Phase 3
N=82
Safety and Efficacy of Adalimumab in Patients With Active Ankylosing Spondylitis
Ankylosing Spondylitis
Bottom Line
View on ClinicalTrials.gov: NCT00195819 ↗Enrolled (actual)
82
Serious AEs
24.4%
Results posted
Apr 2010
Primary outcome: Primary: Number of Subjects With a Reduction in Signs and Symptoms as Measured by Assessments of Ankylosing Spondylitis (ASAS) 20 Response at Week 12 — 18; 12; 20; 32 participants — p=0.060
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- adalimumab (D2E7) (Biological); placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Oct 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With a Reduction in Signs and Symptoms as Measured by Assessments of Ankylosing Spondylitis (ASAS) 20 Response at Week 12 |
18; 12; 20; 32; 0; 0 | 0.060 |
| PRIMARY Mean Change in the Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) Compared Against a Historical Control Group (Outcomes in Ankylosing Spondylitis International Study [OASIS]) Using the ANCOVA Model Adjusting for Baseline mSASSS Score |
0.5; 0.9 | 0.387 |
| SECONDARY Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) 20 - Through Week 260 of Adalimumab Exposure |
48; 52; 60; 57; 60; 57 | — |
| SECONDARY Number of Subjects With a Reduction of Signs and Symptoms as Measured by Assessments in Ankylosing Spondylitis (ASAS) ASAS 50 Through Week 260 of Adalimumab Exposure |
29; 38; 45; 46; 47; 46 | — |
| SECONDARY Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) ASAS 70 Through Week 260 of Adalimumab Exposure |
18; 27; 32; 34; 35; 32 | — |
| SECONDARY Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 |
-28.55; -32.43; -38.67; -40.85; -42.72; -40.99 | — |
| SECONDARY Number of Subjects With a Reduction of Signs and Symptoms as Measured in Patient's Global Assessment of Disease Activity (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure |
53; 56; 61; 59; 64; 57 | — |
| SECONDARY Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260 |
-19.83; -24.39; -27.83; -30.42; -30.51; -30.67 | — |
| SECONDARY BASFI (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure |
46; 52; 53; 55; 55; 51 | — |
| SECONDARY Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260 |
-29.30; -31.89; -39.46; -40.89; -43.85; -44.07 | — |
| SECONDARY Total Back Pain (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure |
56; 57; 66; 62; 64; 62 | — |
| SECONDARY Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260 |
-2.79; -3.29; -3.89; -4.12; -4.50; -4.32 | — |
| SECONDARY Inflammation (Individual Component of ASAS 20) (Mean of BASDAI Questions 5 and 6) Through Week 260 of Adalimumab Exposure |
52; 59; 66; 64; 65; 61 | — |
| SECONDARY Number of Subjects With a Reduction of Signs and Symptoms as Measured in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 20 Through Week 260 of Adalimumab Exposure |
61; 61; 64; 64; 65; 60 | — |
| SECONDARY Number of Subjects With a Reduction of Signs and Symptoms as Measured in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Through Week 260 of Adalimumab Exposure |
32; 41; 48; 52; 52; 45 | — |
| SECONDARY Number of Subjects With a Reduction of Signs and Symptoms as Measured in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 70 Through Week 260 of Adalimumab Exposure |
24; 32; 34; 37; 35; 37 | — |
| SECONDARY Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260 |
-2.48; -2.96; -3.41; -3.70; -3.83; -3.64 | — |
| SECONDARY Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260 |
-1.81; -1.81; -1.60; -1.86; -1.90; -1.92 | — |
| SECONDARY Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Assessments of Ankylosing Spondylitis (ASAS) 40 - Through Week 260 of Adalimumab Exposure |
34; 41; 48; 50; 52; 47 | — |
| SECONDARY Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Assessments of Ankylosing Spondylitis Ankylosing Spondylitis (ASAS) 5/6 in Subjects With Adalimumab Exposure Through Week 260 |
45; 49; 55; 57; 56; 53 | — |
| SECONDARY Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Partial Remission Response in Subjects With Adalimumab Exposure Through Week 260 |
23; 25; 31; 33; 35; 31 | — |
| SECONDARY Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260 |
-0.42; -0.50; -0.61; -0.64; -0.78; -1.01 | — |
| SECONDARY Mean Change in Edmonton Ankylosing Spondylitis Metrology Index (EDASMI) in Subjects With Adalimumab Exposure Through Week 260 |
-1.11; -1.16; -1.47; -1.24; -1.59; -1.50 | — |
| SECONDARY Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260 |
0.47; 0.66; 0.66; 0.51; 0.60; 0.49 | — |
| SECONDARY Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260 |
-2.26; -3.26; -3.61; -3.56; -3.66; -3.52 | — |
| SECONDARY Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260 |
-23.41; -32.78; -39.40; -42.63; -44.78; -43.28 | — |
| SECONDARY Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260 |
-0.29; -1.00; -1.45; -0.92; -0.81; -0.04 | — |
| SECONDARY Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260 of Adalimumab Exposure |
-1.66; -2.36; -3.63; -3.34; -2.78; -3.10 | — |
| SECONDARY Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 |
-24.80; -33.46; -38.68; -38.21; -41.96; -42.26 | — |
| SECONDARY Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260 |
-25.49; -28.08; -33.88; -34.87; -37.07; -36.77 | — |
| SECONDARY Mean Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale in Subjects With Adalimumab Exposure Through Week 260 |
9.49; 9.03; 11.48; 11.61; 12.46; 11.08 | — |
| SECONDARY Mean Change in the SF-36 Health Survey Index Physical Component Summary [PCS] Through Week 260 of Adalimumab Exposure |
7.60; 9.26; 10.63; 11.26; 11.29; 11.76 | — |
| SECONDARY Number of Subjects With SF-36 Physical Component Summary (PCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure |
51; 41; 65; 50; 61; 43 | — |
| SECONDARY Mean Change in the SF-36 Health Survey Index Mental Component Summary [MCS] Through Week 260 of Adalimumab Exposure |
6.91; 3.88; 6.14; 7.00; 6.45; 4.89 | — |
| SECONDARY Number of Subjects With SF-36 Mental Component Summary (MCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure |
49; 29; 50; 39; 46; 30 | — |
| SECONDARY Mean Change in Health Utilities Index-3 (HUI-3) Through Week 260 of Adalimumab Exposure |
0.17; 0.21; 0.19; 0.19; 0.24; 0.23 | — |
| SECONDARY Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure |
-3.90; -3.80; -5.40; -5.47; -5.55; -5.46 | — |
| SECONDARY Number of Subjects With Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) MCID Response (MCID <= -1.8 Points) Through Week 260 of Adalimumab Exposure |
48; 27; 60; 42; 59; 41 | — |
| SECONDARY Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure |
35; 44; 50; 50; 49; 35 | — |
| SECONDARY Mean Change From Baseline in Serum Matrix Metalloproteinase-3 (MMP-3) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure |
-29.06; -6.31; -24.89; -24.64; -23.05; -7.37 | — |
| SECONDARY Mean Change From Baseline in Urine Type II Collagen C Telopeptide (CTX-II) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure |
-72.27; -39.87; -51.56; -89.93; -65.04; -96.53 | — |
| SECONDARY Mean Change From Baseline in Serum Type I Collagen N-telopeptide (NTx) in Subjects Treated With Any Dose of Adalimumab Through Week 260 of Adalimumab Exposure |
0.63; 0.33; -1.02; -0.05; -0.17; -1.00 | — |
| SECONDARY Mean Change in Spinal Spondyloarthritis Research Consortium of Canada (S.P.A.R.C.C.) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score at Weeks 12 and 52 of Adalimumab Exposure |
-9.9; -0.8; -11.2; -13.7 | — |
| SECONDARY Mean Change in Sacroiliac (SI) Spondyloarthritis Research Consortium of Canada (S.P.A.R.C.C.) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score at Weeks 12 and 52 of Adalimumab Exposure |
-4.1; -0.8; -5.4; -5.5 | — |
Summary
The purpose of the study is to assess the safety and clinical efficacy of adalimumab in subjects with active ankylosing spondylitis
Eligibility Criteria
Inclusion Criteria
- Subject was age 18 or older and in relatively good health (Investigator discretion) with a recent stable medical history.
- Subject met the definition of AS based on the Modified New York Criteria.
- Subject had an inadequate response to or intolerance to one or more NSAIDs as defined by the Investigator
Exclusion Criteria
- Subject had previously received anti-TNF therapy.
- Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
- Female subject who is pregnant or breast-feeding or considering becoming pregnant
Data sourced from ClinicalTrials.gov (NCT00195819). 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.