An observational study in Ankylosing Spondylitis, sponsored by AbbVie. Completed at 194 sites in Japan. Open to participants aged 16 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-04-03.
Sponsored by AbbVie · Observational
This study of adalimumab (Humira) will be conducted to clarify the following with regard to the treatment of ankylosing spondylitis with this drug:
623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.
This study's enrollment of 403 is above the median of 202 across 256 observational studies indexed under Spondylitis.
Browse Spondylitis studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients who receive Humira for the treatment of ankylosing spondylitis
Exclusion Criteria:
Contraindications according to the Package Insert
Participants with ankylosing spondylitis (AS) receiving treatment with adalimumab (Humira) as prescribed by their physician.
Number of Participants With Adverse Drug Reactions
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
Number of Participants With Adverse Drug Reactions by Baseline Factors
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
Number of Participants With Adverse Events
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
Number of Participants With Self-injection Errors
Time frame: 24 weeks
Number of Participants With Markedly Improved or Improved Rating
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
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
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)
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
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
Four hundred and three participants were registered at 195 sites in Japan. Survey forms were available for 400 participants from 194 sites.
| Milestone | Adalimumab |
|---|---|
| Started | 403 |
| Safety population | 396 |
| Completed | 374 |
| Not completed | 29 |
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
| Participants | Adalimumab |
|---|---|
| Adverse drug reactions | 101 |
| Serious adverse drug reactions | 15 |
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
| Participants | Adalimumab |
|---|---|
| Age: 15 to < 65 years | 94 |
| Age: ≥ 65 years | 7 |
| Sex: Male | 66 |
| Sex: Female | 35 |
| Body Mass Index: < 18.5 kg/m² | 9 |
| Body Mass Index: 18.5 - < 25 kg/m² | 36 |
| Body Mass Index: 25 - 30 kg/m² | 25 |
| Body Mass Index: ≥ 30 kg/m² | 5 |
| Duration of illness: < 5 years | 34 |
| Duration of illness: 5 to < 10 years | 21 |
| Duration of illness: 10 to < 20 years | 20 |
| Duration of illness: > 20 years | 15 |
| Smoking history: Absent | 39 |
| Smoking history: Present | 35 |
| Complications: Absent | 39 |
| Complications: Present | 62 |
| Complications-renal disorder: Absent | 95 |
| Complications-renal disorder: Present | 6 |
| Complications-cardiovascular disorder: Absent | 86 |
| Complications-cardiovascular disorder: Present | 15 |
| Complications-liver disorder: Absent | 95 |
| Complications-liver disorder: Present | 6 |
| Complications-blood disorder: Absent | 97 |
| Complications-blood disorder: Present | 4 |
| Complications-respiratory disorder: Absent | 94 |
| Complications-respiratory disorder: Present | 7 |
| Complications-diabetes mellitus: Absent | 94 |
| Complications-diabetes mellitus: Present | 7 |
| Complications-uveitis: Absent | 89 |
| Complications-uveitis: Present | 12 |
| Complications-inflammatory bowel disease: Absent | 100 |
| Complications-inflammatory bowel disease: Present | 1 |
| Complications-psoriasis: Absent | 100 |
| Complications-psoriasis: Present | 1 |
| Past illnesses: Absent | 66 |
| Past illnesses: Present | 34 |
| Allergy history: Absent | 83 |
| Allergy history: Present | 12 |
| Adalimumab self-injection: Absent | 37 |
| Adalimumab self-injection: Present | 64 |
| Prior medication-NSAIDs: Absent | 20 |
| Prior medication-NSAIDs: Present | 81 |
| Prior medication-biological products: Absent | 81 |
| Prior medication-biological products: Present | 20 |
| Prior medication-adrenal corticosteroids: Absent | 67 |
| Prior medication-adrenal corticosteroids: Present | 34 |
| Concomitant drugs: Absent | 2 |
| Concomitant drugs: Present | 99 |
| Concomitant drug-NSAIDs: Absent | 32 |
| Concomitant drug-NSAIDs: Present | 69 |
| Concomitant drug-DMARDs: Absent | 42 |
| Concomitant drug-DMARDs: Present | 59 |
| Concomitant drug-methotrexate: Absent | 57 |
| Concomitant drug-methotrexate: Present | 44 |
| Concomitant drug-salazosulfapyridine: Absent | 78 |
| Concomitant drug-salazosulfapyridine: Present | 23 |
| Concomitant drug-adrenal corticosteroids: Absent | 63 |
| Concomitant drug-adrenal corticosteroids: Present | 38 |
| Concomitant therapy: Absent | 97 |
| Concomitant therapy: Present | 4 |
| Human leukocyte antigen B27 (HLA-B27): Negative | 28 |
| Human leukocyte antigen B27 (HLA-B27): Positive | 37 |
| BASDAI: < 4 | 27 |
| BASDAI: ≥4 | 50 |
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.
| Participants | Adalimumab |
|---|---|
| Any adverse event | 125 |
| Serious adverse events | 17 |
| Participants | Adalimumab |
|---|---|
| Number of Participants With Self-injection Errors | 1 |
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
| Participants | Adalimumab |
|---|---|
| 12 weeks | 257 |
| 24 weeks | 292 |
| Last observation | 333 |
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
| Participants | Adalimumab |
|---|---|
| Age: 15 to < 65 years | 291 |
| Age: ≥ 65 years | 42 |
| Sex: Male | 232 |
| Sex: Female | 101 |
| Body Mass Index: < 18.5 kg/m² | 25 |
| Body Mass Index: 18.5 - < 25 kg/m² | 146 |
| Body Mass Index: 25 - 30 kg/m² | 51 |
| Body Mass Index: ≥ 30 kg/m² | 20 |
| Duration of illness: < 5 years | 113 |
| Duration of illness: 5 to < 10 years | 69 |
| Duration of illness: 10 to < 20 years | 64 |
| Duration of illness: > 20 years | 40 |
| Smoking history: Absent | 162 |
| Smoking history: Present | 98 |
| Complications: Absent | 139 |
| Complications: Present | 194 |
| Complications-renal disorder: Absent | 321 |
| Complications-renal disorder: Present | 12 |
| Complications-cardiovascular disorder: Absent | 281 |
| Complications-cardiovascular disorder: Present | 52 |
| Complications-liver disorder: Absent | 308 |
| Complications-liver disorder: Present | 25 |
| Complications-blood disorder: Absent | 324 |
| Complications-blood disorder: Present | 9 |
| Complications-respiratory disorder: Absent | 312 |
| Complications-respiratory disorder: Present | 21 |
| Complications-diabetes mellitus: Absent | 314 |
| Complications-diabetes mellitus: Present | 19 |
| Complications-uveitis: Absent | 298 |
| Complications-uveitis: Present | 35 |
| Complications-inflammatory bowel disease: Absent | 328 |
| Complications-inflammatory bowel disease: Present | 5 |
| Complications-psoriasis: Absent | 328 |
| Complications-psoriasis: Present | 5 |
| Past illnesses: Absent | 249 |
| Past illnesses: Present | 76 |
| Allergy history: Absent | 284 |
| Allergy history: Present | 39 |
| Adalimumab self-injection: Absent | 101 |
| Adalimumab self-injection: Present | 232 |
| Prior medication-NSAIDs: Absent | 51 |
| Prior medication-NSAIDs: Present | 282 |
| Prior medication-biological products: Absent | 272 |
| Prior medication-biological products: Present | 61 |
| Prior medication-adrenal corticosteroids: Absent | 237 |
| Prior medication-adrenal corticosteroids: Present | 96 |
| Concomitant drugs: Absent | 22 |
| Concomitant drugs: Present | 311 |
| Concomitant drug-NSAIDs: Absent | 104 |
| Concomitant drug-NSAIDs: Present | 229 |
| Concomitant drug-DMARDs: Absent | 157 |
| Concomitant drug-DMARDs: Present | 176 |
| Concomitant drug-methotrexate: Absent | 202 |
| Concomitant drug-methotrexate: Present | 131 |
| Concomitant drug-salazosulfapyridine: Absent | 262 |
| Concomitant drug-salazosulfapyridine: Present | 71 |
| Concomitant drug-adrenal corticosteroids: Absent | 245 |
| Concomitant drug-adrenal corticosteroids: Present | 88 |
| Concomitant therapy: Absent | 320 |
| Concomitant therapy: Present | 13 |
| Human leukocyte antigen B27 (HLA-B27): Negative | 83 |
| Human leukocyte antigen B27 (HLA-B27): Positive | 121 |
| BASDAI: < 4 | 87 |
| BASDAI: ≥4 | 162 |
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.
| units on a scale | Adalimumab |
|---|---|
| 12 weeks | -1.9 ± 2.2 |
| 24 weeks | -2.0 ± 2.6 |
Collected over 24 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adalimumab | 0/396 (0%) | 17/396 (4.3%) | 113/396 (28.5%) |
| Event | Adalimumab |
|---|---|
| BronchitisInfections and infestations | 2/396 |
| ImpetigoInfections and infestations | 1/396 |
| InfectionInfections and infestations | 1/396 |
| TonsillitisInfections and infestations | 1/396 |
| Dermatofibrosarcoma protuberansNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/396 |
| Anaphylactic shockImmune system disorders | 1/396 |
| MyelopathyNervous system disorders | 1/396 |
| Upper respiratory tract inflammationRespiratory, thoracic and mediastinal disorders | 1/396 |
| Colitis ulcerativeGastrointestinal disorders | 1/396 |
| Gastric ulcer perforationGastrointestinal disorders | 1/396 |
| Event | Adalimumab |
|---|---|
| Hepatic function abnormalHepatobiliary disorders | 12/396 |
| NasopharyngitisInfections and infestations | 12/396 |
| RashSkin and subcutaneous tissue disorders | 9/396 |
| Upper respiratory tract inflammationRespiratory, thoracic and mediastinal disorders | 5/396 |
| C-reactive protein increasedInvestigations | 5/396 |
| GastroenteritisInfections and infestations | 4/396 |
| PruritusSkin and subcutaneous tissue disorders | 4/396 |
| Injection site erythemaGeneral disorders | 4/396 |
| Injection site reactionGeneral disorders | 4/396 |
| Alanine aminotransferase increasedInvestigations | 4/396 |
Safety analysis set
| Age, Continuous(years) | Adalimumab |
|---|---|
| Mean | 46.3 ± 15.6 |
| Age, Customized(Participants) | Adalimumab |
|---|---|
| 15 to < 65 years | 344 |
| ≥ 65 years | 52 |
| Sex: Female, Male(Participants) | Adalimumab |
|---|---|
| Female | 130 |
| Male | 266 |
| Race/Ethnicity, Customized(Participants) | Adalimumab |
|---|---|
| Japanese | 396 |
| Region of Enrollment(participants) | Adalimumab |
|---|---|
| Japan | 396 |
Showing the first 100 of 194 sites.
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Plan to share: Undecided
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