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Trial record 1 of 1 for:    NCT00293722
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Study Evaluating the Safety and Efficacy of Etanercept in Patients With Psoriatic Arthritis Treated by Rheumatologists

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ClinicalTrials.gov Identifier: NCT00293722
Recruitment Status : Completed
First Posted : February 17, 2006
Results First Posted : February 26, 2014
Last Update Posted : February 26, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Arthritis, Psoriatic
Psoriasis
Skin Diseases, Papulosquamous
Intervention Drug: Etanercept
Enrollment 1308
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Participants With Psoriatic Arthritis
Hide Arm/Group Description Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
Period Title: Overall Study
Started 1291
Completed 864
Not Completed 427
Reason Not Completed
Other             427
Arm/Group Title Participants With Psoriatic Arthritis
Hide Arm/Group Description Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
Overall Number of Baseline Participants 1285
Hide Baseline Analysis Population Description
Safety analysis set included all participants who were enrolled in this study and had safety data available. Out of a total of 1285 participants included in the safety analysis set, data for baseline measure (age) was available only for 1274 participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1285 participants
50.9  (11.4)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1285 participants
Female 708
Male 571
Missing 6
1.Primary Outcome
Title Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Week 52 (end of the observation period) that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.
Time Frame Baseline up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who were enrolled in this study and had safety data available.
Arm/Group Title Participants With Psoriatic Arthritis
Hide Arm/Group Description:
Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
Overall Number of Participants Analyzed 1285
Measure Type: Number
Unit of Measure: percentage of participants
AEs 38.1
SAEs 6.0
2.Secondary Outcome
Title Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52
Hide Description [Not Specified]
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who were greater than (>) 18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
Arm/Group Title Participants With Psoriatic Arthritis
Hide Arm/Group Description:
Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
Overall Number of Participants Analyzed 1227
Mean (Standard Deviation)
Unit of Measure: percentage of BSA
Baseline (n=1227) 9.7  (15.9)
Change at Week 52 (n=796) -6.6  (13.4)
3.Secondary Outcome
Title Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52
Hide Description DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 100 mm; higher scores indicated greater affectation due to disease activity). DAS28 total score range: 0-10, where DAS28 less than or equal to (=<) 3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate disease activity and >5.1 = high disease activity.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
Arm/Group Title Participants With Psoriatic Arthritis
Hide Arm/Group Description:
Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
Overall Number of Participants Analyzed 1093
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=1093) 4.8  (1.4)
Change at Week 52 (n=629) -2.2  (1.5)
4.Secondary Outcome
Title Change From Baseline in Ritchie Index at Week 52
Hide Description Ritchie index: the numerical measurement of joint tenderness (28 joints) in participants with arthritis. The number of quantitative evaluations of the pain experienced by the participants when the joints were subjected to firm pressure when exerted over the articular margin or in some instances by passive movement of the joint. Participant's reaction to pressure exerted by the physician were documented on 4-point scale, 0=not tender, 1=tender, 2=tender and caused wince, 3=reflexive effort to withdraw. Ritchie index was calculated as the total of the individual grades for all joints; ranged from 0 to 84, where higher score indicated higher tenderness.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
Arm/Group Title Participants With Psoriatic Arthritis
Hide Arm/Group Description:
Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
Overall Number of Participants Analyzed 1267
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=1267) 9.9  (9.8)
Change at Week 52 (n=851) -4.1  (11.9)
5.Secondary Outcome
Title Change From Baseline in Physician Global Assessment of Disease Activity at Week 52
Hide Description Physician global assessment of disease activity was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity to 100 mm = most possible disease activity.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
Arm/Group Title Participants With Psoriatic Arthritis
Hide Arm/Group Description:
Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
Overall Number of Participants Analyzed 1278
Mean (Standard Deviation)
Unit of Measure: millimeter
Baseline (n=1278) 60.8  (18.8)
Change at Week 52 (n=851) -39.8  (24.2)
6.Secondary Outcome
Title Number of Participants With Nail Involvement
Hide Description Number of participants with psoriatic arthritis affecting the nails are reported.
Time Frame Baseline, Week 12, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
Arm/Group Title Participants With Psoriatic Arthritis
Hide Arm/Group Description:
Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
Overall Number of Participants Analyzed 1271
Measure Type: Number
Unit of Measure: participants
Baseline (n=1271) 597
Week 12 (n=1121) 456
Week 52 (n=837) 259
7.Secondary Outcome
Title Change From Baseline in C-reactive Protein (CRP) at Week 52
Hide Description The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
Arm/Group Title Participants With Psoriatic Arthritis
Hide Arm/Group Description:
Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
Overall Number of Participants Analyzed 1124
Mean (Standard Deviation)
Unit of Measure: milligram per deciliter (mg/dL)
Baseline (n=1124) 1.8  (3.0)
Change at Week 52 (n=654) -1.0  (3.0)
8.Secondary Outcome
Title Change From Baseline in Patient Assessment of Itching at Week 52
Hide Description Participants rated the severity of their psoriasis itching on a 0 (none) to 100 (most possible) scale.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
Arm/Group Title Participants With Psoriatic Arthritis
Hide Arm/Group Description:
Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
Overall Number of Participants Analyzed 1259
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=1259) 36.8  (31.1)
Change at Week 52 (n=838) -22.7  (31.8)
9.Secondary Outcome
Title Change From Baseline in Patient Assessment of Pain at Week 52
Hide Description Participants rated the severity of their psoriatic arthritis-related pain on a 0 (none) to 100 (most possible) scale.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
Arm/Group Title Participants With Psoriatic Arthritis
Hide Arm/Group Description:
Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
Overall Number of Participants Analyzed 1276
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=1276) 65.7  (21.6)
Change at Week 52 (n=849) -37.9  (28.3)
10.Secondary Outcome
Title Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52
Hide Description SF-12 questionnaire was used to determine participants' quality of life (QoL). It comprised 12 items which covered 8 concepts: physical functionality, role impairment due to physical problems, physical pain, perception of general health, vitality, social functionality, role impairment due to emotional problems, and psychological wellbeing. Results were presented in the form of 2 meta-scores, the physical component and the mental component, each ranged from 0 to 100. Higher scores=better QoL, positive changes from baseline=improvement in QoL.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
Arm/Group Title Participants With Psoriatic Arthritis
Hide Arm/Group Description:
Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
Overall Number of Participants Analyzed 1162
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: Physical component (n=1162) 30.7  (8.5)
Baseline: Mental component (n=1162) 41.4  (11.7)
Change at Week 52: Physical component (n=717) 11.4  (10.8)
Change at Week 52: Mental component (n=717) 7.7  (12.3)
11.Other Pre-specified Outcome
Title Change From Baseline in Patient Global Assessment of Disease Activity at Week 52
Hide Description Measured using a 100 mm visual analog scale (VAS) ranging from 0 mm = very good to 100 mm = very bad.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who were >18 years of age and had confirmed diagnosis of psoriatic arthritis. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time point.
Arm/Group Title Participants With Psoriatic Arthritis
Hide Arm/Group Description:
Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
Overall Number of Participants Analyzed 1277
Mean (Standard Deviation)
Unit of Measure: millimeter
Baseline (n=1277) 65.0  (20.6)
Change at Week 52 (n=852) -38.1  (27.3)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Participants With Psoriatic Arthritis
Hide Arm/Group Description Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
All-Cause Mortality
Participants With Psoriatic Arthritis
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Participants With Psoriatic Arthritis
Affected / at Risk (%)
Total   77/1285 (5.99%) 
Blood and lymphatic system disorders   
Thrombocytopenia * 1  1/1285 (0.08%) 
Cardiac disorders   
Atrial fibrillation * 1  2/1285 (0.16%) 
Bradyarrhythmia * 1  1/1285 (0.08%) 
Coronary artery disease * 1  3/1285 (0.23%) 
Cyanosis * 1  1/1285 (0.08%) 
Pericardial effusion * 1  1/1285 (0.08%) 
Tachyarrhythmia * 1  1/1285 (0.08%) 
Endocrine disorders   
Adrenal mass * 1  1/1285 (0.08%) 
Gastrointestinal disorders   
Abdominal pain upper * 1  1/1285 (0.08%) 
Abdominal wall disorder * 1  1/1285 (0.08%) 
Barrett's oesophagus * 1  1/1285 (0.08%) 
Constipation * 1  1/1285 (0.08%) 
Diarrhoea * 1  1/1285 (0.08%) 
Gastritis * 1  1/1285 (0.08%) 
Haemorrhoids * 1  1/1285 (0.08%) 
General disorders   
Chest discomfort * 1  1/1285 (0.08%) 
Chest pain * 1  2/1285 (0.16%) 
Condition aggravated * 1  4/1285 (0.31%) 
Drug ineffective * 1  1/1285 (0.08%) 
Impaired healing * 1  1/1285 (0.08%) 
Necrosis * 1  1/1285 (0.08%) 
Nonspecific reaction * 1  1/1285 (0.08%) 
Pyrexia * 1  1/1285 (0.08%) 
Hepatobiliary disorders   
Cholecystitis * 1  2/1285 (0.16%) 
Cholelithiasis * 1  2/1285 (0.16%) 
Infections and infestations   
Abscess limb * 1  1/1285 (0.08%) 
Abscess neck * 1  1/1285 (0.08%) 
Bronchitis * 1  1/1285 (0.08%) 
Cellulitis * 1  1/1285 (0.08%) 
Diverticulitis * 1  1/1285 (0.08%) 
Furuncle * 1  1/1285 (0.08%) 
Gastroenteritis Norwalk virus * 1  1/1285 (0.08%) 
Herpes zoster * 1  1/1285 (0.08%) 
Peritonsillar abscess * 1  1/1285 (0.08%) 
Pulmonary tuberculosis * 1  1/1285 (0.08%) 
Pyelonephritis * 1  2/1285 (0.16%) 
Urosepsis * 1  1/1285 (0.08%) 
Injury, poisoning and procedural complications   
Cartilage injury * 1  1/1285 (0.08%) 
Facial bones fracture * 1  1/1285 (0.08%) 
Meniscus lesion * 1  1/1285 (0.08%) 
Pelvic fracture * 1  1/1285 (0.08%) 
Spinal compression fracture * 1  1/1285 (0.08%) 
Tibia fracture * 1  1/1285 (0.08%) 
Investigations   
Liver function test abnormal * 1  1/1285 (0.08%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  1/1285 (0.08%) 
Bone disorder * 1  1/1285 (0.08%) 
Bursitis * 1  1/1285 (0.08%) 
Fracture delayed union * 1  1/1285 (0.08%) 
Intervertebral disc protrusion * 1  5/1285 (0.39%) 
Muscular weakness * 1  1/1285 (0.08%) 
Osteoarthritis * 1  1/1285 (0.08%) 
Osteonecrosis * 1  2/1285 (0.16%) 
Rotator cuff syndrome * 1  2/1285 (0.16%) 
Spinal column stenosis * 1  1/1285 (0.08%) 
Synovitis * 1  1/1285 (0.08%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Adrenal adenoma * 1  1/1285 (0.08%) 
Breast cancer * 1  1/1285 (0.08%) 
Gastric cancer * 1  1/1285 (0.08%) 
Lung adenocarcinoma * 1  1/1285 (0.08%) 
Malignant melanoma * 1  1/1285 (0.08%) 
Metastatic malignant melanoma * 1  1/1285 (0.08%) 
Ovarian adenoma * 1  1/1285 (0.08%) 
Pancreatic neoplasm * 1  1/1285 (0.08%) 
Rectal cancer * 1  1/1285 (0.08%) 
Nervous system disorders   
Amyotrophic lateral sclerosis * 1  1/1285 (0.08%) 
Aphasia * 1  1/1285 (0.08%) 
Carotid artery occlusion * 1  1/1285 (0.08%) 
Cerebral ischaemia * 1  1/1285 (0.08%) 
Cerebrovascular accident * 1  1/1285 (0.08%) 
Demyelination * 1  1/1285 (0.08%) 
Encephalitis * 1  1/1285 (0.08%) 
Multiple sclerosis * 1  1/1285 (0.08%) 
Myelitis * 1  1/1285 (0.08%) 
Optic neuritis * 1  2/1285 (0.16%) 
Sciatica * 1  1/1285 (0.08%) 
Transient ischaemic attack * 1  1/1285 (0.08%) 
Psychiatric disorders   
Depression * 1  1/1285 (0.08%) 
Renal and urinary disorders   
Calculus ureteric * 1  1/1285 (0.08%) 
Respiratory, thoracic and mediastinal disorders   
Alveolitis allergic * 1  1/1285 (0.08%) 
Bronchospasm * 1  1/1285 (0.08%) 
Chronic obstructive pulmonary disease * 1  1/1285 (0.08%) 
Pulmonary sarcoidosis * 1  1/1285 (0.08%) 
Skin and subcutaneous tissue disorders   
Pemphigoid * 1  1/1285 (0.08%) 
Psoriasis * 1  2/1285 (0.16%) 
Pustular psoriasis * 1  1/1285 (0.08%) 
Skin reaction * 1  1/1285 (0.08%) 
Swelling face * 1  1/1285 (0.08%) 
Surgical and medical procedures   
Alcohol rehabilitation * 1  1/1285 (0.08%) 
Vascular operation * 1  1/1285 (0.08%) 
Vascular disorders   
Accelerated hypertension * 1  1/1285 (0.08%) 
Hypertension * 1  1/1285 (0.08%) 
Lymphocele * 1  1/1285 (0.08%) 
Peripheral arterial occlusive disease * 1  1/1285 (0.08%) 
Thrombosis * 1  1/1285 (0.08%) 
Venous insufficiency * 1  1/1285 (0.08%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v10.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Participants With Psoriatic Arthritis
Affected / at Risk (%)
Total   453/1285 (35.25%) 
Blood and lymphatic system disorders   
Leukopenia * 1  5/1285 (0.39%) 
Lymphadenopathy * 1  7/1285 (0.54%) 
Thrombocytopenia * 1  2/1285 (0.16%) 
Cardiac disorders   
Angina pectoris * 1  2/1285 (0.16%) 
Arrhythmia * 1  1/1285 (0.08%) 
Cardiac discomfort * 1  2/1285 (0.16%) 
Cardiovascular disorder * 1  1/1285 (0.08%) 
Cyanosis * 1  1/1285 (0.08%) 
Palpitations * 1  3/1285 (0.23%) 
Tachycardia * 1  1/1285 (0.08%) 
Congenital, familial and genetic disorders   
Type IIb hyperlipidaemia * 1  1/1285 (0.08%) 
Ear and labyrinth disorders   
Ear discomfort * 1  1/1285 (0.08%) 
Ear pain * 1  2/1285 (0.16%) 
Tinnitus * 1  4/1285 (0.31%) 
Vertigo * 1  1/1285 (0.08%) 
Endocrine disorders   
Hyperthyroidism * 1  1/1285 (0.08%) 
Toxic nodular goitre * 1  1/1285 (0.08%) 
Eye disorders   
Abnormal sensation in eye * 1  2/1285 (0.16%) 
Blepharitis * 1  1/1285 (0.08%) 
Cataract * 1  1/1285 (0.08%) 
Conjunctivitis * 1  3/1285 (0.23%) 
Conjunctivitis allergic * 1  1/1285 (0.08%) 
Eye inflammation * 1  2/1285 (0.16%) 
Eye pain * 1  1/1285 (0.08%) 
Eyelid oedema * 1  1/1285 (0.08%) 
Iridocyclitis * 1  1/1285 (0.08%) 
Iritis * 1  3/1285 (0.23%) 
Keratitis * 1  1/1285 (0.08%) 
Lacrimation increased * 1  1/1285 (0.08%) 
Photophobia * 1  1/1285 (0.08%) 
Scleritis * 1  1/1285 (0.08%) 
Sicca syndrome * 1  1/1285 (0.08%) 
Uveitis * 1  1/1285 (0.08%) 
Vision blurred * 1  1/1285 (0.08%) 
Visual acuity reduced * 1  1/1285 (0.08%) 
Gastrointestinal disorders   
Abdominal discomfort * 1  2/1285 (0.16%) 
Abdominal pain * 1  1/1285 (0.08%) 
Abdominal pain lower * 1  1/1285 (0.08%) 
Abdominal pain upper * 1  2/1285 (0.16%) 
Aphthous stomatitis * 1  2/1285 (0.16%) 
Colitis * 1  1/1285 (0.08%) 
Constipation * 1  1/1285 (0.08%) 
Diarrhoea * 1  18/1285 (1.40%) 
Duodenal polyp * 1  1/1285 (0.08%) 
Dysphagia * 1  1/1285 (0.08%) 
Epigastric discomfort * 1  1/1285 (0.08%) 
Frequent bowel movements * 1  1/1285 (0.08%) 
Gastric ulcer * 1  1/1285 (0.08%) 
Gastritis * 1  1/1285 (0.08%) 
Gastrointestinal pain * 1  1/1285 (0.08%) 
Gastrooesophageal reflux disease * 1  1/1285 (0.08%) 
Gingival bleeding * 1  1/1285 (0.08%) 
Mouth ulceration * 1  1/1285 (0.08%) 
Mucous stools * 1  1/1285 (0.08%) 
Nausea * 1  16/1285 (1.25%) 
Oral mucosal blistering * 1  1/1285 (0.08%) 
Paraesthesia oral * 1  1/1285 (0.08%) 
Periodontitis * 1  2/1285 (0.16%) 
Stomach discomfort * 1  1/1285 (0.08%) 
Stomatitis * 1  1/1285 (0.08%) 
Toothache * 1  1/1285 (0.08%) 
Vomiting * 1  4/1285 (0.31%) 
General disorders   
Asthenia * 1  1/1285 (0.08%) 
Chest discomfort * 1  4/1285 (0.31%) 
Chills * 1  3/1285 (0.23%) 
Condition aggravated * 1  41/1285 (3.19%) 
Drug ineffective * 1  2/1285 (0.16%) 
Facial pain * 1  1/1285 (0.08%) 
Fatigue * 1  20/1285 (1.56%) 
Feeling cold * 1  1/1285 (0.08%) 
Feeling hot * 1  1/1285 (0.08%) 
General physical health deterioration * 1  1/1285 (0.08%) 
Influenza like illness * 1  1/1285 (0.08%) 
Injection site discolouration * 1  1/1285 (0.08%) 
Injection site erythema * 1  66/1285 (5.14%) 
Injection site hypersensitivity * 1  1/1285 (0.08%) 
Injection site induration * 1  1/1285 (0.08%) 
Injection site inflammation * 1  2/1285 (0.16%) 
Injection site irritation * 1  5/1285 (0.39%) 
Injection site macule * 1  1/1285 (0.08%) 
Injection site oedema * 1  2/1285 (0.16%) 
Injection site pain * 1  2/1285 (0.16%) 
Injection site papule * 1  1/1285 (0.08%) 
Injection site pruritus * 1  32/1285 (2.49%) 
Injection site rash * 1  6/1285 (0.47%) 
Injection site reaction * 1  19/1285 (1.48%) 
Injection site swelling * 1  16/1285 (1.25%) 
Injection site urticaria * 1  2/1285 (0.16%) 
Injection site warmth * 1  3/1285 (0.23%) 
Local swelling * 1  1/1285 (0.08%) 
Malaise * 1  2/1285 (0.16%) 
Mucosal haemorrhage * 1  1/1285 (0.08%) 
Oedema * 1  1/1285 (0.08%) 
Oedema peripheral * 1  5/1285 (0.39%) 
Pain * 1  2/1285 (0.16%) 
Paradoxical pain * 1  1/1285 (0.08%) 
Performance status decreased * 1  2/1285 (0.16%) 
Pyrexia * 1  2/1285 (0.16%) 
Sensation of foreign body * 1  2/1285 (0.16%) 
Swelling * 1  1/1285 (0.08%) 
Hepatobiliary disorders   
Cholelithiasis * 1  1/1285 (0.08%) 
Hepatic cirrhosis * 1  1/1285 (0.08%) 
Hepatic steatosis * 1  1/1285 (0.08%) 
Hepatocellular damage * 1  1/1285 (0.08%) 
Hyperbilirubinaemia * 1  1/1285 (0.08%) 
Liver disorder * 1  1/1285 (0.08%) 
Immune system disorders   
Food allergy * 1  1/1285 (0.08%) 
Hypersensitivity * 1  5/1285 (0.39%) 
Seasonal allergy * 1  1/1285 (0.08%) 
Type IV hypersensitivity reaction * 1  1/1285 (0.08%) 
Infections and infestations   
Acute tonsillitis * 1  2/1285 (0.16%) 
Arthritis infective * 1  1/1285 (0.08%) 
Bacterial infection * 1  1/1285 (0.08%) 
Bronchitis * 1  19/1285 (1.48%) 
Bronchopneumonia * 1  1/1285 (0.08%) 
Campylobacter infection * 1  1/1285 (0.08%) 
Candidiasis * 1  2/1285 (0.16%) 
Conjunctivitis infective * 1  1/1285 (0.08%) 
Cystitis * 1  3/1285 (0.23%) 
Ear infection * 1  1/1285 (0.08%) 
Erysipelas * 1  2/1285 (0.16%) 
Febrile infection * 1  4/1285 (0.31%) 
Fungal skin infection * 1  1/1285 (0.08%) 
Furuncle * 1  1/1285 (0.08%) 
Gastroenteritis * 1  3/1285 (0.23%) 
Gastrointestinal infection * 1  5/1285 (0.39%) 
Helicobacter infection * 1  1/1285 (0.08%) 
Herpes simplex * 1  2/1285 (0.16%) 
Herpes virus infection * 1  3/1285 (0.23%) 
Herpes zoster * 1  2/1285 (0.16%) 
Hordeolum * 1  1/1285 (0.08%) 
Infection * 1  7/1285 (0.54%) 
Infection in an immunocompromised host * 1  2/1285 (0.16%) 
Influenza * 1  1/1285 (0.08%) 
Laryngitis * 1  1/1285 (0.08%) 
Laryngopharyngitis * 1  1/1285 (0.08%) 
Nail bed infection * 1  1/1285 (0.08%) 
Nasopharyngitis * 1  50/1285 (3.89%) 
Onychomycosis * 1  1/1285 (0.08%) 
Oral candidiasis * 1  2/1285 (0.16%) 
Oral herpes * 1  7/1285 (0.54%) 
Oral infection * 1  1/1285 (0.08%) 
Otitis media * 1  1/1285 (0.08%) 
Pertussis * 1  1/1285 (0.08%) 
Pharyngitis * 1  2/1285 (0.16%) 
Pneumonia * 1  1/1285 (0.08%) 
Purulence * 1  2/1285 (0.16%) 
Rash pustular * 1  1/1285 (0.08%) 
Respiratory tract infection * 1  13/1285 (1.01%) 
Rhinitis * 1  2/1285 (0.16%) 
Sinobronchitis * 1  1/1285 (0.08%) 
Sinusitis * 1  12/1285 (0.93%) 
Skin infection * 1  1/1285 (0.08%) 
Staphylococcal skin infection * 1  1/1285 (0.08%) 
Subcutaneous abscess * 1  2/1285 (0.16%) 
Tinea pedis * 1  1/1285 (0.08%) 
Tonsillitis * 1  1/1285 (0.08%) 
Tooth abscess * 1  1/1285 (0.08%) 
Toxoplasmosis * 1  1/1285 (0.08%) 
Tracheitis * 1  1/1285 (0.08%) 
Upper respiratory tract infection * 1  22/1285 (1.71%) 
Urinary tract infection * 1  10/1285 (0.78%) 
Vaginal candidiasis * 1  1/1285 (0.08%) 
Viral infection * 1  3/1285 (0.23%) 
Injury, poisoning and procedural complications   
Animal bite * 1  1/1285 (0.08%) 
Arthropod bite * 1  1/1285 (0.08%) 
Contusion * 1  3/1285 (0.23%) 
Epicondylitis * 1  1/1285 (0.08%) 
Fall * 1  3/1285 (0.23%) 
Forearm fracture * 1  1/1285 (0.08%) 
Joint sprain * 1  2/1285 (0.16%) 
Limb injury * 1  2/1285 (0.16%) 
Meniscus lesion * 1  1/1285 (0.08%) 
Post procedural complication * 1  1/1285 (0.08%) 
Road traffic accident * 1  1/1285 (0.08%) 
Scratch * 1  1/1285 (0.08%) 
Skin laceration * 1  1/1285 (0.08%) 
Tendon injury * 1  1/1285 (0.08%) 
Thoracic vertebral fracture * 1  1/1285 (0.08%) 
Wound * 1  1/1285 (0.08%) 
Wrist fracture * 1  1/1285 (0.08%) 
Investigations   
Alanine aminotransferase increased * 1  3/1285 (0.23%) 
Antinuclear antibody increased * 1  1/1285 (0.08%) 
Arthroscopy * 1  1/1285 (0.08%) 
Blood creatinine increased * 1  1/1285 (0.08%) 
Blood pressure increased * 1  6/1285 (0.47%) 
Body temperature increased * 1  2/1285 (0.16%) 
Gamma-glutamyltransferase increased * 1  6/1285 (0.47%) 
Haematocrit increased * 1  1/1285 (0.08%) 
Haemoglobin decreased * 1  1/1285 (0.08%) 
Liver function test abnormal * 1  8/1285 (0.62%) 
Mean cell haemoglobin increased * 1  1/1285 (0.08%) 
Mean cell volume increased * 1  1/1285 (0.08%) 
Red blood cell count decreased * 1  1/1285 (0.08%) 
Transaminases increased * 1  5/1285 (0.39%) 
Weight decreased * 1  1/1285 (0.08%) 
Weight increased * 1  2/1285 (0.16%) 
White blood cell count decreased * 1  3/1285 (0.23%) 
Metabolism and nutrition disorders   
Diabetes mellitus * 1  1/1285 (0.08%) 
Hyperlipidaemia * 1  1/1285 (0.08%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  7/1285 (0.54%) 
Arthritis * 1  2/1285 (0.16%) 
Arthropathy * 1  2/1285 (0.16%) 
Back pain * 1  2/1285 (0.16%) 
Bone disorder * 1  1/1285 (0.08%) 
Bone pain * 1  1/1285 (0.08%) 
Fibromyalgia * 1  2/1285 (0.16%) 
Intervertebral disc protrusion * 1  4/1285 (0.31%) 
Joint ankylosis * 1  1/1285 (0.08%) 
Joint effusion * 1  1/1285 (0.08%) 
Joint swelling * 1  1/1285 (0.08%) 
Lupus-like syndrome * 1  1/1285 (0.08%) 
Muscle atrophy * 1  1/1285 (0.08%) 
Muscle spasms * 1  1/1285 (0.08%) 
Musculoskeletal chest pain * 1  1/1285 (0.08%) 
Musculoskeletal pain * 1  2/1285 (0.16%) 
Myalgia * 1  3/1285 (0.23%) 
Osteoarthritis * 1  1/1285 (0.08%) 
Pain in extremity * 1  3/1285 (0.23%) 
Plantar fasciitis * 1  1/1285 (0.08%) 
Psoriatic arthropathy * 1  5/1285 (0.39%) 
Rheumatoid arthritis * 1  2/1285 (0.16%) 
Sacroiliitis * 1  1/1285 (0.08%) 
Synovitis * 1  1/1285 (0.08%) 
Tenosynovitis * 1  2/1285 (0.16%) 
Nervous system disorders   
Burning sensation * 1  1/1285 (0.08%) 
Carpal tunnel syndrome * 1  1/1285 (0.08%) 
Cervicobrachial syndrome * 1  2/1285 (0.16%) 
Disturbance in attention * 1  1/1285 (0.08%) 
Dizziness * 1  6/1285 (0.47%) 
Dysaesthesia * 1  1/1285 (0.08%) 
Dysgeusia * 1  1/1285 (0.08%) 
Facial paresis * 1  1/1285 (0.08%) 
Grand mal convulsion * 1  1/1285 (0.08%) 
Headache * 1  12/1285 (0.93%) 
Hyperaesthesia * 1  1/1285 (0.08%) 
Intercostal neuralgia * 1  1/1285 (0.08%) 
Migraine * 1  2/1285 (0.16%) 
Paraesthesia * 1  3/1285 (0.23%) 
Pseudoradicular syndrome * 1  1/1285 (0.08%) 
Retrograde amnesia * 1  1/1285 (0.08%) 
Reversible ischaemic neurological deficit * 1  1/1285 (0.08%) 
Sciatica * 1  1/1285 (0.08%) 
Tension headache * 1  1/1285 (0.08%) 
Tremor * 1  3/1285 (0.23%) 
Trigeminal neuralgia * 1  1/1285 (0.08%) 
Pregnancy, puerperium and perinatal conditions   
Pregnancy * 1  2/1285 (0.16%) 
Psychiatric disorders   
Agitation * 1  2/1285 (0.16%) 
Alcoholism * 1  1/1285 (0.08%) 
Anxiety * 1  1/1285 (0.08%) 
Depressed mood * 1  1/1285 (0.08%) 
Depression * 1  3/1285 (0.23%) 
Disorientation * 1  1/1285 (0.08%) 
Renal and urinary disorders   
Nephrolithiasis * 1  1/1285 (0.08%) 
Renal colic * 1  1/1285 (0.08%) 
Renal impairment * 1  1/1285 (0.08%) 
Reproductive system and breast disorders   
Prostatitis * 1  1/1285 (0.08%) 
Respiratory, thoracic and mediastinal disorders   
Asthma * 1  3/1285 (0.23%) 
Chronic obstructive pulmonary disease * 1  1/1285 (0.08%) 
Cough * 1  15/1285 (1.17%) 
Dyspnoea * 1  7/1285 (0.54%) 
Dyspnoea exertional * 1  3/1285 (0.23%) 
Epistaxis * 1  2/1285 (0.16%) 
Nasal congestion * 1  1/1285 (0.08%) 
Nasal mucosal disorder * 1  1/1285 (0.08%) 
Pharyngolaryngeal pain * 1  4/1285 (0.31%) 
Productive cough * 1  1/1285 (0.08%) 
Throat tightness * 1  3/1285 (0.23%) 
Skin and subcutaneous tissue disorders   
Acne * 1  3/1285 (0.23%) 
Actinic keratosis * 1  1/1285 (0.08%) 
Alopecia * 1  4/1285 (0.31%) 
Alopecia areata * 1  1/1285 (0.08%) 
Blister * 1  1/1285 (0.08%) 
Dermatitis allergic * 1  9/1285 (0.70%) 
Dermatitis psoriasiform * 1  1/1285 (0.08%) 
Dry skin * 1  1/1285 (0.08%) 
Eczema * 1  4/1285 (0.31%) 
Erythema * 1  10/1285 (0.78%) 
Guttate psoriasis * 1  1/1285 (0.08%) 
Hyperhidrosis * 1  2/1285 (0.16%) 
Increased tendency to bruise * 1  1/1285 (0.08%) 
Lichenoid keratosis * 1  1/1285 (0.08%) 
Livedo reticularis * 1  1/1285 (0.08%) 
Nail bed tenderness * 1  1/1285 (0.08%) 
Nail discolouration * 1  1/1285 (0.08%) 
Nail dystrophy * 1  1/1285 (0.08%) 
Night sweats * 1  1/1285 (0.08%) 
Pain of skin * 1  2/1285 (0.16%) 
Pruritus * 1  17/1285 (1.32%) 
Pruritus generalised * 1  6/1285 (0.47%) 
Psoriasis * 1  23/1285 (1.79%) 
Pustular psoriasis * 1  9/1285 (0.70%) 
Rash * 1  13/1285 (1.01%) 
Rash generalised * 1  1/1285 (0.08%) 
Rash macular * 1  2/1285 (0.16%) 
Rash papular * 1  1/1285 (0.08%) 
Rash pruritic * 1  3/1285 (0.23%) 
Rosacea * 1  1/1285 (0.08%) 
Scab * 1  1/1285 (0.08%) 
Skin burning sensation * 1  1/1285 (0.08%) 
Skin disorder * 1  1/1285 (0.08%) 
Skin fissures * 1  1/1285 (0.08%) 
Skin necrosis * 1  1/1285 (0.08%) 
Skin nodule * 1  1/1285 (0.08%) 
Skin reaction * 1  3/1285 (0.23%) 
Skin ulcer * 1  1/1285 (0.08%) 
Urticaria * 1  4/1285 (0.31%) 
Urticaria generalised * 1  1/1285 (0.08%) 
Surgical and medical procedures   
Bone operation * 1  1/1285 (0.08%) 
Carpal tunnel decompression * 1  1/1285 (0.08%) 
Cataract operation * 1  1/1285 (0.08%) 
Dental operation * 1  1/1285 (0.08%) 
Inguinal hernia repair * 1  1/1285 (0.08%) 
Intervertebral disc operation * 1  1/1285 (0.08%) 
Joint injection * 1  1/1285 (0.08%) 
Knee arthroplasty * 1  1/1285 (0.08%) 
Limb operation * 1  1/1285 (0.08%) 
Meniscus operation * 1  1/1285 (0.08%) 
Ossiculoplasty * 1  1/1285 (0.08%) 
Tooth extraction * 1  1/1285 (0.08%) 
Transfusion * 1  1/1285 (0.08%) 
Varicose vein operation * 1  1/1285 (0.08%) 
Vascular disorders   
Circulatory collapse * 1  1/1285 (0.08%) 
Flushing * 1  1/1285 (0.08%) 
Hot flush * 1  1/1285 (0.08%) 
Hypertension * 1  3/1285 (0.23%) 
Hypertensive crisis * 1  1/1285 (0.08%) 
Thrombosis * 1  1/1285 (0.08%) 
Varicose vein * 1  1/1285 (0.08%) 
Venous thrombosis limb * 1  1/1285 (0.08%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v10.0
Results for Psoriasis Area and Severity Index (PASI) was not reported since it was not to be analyzed by rheumatologists as part of this study, as per planned analysis.
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00293722    
Other Study ID Numbers: 0881A6-102064
B1801127
First Submitted: February 15, 2006
First Posted: February 17, 2006
Results First Submitted: January 10, 2014
Results First Posted: February 26, 2014
Last Update Posted: February 26, 2014