Trial · NCT00962741
Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis
NCT00962741, Phase 3, Completed, Pfizer; results first posted 2012-07-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis. Trials, record NCT00962741. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00962741
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis
- NCT number
- NCT00962741
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 127 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Arthritis, Juvenile Idiopathic
- Interventions
- Etanercept
- First posted
- 2009-08-20
- Last updated
- 2014-06-10
- Results first posted
- 2012-07-19
- Limitations and caveats
- Results include data for Part 1 (up to Week 12) and Part 2 (up to week 96) of the study.
Source ClinicalTrials.gov
Registered outcomes88
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With an American College of Rheumatology Pediatric 30 (ACR Pedi 30) Response at Week 12 | Week 12 | ACR Pedi 30 response: greater than or equal to (\>=) 30% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) childhood health assessment questionnaire (CHAQ) 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein. |
| Secondary | Percentage of Participants With an ACR Pedi 30 Response | Week 4, Week 8, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | ACR Pedi 30 response: \>= 30% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein. |
| Secondary | Percentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-population | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | ACR Pedi 30 response: \>= 30% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein. |
| Secondary | Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | ACR Pedi 30 response: \>= 30% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks). |
| Secondary | Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | ACR Pedi 30 response: \>= 30% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein. |
| Secondary | Percentage of Participants With an ACR Pedi 50 Response | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | ACR Pedi 50 response: \>= 50% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. |
| Secondary | Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | ACR Pedi 50 response: \>= 50% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. |
| Secondary | Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | ACR Pedi 50 response: \>= 50% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. |
| Secondary | Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | ACR Pedi 50 response: \>= 50% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. |
| Secondary | Percentage of Participants With an ACR Pedi 70 Response | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | ACR Pedi 70 response: \>= 70% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 registered outcomesOutcomes88
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With an American College of Rheumatology Pediatric 30 (ACR Pedi 30) Response at Week 12 | Week 12 | Modified Intent-to-Treat (mITT) population included all participants who received at least 1 dose of the study medication. Here 'N' (Number of participants analyzed) signified those participants who were evaluable for this measure at week 12. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With an ACR Pedi 30 Response | Week 4, Week 8, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks). | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-population | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks). | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | ERA:participants with arthritis(Ar) or(/)enthesitis,any 2:sacroiliac joint tenderness/inflammatory(Ifm)lumbosacral pain history;ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter's syndrome history;human leukocyte antigen;Ar in male\>6years;acute anterior uveitis(AAU)/AAU first-degree relative. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks). | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With an ACR Pedi 50 Response | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks). | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks). | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter's syndrome history;human leukocyte antigen;Ar in male\>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks). | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks). | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With an ACR Pedi 70 Response | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks). | Percentage of participants | NUMBER |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 outcomesResults by group879
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With an American College of Rheumatology Pediatric 30 (ACR Pedi 30) Response at Week 12 | Etanercept | 88.6 | 95% Confidence Interval 81.6 to 93.6 | Percentage of participants | |
| Percentage of Participants With an ACR Pedi 30 Response | Etanercept | Week 4 (N = 126) | 71.4 | 95% Confidence Interval 62.7 to 79.1 | Percentage of participants |
| Percentage of Participants With an ACR Pedi 30 Response | Etanercept | Week 8 (N = 121) | 88.4 | 95% Confidence Interval 81.3 to 93.5 | Percentage of participants |
| Percentage of Participants With an ACR Pedi 30 Response | Etanercept | Week 12 (N = 123) | 88.6 | 95% Confidence Interval 81.6 to 93.6 | Percentage of participants |
| Percentage of Participants With an ACR Pedi 30 Response | Etanercept | Week 24 (N = 122) | 94.3 | 95% Confidence Interval 88.5 to 97.7 | Percentage of participants |
| Percentage of Participants With an ACR Pedi 30 Response | Etanercept | Week 36 (N = 120) | 95.8 | 95% Confidence Interval 90.5 to 98.6 | Percentage of participants |
| Percentage of Participants With an ACR Pedi 30 Response | Etanercept | Week 48 (N = 119) | 94.1 | 95% Confidence Interval 88.3 to 97.6 | Percentage of participants |
| Percentage of Participants With an ACR Pedi 30 Response | Etanercept | Week 60 (N = 116) | 95.7 | 95% Confidence Interval 90.2 to 98.6 | Percentage of participants |
| Percentage of Participants With an ACR Pedi 30 Response | Etanercept | Week 72 (N = 114) | 96.5 | 95% Confidence Interval 91.3 to 99.0 | Percentage of participants |
| Percentage of Participants With an ACR Pedi 30 Response | Etanercept | Week 84 (N = 113) | 93.8 | 95% Confidence Interval 87.7 to 97.5 | Percentage of participants |
1 to 10 of 879Source ClinicalTrials.gov
See all 879 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Etanercept | 127 | |
| Overall Study | COMPLETED | Etanercept | 119 | |
| Overall Study | NOT COMPLETED | Etanercept | 8 |
Source ClinicalTrials.gov
Adverse events53
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 | Abdominal pain | Gastrointestinal disorders | Etanercept | 6 | 127 | |
| other | Diarrhoea | Gastrointestinal disorders | Etanercept | 10 | 127 | |
| other | Pyrexia | General disorders | Etanercept | 9 | 127 | |
| other | Bronchitis | Infections and infestations | Etanercept | 13 | 127 | |
| other | Gastroenteritis | Infections and infestations | Etanercept | 18 | 127 | |
| other | Nasopharyngitis | Infections and infestations | Etanercept | 16 | 127 | |
| other | Pharyngitis | Infections and infestations | Etanercept | 32 | 127 | |
| other | Rhinitis | Infections and infestations | Etanercept | 11 | 127 | |
| other | Upper respiratory tract infection | Infections and infestations | Etanercept | 42 | 127 | |
| other | Headache | Nervous system disorders | Etanercept | 17 | 127 |
1 to 10 of 53Source ClinicalTrials.gov
See all 53 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Etanercept | ||
| Total, other adverse events | Etanercept | 106 | 127 |
| Total, serious adverse events | Etanercept | 24 | 127 |
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/NCT00962741
GET https://conductscience.org/api/trials/v1/NCT00962741/registered?page=2