or recent episode of uveitis Evidence of IBD flare within 6 months Previous treatment with an anti Tumor necrosis factor(TNF) Active tuberculosis Radiographic sacroiliitis grade 3-4 unilaterally or >= 2 bilaterally

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Centro Medico Privado de Reumatologia

City

San Miguel de Tucuman

State/Province

Tucuman

ZIP/Postal Code

T4000AXL

Country

Argentina

Facility Name

Consultorios Reumatológicos Pampa

City

Buenos Aires

ZIP/Postal Code

C1428DZF

Country

Argentina

Facility Name

Universitair Ziekenhuis Gent

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Reuma Instituut

City

Hasselt

ZIP/Postal Code

3500

Country

Belgium

Facility Name

AZ Groeninge

City

Kortrijk

ZIP/Postal Code

8500

Country

Belgium

Facility Name

Preventive Care Ltda.

City

Chia

State/Province

Cundinamarca

Country

Colombia

Facility Name

Ips Medicity S.A.S

City

Bucaramanga

State/Province

Santander

Country

Colombia

Facility Name

Servimed Sas

City

Bucaramanga

State/Province

Santander

Country

Colombia

Facility Name

Mediscan Group, s.r.o.

City

Praha 11 - Chodov

ZIP/Postal Code

14800

Country

Czech Republic

Facility Name

Revmatologicky ustav

City

Praha 2

ZIP/Postal Code

128 50

Country

Czech Republic

Facility Name

Medical Plus s.r.o.

City

Uherske Hradiste

ZIP/Postal Code

68601

Country

Czech Republic

Facility Name

Meilahden kolmiosairaala

City

Helsinki

ZIP/Postal Code

00029

Country

Finland

Facility Name

Kiljavan Lääketutkimus

City

Hyvinkää

ZIP/Postal Code

05800

Country

Finland

Facility Name

Hopital de Bicetre

City

LE KREMLIN-BICETRE Cedex

ZIP/Postal Code

94270

Country

France

Facility Name

CHU Lapeyronie, Immuno-Rhumatologie

City

Montpellier

ZIP/Postal Code

34000

Country

France

Facility Name

Hôpital Cochin

City

Paris

ZIP/Postal Code

75014

Country

France

Facility Name

CHU de Tours

City

Tours Cedex 9

ZIP/Postal Code

37044

Country

France

Facility Name

Charite - Campus Benjamin Franklin, Medizinische Klinik I - Rheumatologie

City

Berlin

ZIP/Postal Code

12203

Country

Germany

Facility Name

Studienambulanz, Medizinische Klinik 3, Universitaetsklinikum Erlangen

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Schoen Klinik Hamburg-Eilbek, Abt. Rheumatologie und Klin. Immunologie

City

Hamburg

ZIP/Postal Code

22081

Country

Germany

Facility Name

Rheumazentrum Ruhrgebiet

City

Herne

ZIP/Postal Code

44649

Country

Germany

Facility Name

MEDIGREIF Verwaltungs- und Betriebsgesellschaft Fachkrankenhaus Vogelsang-Gommern mbH

City

Vogelsang-Gommern

ZIP/Postal Code

39245

Country

Germany

Facility Name

Orszagos Reumatologiai es Fizioterapias Intezet/Klinikai Immunologiai es Reumatologiai Osztaly

City

Budapest

ZIP/Postal Code

1023

Country

Hungary

Facility Name

Budai Irgalmasrendi Korhaz

City

Budapest

ZIP/Postal Code

1027

Country

Hungary

Facility Name

Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft.

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft.

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Kenezy Gyula Korhaz es Rendelointezet

City

Debrecen

ZIP/Postal Code

4031

Country

Hungary

Facility Name

Csolnoky Ferenc Korhaz

City

Veszprem

ZIP/Postal Code

8200

Country

Hungary

Facility Name

Gachon University Gil Hospital

City

Incheon

State/Province

Gwangyeogsiv

ZIP/Postal Code

405-760

Country

Korea, Republic of

Facility Name

Chonnam National University Hospital

City

Gwangju

ZIP/Postal Code

501-757

Country

Korea, Republic of

Facility Name

Hanyang University Hospital

City

Seoul

ZIP/Postal Code

133-792

Country

Korea, Republic of

Facility Name

Academic Medical Centre (AMC) / Division of Clinical Immunology and Rheumatology

City

Amsterdam

State/Province

North-Holland

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

Leiden University Medical Center, Reumatologie

City

Leiden

ZIP/Postal Code

2333 ZA

Country

Netherlands

Facility Name

Rheumatology Research Institute of Russian Academy of Medical Sciences

City

Moscow

ZIP/Postal Code

115522

Country

Russian Federation

Facility Name

Russian Cardiology Research-and-Production Complex

City

Moscow

ZIP/Postal Code

121552

Country

Russian Federation

Facility Name

Saint-Petersburg State Budgetary Healthcare Institution

City

Saint-Petersburg

ZIP/Postal Code

190068

Country

Russian Federation

Facility Name

Limited Liability Company NMC Tomography

City

Saint-Petersburg

ZIP/Postal Code

191014

Country

Russian Federation

Facility Name

Leningrad Regional Clinical Hospital

City

Saint-Petersburg

ZIP/Postal Code

194291

Country

Russian Federation

Facility Name

Hospital Virgen Macarena

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41009

Country

Spain

Facility Name

Fundacion Hospital Alcorcon

City

Alcorcon

State/Province

Madrid

ZIP/Postal Code

28922

Country

Spain

Facility Name

Hospital Reina Sofia

City

Cordoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Complexo Hospitalario Universitario A Coruña

City

La Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

Chung-Ho Memorial Hospital, Kaohsiung Medical University

City

Kaohsiung

ZIP/Postal Code

807

Country

Taiwan

Facility Name

Chung Shan Medical University Hospital

City

Taichung

ZIP/Postal Code

40201

Country

Taiwan

Facility Name

Taipei Veterans General Hospital

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

Rhuematology Clinical Research Unit

City

Cambridge

State/Province

Cambridgeshire

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Facility Name

Hampshire Hospitals NHS Foundation Trust

City

Basingstoke

State/Province

Hants.

ZIP/Postal Code

RG24 9NA

Country

United Kingdom

Facility Name

Norfolk and Norwich University Hospital NHS Trust

City

Norwich

State/Province

Norfolk

ZIP/Postal Code

NR4 7UY

Country

United Kingdom

Facility Name

Russells Hall Hospital

City

Dudley

State/Province

West Midlands

ZIP/Postal Code

DY1 2HQ

Country

United Kingdom

Facility Name

Whipps Cross University Hospital,

City

London

ZIP/Postal Code

E11 1NR

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

35840157

Citation

Schneeberger EE, Citera G, de Leon DP, Szumski AE, Kwok K, Cutri M, Dougados M. Simplified Ankylosing Spondylitis Disease Activity Score (SASDAS) Versus ASDAS: A Post Hoc Analysis of a Randomized Controlled Trial. J Rheumatol. 2022 Oct;49(10):1100-1108. doi: 10.3899/jrheum.211075. Epub 2022 Jul 15.

Results Reference

derived

PubMed Identifier

33514428

Citation

Maksymowych WP, Claudepierre P, de Hooge M, Lambert RG, Landewe R, Molto A, van der Heijde D, Bukowski JF, Jones H, Pedersen R, Szumski A, Vlahos B, Dougados M. Structural changes in the sacroiliac joint on MRI and relationship to ASDAS inactive disease in axial spondyloarthritis: a 2-year study comparing treatment with etanercept in EMBARK to a contemporary control cohort in DESIR. Arthritis Res Ther. 2021 Jan 29;23(1):43. doi: 10.1186/s13075-021-02428-8.

Results Reference

derived

PubMed Identifier

31900174

Citation

Dougados M, van der Heijde D, Tsai WC, Saaibi D, Marshall L, Jones H, Pedersen R, Vlahos B, Tarallo M. Relationship between disease activity status or clinical response and patient-reported outcomes in patients with non-radiographic axial spondyloarthritis: 104-week results from the randomized controlled EMBARK study. Health Qual Life Outcomes. 2020 Jan 3;18(1):4. doi: 10.1186/s12955-019-1260-4.

Results Reference

derived

PubMed Identifier

28970213

Citation

Dougados M, Maksymowych WP, Landewe RBM, Molto A, Claudepierre P, de Hooge M, Lambert RG, Bonin R, Bukowski JF, Jones HE, Logeart I, Pedersen R, Szumski A, Vlahos B, van der Heijde D. Evaluation of the change in structural radiographic sacroiliac joint damage after 2 years of etanercept therapy (EMBARK trial) in comparison to a contemporary control cohort (DESIR cohort) in recent onset axial spondyloarthritis. Ann Rheum Dis. 2018 Feb;77(2):221-227. doi: 10.1136/annrheumdis-2017-212008. Epub 2017 Sep 29.

Results Reference

derived

PubMed Identifier

28970212

Citation

Maksymowych WP, Wichuk S, Dougados M, Jones HE, Pedersen R, Szumski A, Marshall L, Bukowski JF, Lambert RG. Modification of structural lesions on MRI of the sacroiliac joints by etanercept in the EMBARK trial: a 12-week randomised placebo-controlled trial in patients with non-radiographic axial spondyloarthritis. Ann Rheum Dis. 2018 Jan;77(1):78-84. doi: 10.1136/annrheumdis-2017-211605. Epub 2017 Sep 29.

Results Reference

derived

PubMed Identifier

28673924

Citation

Brown MA, Bird PA, Robinson PC, Mease PJ, Bosch FVD, Surian C, Jones H, Szumski A, Marshall L, Wiid Z, Dougados M. Evaluation of the effect of baseline MRI sacroiliitis and C reactive protein status on etanercept treatment response in non-radiographic axial spondyloarthritis: a post hoc analysis of the EMBARK study. Ann Rheum Dis. 2018 Jul;77(7):1091-1093. doi: 10.1136/annrheumdis-2017-211313. Epub 2017 Jul 3. No abstract available.

Results Reference

derived

PubMed Identifier

28587658

Citation

Maksymowych WP, Wichuk S, Dougados M, Jones H, Szumski A, Bukowski JF, Marshall L, Lambert RG. MRI evidence of structural changes in the sacroiliac joints of patients with non-radiographic axial spondyloarthritis even in the absence of MRI inflammation. Arthritis Res Ther. 2017 Jun 6;19(1):126. doi: 10.1186/s13075-017-1342-9.

Results Reference

derived

PubMed Identifier

28482137

Citation

Dougados M, van der Heijde D, Sieper J, Braun J, Citera G, Lenaerts J, van den Bosch F, Wei JC, Pedersen R, Bonin R, Jones H, Marshall L, Logeart I, Vlahos B, Bukowski JF, Maksymowych WP. Effects of Long-Term Etanercept Treatment on Clinical Outcomes and Objective Signs of Inflammation in Early Nonradiographic Axial Spondyloarthritis: 104-Week Results From a Randomized, Placebo-Controlled Study. Arthritis Care Res (Hoboken). 2017 Oct;69(10):1590-1598. doi: 10.1002/acr.23276. Epub 2017 Aug 31.

Results Reference

derived

PubMed Identifier

26269397

Citation

Maksymowych WP, Dougados M, van der Heijde D, Sieper J, Braun J, Citera G, Van den Bosch F, Logeart I, Wajdula J, Jones H, Marshall L, Bonin R, Pedersen R, Vlahos B, Kotak S, Bukowski JF. Clinical and MRI responses to etanercept in early non-radiographic axial spondyloarthritis: 48-week results from the EMBARK study. Ann Rheum Dis. 2016 Jul;75(7):1328-35. doi: 10.1136/annrheumdis-2015-207596. Epub 2015 Aug 12.

Results Reference

derived

PubMed Identifier

24891317

Citation

Dougados M, van der Heijde D, Sieper J, Braun J, Maksymowych WP, Citera G, Miceli-Richard C, Wei JC, Pedersen R, Bonin R, Rahman MU, Logeart I, Wajdula J, Koenig AS, Vlahos B, Alvarez D, Bukowski JF. Symptomatic efficacy of etanercept and its effects on objective signs of inflammation in early nonradiographic axial spondyloarthritis: a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheumatol. 2014 Aug;66(8):2091-102. doi: 10.1002/art.38721.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1801031&StudyName=Study%20Comparing%20Etanercept%20%28ETN%29%20Against%20a%20Placebo%20for%20Etanercept%20on%20a%20Background%20Nonsteroidal%20Anti%20Inflammatory%20Drug%20%28NSAIDs%29%20in%20

Description

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