Phase 4 N=82 Randomized Double-blind Treatment

Study Evaluating Etanercept for the Treatment of Active, Severe, and Advanced Axial Ankylosing Spondylitis

Ankylosing Spondylitis

Bottom Line

View on ClinicalTrials.gov: NCT00420238 ↗

Enrolled (actual)

Serious AEs

2.5%

Results posted

Jun 2010

Primary outcome: Primary: Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Disease Activities Index (BASDAI) Between Randomization and Week 12 — -19.79; -10.96 millimeters — p=0.019

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Etanercept (Enbrel) (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Primary completion: Feb 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Disease Activities Index (BASDAI) Between Randomization and Week 12	-19.79; -10.96	0.019 sig
SECONDARY Percent of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response	23.08; 9.30; 28.21; 16.28; 41.03; 23.26	0.098
SECONDARY Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 2, 4, 8, 12	30.77; 20.93; 41.03; 30.23; 64.10; 27.91	0.310
SECONDARY Percent of Subjects Acheiving Assessment Ankylosing Spondylitis (ASAS) 20 at Weeks 14, 18, 24	71.05; 53.85; 71.05; 64.10; 84.21; 66.67	—
SECONDARY Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 2, 4, 8, 12	17.95; 9.30; 23.08; 16.28; 35.90; 16.28	0.259
SECONDARY Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 50 at Weeks 14, 18, 24	44.74; 43.59; 50.00; 48.72; 60.53; 51.28	—
SECONDARY Percent of Subjects Achieving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 2, 4, 8, 12	12.82; 4.65; 17.95; 4.65; 15.38; 4.65	0.204
SECONDARY Percent of Subjects Achieiving Assessment Ankylosing Spondylitis (ASAS) 70 at Weeks 14, 18, 24	31.58; 33.33; 31.58; 30.77; 36.84; 35.90	—
SECONDARY Percent of Subjects Achieving Partial Remission at Weeks 2, 4, 8, 12	7.69; 2.33; 10.26; 2.33; 17.95; 4.65	0.287
SECONDARY Percent of Subjects Achieving Partial Remission at Weeks 14, 18, 24	28.95; 23.08; 31.58; 25.64; 28.95; 23.08	—
SECONDARY Normalized Net Incremental Area Under the Curve (AUC) for Patient Global Assessment (PGA) Between Baseline and Week 12	-20.35; -10.39	0.018 sig
SECONDARY Change From Baseline in Patient Global Assessment Visual Analog Scale (VAS) at Weeks 2, 4, 8, 12	-16.90; -8.36; -19.06; -11.04; -25.29; -10.56	0.089
SECONDARY Change From Baseline in Patient Global Assessment at Weeks 14, 18, 24	-31.26; -31.20; -35.50; -31.92; -40.70; -34.19	—
SECONDARY Normalized Net Incremental Area Under the Curve (AUC) for Physician Global Assessment (PGA) Between Baseline and Week 12	-24.14; -13.15	0.002 sig
SECONDARY Change From Baseline in Physician Global Assessment Visual Analog Scale at Weeks 2, 4, 8, 12	-15.77; -7.43; -26.25; -15.23; -28.80; -16.05	0.054
SECONDARY Change From Baseline in Physician Global Assessment at Weeks 14, 18, 24	-37.66; -35.57; -43.22; -37.05; -42.68; -40.41	—
SECONDARY Normalized Net Incremental Area Under the Curve (AUC) for Nocturnal Back Pain Between Baseline and Week 12	-23.23; -13.64	0.039 sig
SECONDARY Change From Baseline in Nocturnal Back Pain at Weeks 2, 4, 8, 12	-19.41; -13.12; -20.90; -15.72; -29.27; -15.54	0.254
SECONDARY Change From Baseline in Nocturnal Back Pain at Weeks 14, 18, 24	-36.92; -27.76; -41.73; -27.89; -45.26; -28.44	—
SECONDARY Normalized Net Incremental Area Under the Curve (AUC) for Total Back Pain Between Baseline and Week 12	-21.73; -13.24	0.071
SECONDARY Change From Baseline in Total Back Pain at Weeks 2, 4, 8, 12	-15.37; -11.80; -18.93; -14.36; -28.24; -15.78	0.511
SECONDARY Change From Baseline in Total Back Pain at Weeks 14, 18, 24	-35.21; -30.29; -40.02; -31.19; -44.50; -32.27	—
SECONDARY Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Functional Index (BASFI) Between Baseline and Week 12	-14.59; -9.34	0.127
SECONDARY Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8, 12	-8.23; -7.80; -12.44; -10.04; -19.75; -11.54	0.914
SECONDARY Bath Ankylosing Functional Index (BASFI): Independent Components at Weeks 2, 4, 8, 12	51.1; 43.8; 47.6; 36.5; 41.1; 32.7	—
SECONDARY Bath Ankylosing Functional Index (BASFI) Independent Components at Weeks 14, 18, 24	32.7; 25.7; 31.3; 26.6; 26.7; 24.5	—
SECONDARY Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 2, 4, 8, 12	-14.25; -7.39; -18.41; -11.97; -26.06; -13.51	0.122
SECONDARY Change From Baseline in the Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) at Weeks 14, 18, 24	-29.26; -27.41; -34.20; -28.21; -37.62; -28.62	—
SECONDARY Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 2, 4, 8, 12	68.2; 61.9; 56.6; 55.8; 51.4; 54.2	—
SECONDARY Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI) Independent Components at Weeks 14, 18, 24	41.7; 38.3; 33.1; 38.9; 28.0; 35.3	—
SECONDARY Normalized Net Incremental Area Under the Curve (AUC) for Bath Ankylosing Spondylitis-Global Score (BAS-G) Visual Analog Scale Between Baseline and Week 12	-21.36; -15.43	0.139
SECONDARY Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 2, 4, 8, 12	-13.74; -14.64; -20.09; -14.99; -28.17; -18.27	0.857
SECONDARY Change From Baseline in the Bath Ankylosing Spondylitis-Global Score (BAS-G) at Weeks 14, 18, 24	-34.29; -34.93; -36.93; -35.98; -42.35; -35.89	—
SECONDARY Bath Ankylosing Spondylitis Global Score (BAS-G) Independent Component: Effect of Disease on Well-being at Weeks 2, 4, 8, 12	72.1; 68.3; 57.8; 54.4; 51.4; 54.0	—
SECONDARY Change From Baseline to Week 12 in Forced Vital Capacity (FVC), Vital Capacity (VC), and Forced Expiratory Volume in One Second (FEV1)	0.14; -0.05; 0.16; -0.02; 0.05; -0.02	0.003 sig
SECONDARY Change From Baseline to Week 12 in Ratio Forced Expitatory Volume in One Second (FEV1)/Forced Vital Capacity (FVC) (%)	-2.49; 0.10	0.030 sig
SECONDARY Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Metrology Index (BASMI) Between Baseline and Week 12	-0.41; -0.18	0.035 sig
SECONDARY Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8, 12	-0.27; -0.17; -0.37; -0.23; -0.57; -0.18	0.515
SECONDARY Change From Baseline in Spinal Mobility Measured With the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 14, 18, 24	-0.73; -0.49; -0.65; -0.49; -0.80; -0.50	—
SECONDARY Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Cervical Rotation at Weeks 2, 4, 8, 12	39.85; 37.14; 43.05; 38.34; 42.55; 39.67	—
SECONDARY Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Cervical Rotation at Weeks 14, 18, 24	47.75; 44.78; 44.62; 43.92; 48.74; 43.82	—
SECONDARY Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Tragus-to-wall Distance at Baseline and Weeks 2, 4, 8, 12	20.18; 19.76; 19.69; 18.81; 19.19; 18.82	—
SECONDARY Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Tragus-to-wall Measurement at Weeks 14, 18, 24	19.12; 18.38; 19.86; 18.55; 18.99; 18.60	—
SECONDARY Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Lateral Flexion at Baseline and Weeks 2, 4, 8, and 12	13.79; 9.80; 13.58; 10.62; 13.01; 10.60	—
SECONDARY Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Lateral Flexion at Weeks 14, 18, 24	12.93; 8.19; 12.02; 8.08; 10.95; 10.48	—
SECONDARY Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Modified Schober's Test at Baseline and Weeks 2, 4, 8, 12	1.63; 1.52; 1.73; 1.57; 1.85; 1.77	—
SECONDARY Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Modified Schober's Test at Weeks 14, 18, 24	1.87; 1.63; 1.71; 1.69; 1.92; 1.79	—
SECONDARY Bath Ankylosing Spondylitis Metrology Index (BASMI) Independent Component: Spinal Mobility Measured With Intermalleolar Distance at Baseline and Weeks 2, 4, 8, 12	82.31; 89.30; 87.89; 92.08; 90.86; 91.53	—
SECONDARY Bath Ankylosing Spondylitis Metrology Index (BASMI): Spinal Mobility Measured With Intermalleolar Distance at Weeks 14, 18, 24	95.79; 98.03; 96.27; 96.66; 95.71; 96.41	—
SECONDARY Normalized Net Incremental Area Under the Curve (AUC) for the Chest Expansion Test Between Baseline and Week 12	0.26; 0.19	0.613
SECONDARY Change From Baseline in the Chest Expansion Test at Weeks 2, 4, 8, 12	0.17; 0.10; 0.09; 0.19; 0.43; 0.23	0.744
SECONDARY Change From Baseline in the Chest Expansion Test at Weeks 14, 18, 24	0.26; 0.22; 0.22; 0.33; 0.46; 0.44	—
SECONDARY Change From Baseline in Level of Difficulty to Perform Physically Demanding Activities Due to Ankylosing Spondylitis at Weeks 2, 4, 8, 12	-11.88; -7.16; -15.14; -12.04; -18.65; -17.25	0.490
SECONDARY Change From Baseline in Self Assessment of Ability and or Easiness to Perform Physically Demanding Activities at Weeks 14, 18, 24	-20.01; -22.95; -22.39; -27.80; -24.21; -25.55	—
SECONDARY Normalized Net Incremental Area Under the Curve (AUC) for Erythtocyte Sedimentation Rate Between Baseline and Week 12	-16.18; -1.45	<0.0001 sig
SECONDARY Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12	-15.00; -2.62; -20.05; -2.60; -17.02; -0.07	<0.0001 sig
SECONDARY Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 14, 18, 24	-20.32; -10.21; -17.95; -12.32; -18.53; -14.61	—
SECONDARY Normalized Net Incremental Area Under the Curve (AUC) for C-reactive Protein Between Baseline and Week 12	-14.41; -1.17	<0.0001 sig
SECONDARY Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12	-15.37; -1.05; -16.99; -2.01; -16.19; -1.01	<0.0001 sig
SECONDARY Change From Baseline in C-reactive Protein (CRP) at Weeks 14, 18, 24	-18.11; -10.04; -17.15; -9.47; -16.05; -9.62	—
SECONDARY Percent of Subjects With Normal and Abnormal C-Reactive Protein at Weeks 14, 18, 24	60.53; 70.59; 39.47; 29.41; 63.16; 66.67	—
SECONDARY Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 2, 4, 8, 12	43.24; 30.00; 56.76; 70.00; 57.89; 35.71	0.184
SECONDARY Percent of Subjects With Patient Acceptable and Unacceptable Symptom State (PASS) at Weeks 14, 18, 24	69.44; 64.71; 30.56; 35.29; 74.29; 66.67	—
SECONDARY Percent of Subjects With Minimum Clinically Important Improvement (MCII) in Pain Rating at Weeks 2, 4, 8, 12	50.00; 20.00; 50.00; 80.00; 52.63; 30.95	0.004 sig
SECONDARY Percent of Subjects With Minimum Clinially Important Improvement (MCII) at Weeks 14, 18, 24	77.78; 77.14; 22.22; 22.86; 94.12; 78.38	—

Summary

Evaluation of the efficacy and safety of etanercept (Enbrel) in patients with active, severe and advanced ankylosing spondylitis.

Eligibility Criteria

Inclusion criteria

Active and severe ankylosing spondylitis
Ankylosing spondylitis refractory to standard anti-rheumatic treatment
Between 18 and 70 years of age

Exclusion criteria

Prior exposure to any TNF-inhibitor, including etanercept
DMARDs (other than hydroxychloroquine, methotrexate and sulphasalazine) within 4 weeks of study drug initiation
Dose of NSAIDs changed within two weeks of study drug initiation

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00420238). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.