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Special Investigation in Patients With Ankylosing Spondylitis (All Patients Investigation)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01329380
Recruitment Status : Completed
First Posted : April 5, 2011
Results First Posted : April 3, 2019
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Ankylosing Spondylitis
Enrollment 403
Recruitment Details Four hundred and three participants were registered at 195 sites in Japan. Survey forms were available for 400 participants from 194 sites.
Pre-assignment Details  
Arm/Group Title Adalimumab
Hide Arm/Group Description Participants with ankylosing spondylitis (AS) receiving treatment with adalimumab (Humira) as prescribed by their physician.
Period Title: Overall Study
Started [1] 403
Safety Population [2] 396
Completed [3] 374
Not Completed 29
[1]
Participants who were registered
[2]
Excludes duplicate participants and participants starting treatment prior to study registration
[3]
Participants with available efficacy data at 12 weeks or 24 weeks after the start of treatment
Arm/Group Title Adalimumab
Hide Arm/Group Description Participants with ankylosing spondylitis (AS) receiving treatment with adalimumab (Humira) as prescribed by their physician.
Overall Number of Baseline Participants 396
Hide Baseline Analysis Population Description
Safety analysis set
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 396 participants
46.3  (15.6)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 396 participants
15 to < 65 years
344
  86.9%
≥ 65 years
52
  13.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 396 participants
Female
130
  32.8%
Male
266
  67.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Japanese Number Analyzed 396 participants
396
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 396 participants
396
1.Primary Outcome
Title Number of Participants With Adverse Drug Reactions
Hide Description

An adverse drug reaction (ADR) is an injury caused by taking a medication, in which a causative relationship can be shown.

A serious adverse drug reaction is any untoward medical occurrence that at any dose;

  • Results in death
  • Life threatening
  • Requires inpatient hospitalization or prolongation of existing hospitalization
  • Results in persistent of significant disability or incapacity
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants with ankylosing spondylitis (AS) receiving treatment with adalimumab (Humira) as prescribed by their physician.
Overall Number of Participants Analyzed 396
Measure Type: Count of Participants
Unit of Measure: Participants
Adverse drug reactions
101
  25.5%
Serious adverse drug reactions
15
   3.8%
2.Primary Outcome
Title Number of Participants With Adverse Drug Reactions by Baseline Factors
Hide Description

An adverse drug reaction (ADR) is an injury caused by taking a medication, in which a causative relationship can be shown. ADRs are reported by baseline characteristics.

NSAID: non-steroidal anti-inflammatory drug

DMARD: disease-modifying anti-rheumatic drug

BASDAI: Bath Ankylosing Spondylitis Disease Activity Index

Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set; results are only included for participants with non-missing baseline data for each characteristic.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants with ankylosing spondylitis (AS) receiving treatment with adalimumab (Humira) as prescribed by their physician.
Overall Number of Participants Analyzed 396
Measure Type: Count of Participants
Unit of Measure: Participants
Age: 15 to < 65 years Number Analyzed 344 participants
94
  27.3%
Age: ≥ 65 years Number Analyzed 52 participants
7
  13.5%
Sex: Male Number Analyzed 266 participants
66
  24.8%
Sex: Female Number Analyzed 130 participants
35
  26.9%
Body Mass Index: < 18.5 kg/m² Number Analyzed 31 participants
9
  29.0%
Body Mass Index: 18.5 - < 25 kg/m² Number Analyzed 164 participants
36
  22.0%
Body Mass Index: 25 - 30 kg/m² Number Analyzed 63 participants
25
  39.7%
Body Mass Index: ≥ 30 kg/m² Number Analyzed 25 participants
5
  20.0%
Duration of illness: < 5 years Number Analyzed 129 participants
34
  26.4%
Duration of illness: 5 to < 10 years Number Analyzed 80 participants
21
  26.3%
Duration of illness: 10 to < 20 years Number Analyzed 80 participants
20
  25.0%
Duration of illness: > 20 years Number Analyzed 48 participants
15
  31.3%
Smoking history: Absent Number Analyzed 188 participants
39
  20.7%
Smoking history: Present Number Analyzed 111 participants
35
  31.5%
Complications: Absent Number Analyzed 165 participants
39
  23.6%
Complications: Present Number Analyzed 231 participants
62
  26.8%
Complications-renal disorder: Absent Number Analyzed 382 participants
95
  24.9%
Complications-renal disorder: Present Number Analyzed 14 participants
6
  42.9%
Complications-cardiovascular disorder: Absent Number Analyzed 333 participants
86
  25.8%
Complications-cardiovascular disorder: Present Number Analyzed 63 participants
15
  23.8%
Complications-liver disorder: Absent Number Analyzed 366 participants
95
  26.0%
Complications-liver disorder: Present Number Analyzed 30 participants
6
  20.0%
Complications-blood disorder: Absent Number Analyzed 385 participants
97
  25.2%
Complications-blood disorder: Present Number Analyzed 11 participants
4
  36.4%
Complications-respiratory disorder: Absent Number Analyzed 372 participants
94
  25.3%
Complications-respiratory disorder: Present Number Analyzed 24 participants
7
  29.2%
Complications-diabetes mellitus: Absent Number Analyzed 370 participants
94
  25.4%
Complications-diabetes mellitus: Present Number Analyzed 26 participants
7
  26.9%
Complications-uveitis: Absent Number Analyzed 355 participants
89
  25.1%
Complications-uveitis: Present Number Analyzed 41 participants
12
  29.3%
Complications-inflammatory bowel disease: Absent Number Analyzed 390 participants
100
  25.6%
Complications-inflammatory bowel disease: Present Number Analyzed 6 participants
1
  16.7%
Complications-psoriasis: Absent Number Analyzed 391 participants
100
  25.6%
Complications-psoriasis: Present Number Analyzed 5 participants
1
  20.0%
Past illnesses: Absent Number Analyzed 292 participants
66
  22.6%
Past illnesses: Present Number Analyzed 94 participants
34
  36.2%
Allergy history: Absent Number Analyzed 336 participants
83
  24.7%
Allergy history: Present Number Analyzed 48 participants
12
  25.0%
Adalimumab self-injection: Absent Number Analyzed 131 participants
37
  28.2%
Adalimumab self-injection: Present Number Analyzed 265 participants
64
  24.2%
Prior medication-NSAIDs: Absent Number Analyzed 64 participants
20
  31.3%
Prior medication-NSAIDs: Present Number Analyzed 332 participants
81
  24.4%
Prior medication-biological products: Absent Number Analyzed 315 participants
81
  25.7%
Prior medication-biological products: Present Number Analyzed 81 participants
20
  24.7%
Prior medication-adrenal corticosteroids: Absent Number Analyzed 281 participants
67
  23.8%
Prior medication-adrenal corticosteroids: Present Number Analyzed 115 participants
34
  29.6%
Concomitant drugs: Absent Number Analyzed 27 participants
2
   7.4%
Concomitant drugs: Present Number Analyzed 369 participants
99
  26.8%
Concomitant drug-NSAIDs: Absent Number Analyzed 127 participants
32
  25.2%
Concomitant drug-NSAIDs: Present Number Analyzed 269 participants
69
  25.7%
Concomitant drug-DMARDs: Absent Number Analyzed 186 participants
42
  22.6%
Concomitant drug-DMARDs: Present Number Analyzed 210 participants
59
  28.1%
Concomitant drug-methotrexate: Absent Number Analyzed 247 participants
57
  23.1%
Concomitant drug-methotrexate: Present Number Analyzed 149 participants
44
  29.5%
Concomitant drug-salazosulfapyridine: Absent Number Analyzed 306 participants
78
  25.5%
Concomitant drug-salazosulfapyridine: Present Number Analyzed 90 participants
23
  25.6%
Concomitant drug-adrenal corticosteroids: Absent Number Analyzed 288 participants
63
  21.9%
Concomitant drug-adrenal corticosteroids: Present Number Analyzed 108 participants
38
  35.2%
Concomitant therapy: Absent Number Analyzed 378 participants
97
  25.7%
Concomitant therapy: Present Number Analyzed 18 participants
4
  22.2%
Human leukocyte antigen B27 (HLA-B27): Negative Number Analyzed 105 participants
28
  26.7%
Human leukocyte antigen B27 (HLA-B27): Positive Number Analyzed 131 participants
37
  28.2%
BASDAI: < 4 Number Analyzed 101 participants
27
  26.7%
BASDAI: ≥4 Number Analyzed 191 participants
50
  26.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Age
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0328
Comments [Not Specified]
Method Mann-Whitney U-test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Sex
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7128
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Body mass index
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0465
Comments [Not Specified]
Method Mann-Whitney U-test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Duration of illness
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8872
Comments [Not Specified]
Method Mann-Whitney U-test
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Smoking history
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0388
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Complications
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4855
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Complications - Liver disorder
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6630
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Complications - Renal disorder
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2067
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Complications - Cardiovascular disorder
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8749
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Complications - Blood disorder
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4820
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Complications - Respiratory disorder
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6355
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Complications - Diabetes mellitus
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8193
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Complications - Uveitis
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5723
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Complications - Inflammatory bowel disease
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Complications - Psoriasis
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Past Illnesses
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0144
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Allergy history
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Adalimumab self-injection status
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3928
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Prior medications - NSAIDs
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2735
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Prior medications - Biological products
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8875
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Prior medications - Adrenal corticosteroids
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2540
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Concomitant drugs
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0226
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Concomitant drug: NSAIDs
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Concomitant drugs - DMARDs
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2481
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Concomitant drugs - Methotrexate
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1558
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Concomitant drugs - salazosulfapyridine
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Concomitant drugs - Adrenal corticosteroids
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0094
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 28 Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Concomitant therapy
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 29 Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments Human leukocyte antigen B27 (HLA-B27) test result
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8836
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 30 Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Adalimumab
Comments BASDAI at start of treatment
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage.

Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants with ankylosing spondylitis (AS) receiving treatment with adalimumab (Humira) as prescribed by their physician.
Overall Number of Participants Analyzed 396
Measure Type: Count of Participants
Unit of Measure: Participants
Any adverse event
125
  31.6%
Serious adverse events
17
   4.3%
4.Primary Outcome
Title Number of Participants With Self-injection Errors
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the safety analysis set who self-injected adalimumab
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants with ankylosing spondylitis (AS) receiving treatment with adalimumab (Humira) as prescribed by their physician.
Overall Number of Participants Analyzed 265
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.4%
5.Secondary Outcome
Title Number of Participants With Markedly Improved or Improved Rating
Hide Description

Participants were evaluated for improvement at weeks 12 and 24 of treatment or discontinuation of treatment or participation in the survey based on the clinical course from baseline using the following scale:

1. Markedly improved, 2. Improved, 3.Not improved, 5. Not assessable

Time Frame Weeks 12, 24, and at the last visit
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis population; participants with available data at each timepoint
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants with ankylosing spondylitis (AS) receiving treatment with adalimumab (Humira) as prescribed by their physician.
Overall Number of Participants Analyzed 374
Measure Type: Count of Participants
Unit of Measure: Participants
12 weeks Number Analyzed 287 participants
257
  89.5%
24 weeks Number Analyzed 321 participants
292
  91.0%
Last observation Number Analyzed 374 participants
333
  89.0%
6.Secondary Outcome
Title Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Hide Description

Participants were evaluated for improvement at weeks 12 and 24 of treatment or discontinuation of treatment or participation in the survey based on the clinical course from baseline using the following scale:

1. Markedly improved, 2. Improved, 3.Not improved, 5. Not assessable

Time Frame 24 weeks (or last visit if earlier)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set; results are only included for participants with non-missing data for each baseline characteristic.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants with ankylosing spondylitis (AS) receiving treatment with adalimumab (Humira) as prescribed by their physician.
Overall Number of Participants Analyzed 374
Measure Type: Count of Participants
Unit of Measure: Participants
Age: 15 to < 65 years Number Analyzed 324 participants
291
  89.8%
Age: ≥ 65 years Number Analyzed 50 participants
42
  84.0%
Sex: Male Number Analyzed 255 participants
232
  91.0%
Sex: Female Number Analyzed 119 participants
101
  84.9%
Body Mass Index: < 18.5 kg/m² Number Analyzed 31 participants
25
  80.6%
Body Mass Index: 18.5 - < 25 kg/m² Number Analyzed 158 participants
146
  92.4%
Body Mass Index: 25 - 30 kg/m² Number Analyzed 56 participants
51
  91.1%
Body Mass Index: ≥ 30 kg/m² Number Analyzed 25 participants
20
  80.0%
Duration of illness: < 5 years Number Analyzed 125 participants
113
  90.4%
Duration of illness: 5 to < 10 years Number Analyzed 77 participants
69
  89.6%
Duration of illness: 10 to < 20 years Number Analyzed 77 participants
64
  83.1%
Duration of illness: > 20 years Number Analyzed 43 participants
40
  93.0%
Smoking history: Absent Number Analyzed 182 participants
162
  89.0%
Smoking history: Present Number Analyzed 107 participants
98
  91.6%
Complications: Absent Number Analyzed 154 participants
139
  90.3%
Complications: Present Number Analyzed 220 participants
194
  88.2%
Complications-renal disorder: Absent Number Analyzed 360 participants
321
  89.2%
Complications-renal disorder: Present Number Analyzed 14 participants
12
  85.7%
Complications-cardiovascular disorder: Absent Number Analyzed 314 participants
281
  89.5%
Complications-cardiovascular disorder: Present Number Analyzed 60 participants
52
  86.7%
Complications-liver disorder: Absent Number Analyzed 345 participants
308
  89.3%
Complications-liver disorder: Present Number Analyzed 29 participants
25
  86.2%
Complications-blood disorder: Absent Number Analyzed 364 participants
324
  89.0%
Complications-blood disorder: Present Number Analyzed 10 participants
9
  90.0%
Complications-respiratory disorder: Absent Number Analyzed 350 participants
312
  89.1%
Complications-respiratory disorder: Present Number Analyzed 24 participants
21
  87.5%
Complications-diabetes mellitus: Absent Number Analyzed 349 participants
314
  90.0%
Complications-diabetes mellitus: Present Number Analyzed 25 participants
19
  76.0%
Complications-uveitis: Absent Number Analyzed 336 participants
298
  88.7%
Complications-uveitis: Present Number Analyzed 38 participants
35
  92.1%
Complications-inflammatory bowel disease: Absent Number Analyzed 369 participants
328
  88.9%
Complications-inflammatory bowel disease: Present Number Analyzed 5 participants
5
 100.0%
Complications-psoriasis: Absent Number Analyzed 369 participants
328
  88.9%
Complications-psoriasis: Present Number Analyzed 5 participants
5
 100.0%
Past illnesses: Absent Number Analyzed 277 participants
249
  89.9%
Past illnesses: Present Number Analyzed 88 participants
76
  86.4%
Allergy history: Absent Number Analyzed 318 participants
284
  89.3%
Allergy history: Present Number Analyzed 45 participants
39
  86.7%
Adalimumab self-injection: Absent Number Analyzed 120 participants
101
  84.2%
Adalimumab self-injection: Present Number Analyzed 254 participants
232
  91.3%
Prior medication-NSAIDs: Absent Number Analyzed 58 participants
51
  87.9%
Prior medication-NSAIDs: Present Number Analyzed 316 participants
282
  89.2%
Prior medication-biological products: Absent Number Analyzed 301 participants
272
  90.4%
Prior medication-biological products: Present Number Analyzed 73 participants
61
  83.6%
Prior medication-adrenal corticosteroids: Absent Number Analyzed 263 participants
237
  90.1%
Prior medication-adrenal corticosteroids: Present Number Analyzed 111 participants
96
  86.5%
Concomitant drugs: Absent Number Analyzed 24 participants
22
  91.7%
Concomitant drugs: Present Number Analyzed 350 participants
311
  88.9%
Concomitant drug-NSAIDs: Absent Number Analyzed 117 participants
104
  88.9%
Concomitant drug-NSAIDs: Present Number Analyzed 257 participants
229
  89.1%
Concomitant drug-DMARDs: Absent Number Analyzed 177 participants
157
  88.7%
Concomitant drug-DMARDs: Present Number Analyzed 197 participants
176
  89.3%
Concomitant drug-methotrexate: Absent Number Analyzed 232 participants
202
  87.1%
Concomitant drug-methotrexate: Present Number Analyzed 142 participants
131
  92.3%
Concomitant drug-salazosulfapyridine: Absent Number Analyzed 291 participants
262
  90.0%
Concomitant drug-salazosulfapyridine: Present Number Analyzed 83 participants
71
  85.5%
Concomitant drug-adrenal corticosteroids: Absent Number Analyzed 270 participants
245
  90.7%
Concomitant drug-adrenal corticosteroids: Present Number Analyzed 104 participants
88
  84.6%
Concomitant therapy: Absent Number Analyzed 356 participants
320
  89.9%
Concomitant therapy: Present Number Analyzed 18 participants
13
  72.2%
Human leukocyte antigen B27 (HLA-B27): Negative Number Analyzed 98 participants
83
  84.7%
Human leukocyte antigen B27 (HLA-B27): Positive Number Analyzed 128 participants
121
  94.5%
BASDAI: < 4 Number Analyzed 99 participants
87
  87.9%
BASDAI: ≥4 Number Analyzed 184 participants
162
  88.0%
7.Secondary Outcome
Title Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Hide Description The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) assesses disease activity by asking the participant to answer 6 questions (each on a 10 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10 where lower scores indicate less disease activity.
Time Frame Baseline and weeks 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis population with available BASDAI data at baseline and each timepoint
Arm/Group Title Adalimumab
Hide Arm/Group Description:
Participants with ankylosing spondylitis (AS) receiving treatment with adalimumab (Humira) as prescribed by their physician.
Overall Number of Participants Analyzed 216
Mean (Standard Deviation)
Unit of Measure: units on a scale
12 weeks Number Analyzed 181 participants
-1.9  (2.2)
24 weeks Number Analyzed 143 participants
-2.0  (2.6)
Time Frame 24 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adalimumab
Hide Arm/Group Description Participants with ankylosing spondylitis (AS) receiving treatment with adalimumab (Humira) as prescribed by their physician.
All-Cause Mortality
Adalimumab
Affected / at Risk (%)
Total   0/396 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Adalimumab
Affected / at Risk (%)
Total   17/396 (4.29%) 
Gastrointestinal disorders   
Colitis ulcerative  1  1/396 (0.25%) 
Gastric ulcer perforation  1  1/396 (0.25%) 
Haemorrhoids  1  1/396 (0.25%) 
Ileus paralytic  1  1/396 (0.25%) 
Pancreatitis acute  1  1/396 (0.25%) 
Hepatobiliary disorders   
Hepatic function abnormal  1  1/396 (0.25%) 
Immune system disorders   
Anaphylactic shock  1  1/396 (0.25%) 
Infections and infestations   
Bronchitis  1  2/396 (0.51%) 
Impetigo  1  1/396 (0.25%) 
Infection  1  1/396 (0.25%) 
Tonsillitis  1  1/396 (0.25%) 
Musculoskeletal and connective tissue disorders   
Lupus-like syndrome  1  1/396 (0.25%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Dermatofibrosarcoma protuberans  1  1/396 (0.25%) 
Nervous system disorders   
Myelopathy  1  1/396 (0.25%) 
Renal and urinary disorders   
Urinary retention  1  1/396 (0.25%) 
Respiratory, thoracic and mediastinal disorders   
Upper respiratory tract inflammation  1  1/396 (0.25%) 
1
Term from vocabulary, MedDRA (20.1)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adalimumab
Affected / at Risk (%)
Total   113/396 (28.54%) 
Blood and lymphatic system disorders   
Anaemia  1  1/396 (0.25%) 
Iron deficiency anaemia  1  1/396 (0.25%) 
Neutropenia  1  1/396 (0.25%) 
Thrombocytopenia  1  1/396 (0.25%) 
Ear and labyrinth disorders   
External ear inflammation  1  1/396 (0.25%) 
Eye disorders   
Uveitis  1  2/396 (0.51%) 
Vision blurred  1  1/396 (0.25%) 
Gastrointestinal disorders   
Abdominal discomfort  1  1/396 (0.25%) 
Abdominal pain  1  1/396 (0.25%) 
Diarrhoea  1  3/396 (0.76%) 
Enterocolitis  1  1/396 (0.25%) 
Gastrointestinal disorder  1  1/396 (0.25%) 
Nausea  1  3/396 (0.76%) 
Stomatitis  1  1/396 (0.25%) 
Swollen tongue  1  1/396 (0.25%) 
Vomiting  1  2/396 (0.51%) 
General disorders   
Injection site erythema  1  4/396 (1.01%) 
Injection site pain  1  1/396 (0.25%) 
Injection site pruritus  1  1/396 (0.25%) 
Injection site rash  1  1/396 (0.25%) 
Injection site reaction  1  4/396 (1.01%) 
Malaise  1  3/396 (0.76%) 
Thirst  1  1/396 (0.25%) 
Injection site swelling  1  1/396 (0.25%) 
Injection site eczema  1  1/396 (0.25%) 
Hepatobiliary disorders   
Hepatic function abnormal  1  12/396 (3.03%) 
Hepatic steatosis  1  2/396 (0.51%) 
Liver disorder  1  2/396 (0.51%) 
Immune system disorders   
Hypogammaglobulinaemia  1  1/396 (0.25%) 
Infections and infestations   
Bronchitis  1  3/396 (0.76%) 
Fungal infection  1  1/396 (0.25%) 
Gastroenteritis  1  4/396 (1.01%) 
Herpes zoster  1  1/396 (0.25%) 
Oral candidiasis  1  1/396 (0.25%) 
Pharyngitis  1  1/396 (0.25%) 
Pneumonia  1  1/396 (0.25%) 
Pyelonephritis  1  1/396 (0.25%) 
Urinary tract infection  1  1/396 (0.25%) 
Chlamydial infection  1  1/396 (0.25%) 
Enterocolitis bacterial  1  2/396 (0.51%) 
Tonsillitis bacterial  1  1/396 (0.25%) 
Oral herpes  1  1/396 (0.25%) 
Nasopharyngitis  1  12/396 (3.03%) 
Ophthalmic herpes zoster  1  1/396 (0.25%) 
Injury, poisoning and procedural complications   
Contusion  1  3/396 (0.76%) 
Investigations   
Alanine aminotransferase increased  1  4/396 (1.01%) 
Aspartate aminotransferase increased  1  3/396 (0.76%) 
Blood creatine phosphokinase increased  1  1/396 (0.25%) 
Blood urea increased  1  2/396 (0.51%) 
C-reactive protein increased  1  5/396 (1.26%) 
Haematocrit decreased  1  1/396 (0.25%) 
Haemoglobin decreased  1  1/396 (0.25%) 
Liver function test abnormal  1  3/396 (0.76%) 
Lymphocyte count decreased  1  4/396 (1.01%) 
Lymphocyte count increased  1  2/396 (0.51%) 
Neutrophil count decreased  1  2/396 (0.51%) 
Neutrophil count increased  1  2/396 (0.51%) 
Platelet count decreased  1  1/396 (0.25%) 
Red blood cell count decreased  1  1/396 (0.25%) 
White blood cell count decreased  1  2/396 (0.51%) 
White blood cell count increased  1  2/396 (0.51%) 
Platelet count increased  1  1/396 (0.25%) 
Blood beta-D-glucan increased  1  1/396 (0.25%) 
Blood beta-D-glucan abnormal  1  1/396 (0.25%) 
Transaminases increased  1  1/396 (0.25%) 
Hepatic enzyme increased  1  4/396 (1.01%) 
Liver function test increased  1  2/396 (0.51%) 
Metabolism and nutrition disorders   
Dehydration  1  3/396 (0.76%) 
Diabetes mellitus  1  2/396 (0.51%) 
Hyperuricaemia  1  1/396 (0.25%) 
Hyperlipidaemia  1  2/396 (0.51%) 
Musculoskeletal and connective tissue disorders   
Ankylosing spondylitis  1  2/396 (0.51%) 
Pain in extremity  1  1/396 (0.25%) 
Nervous system disorders   
Dizziness  1  1/396 (0.25%) 
Headache  1  1/396 (0.25%) 
Loss of consciousness  1  1/396 (0.25%) 
Presyncope  1  1/396 (0.25%) 
Somnolence  1  1/396 (0.25%) 
Psychiatric disorders   
Anxiety  1  1/396 (0.25%) 
Renal and urinary disorders   
Calculus urinary  1  1/396 (0.25%) 
Reproductive system and breast disorders   
Genital haemorrhage  1  1/396 (0.25%) 
Lactation disorder  1  1/396 (0.25%) 
Respiratory, thoracic and mediastinal disorders   
Asthma  1  1/396 (0.25%) 
Atelectasis  1  1/396 (0.25%) 
Epistaxis  1  1/396 (0.25%) 
Rhinorrhoea  1  1/396 (0.25%) 
Upper respiratory tract inflammation  1  5/396 (1.26%) 
Pulmonary mass  1  1/396 (0.25%) 
Oropharyngeal pain  1  1/396 (0.25%) 
Skin and subcutaneous tissue disorders   
Dermatitis  1  1/396 (0.25%) 
Erythema  1  2/396 (0.51%) 
Pruritus  1  4/396 (1.01%) 
Rash  1  9/396 (2.27%) 
Rash erythematous  1  1/396 (0.25%) 
Rash pruritic  1  1/396 (0.25%) 
Urticaria  1  1/396 (0.25%) 
Generalised erythema  1  1/396 (0.25%) 
1
Term from vocabulary, MedDRA (20.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
EMail: abbvieclinicaltrials@abbvie.com
Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01329380     History of Changes
Other Study ID Numbers: P12-764
First Submitted: March 17, 2011
First Posted: April 5, 2011
Results First Submitted: December 20, 2018
Results First Posted: April 3, 2019
Last Update Posted: April 3, 2019