Phase 3
N=315
Human Anti-tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis
Ankylosing Spondylitis
Bottom Line
View on ClinicalTrials.gov: NCT00085644 ↗Enrolled (actual)
315
Serious AEs
30.9%
Results posted
Mar 2010
Primary outcome: Primary: Number of Responders With a Reduction of Signs and Symptoms of Ankylosing Spondylitis (AS) as Measured With ASAS International Working Group Response Criteria (ASAS 20). — 121; 22; 83; 82 Participants (responders, nonresponders) — p=< 0.001
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
- Dec 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Responders With a Reduction of Signs and Symptoms of Ankylosing Spondylitis (AS) as Measured With ASAS International Working Group Response Criteria (ASAS 20). |
121; 22; 83; 82; 4; 3 | < 0.001 sig |
| 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 |
0.9; 0.9 | 0.985 |
| 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 |
171; 204; 198; 199; 192; 181 | — |
| SECONDARY Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) 50 - Through Week 260 of Adalimumab Exposure |
105; 122; 131; 144; 144; 127 | — |
| SECONDARY Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) 70 - Through Week 260 of Adalimumab Exposure |
62; 74; 91; 99; 102; 98 | — |
| SECONDARY Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 |
-25.24; -31.07; -33.62; -36.58; -37.21; -38.10 | — |
| 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 |
192; 214; 213; 211; 201; 185 | — |
| SECONDARY Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260 |
-16.12; -20.45; -22.94; -25.13; -26.24; -26.52 | — |
| SECONDARY Number of Subjects With a Reduction of Signs and Symptoms as Measured in BASFI (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure |
170; 190; 186; 188; 189; 179 | — |
| SECONDARY Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260 |
-24.51; -31.02; -34.09; -36.55; -37.34; -38.15 | — |
| SECONDARY Number of Subjects With a Reduction of Signs and Symptoms as Measured in Total Back Pain (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure |
181; 210; 208; 204; 199; 188 | — |
| SECONDARY Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260 |
-2.82; -3.48; -3.80; -3.98; -4.12; -4.04 | — |
| SECONDARY Number of Subjects With a Reduction of Signs and Symptoms as Measured in Inflammation (Individual Component of ASAS 20) (Mean of BASDAI Questions 5 and 6) Through Week 260 of Adalimumab Exposure |
198; 231; 224; 221; 215; 230 | — |
| 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 |
205; 225; 218; 219; 212; 202 | — |
| 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 |
133; 157; 169; 173; 170; 155 | — |
| 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 |
80; 103; 113; 114; 129; 115 | — |
| SECONDARY Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260 |
-2.38; -2.90; -3.16; -3.38; -3.54; -3.53 | — |
| SECONDARY Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260 |
-1.27; -1.24; -1.30; -1.35; -1.45; -1.36 | — |
| 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 |
115; 144; 143; 157; 155; 140 | — |
| 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 |
145; 184; 169; 179; 177; 159 | — |
| SECONDARY Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured by ASAS Partial Remission Response in Subjects With Adalimumab Exposure Through Week 260 |
62; 75; 94; 101; 100; 97 | — |
| SECONDARY Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260 |
-0.43; -0.60; -0.73; -0.77; -0.70; -0.67 | — |
| SECONDARY Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260 [ |
0.34; 0.25; 0.71; 0.59; 1.24; 0.58 | — |
| SECONDARY Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260 |
-2.25; -2.97; -3.28; -3.27; -3.43; -3.18 | — |
| SECONDARY Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260 |
-20.55; -29.74; -35.48; -39.29; -40.36; -41.47 | — |
| SECONDARY Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260 |
-0.18; -0.40; -0.36; -0.59; -0.60; -0.79 | — |
| SECONDARY Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260 |
-1.09; -1.41; -1.70; -1.87; -2.22; -2.16 | — |
| SECONDARY Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260 |
-24.36; -29.69; -34.01; -37.16; -37.58; -38.17 | — |
| SECONDARY Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260 |
-24.29; -30.85; -33.91; -37.17; -36.71; -37.52 | — |
| SECONDARY Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 260 of Adalimumab Exposure |
6.92; 7.30; 9.07; 9.70; 9.95; 10.01 | — |
| SECONDARY Number of Subjects With SF-36 Physical Component Summary (PCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure |
178; 162; 198; 166; 194; 141 | — |
| SECONDARY Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 260 of Adalimumab Exposure |
3.18; 4.24; 4.56; 4.31; 4.42; 3.71 | — |
| SECONDARY Number of Subjects With SF-36 Mental Component Summary (MCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure |
132; 121; 137; 120; 132; 100 | — |
| SECONDARY Mean Change in Health Utilities Index-3 (HUI-3) Through Week 260 of Adalimumab Exposure |
0.18; 0.20; 0.20; 0.20; 0.22; 0.22 | — |
| SECONDARY Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure |
-3.26; -3.69; -4.29; -4.36; -4.80; -4.59 | — |
| SECONDARY Number of Subjects With Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) MCID Response (MCID <= -1.8 Points) Through Week 260 of Adalimumab Exposure |
176; 160; 204; 170; 198; 151 | — |
| SECONDARY Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure |
140; 153; 164; 162; 172; 124 | — |
Summary
The objective of this study was to evaluate the safety and efficacy of adalimumab 40 mg given every other week (eow) in subjects with active ankylosing spondylitis (AS) who have had an inadequate response to, or who are intolerant to, treatment with at least 1 nonsteroidal anti-inflammatory drug (NSAID) and who may have also failed treatment with at least 1 disease-modifying antirheumatic drug (DMARD).
Eligibility Criteria
Inclusion Criteria
- Subjects must be >= 18 years of age
- meet Modified NY Criteria definition of ankylosing spondylitis (AS)
- have diagnosis of active AS based on protocol specified criteria
- inadequate response or intolerance to >= 1 nonsteroidal antiinflammatory drug (NSAID)
- be able and willing to learn to self-administer subcutaneous (SC) injections
Exclusion Criteria
- Active tuberculosis, listeriosis,or hepatitis B, or any history of hepatitis C
- History of demyelinating disease, multiple sclerosis, cancer, or lymphoproliferative disease
- Previous anti-tumor necrosis factor therapy
- Treatment with disease-modifying antirheumatic drugs (DMARDs - other than methotrexate, hydroxychloroquine, and sulfasalazine)
- Treatment with intra-articular corticosteroid joint injections within 4 weeks of study dosing
- Biologic or investigational therapy within 6 weeks of study dosing
- Treatment with intravenous (IV) antibiotics within 30 days of study dosing
- Treatment with oral antibiotics within 14 days of study dosing
Data sourced from ClinicalTrials.gov (NCT00085644). 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.