Trial · NCT01421069
Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis
NCT01421069, Phase 3, Completed, Pfizer; results first posted 2022-11-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis. Trials, record NCT01421069. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01421069
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis
- NCT number
- NCT01421069
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 109 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Juvenile Idiopahtic Arthritis
- Interventions
- etanercept
- First posted
- 2011-08-22
- Last updated
- 2022-11-14
- Other registries' IDs
- eudract:2010-023802-10
- Results first posted
- 2022-11-14
Source ClinicalTrials.gov
Registered outcomes80
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Malignancy: All Periods of Parent and Extension Study | First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study) | Number of participants who had adverse event (AE) of malignancy were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it. |
| Secondary | Number of Participants With Serious Adverse Events: All Periods of Parent and Extension Study | First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study) | A serious adverse event (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. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it. |
| Secondary | Number of Participants With Serious Infections: All Periods of Parent and Extension Study | First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study) | Serious infections were defined as any infections those were life threatening or resulted in disability, infections requiring intravenous antibiotic treatment and hospitalization. |
| Secondary | Number of Participants With Medically Important Infections: All Periods of Parent and Extension Study | First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study) | Medically important infections were defined as an infection requiring parenteral (intravenous \[IV\], intramuscular \[IM\]) anti-infective agent(s) and/or hospitalization. |
| Secondary | Number of Participants With Infections: All Periods of Parent and Extension Study | First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study) | Number of participants who had infections as AEs were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it. |
| Secondary | Number of Participants With Treatment Emergent Infections and Injection Site Reactions: All Periods of Extension Study | Extension study: Baseline (Day 1) up to 30 days after the last dose of investigational product (maximum up to 97 months) | Number of participants who had treatment emergent infections and injection site reactions as adverse events were reported. Treatment emergent infections were infections occurring in a participant who received study medication without regard to possibility of causal relationship to it. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it. |
| Secondary | Number of Participants With Infections: Extension Study: Withdrawal Period | Extension study: Day of study treatment withdrawal up to entering re-treatment period or observational period (for a maximum of 96 months) | Number of participants who had treatment emergent infections as AEs were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it. |
| Secondary | Number of Participants Withdrawn Due to Adverse Events: All Periods of Parent and Extension Study | First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study) | Participants withdrew from the study due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it. |
| Secondary | Number of Participants Withdrawn Due to Adverse Events: Extension Study: Withdrawal Period | Extension study: Day of study treatment withdrawal up to entering re-treatment period or observational period (for a maximum of 96 months) | Participants withdrew from the study due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it. |
| Secondary | Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities Based on National Cancer Institute Criteria Version 4.03: All Periods of Extension Study | Extension study: Baseline (Day 1) up to 30 days after the last dose of investigational product (maximum up to 97 months) | Abnormality of laboratory parameters was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 registered outcomesOutcomes80
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Malignancy: All Periods of Parent and Extension Study | First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study) | Analysis population included all participants who were enrolled in the parent and extension study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Serious Adverse Events: All Periods of Parent and Extension Study | First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study) | Analysis population included all participants who were enrolled in the parent and extension study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Serious Infections: All Periods of Parent and Extension Study | First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study) | Analysis population included all participants who were enrolled in the parent and extension study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Medically Important Infections: All Periods of Parent and Extension Study | First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study) | Analysis population included all participants who were enrolled in the parent and extension study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Infections: All Periods of Parent and Extension Study | First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study) | Analysis population included all participants who were enrolled in the parent and extension study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment Emergent Infections and Injection Site Reactions: All Periods of Extension Study | Extension study: Baseline (Day 1) up to 30 days after the last dose of investigational product (maximum up to 97 months) | Analysis population included all participants who were enrolled in the extension study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Infections: Extension Study: Withdrawal Period | Extension study: Day of study treatment withdrawal up to entering re-treatment period or observational period (for a maximum of 96 months) | Withdrawal analysis set (WAS) included those participants who entered the withdrawal period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Withdrawn Due to Adverse Events: All Periods of Parent and Extension Study | First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study) | Analysis population included all participants who were enrolled in the parent and extension study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Withdrawn Due to Adverse Events: Extension Study: Withdrawal Period | Extension study: Day of study treatment withdrawal up to entering re-treatment period or observational period (for a maximum of 96 months) | WAS included those participants who entered the withdrawal period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities Based on National Cancer Institute Criteria Version 4.03: All Periods of Extension Study | Extension study: Baseline (Day 1) up to 30 days after the last dose of investigational product (maximum up to 97 months) | Analysis population included all participants who were enrolled in the extension study. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 outcomesResults by group999
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Malignancy: All Periods of Parent and Extension Study | Etanercept | 1 | Participants | ||
| Number of Participants With Serious Adverse Events: All Periods of Parent and Extension Study | Etanercept | 45 | Participants | ||
| Number of Participants With Serious Infections: All Periods of Parent and Extension Study | Etanercept | 14 | Participants | ||
| Number of Participants With Medically Important Infections: All Periods of Parent and Extension Study | Etanercept | 12 | Participants | ||
| Number of Participants With Infections: All Periods of Parent and Extension Study | Etanercept | 111 | Participants | ||
| Number of Participants With Treatment Emergent Infections and Injection Site Reactions: All Periods of Extension Study | Etanercept | Treatment emergent infections | 67 | Participants | |
| Number of Participants With Treatment Emergent Infections and Injection Site Reactions: All Periods of Extension Study | Etanercept | Injection site reactions | 6 | Participants | |
| Number of Participants With Infections: Extension Study: Withdrawal Period | Etanercept | Infections | 8 | Participants | |
| Number of Participants With Infections: Extension Study: Withdrawal Period | Etanercept | Infections considered preventable by vaccination | 1 | Participants | |
| Number of Participants Withdrawn Due to Adverse Events: All Periods of Parent and Extension Study | Etanercept | Due to infections | 3 | Participants |
1 to 10 of 999Source ClinicalTrials.gov
See all 999 results by groupParticipant flow26
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Parent Study | STARTED | Etanercept | 127 | |
| Parent Study | COMPLETED | Etanercept | 119 | |
| Parent Study | NOT COMPLETED | Etanercept | 8 | |
| Overall Period for Extension Study | STARTED | Etanercept | 109 | |
| Overall Period for Extension Study | Enrolled Into Active Treatment Period | Etanercept | 99 | |
| Overall Period for Extension Study | Enrolled Into Observational Period | Etanercept | 10 | |
| Overall Period for Extension Study | COMPLETED | Etanercept | 84 | |
| Overall Period for Extension Study | NOT COMPLETED | Etanercept | 25 | |
| Active Treatment Period | STARTED | Etanercept | 99 | |
| Active Treatment Period | ERA | Etanercept | 31 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 participant flowAdverse events200
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Etanercept | 2 | 109 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Etanercept | 1 | 109 | |
| other | Lymphadenitis | Blood and lymphatic system disorders | Etanercept | 1 | 109 | |
| other | Neutropenia | Blood and lymphatic system disorders | Etanercept | 1 | 109 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Etanercept | 1 | 109 | |
| other | Eustachian tube disorder | Ear and labyrinth disorders | Etanercept | 1 | 109 | |
| other | Tympanic membrane disorder | Ear and labyrinth disorders | Etanercept | 1 | 109 | |
| other | Vertigo | Ear and labyrinth disorders | Etanercept | 1 | 109 | |
| other | Iridocyclitis | Eye disorders | Etanercept | 5 | 109 | |
| other | Tympanic membrane perforation | Ear and labyrinth disorders | Etanercept | 1 | 109 |
1 to 10 of 200Source ClinicalTrials.gov
See all 200 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Etanercept | 0 | 109 |
| Total, other adverse events | Etanercept | 85 | 109 |
| Total, serious adverse events | Etanercept | 22 | 109 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01421069
GET https://conductscience.org/api/trials/v1/NCT01421069/registered?page=2