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Drug Use Investigation for Humira® - All Patient Investigation for Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT01076959
Recruitment Status : Completed
First Posted : February 26, 2010
Results First Posted : August 7, 2012
Last Update Posted : August 28, 2012
Sponsor:
Information provided by (Responsible Party):
Abbott

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Rheumatoid Arthritis
Enrollment 7972
Recruitment Details The sponsor was required to include all patients diagnosed with rheumatoid arthritis and who were treated Humira in routine medical practice during the review period by the Pharmaceuticals and Medical Devices Agency (PMDA).
Pre-assignment Details The study was completed when the PMDA had completed their review. A total of 7972 patients were registered and case report forms were retrieved for 7891 patients; 151 patients were excluded from the analysis because the case report forms were either duplicated (n=150) or the patient was included in another survey (n=1).
Arm/Group Title Humira
Hide Arm/Group Description Patients who received Humira for 24 weeks during the PMDA review period.
Period Title: Overall Study
Started 7740
Completed 5490
Not Completed 2250
Reason Not Completed
Adverse Event             767
Lack of Efficacy             849
Non-compliance             274
Lost to Follow-up             241
Other             119
Arm/Group Title Humira
Hide Arm/Group Description Patients who received Humira for 24 weeks during the PMDA review period.
Overall Number of Baseline Participants 7740
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7740 participants
60.1  (13.0)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 7740 participants
<20 years 26
>=20-<30 165
>=30-<40 461
>=40-<50 828
>=50-<60 1803
>=60-<70 2515
>=70-<80 1676
>=80-<90 261
>=90 4
No data 1
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7740 participants
Female
6388
  82.5%
Male
1352
  17.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 7740 participants
7740
1.Primary Outcome
Title Total Number of Patients With Adverse Events
Hide Description Adverse events were assessed from the time treatment began until treatment ended after 24 weeks. Details about the adverse events and serious adverse events are presented with the adverse event section of the disclosure. This outcome is measured as a percentage of patients with adverse events.
Time Frame Baseline to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety population included all patients who received at least one dose of Humira, had one set of case report forms, and were registered with PMDA during the review period.
Arm/Group Title Humira
Hide Arm/Group Description:
Patients who received Humira for 24 weeks during the PMDA review period.
Overall Number of Participants Analyzed 7740
Measure Type: Number
Unit of Measure: Percentage of Patients
27.8
2.Primary Outcome
Title Patient Effectiveness Response Rating and Effective Rate of Humira With Disease Activity Score (DAS) 28 at Week 4
Hide Description Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 4. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).
Time Frame Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.
Arm/Group Title Humira - Good Response Humira - Moderate Response Humira - No Response Effective Rate-Sum of Patients With Good or Moderate Response
Hide Arm/Group Description:
Patients who received Humira during the PMDA review period and had a good response according to DAS 28 (improvement > 1.2) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
Patients who received Humira during the PMDA review period and had a moderate response according to DAS 28 (improvement 0.6 to 1.2) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
Patients who received Humira during the PMDA review period and had no response according to DAS 28 (improvement <0.6) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
Patients who received Humira during the PMDA review period and had a moderate or good response to DAS 28 (improvement =>0.6) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
Overall Number of Participants Analyzed 3341 3341 3341 3341
Measure Type: Number
Unit of Measure: Percentage of patients
20.4 45.7 33.9 66.1
3.Primary Outcome
Title Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 12
Hide Description Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 12. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.
Arm/Group Title Humira - Good Response Humira - Moderate Response Humira - No Response Effective Rate-Sum of Patients With Good or Moderate Response
Hide Arm/Group Description:
Patients who received Humira during the PMDA review period and had a good response to DAS 28 (improvement > 1.2) at Week 12. All variables may not have been tested; therefore, a patient may not have been included.
Patients who received Humira during the PMDA review period and had a moderate response to DAS 28 (improvement 0.6 to 1.2) at Week 12. All variables may not have been tested; therefore, a patient may not have been included.
Patients who received Humira during the PMDA review period and had no response to DAS 28 (improvement < 0.6) at Week 12. All variables may not have been tested; therefore, a patient may not have been included.
Patients who received Humira during the PMDA review period and had a moderate or good response to DAS 28 (improvement =>0.6) at Week 12. All variables may not have been tested; therefore, a patient may not have been included.
Overall Number of Participants Analyzed 3927 3927 3927 3927
Measure Type: Number
Unit of Measure: percentage of patients
26.4 42.6 31.1 68.9
4.Primary Outcome
Title Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 24
Hide Description Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 24. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.
Arm/Group Title Humira - Good Response Humira - Moderate Response Humira - No Response Effective Rate-Sum of Patients With Good and Moderate Response
Hide Arm/Group Description:
Patients who received Humira during the PMDA review period and had a good response to DAS 28 (improvement > 1.2) at Week 4.at Week 24. All variables may not have been tested; therefore, a patient may not have been included.
Patients who received Humira during the PMDA review period and had a moderate response to DAS 28 (improvement 0.6 to 1.2) at Week 24. All variables may not have been tested; therefore, a patient may not have been included.
Patients who received Humira during the PMDA review period and had no response to DAS 28 (improvement < 0.6) at Week 24. All variables may not have been tested; therefore, a patient may not have been included.
Patients who received Humira during the PMDA review period and had a moderate or good response to DAS 28 (improvement =>0.6) at Week 24. All variables may not have been tested; therefore, a patient may not have been included.
Overall Number of Participants Analyzed 4410 4410 4410 4410
Measure Type: Number
Unit of Measure: Percentage of Patients
30.7 39.3 29.9 70.1
5.Secondary Outcome
Title Physicians' Overall Effectiveness Response Rating
Hide Description Physicians' rated the level of overall patient improvement as "markedly improved," "improved," "not changed," or "not assessable" by comparing clinical conditions at Week 24 or at discontinuation with baseline conditions.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication label, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.
Arm/Group Title Physician Response Rating
Hide Arm/Group Description:
The full analysis set was used to determine the physicians' overall response rating.
Overall Number of Participants Analyzed 6802
Measure Type: Number
Unit of Measure: Percentage of Patients
Markedly Improved 29.1
Improved 45.2
Not Changed 19.6
Not Assessable 6.1
Time Frame Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Humira
Hide Arm/Group Description Patients who received Humira for 24 weeks during the PMDA review period.
All-Cause Mortality
Humira
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Humira
Affected / at Risk (%)
Total   469/7740 (6.06%) 
Blood and lymphatic system disorders   
Agranulocytosis  1/7740 (0.01%) 
Anemia  4/7740 (0.05%) 
Anemia folate deficiency  1/7740 (0.01%) 
Disseminated intravascular coagulation  3/7740 (0.04%) 
Lymphadenitis  2/7740 (0.03%) 
Lymphadenopathy  1/7740 (0.01%) 
Pancytopenia  5/7740 (0.06%) 
Thrombocytopenia  4/7740 (0.05%) 
Bone Marrow Failure  1/7740 (0.01%) 
Cardiac disorders   
Acute myocardial infarction  5/7740 (0.06%) 
Angina pectoris  1/7740 (0.01%) 
Atrial fibrillation  2/7740 (0.03%) 
Atrial tachycardia  1/7740 (0.01%) 
Cardiac failure  5/7740 (0.06%) 
Cardiac failure acute  1/7740 (0.01%) 
Cardiac failure congestive  1/7740 (0.01%) 
Pericardial effusion  2/7740 (0.03%) 
Right ventricular failure  1/7740 (0.01%) 
Sick sinus syndrome  1/7740 (0.01%) 
Ear and labyrinth disorders   
Deafness neurosensory  1/7740 (0.01%) 
Vertigo  1/7740 (0.01%) 
Eye disorders   
Retinal vein occlusion  1/7740 (0.01%) 
Scleritis  1/7740 (0.01%) 
Uveitis  1/7740 (0.01%) 
Visual impairment  1/7740 (0.01%) 
Gastrointestinal disorders   
Colitis ischemic  1/7740 (0.01%) 
Diarrhea  2/7740 (0.03%) 
Duodenal ulcer  1/7740 (0.01%) 
Enterocolitis  2/7740 (0.03%) 
Gastric ulcer  1/7740 (0.01%) 
Gastric ulcer hemorrhage  2/7740 (0.03%) 
Gastric ulcer perforation  1/7740 (0.01%) 
Gastritis atrophic  1/7740 (0.01%) 
Gastritis hemorrhagic  1/7740 (0.01%) 
Gastrointestinal hemorrhage  2/7740 (0.03%) 
Gastrointestinal necrosis  1/7740 (0.01%) 
Ileitis  1/7740 (0.01%) 
Ileus paralytic  1/7740 (0.01%) 
Intestinal obstruction  1/7740 (0.01%) 
Intestinal perforation  1/7740 (0.01%) 
Melena  2/7740 (0.03%) 
Esophageal ulcer  1/7740 (0.01%) 
Pancreatitis acute  2/7740 (0.03%) 
Peritonitis  1/7740 (0.01%) 
Small intestine ulcer  1/7740 (0.01%) 
Upper gastrointestinal hemorrhage  1/7740 (0.01%) 
Duodenal stenosis  1/7740 (0.01%) 
Pneumatosis intestinalis  1/7740 (0.01%) 
Diverticular perforation  1/7740 (0.01%) 
General disorders   
Chest pain  3/7740 (0.04%) 
Death  4/7740 (0.05%) 
Device breakage  1/7740 (0.01%) 
Drowning  1/7740 (0.01%) 
Gait disturbance  1/7740 (0.01%) 
Hyperthermia  1/7740 (0.01%) 
Local swelling  1/7740 (0.01%) 
Malaise  2/7740 (0.03%) 
Multiorgan failure  2/7740 (0.03%) 
Edema  1/7740 (0.01%) 
Edema peripheral  1/7740 (0.01%) 
Pyrexia  13/7740 (0.17%) 
Hepatobiliary disorders   
Cholecystitis  1/7740 (0.01%) 
Cholecystitis acute  2/7740 (0.03%) 
Hepatic failure  1/7740 (0.01%) 
Hepatic function abnormal  4/7740 (0.05%) 
Hepatitis  2/7740 (0.03%) 
Jaundice  1/7740 (0.01%) 
Liver disorder  2/7740 (0.03%) 
Gallbladder polyp  1/7740 (0.01%) 
Immune system disorders   
Anaphylactic reaction  1/7740 (0.01%) 
Anaphylactoid reaction  1/7740 (0.01%) 
Hypersensitivity  1/7740 (0.01%) 
Sarcoidosis  1/7740 (0.01%) 
Infections and infestations   
Bronchiolitis  1/7740 (0.01%) 
Bronchitis  3/7740 (0.04%) 
Bronchopneumonia  5/7740 (0.06%) 
Bronchopulmonary aspergillosis  1/7740 (0.01%) 
Cellulitis  12/7740 (0.16%) 
Cystitis  2/7740 (0.03%) 
Disseminated tuberculosis  1/7740 (0.01%) 
Endophthalmitis  1/7740 (0.01%) 
Erysipelas  1/7740 (0.01%) 
Gastroenteritis  4/7740 (0.05%) 
Hepatitis B  1/7740 (0.01%) 
Herpes zoster  12/7740 (0.16%) 
Infection  1/7740 (0.01%) 
Influenza  1/7740 (0.01%) 
Lymph node tuberculosis  1/7740 (0.01%) 
Meningitis  1/7740 (0.01%) 
Meningitis aseptic  2/7740 (0.03%) 
Nasopharyngitis  1/7740 (0.01%) 
Peritonsillar abscess  1/7740 (0.01%) 
Pharyngitis  1/7740 (0.01%) 
Pneumonia  41/7740 (0.53%) 
Pneumonia chlamydial  2/7740 (0.03%) 
Pneumonia cytomegaloviral  2/7740 (0.03%) 
Pneumonia legionella  3/7740 (0.04%) 
Pneumonia pneumococcal  2/7740 (0.03%) 
Postoperative wound infection  1/7740 (0.01%) 
Pseudomembranous colitis  1/7740 (0.01%) 
Pulmonary tuberculosis  3/7740 (0.04%) 
Pulpitis dental  1/7740 (0.01%) 
Pyelonephritis  4/7740 (0.05%) 
Pyelonephritis acute  1/7740 (0.01%) 
Pyothorax  2/7740 (0.03%) 
Rash pustular  2/7740 (0.03%) 
Sepsis  13/7740 (0.17%) 
Septic shock  2/7740 (0.03%) 
Tonsillitis  1/7740 (0.01%) 
Tooth abscess  1/7740 (0.01%) 
Tuberculosis  1/7740 (0.01%) 
Tuberculous pleurisy  2/7740 (0.03%) 
Urinary tract infection  4/7740 (0.05%) 
Muscle abscess  2/7740 (0.03%) 
Abscess limb  2/7740 (0.03%) 
Arthritis bacterial  7/7740 (0.09%) 
Peritoneal tuberculosis  1/7740 (0.01%) 
Psoas abscess  1/7740 (0.01%) 
Wound abscess  1/7740 (0.01%) 
Pneumonia bacterial  13/7740 (0.17%) 
Bursitis infective  2/7740 (0.03%) 
Lung infection  1/7740 (0.01%) 
Tuberculosis gastrointestinal  1/7740 (0.01%) 
Atypical mycobacterial infection  1/7740 (0.01%) 
Enterocolitis viral  1/7740 (0.01%) 
Purulence  1/7740 (0.01%) 
Mycobacterial infection  1/7740 (0.01%) 
Pneumocystis jiroveci pneumonia  26/7740 (0.34%) 
Device related infection  1/7740 (0.01%) 
Enterocolitis bacterial  1/7740 (0.01%) 
Post procedural infection  1/7740 (0.01%) 
Pneumonia cryptococcal  2/7740 (0.03%) 
Injury, poisoning and procedural complications   
Compression fracture  2/7740 (0.03%) 
Fall  3/7740 (0.04%) 
Femoral neck fracture  10/7740 (0.13%) 
Femur fracture  5/7740 (0.06%) 
Fibula fracture  2/7740 (0.03%) 
Foot fracture  1/7740 (0.01%) 
Fracture  1/7740 (0.01%) 
Fractured sacrum  2/7740 (0.03%) 
Head injury  1/7740 (0.01%) 
Humerus fracture  2/7740 (0.03%) 
Pneumothorax traumatic  1/7740 (0.01%) 
Radius fracture  2/7740 (0.03%) 
Rib fracture  1/7740 (0.01%) 
Road traffic accident  1/7740 (0.01%) 
Spinal compression fracture  6/7740 (0.08%) 
Subdural hematoma  1/7740 (0.01%) 
Tendon rupture  6/7740 (0.08%) 
Tibia fracture  1/7740 (0.01%) 
Ulna fracture  1/7740 (0.01%) 
Contusion  3/7740 (0.04%) 
Joint injury  1/7740 (0.01%) 
Pelvic fracture  3/7740 (0.04%) 
Upper limb fracture  1/7740 (0.01%) 
Periprosthetic fracture  1/7740 (0.01%) 
Pubis fracture  1/7740 (0.01%) 
Investigations   
Blood creatine phosphokinase increased  1/7740 (0.01%) 
Blood glucose decreased  1/7740 (0.01%) 
Blood glucose increased  1/7740 (0.01%) 
Blood pressure increased  1/7740 (0.01%) 
C-reactive protein increased  2/7740 (0.03%) 
Carcinoembryonic antigen increased  1/7740 (0.01%) 
Platelet count decreased  1/7740 (0.01%) 
White blood cell count decreased  1/7740 (0.01%) 
Blood beta-D-glucan abnormal  1/7740 (0.01%) 
Hepatic enzyme increased  1/7740 (0.01%) 
Cell marker increased  1/7740 (0.01%) 
Candida test positive  1/7740 (0.01%) 
Metabolism and nutrition disorders   
Diabetes mellitus  1/7740 (0.01%) 
Hyperglycemia  1/7740 (0.01%) 
Hypoglycemia  2/7740 (0.03%) 
Decreased appetite  2/7740 (0.03%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  4/7740 (0.05%) 
Arthritis  2/7740 (0.03%) 
Arthropathy  1/7740 (0.01%) 
Back pain  5/7740 (0.06%) 
Bursitis  1/7740 (0.01%) 
Myalgia  1/7740 (0.01%) 
Myositis  1/7740 (0.01%) 
Polymyalgia rheumatic  1/7740 (0.01%) 
Polymyositis  3/7740 (0.04%) 
Rhabdomyolysis  1/7740 (0.01%) 
Scleroderma  1/7740 (0.01%) 
Spinal column stenosis  1/7740 (0.01%) 
Systemic lupus erythematosus  2/7740 (0.03%) 
Foot deformity  1/7740 (0.01%) 
Spondylolisthesis  1/7740 (0.01%) 
Atlantoaxial instability  1/7740 (0.01%) 
Rheumatoid arthritis  5/7740 (0.06%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Bile duct cancer  1/7740 (0.01%) 
Bladder cancer recurrent  1/7740 (0.01%) 
Bone neoplasm  1/7740 (0.01%) 
Breast cancer recurrent  1/7740 (0.01%) 
Cervix carcinoma stage IV  1/7740 (0.01%) 
Colon cancer  1/7740 (0.01%) 
Gastric cancer  1/7740 (0.01%) 
Hepatic neoplasm malignant  1/7740 (0.01%) 
Laryngeal cancer  1/7740 (0.01%) 
Lung carcinoma cell type unspecified recurrent  1/7740 (0.01%) 
Lung squamous cell carcinoma stage unspecified  2/7740 (0.03%) 
Malignant ascites  1/7740 (0.01%) 
Meningioma  1/7740 (0.01%) 
Non-Hodgkin's Lymphoma  1/7740 (0.01%) 
Rectal cancer  1/7740 (0.01%) 
Squamous cell carcinoma of the cervix  1/7740 (0.01%) 
Tongue neoplasm malignant stage unspecified  1/7740 (0.01%) 
Tumour embolism  1/7740 (0.01%) 
Gallbladder cancer stage IV  1/7740 (0.01%) 
Large intestine carcinoma  1/7740 (0.01%) 
Prostate cancer  1/7740 (0.01%) 
Salivary gland neoplasm  1/7740 (0.01%) 
Ovarian neoplasm  1/7740 (0.01%) 
Metastatis  1/7740 (0.01%) 
Nervous system disorders   
Amnesia  1/7740 (0.01%) 
Cauda equina syndrome  1/7740 (0.01%) 
Cerebellar infarction  1/7740 (0.01%) 
Cerebral hemorrhage  3/7740 (0.04%) 
Cerebral thrombosis  1/7740 (0.01%) 
Cerebrovascular accident  1/7740 (0.01%) 
Cerebrovascular disorder  1/7740 (0.01%) 
Demyelination  1/7740 (0.01%) 
Nervous system disorder  1/7740 (0.01%) 
Optic neuritis  1/7740 (0.01%) 
Sciatica  1/7740 (0.01%) 
Subarachnoid hemorrhage  5/7740 (0.06%) 
Syncope  1/7740 (0.01%) 
Transient ischaemic attack  1/7740 (0.01%) 
Putamen hemorrhage  1/7740 (0.01%) 
Thrombotic cerebral infarction  1/7740 (0.01%) 
Cerebral infarction  4/7740 (0.05%) 
Psychiatric disorders   
Completed suicide  2/7740 (0.03%) 
Insomnia  1/7740 (0.01%) 
Renal and urinary disorders   
Calculus ureteric  1/7740 (0.01%) 
Nephrotic syndrome  1/7740 (0.01%) 
Renal failure  1/7740 (0.01%) 
Renal failure acute  3/7740 (0.04%) 
Renal impairment  2/7740 (0.03%) 
Henoch-Schonlein purpura nephritis  1/7740 (0.01%) 
Respiratory, thoracic and mediastinal disorders   
Asthma  1/7740 (0.01%) 
Cough  1/7740 (0.01%) 
Dyspnea  4/7740 (0.05%) 
Interstitial lung disease  40/7740 (0.52%) 
Lung disorder  1/7740 (0.01%) 
Pleural effusion  4/7740 (0.05%) 
Pleurisy  3/7740 (0.04%) 
Pneumonia aspiration  1/7740 (0.01%) 
Pulmonary embolism  1/7740 (0.01%) 
Pulmonary edema  1/7740 (0.01%) 
Respiratory failure  4/7740 (0.05%) 
Rheumatoid lung  1/7740 (0.01%) 
Diffuse panbronchiolitis  1/7740 (0.01%) 
Organising pneumonia  5/7740 (0.06%) 
Skin and subcutaneous tissue disorders   
Dermatitis acneiform  1/7740 (0.01%) 
Dermatitis allergic  1/7740 (0.01%) 
Dermatomyositis  1/7740 (0.01%) 
Drug eruption  2/7740 (0.03%) 
Eczema  1/7740 (0.01%) 
Erythema  2/7740 (0.03%) 
Leukocytoclastic vasculitis  1/7740 (0.01%) 
Rash  4/7740 (0.05%) 
Rash erythematosus  1/7740 (0.01%) 
Rash generalized  2/7740 (0.03%) 
Skin necrosis  1/7740 (0.01%) 
Skin ulcer  1/7740 (0.01%) 
Stevens-Johnson syndrome  1/7740 (0.01%) 
Urticaria  1/7740 (0.01%) 
Generalized erythema  1/7740 (0.01%) 
Toxic skin eruption  1/7740 (0.01%) 
Dermatitis psoriasiform  1/7740 (0.01%) 
Vascular disorders   
Aortic aneurysm  1/7740 (0.01%) 
Aortic dissection  1/7740 (0.01%) 
Hypotension  1/7740 (0.01%) 
Peripheral circulatory failure  1/7740 (0.01%) 
Shock  1/7740 (0.01%) 
Vasculitis  1/7740 (0.01%) 
Vasculitis necrotizing  1/7740 (0.01%) 
Deep vein thrombosis  2/7740 (0.03%) 
Arterial hemorrhage  1/7740 (0.01%) 
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Humira
Affected / at Risk (%)
Total   863/7740 (11.15%) 
General disorders   
Injection site erythema  160/7740 (2.07%) 
Injection site reaction  108/7740 (1.40%) 
Pyrexia  99/7740 (1.28%) 
Hepatobiliary disorders   
Hepatic function abnormal  110/7740 (1.42%) 
Infections and infestations   
Nasopharyngitis  94/7740 (1.21%) 
Respiratory, thoracic and mediastinal disorders   
Upper respiratory tract inflammation  79/7740 (1.02%) 
Skin and subcutaneous tissue disorders   
Pruritus  78/7740 (1.01%) 
Rash  255/7740 (3.29%) 
1
Term from vocabulary, MedDRA 14.0
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.
Abbott 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. Abbott 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 Abbott needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title: Global Medical Services
Organization: Abbott
Phone: 800-633-9110
Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01076959     History of Changes
Other Study ID Numbers: P10-559
First Submitted: February 25, 2010
First Posted: February 26, 2010
Results First Submitted: June 29, 2012
Results First Posted: August 7, 2012
Last Update Posted: August 28, 2012