Trial Outcomes & Findings for Enbrel-Juvenile Idiopathic Arthritis (JIA) Use Results Survey [All-Case Surveillance] (NCT NCT01145352)

Last Updated: 2014-09-04

Results Overview

Adverse events are all unfavorable events, including clinically problematic abnormal changes in laboratory test values, which develop in participants after the administration of Etanercept, irrespective of causal relationship to Etanercept. The causal relationship between an adverse event and Etanercept was evaluated by the sponsor.

Recruitment status

COMPLETED

Target enrollment

113 participants

Primary outcome timeframe

24 weeks

Results posted on

2014-09-04

Participant Flow

Participant milestones

Participant milestones
Measure	Etanercept (Genetical Recombination) Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
Overall Study STARTED	113
Overall Study COMPLETED	102
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Etanercept (Genetical Recombination) Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
Overall Study Found to have been registered twice	6
Overall Study Treated before marketing approval	4
Overall Study Syringe formulation was used	1

Baseline Characteristics

Enbrel-Juvenile Idiopathic Arthritis (JIA) Use Results Survey [All-Case Surveillance]

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Etanercept (Genetical Recombination) n=102 Participants Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
Age, Customized <5 years	1 participants n=5 Participants
Age, Customized >= 5 to < 10 years	24 participants n=5 Participants
Age, Customized >= 10 to < 15 years	37 participants n=5 Participants
Age, Customized >= 15 to < 20 years	30 participants n=5 Participants
Age, Customized >= 20 to < 30 years	10 participants n=5 Participants
Age, Customized >=30 years	0 participants n=5 Participants
Sex: Female, Male Female	78 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: The safety analysis population consisted of the participants who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection indicated for polyarticular JIA after the marketing authorization had been granted.

Outcome measures

Outcome measures
Measure	Etanercept (Genetical Recombination) n=102 Participants Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
Number of Participants With Treatment-Related Adverse Events of Etanercept	22 participants

PRIMARY outcome

Timeframe: 24 weeks

Serious treatment-related adverse events are defined as any events that lead to death, life-thretening, hospitalization or prolonged hospitalization, a permanent or remarkable disorder/dysfunction, congenital anormaly/congenital deficiency, or other medically significant events or disorder.

Outcome measures

Outcome measures
Measure	Etanercept (Genetical Recombination) n=102 Participants Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
Number of Participants With Serious Treatment-Related Adverse Events of Etanercept	1 participants

PRIMARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome measures
Measure	Etanercept (Genetical Recombination) n=102 Participants Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
Number of Unlisted Treatment-Related Adverse Events of Etanercept	3 events

PRIMARY outcome

Timeframe: 24 weeks

Population: The efficacy analysis population consisted of the participants in whom DAS28 (4/ESR) was calculated (N = number of participants evaluated). The last observation carried forward (LOCF) method was used to impute missing data.

The Disease Activity Score Based on 28-joints Count based (DAS28-based) EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 =\< 3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 or change from baseline \>0.6 to =\<1.2 with DAS28 =\<5.1; non-responders: change from baseline =\< 0.6 or change from baseline \>0.6 and =\<1.2 with DAS28 \>5.1.

Outcome measures

Outcome measures
Measure	Etanercept (Genetical Recombination) n=87 Participants Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
Percentage of Good Responders and Moderate Responders Among Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 At 4 weeks (N = 25)	72.00 Percentage of participants Interval 50.61 to 87.93
Percentage of Good Responders and Moderate Responders Among Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 At 8 weeks (N = 30)	73.33 Percentage of participants Interval 54.11 to 87.72
Percentage of Good Responders and Moderate Responders Among Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 At 12 weeks (N = 31)	70.97 Percentage of participants Interval 51.96 to 85.78
Percentage of Good Responders and Moderate Responders Among Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 At 16 weeks (N = 32)	75.00 Percentage of participants Interval 56.6 to 88.54
Percentage of Good Responders and Moderate Responders Among Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 At 20 weeks (N = 34)	73.53 Percentage of participants Interval 55.64 to 87.12
Percentage of Good Responders and Moderate Responders Among Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 At 24 weeks (N = 46)	63.04 Percentage of participants Interval 47.55 to 76.79

SECONDARY outcome

Timeframe: 24 weeks

Percentage of participants in whom the efficacy of etanercept was assessed as either markedly effective or effective.

Outcome measures

Outcome measures
Measure	Etanercept (Genetical Recombination) n=87 Participants Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
Percentage of Participants With Overall Improvement On Physician's Assessment. At 4 weeks (N = 51)	94.12 percent Interval 83.76 to 98.77
Percentage of Participants With Overall Improvement On Physician's Assessment. At 8 weeks (N = 63)	93.65 percent Interval 84.53 to 98.24
Percentage of Participants With Overall Improvement On Physician's Assessment. At 12 weeks (N = 64)	93.75 percent Interval 84.76 to 98.27
Percentage of Participants With Overall Improvement On Physician's Assessment. At 16 weeks (N = 65)	93.85 percent Interval 84.99 to 98.3
Percentage of Participants With Overall Improvement On Physician's Assessment. At 20 weeks (N = 67)	91.04 percent Interval 81.52 to 96.64
Percentage of Participants With Overall Improvement On Physician's Assessment. At 24 weeks (N = 83)	95.18 percent Interval 88.12 to 98.67

Adverse Events

Etanercept (Genetical Recombination)

Serious events: 1 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Etanercept (Genetical Recombination) n=102 participants at risk Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
Gastrointestinal disorders Diarrhoea	0.98% 1/102 • Number of events 1 The frequency of treatment related adverse events during the study

Other adverse events

Other adverse events
Measure	Etanercept (Genetical Recombination) n=102 participants at risk Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
Infections and infestations Erythema infectiosum	0.98% 1/102 • Number of events 1 The frequency of treatment related adverse events during the study
Infections and infestations Gastroenteritis	0.98% 1/102 • Number of events 1 The frequency of treatment related adverse events during the study
Infections and infestations Gastroenteritis viral	0.98% 1/102 • Number of events 1 The frequency of treatment related adverse events during the study
Infections and infestations Influenza	4.9% 5/102 • Number of events 5 The frequency of treatment related adverse events during the study
Infections and infestations Nasopharyngitis	3.9% 4/102 • Number of events 4 The frequency of treatment related adverse events during the study
Infections and infestations Paronychia	0.98% 1/102 • Number of events 1 The frequency of treatment related adverse events during the study
Infections and infestations Pharyngitis	2.0% 2/102 • Number of events 2 The frequency of treatment related adverse events during the study
Immune system disorders Seasonal allergy	0.98% 1/102 • Number of events 1 The frequency of treatment related adverse events during the study
Metabolism and nutrition disorders Hypertriglyceridaemia	0.98% 1/102 • Number of events 1 The frequency of treatment related adverse events during the study
Nervous system disorders Headache	0.98% 1/102 • Number of events 1 The frequency of treatment related adverse events during the study
Eye disorders Iritis	0.98% 1/102 • Number of events 1 The frequency of treatment related adverse events during the study
Respiratory, thoracic and mediastinal disorders Cough	2.0% 2/102 • Number of events 2 The frequency of treatment related adverse events during the study
Respiratory, thoracic and mediastinal disorders Epistaxis	2.0% 2/102 • Number of events 2 The frequency of treatment related adverse events during the study
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	2.9% 3/102 • Number of events 3 The frequency of treatment related adverse events during the study
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.98% 1/102 • Number of events 1 The frequency of treatment related adverse events during the study
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	5.9% 6/102 • Number of events 6 The frequency of treatment related adverse events during the study
Gastrointestinal disorders Diarrhoea	0.98% 1/102 • Number of events 1 The frequency of treatment related adverse events during the study
Gastrointestinal disorders Gastritis	0.98% 1/102 • Number of events 1 The frequency of treatment related adverse events during the study
Gastrointestinal disorders Nausea	2.0% 2/102 • Number of events 2 The frequency of treatment related adverse events during the study
Gastrointestinal disorders Vomiting	0.98% 1/102 • Number of events 1 The frequency of treatment related adverse events during the study
Skin and subcutaneous tissue disorders Acne	0.98% 1/102 • Number of events 1 The frequency of treatment related adverse events during the study
Skin and subcutaneous tissue disorders Alopecia	0.98% 1/102 • Number of events 1 The frequency of treatment related adverse events during the study
Skin and subcutaneous tissue disorders Dermatitis	2.0% 2/102 • Number of events 2 The frequency of treatment related adverse events during the study
Skin and subcutaneous tissue disorders Pruritus	0.98% 1/102 • Number of events 1 The frequency of treatment related adverse events during the study
Skin and subcutaneous tissue disorders Rash	0.98% 1/102 • Number of events 1 The frequency of treatment related adverse events during the study
Skin and subcutaneous tissue disorders Urticaria	0.98% 1/102 • Number of events 1 The frequency of treatment related adverse events during the study
Musculoskeletal and connective tissue disorders Joint swelling	0.98% 1/102 • Number of events 1 The frequency of treatment related adverse events during the study
General disorders Fatigue	0.98% 1/102 • Number of events 1 The frequency of treatment related adverse events during the study
General disorders Injection site erythema	0.98% 1/102 • Number of events 1 The frequency of treatment related adverse events during the study
General disorders Injection site reaction	4.9% 5/102 • Number of events 5 The frequency of treatment related adverse events during the study
General disorders Malaise	0.98% 1/102 • Number of events 1 The frequency of treatment related adverse events during the study
General disorders Pyrexia	2.0% 2/102 • Number of events 2 The frequency of treatment related adverse events during the study
Investigations Alanine aminotransferase increased	2.9% 3/102 • Number of events 3 The frequency of treatment related adverse events during the study
Investigations Aspartate aminotransferase increased	2.0% 2/102 • Number of events 2 The frequency of treatment related adverse events during the study
Investigations Blood creatine phosphokinase increased	0.98% 1/102 • Number of events 1 The frequency of treatment related adverse events during the study
Investigations Liver function test abnormal	0.98% 1/102 • Number of events 1 The frequency of treatment related adverse events during the study
Investigations Blood beta-D-glucan increased	0.98% 1/102 • Number of events 1 The frequency of treatment related adverse events during the study

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER