Trial Outcomes & Findings for Special Investigation in Patients With Ankylosing Spondylitis (All Patients Investigation) (NCT NCT01329380)
NCT ID: NCT01329380
Last Updated: 2019-04-03
Results Overview
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
Recruitment status
COMPLETED
Target enrollment
403 participants
Primary outcome timeframe
24 weeks
Results posted on
2019-04-03
Participant Flow
Four hundred and three participants were registered at 195 sites in Japan. Survey forms were available for 400 participants from 194 sites.
Participant milestones
| Measure |
Adalimumab
Participants with ankylosing spondylitis (AS) receiving treatment with adalimumab (Humira) as prescribed by their physician.
|
|---|---|
|
Overall Study
STARTED
|
403
|
|
Overall Study
Safety Population
|
396
|
|
Overall Study
COMPLETED
|
374
|
|
Overall Study
NOT COMPLETED
|
29
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Special Investigation in Patients With Ankylosing Spondylitis (All Patients Investigation)
Baseline characteristics by cohort
| Measure |
Adalimumab
n=396 Participants
Participants with ankylosing spondylitis (AS) receiving treatment with adalimumab (Humira) as prescribed by their physician.
|
|---|---|
|
Age, Continuous
|
46.3 years
STANDARD_DEVIATION 15.6 • n=5 Participants
|
|
Age, Customized
15 to < 65 years
|
344 Participants
n=5 Participants
|
|
Age, Customized
≥ 65 years
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
130 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
266 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
396 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
396 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Safety analysis set
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
Outcome measures
| Measure |
Adalimumab
n=396 Participants
Participants with ankylosing spondylitis (AS) receiving treatment with adalimumab (Humira) as prescribed by their physician.
|
|---|---|
|
Number of Participants With Adverse Drug Reactions
Adverse drug reactions
|
101 Participants
|
|
Number of Participants With Adverse Drug Reactions
Serious adverse drug reactions
|
15 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Safety analysis set; results are only included for participants with non-missing baseline data for each characteristic.
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
Outcome measures
| Measure |
Adalimumab
n=396 Participants
Participants with ankylosing spondylitis (AS) receiving treatment with adalimumab (Humira) as prescribed by their physician.
|
|---|---|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Age: 15 to < 65 years
|
94 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Age: ≥ 65 years
|
7 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Sex: Male
|
66 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Sex: Female
|
35 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Body Mass Index: < 18.5 kg/m²
|
9 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Body Mass Index: 18.5 - < 25 kg/m²
|
36 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Body Mass Index: 25 - 30 kg/m²
|
25 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Body Mass Index: ≥ 30 kg/m²
|
5 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Duration of illness: < 5 years
|
34 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Duration of illness: 5 to < 10 years
|
21 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Duration of illness: 10 to < 20 years
|
20 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Duration of illness: > 20 years
|
15 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Smoking history: Absent
|
39 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Smoking history: Present
|
35 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Complications: Absent
|
39 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Complications: Present
|
62 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Complications-renal disorder: Absent
|
95 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Complications-renal disorder: Present
|
6 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Complications-cardiovascular disorder: Absent
|
86 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Complications-cardiovascular disorder: Present
|
15 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Complications-liver disorder: Absent
|
95 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Complications-liver disorder: Present
|
6 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Complications-blood disorder: Absent
|
97 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Complications-blood disorder: Present
|
4 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Complications-respiratory disorder: Absent
|
94 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Complications-respiratory disorder: Present
|
7 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Complications-diabetes mellitus: Absent
|
94 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Complications-diabetes mellitus: Present
|
7 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Complications-uveitis: Absent
|
89 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Complications-uveitis: Present
|
12 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Complications-inflammatory bowel disease: Absent
|
100 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Complications-inflammatory bowel disease: Present
|
1 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Complications-psoriasis: Absent
|
100 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Complications-psoriasis: Present
|
1 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Past illnesses: Absent
|
66 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Past illnesses: Present
|
34 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Allergy history: Absent
|
83 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Allergy history: Present
|
12 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Adalimumab self-injection: Absent
|
37 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Adalimumab self-injection: Present
|
64 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Prior medication-NSAIDs: Absent
|
20 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Prior medication-NSAIDs: Present
|
81 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Prior medication-biological products: Absent
|
81 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Prior medication-biological products: Present
|
20 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Prior medication-adrenal corticosteroids: Absent
|
67 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Prior medication-adrenal corticosteroids: Present
|
34 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Concomitant drugs: Absent
|
2 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Concomitant drugs: Present
|
99 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Concomitant drug-NSAIDs: Absent
|
32 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Concomitant drug-NSAIDs: Present
|
69 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Concomitant drug-DMARDs: Absent
|
42 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Concomitant drug-DMARDs: Present
|
59 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Concomitant drug-methotrexate: Absent
|
57 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Concomitant drug-methotrexate: Present
|
44 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Concomitant drug-salazosulfapyridine: Absent
|
78 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Concomitant drug-salazosulfapyridine: Present
|
23 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Concomitant drug-adrenal corticosteroids: Absent
|
63 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Concomitant drug-adrenal corticosteroids: Present
|
38 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Concomitant therapy: Absent
|
97 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Concomitant therapy: Present
|
4 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Human leukocyte antigen B27 (HLA-B27): Negative
|
28 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
Human leukocyte antigen B27 (HLA-B27): Positive
|
37 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
BASDAI: < 4
|
27 Participants
|
|
Number of Participants With Adverse Drug Reactions by Baseline Factors
BASDAI: ≥4
|
50 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Safety analysis set
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.
Outcome measures
| Measure |
Adalimumab
n=396 Participants
Participants with ankylosing spondylitis (AS) receiving treatment with adalimumab (Humira) as prescribed by their physician.
|
|---|---|
|
Number of Participants With Adverse Events
Any adverse event
|
125 Participants
|
|
Number of Participants With Adverse Events
Serious adverse events
|
17 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Participants in the safety analysis set who self-injected adalimumab
Outcome measures
| Measure |
Adalimumab
n=265 Participants
Participants with ankylosing spondylitis (AS) receiving treatment with adalimumab (Humira) as prescribed by their physician.
|
|---|---|
|
Number of Participants With Self-injection Errors
|
1 Participants
|
SECONDARY outcome
Timeframe: Weeks 12, 24, and at the last visitPopulation: Efficacy analysis population; participants with available data at each timepoint
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
Outcome measures
| Measure |
Adalimumab
n=374 Participants
Participants with ankylosing spondylitis (AS) receiving treatment with adalimumab (Humira) as prescribed by their physician.
|
|---|---|
|
Number of Participants With Markedly Improved or Improved Rating
12 weeks
|
257 Participants
|
|
Number of Participants With Markedly Improved or Improved Rating
24 weeks
|
292 Participants
|
|
Number of Participants With Markedly Improved or Improved Rating
Last observation
|
333 Participants
|
SECONDARY outcome
Timeframe: 24 weeks (or last visit if earlier)Population: Efficacy analysis set; results are only included for participants with non-missing data for each baseline characteristic.
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
Outcome measures
| Measure |
Adalimumab
n=374 Participants
Participants with ankylosing spondylitis (AS) receiving treatment with adalimumab (Humira) as prescribed by their physician.
|
|---|---|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Age: 15 to < 65 years
|
291 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Age: ≥ 65 years
|
42 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Sex: Male
|
232 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Sex: Female
|
101 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Body Mass Index: < 18.5 kg/m²
|
25 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Body Mass Index: 18.5 - < 25 kg/m²
|
146 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Body Mass Index: 25 - 30 kg/m²
|
51 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Body Mass Index: ≥ 30 kg/m²
|
20 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Duration of illness: < 5 years
|
113 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Duration of illness: 5 to < 10 years
|
69 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Duration of illness: 10 to < 20 years
|
64 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Duration of illness: > 20 years
|
40 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Smoking history: Absent
|
162 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Smoking history: Present
|
98 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Complications: Absent
|
139 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Complications: Present
|
194 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Complications-renal disorder: Absent
|
321 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Complications-renal disorder: Present
|
12 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Complications-cardiovascular disorder: Absent
|
281 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Complications-cardiovascular disorder: Present
|
52 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Complications-liver disorder: Absent
|
308 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Complications-liver disorder: Present
|
25 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Complications-blood disorder: Absent
|
324 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Complications-blood disorder: Present
|
9 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Complications-respiratory disorder: Absent
|
312 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Complications-respiratory disorder: Present
|
21 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Complications-diabetes mellitus: Absent
|
314 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Complications-diabetes mellitus: Present
|
19 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Complications-uveitis: Absent
|
298 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Complications-uveitis: Present
|
35 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Complications-inflammatory bowel disease: Absent
|
328 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Complications-inflammatory bowel disease: Present
|
5 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Complications-psoriasis: Absent
|
328 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Complications-psoriasis: Present
|
5 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Past illnesses: Absent
|
249 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Past illnesses: Present
|
76 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Allergy history: Absent
|
284 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Allergy history: Present
|
39 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Adalimumab self-injection: Absent
|
101 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Adalimumab self-injection: Present
|
232 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Prior medication-NSAIDs: Absent
|
51 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Prior medication-NSAIDs: Present
|
282 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Prior medication-biological products: Absent
|
272 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Prior medication-biological products: Present
|
61 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Prior medication-adrenal corticosteroids: Absent
|
237 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Prior medication-adrenal corticosteroids: Present
|
96 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Concomitant drugs: Absent
|
22 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Concomitant drugs: Present
|
311 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Concomitant drug-NSAIDs: Absent
|
104 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Concomitant drug-NSAIDs: Present
|
229 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Concomitant drug-DMARDs: Absent
|
157 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Concomitant drug-DMARDs: Present
|
176 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Concomitant drug-methotrexate: Absent
|
202 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Concomitant drug-methotrexate: Present
|
131 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Concomitant drug-salazosulfapyridine: Absent
|
262 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Concomitant drug-salazosulfapyridine: Present
|
71 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Concomitant drug-adrenal corticosteroids: Absent
|
245 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Concomitant drug-adrenal corticosteroids: Present
|
88 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Concomitant therapy: Absent
|
320 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Concomitant therapy: Present
|
13 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Human leukocyte antigen B27 (HLA-B27): Negative
|
83 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Human leukocyte antigen B27 (HLA-B27): Positive
|
121 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
BASDAI: < 4
|
87 Participants
|
|
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
BASDAI: ≥4
|
162 Participants
|
SECONDARY outcome
Timeframe: Baseline and weeks 12 and 24Population: Efficacy analysis population with available BASDAI data at baseline and each timepoint
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.
Outcome measures
| Measure |
Adalimumab
n=216 Participants
Participants with ankylosing spondylitis (AS) receiving treatment with adalimumab (Humira) as prescribed by their physician.
|
|---|---|
|
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
12 weeks
|
-1.9 units on a scale
Standard Deviation 2.2
|
|
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
24 weeks
|
-2.0 units on a scale
Standard Deviation 2.6
|
Adverse Events
Adalimumab
Serious events: 17 serious events
Other events: 113 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adalimumab
n=396 participants at risk
Participants with ankylosing spondylitis (AS) receiving treatment with adalimumab (Humira) as prescribed by their physician.
|
|---|---|
|
Infections and infestations
Bronchitis
|
0.51%
2/396 • 24 weeks
|
|
Infections and infestations
Impetigo
|
0.25%
1/396 • 24 weeks
|
|
Infections and infestations
Infection
|
0.25%
1/396 • 24 weeks
|
|
Infections and infestations
Tonsillitis
|
0.25%
1/396 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dermatofibrosarcoma protuberans
|
0.25%
1/396 • 24 weeks
|
|
Immune system disorders
Anaphylactic shock
|
0.25%
1/396 • 24 weeks
|
|
Nervous system disorders
Myelopathy
|
0.25%
1/396 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.25%
1/396 • 24 weeks
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.25%
1/396 • 24 weeks
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.25%
1/396 • 24 weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.25%
1/396 • 24 weeks
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.25%
1/396 • 24 weeks
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.25%
1/396 • 24 weeks
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.25%
1/396 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Lupus-like syndrome
|
0.25%
1/396 • 24 weeks
|
|
Renal and urinary disorders
Urinary retention
|
0.25%
1/396 • 24 weeks
|
Other adverse events
| Measure |
Adalimumab
n=396 participants at risk
Participants with ankylosing spondylitis (AS) receiving treatment with adalimumab (Humira) as prescribed by their physician.
|
|---|---|
|
Infections and infestations
Bronchitis
|
0.76%
3/396 • 24 weeks
|
|
Infections and infestations
Fungal infection
|
0.25%
1/396 • 24 weeks
|
|
Infections and infestations
Gastroenteritis
|
1.0%
4/396 • 24 weeks
|
|
Infections and infestations
Herpes zoster
|
0.25%
1/396 • 24 weeks
|
|
Infections and infestations
Oral candidiasis
|
0.25%
1/396 • 24 weeks
|
|
Infections and infestations
Pharyngitis
|
0.25%
1/396 • 24 weeks
|
|
Infections and infestations
Pneumonia
|
0.25%
1/396 • 24 weeks
|
|
Infections and infestations
Pyelonephritis
|
0.25%
1/396 • 24 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.25%
1/396 • 24 weeks
|
|
Infections and infestations
Chlamydial infection
|
0.25%
1/396 • 24 weeks
|
|
Infections and infestations
Enterocolitis bacterial
|
0.51%
2/396 • 24 weeks
|
|
Infections and infestations
Tonsillitis bacterial
|
0.25%
1/396 • 24 weeks
|
|
Infections and infestations
Oral herpes
|
0.25%
1/396 • 24 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.25%
1/396 • 24 weeks
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.25%
1/396 • 24 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.25%
1/396 • 24 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.25%
1/396 • 24 weeks
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.25%
1/396 • 24 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.76%
3/396 • 24 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.51%
2/396 • 24 weeks
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.25%
1/396 • 24 weeks
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.51%
2/396 • 24 weeks
|
|
Psychiatric disorders
Anxiety
|
0.25%
1/396 • 24 weeks
|
|
Nervous system disorders
Dizziness
|
0.25%
1/396 • 24 weeks
|
|
Nervous system disorders
Headache
|
0.25%
1/396 • 24 weeks
|
|
Nervous system disorders
Loss of consciousness
|
0.25%
1/396 • 24 weeks
|
|
Nervous system disorders
Presyncope
|
0.25%
1/396 • 24 weeks
|
|
Nervous system disorders
Somnolence
|
0.25%
1/396 • 24 weeks
|
|
Eye disorders
Uveitis
|
0.51%
2/396 • 24 weeks
|
|
Eye disorders
Vision blurred
|
0.25%
1/396 • 24 weeks
|
|
Ear and labyrinth disorders
External ear inflammation
|
0.25%
1/396 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.25%
1/396 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.25%
1/396 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.25%
1/396 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.25%
1/396 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
1.3%
5/396 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.25%
1/396 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.25%
1/396 • 24 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.25%
1/396 • 24 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.25%
1/396 • 24 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.76%
3/396 • 24 weeks
|
|
Gastrointestinal disorders
Enterocolitis
|
0.25%
1/396 • 24 weeks
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.25%
1/396 • 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.76%
3/396 • 24 weeks
|
|
Gastrointestinal disorders
Stomatitis
|
0.25%
1/396 • 24 weeks
|
|
Gastrointestinal disorders
Swollen tongue
|
0.25%
1/396 • 24 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.51%
2/396 • 24 weeks
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
3.0%
12/396 • 24 weeks
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.51%
2/396 • 24 weeks
|
|
Hepatobiliary disorders
Liver disorder
|
0.51%
2/396 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.25%
1/396 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.51%
2/396 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.0%
4/396 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.3%
9/396 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.25%
1/396 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.25%
1/396 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.25%
1/396 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Generalised erythema
|
0.25%
1/396 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
0.51%
2/396 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.25%
1/396 • 24 weeks
|
|
Renal and urinary disorders
Calculus urinary
|
0.25%
1/396 • 24 weeks
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
0.25%
1/396 • 24 weeks
|
|
Reproductive system and breast disorders
Lactation disorder
|
0.25%
1/396 • 24 weeks
|
|
General disorders
Injection site erythema
|
1.0%
4/396 • 24 weeks
|
|
General disorders
Injection site pain
|
0.25%
1/396 • 24 weeks
|
|
General disorders
Injection site pruritus
|
0.25%
1/396 • 24 weeks
|
|
General disorders
Injection site rash
|
0.25%
1/396 • 24 weeks
|
|
General disorders
Injection site reaction
|
1.0%
4/396 • 24 weeks
|
|
General disorders
Malaise
|
0.76%
3/396 • 24 weeks
|
|
General disorders
Thirst
|
0.25%
1/396 • 24 weeks
|
|
General disorders
Injection site swelling
|
0.25%
1/396 • 24 weeks
|
|
General disorders
Injection site eczema
|
0.25%
1/396 • 24 weeks
|
|
Investigations
Alanine aminotransferase increased
|
1.0%
4/396 • 24 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.76%
3/396 • 24 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
0.25%
1/396 • 24 weeks
|
|
Investigations
Blood urea increased
|
0.51%
2/396 • 24 weeks
|
|
Investigations
C-reactive protein increased
|
1.3%
5/396 • 24 weeks
|
|
Investigations
Haematocrit decreased
|
0.25%
1/396 • 24 weeks
|
|
Investigations
Haemoglobin decreased
|
0.25%
1/396 • 24 weeks
|
|
Investigations
Liver function test abnormal
|
0.76%
3/396 • 24 weeks
|
|
Investigations
Lymphocyte count decreased
|
1.0%
4/396 • 24 weeks
|
|
Investigations
Lymphocyte count increased
|
0.51%
2/396 • 24 weeks
|
|
Investigations
Neutrophil count decreased
|
0.51%
2/396 • 24 weeks
|
|
Investigations
Neutrophil count increased
|
0.51%
2/396 • 24 weeks
|
|
Investigations
Platelet count decreased
|
0.25%
1/396 • 24 weeks
|
|
Investigations
Red blood cell count decreased
|
0.25%
1/396 • 24 weeks
|
|
Investigations
White blood cell count decreased
|
0.51%
2/396 • 24 weeks
|
|
Investigations
White blood cell count increased
|
0.51%
2/396 • 24 weeks
|
|
Investigations
Platelet count increased
|
0.25%
1/396 • 24 weeks
|
|
Investigations
Blood beta-D-glucan increased
|
0.25%
1/396 • 24 weeks
|
|
Investigations
Blood beta-D-glucan abnormal
|
0.25%
1/396 • 24 weeks
|
|
Investigations
Transaminases increased
|
0.25%
1/396 • 24 weeks
|
|
Investigations
Hepatic enzyme increased
|
1.0%
4/396 • 24 weeks
|
|
Investigations
Liver function test increased
|
0.51%
2/396 • 24 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
0.76%
3/396 • 24 weeks
|
|
Infections and infestations
Nasopharyngitis
|
3.0%
12/396 • 24 weeks
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.25%
1/396 • 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER