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NCT02509026: RE-EMBARK

Etanercept Withdrawal And Retreament Study In Subjects With Nr-ax SpA

Completed Phase 4 Results posted Last updated 16 June 2020
What this trial tests

Phase 4 trial testing Etanercept in Spondylitis, Ankylosing in 210 participants. Completed in 6 September 2019.

Timeline
24 September 2015
Primary endpoint
28 May 2019
6 September 2019

Quick facts

Lead sponsorPfizer
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment210
Start date24 September 2015
Primary completion28 May 2019
Estimated completion6 September 2019
Sites82 locations across France, Colombia, Finland, Netherlands, Belgium, Sweden, Taiwan, Germany

Drugs / interventions tested

Conditions studied

Sponsor

Pfizer — full company profile →

Who can join

Adults 18 to 49, any sex, with Spondylitis, Ankylosing. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Who Experienced Flare Within 40 Weeks Following Withdrawal of 24 Weeks of Etanercept Treatment Primary · Within 40 weeks after Etanercept withdrawal (from Week 24 to Week 64)

Participants who experienced ASDAS-Erythrocyte Sedimentation Rate (ESR) level of \>=2.1 were defined as being flared. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 10= high disease activity. CRP measured in milligram per liter (mg/L) and ESR measured in millimeter per hour (mm/hr). Percentage of participants who flared within 40 weeks after the withdrawa

GroupValue95% CI
Etanercept74.866.30 – 82.04
Time to Flare Following Withdrawal of Etanercept Treatment Secondary · Within 40 weeks after Etanercept withdrawal (from Week 24 to Week 64)

Participants who experienced ASDAS-ESR level of \>=2.1 were defined as being flared. Time to experience flare in participants was defined as time to achieve ASDAS-ESR level of \>=2.1 after the withdrawal of Etanercept treatment of 24 weeks in induction period. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 10= high disease activity. CRP measured in mg/L a

GroupValue95% CI
Etanercept16.112.57 – 24.00
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 1 Secondary · Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24

ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0 \<= ASDAS-CRP \<1.3; moderate disease activity: 1.3 \<= ASDAS-CRP \<2.1; high disease activity: 2.1 \<= ASDAS-CRP \<=3.5; very high disease activity: 3.5 \< ASDAS-CRP.

Baseline
GroupValue95% CI
Etanercept0.50.05 – 2.25
Week 4
GroupValue95% CI
Etanercept14.410.15 – 19.68
Week 8
GroupValue95% CI
Etanercept27.421.55 – 33.82
Week 12
GroupValue95% CI
Etanercept38.131.50 – 44.99
Week 16
GroupValue95% CI
Etanercept41.935.05 – 48.96
Week 24
GroupValue95% CI
Etanercept62.655.60 – 69.28
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 2 Secondary · Week 28, 32, 40, 48, 56, 64

ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0 \<= ASDAS-CRP \<1.3; moderate disease activity: 1.3 \<= ASDAS-CRP \<2.1; high disease activity: 2.1 \<= ASDAS-CRP \<=3.5; very high disease activity: 3.5 \< ASDAS-CRP.

Week 28
GroupValue95% CI
Etanercept52.743.43 – 61.89
Week 32
GroupValue95% CI
Etanercept45.235.32 – 55.29
Week 40
GroupValue95% CI
Etanercept48.536.71 – 60.39
Week 48
GroupValue95% CI
Etanercept42.029.09 – 55.81
Week 56
GroupValue95% CI
Etanercept56.140.93 – 70.44
Week 64
GroupValue95% CI
Etanercept55.939.28 – 71.53
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 3 Secondary · Week 68, 72, 76

ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0 \<= ASDAS-CRP \<1.3; moderate disease activity: 1.3 \<= ASDAS-CRP \<2.1; high disease activity: 2.1 \<= ASDAS-CRP \<=3.5; very high disease activity: 3.5 \< ASDAS-CRP.

Week 68
GroupValue95% CI
Etanercept53.642.94 – 63.96
Week 72
GroupValue95% CI
Etanercept61.651.10 – 71.38
Week 76
GroupValue95% CI
Etanercept62.451.78 – 72.10
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<) 1.3: Last Observation Carried Forward (LOCF): Period 1 Secondary · Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24

ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0 \<= ASDAS-CRP \<1.3; moderate disease activity: 1.3 \<= ASDAS-CRP \<2.1; high disease activity: 2.1 \<= ASDAS-CRP \<=3.5; very high disease activity: 3.5 \< ASDAS-CRP.

Baseline
GroupValue95% CI
Etanercept0.50.05 – 2.25
Week 4
GroupValue95% CI
Etanercept14.410.15 – 19.68
Week 8
GroupValue95% CI
Etanercept27.421.68 – 33.75
Week 12
GroupValue95% CI
Etanercept36.530.22 – 43.23
Week 16
GroupValue95% CI
Etanercept40.433.89 – 47.15
Week 24
GroupValue95% CI
Etanercept58.751.88 – 65.19
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<) 1.3: Last Observation Carried Forward (LOCF): Period 2 Secondary · Week 28, 32, 40, 48, 56, 64

ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0 \<= ASDAS-CRP \<1.3; moderate disease activity: 1.3 \<= ASDAS-CRP \<2.1; high disease activity: 2.1 \<= ASDAS-CRP \<=3.5; very high disease activity: 3.5 \< ASDAS-CRP.

Week 28
GroupValue95% CI
Etanercept52.743.43 – 61.89
Week 32
GroupValue95% CI
Etanercept39.831.15 – 49.01
Week 40
GroupValue95% CI
Etanercept34.526.23 – 43.58
Week 48
GroupValue95% CI
Etanercept26.519.07 – 35.21
Week 56
GroupValue95% CI
Etanercept29.221.42 – 38.03
Week 64
GroupValue95% CI
Etanercept24.817.52 – 33.31
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<) 1.3: Last Observation Carried Forward (LOCF): Period 3 Secondary · Week 68, 72, 76

ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0 \<= ASDAS-CRP \<1.3; moderate disease activity: 1.3 \<= ASDAS-CRP \<2.1; high disease activity: 2.1 \<= ASDAS-CRP \<=3.5; very high disease activity: 3.5 \< ASDAS-CRP.

Week 68
GroupValue95% CI
Etanercept52.942.38 – 63.31
Week 72
GroupValue95% CI
Etanercept60.950.45 – 70.68
Week 76
GroupValue95% CI
Etanercept62.151.61 – 71.74
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 1 Secondary · Week 4, 8, 12, 16, 24

ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from \[Bath Ankylosing Spondylitis Functional Index\] BASFI) and inflammation (from \[Bath Ankylosing Spondylitis Disease Activity Index\] BASDAI). ASAS 20 responders were defined as participants with at least 20% improvement from baseline in disease activity and an absolute change of at least 1 unit on a 0 to 10 cm scale (0=no disease activity; 10=high disease activity, where higher scores indicated higher disease activity) in 3 or more domains, and no worsen

Week 4
GroupValue95% CI
Etanercept58.751.88 – 65.19
Week 8
GroupValue95% CI
Etanercept68.762.01 – 74.77
Week 12
GroupValue95% CI
Etanercept71.765.16 – 77.64
Week 16
GroupValue95% CI
Etanercept78.171.88 – 83.52
Week 24
GroupValue95% CI
Etanercept85.880.30 – 90.20
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 2 Secondary · Week 28, 32, 40, 48, 56, 64

ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 20 responders were defined as participants with at least 20% improvement from baseline in disease activity and an absolute change of at least 1 unit on a 0 to 10 cm scale (0=no disease activity; 10=high disease activity, where higher scores indicated higher disease activity) in 3 or more domains, and no worsening of \>=20% and absolute change 1 unit in the remaining domain. All 4 domains were measured on a 0-100

Week 28
GroupValue95% CI
Etanercept86.078.21 – 91.74
Week 32
GroupValue95% CI
Etanercept88.980.71 – 94.36
Week 40
GroupValue95% CI
Etanercept83.172.02 – 90.94
Week 48
GroupValue95% CI
Etanercept91.581.02 – 97.06
Week 56
GroupValue95% CI
Etanercept91.478.86 – 97.53
Week 64
GroupValue95% CI
Etanercept92.678.30 – 98.43
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 3 Secondary · Week 64, 68, 72, 76

ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 20 responders: participants with at least 20% improvement from baseline in disease activity and an absolute change of at least 1 unit on 0 to 10 cm scale(0=no disease activity; 10=high disease activity, where higher scores indicated higher disease activity)in 3 or more domains, and no worsening of \>=20% and absolute change 1 unit in the remaining domain. All 4 domains measured on 0-100 millimeter (mm) scale (0=

Week 64
GroupValue95% CI
Etanercept33.314.03 – 58.42
Week 68
GroupValue95% CI
Etanercept80.070.58 – 87.42
Week 72
GroupValue95% CI
Etanercept81.672.51 – 88.65
Week 76
GroupValue95% CI
Etanercept87.178.72 – 92.93
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Last Observation Carried Forward (LOCF): Period 1 Secondary · Week 4, 8, 12, 16, 24

ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 20 responders were defined as participants with at least 20% improvement from baseline in disease activity and an absolute change of at least 1 unit on a 0 to 10 cm scale (0=no disease activity; 10=high disease activity, where higher scores indicated higher disease activity) in 3 or more domains, and no worsening of \>=20% and absolute change 1 unit in the remaining domain. All 4 domains were measured on a 0-100

Week 4
GroupValue95% CI
Etanercept58.751.88 – 65.19
Week 8
GroupValue95% CI
Etanercept68.862.23 – 74.76
Week 12
GroupValue95% CI
Etanercept71.264.74 – 76.99
Week 16
GroupValue95% CI
Etanercept76.470.34 – 81.82
Week 24
GroupValue95% CI
Etanercept83.277.65 – 87.78

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Etanercept: Period 1
Serious: 6/209 (3%)
Deaths: 0/209
Etanercept: Period 2
Serious: 1/119 (1%)
Deaths: 0/119
Etanercept: Period 3
Serious: 0/87 (0%)
Deaths: 0/87

Serious adverse events (7 terms)

ReactionSystemEtanercept: Period 1Etanercept: Period 2Etanercept: Period 3
Abdominal adhesionsGastrointestinal disorders———
CellulitisInfections and infestations———
Limb injuryInjury, poisoning and procedural complications———
Meniscus injuryInjury, poisoning and procedural complications———
Intraductal proliferative breast lesionNeoplasms benign, malignant and unspecified (incl cysts and polyps)———
Cerebral infarctionNervous system disorders———
Uterovaginal prolapseReproductive system and breast disorders———
Other adverse events (4 terms — click to expand)

ReactionSystemEtanercept: Period 1Etanercept: Period 2Etanercept: Period 3
Viral upper respiratory tract infectionInfections and infestations———
Upper respiratory tract infectionInfections and infestations———
Injection site erythemaGeneral disorders———
Injection site reactionGeneral disorders———

Most-reported serious reactions: Abdominal adhesions, Cellulitis, Limb injury, Meniscus injury, Intraductal proliferative breast lesion, Cerebral infarction, Uterovaginal prolapse.

Data from ClinicalTrials.gov NCT02509026 adverse events section.

Sponsor's own description

The purpose of this study is to study the benefits and risks of etanercept withdrawal in patients who have achieved a significant clinical response.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Etanercept Withdrawal and Retreatment in Nonradiographic Axial Spondyloarthritis: Results of RE-EMBARK, an Open-Label Phase IV Trial.
    Van den Bosch F, Wei JC, Nash P, Blanco FJ, et al · · 2023 · cited 3× · PMID 36379575 · DOI 10.3899/jrheum.220353

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