Trial · NCT00443430
Trial of Early Aggressive Drug Therapy in Juvenile Idiopathic Arthritis
NCT00443430, Phase 4, Completed, Seattle Children's Hospital; results first posted 2013-05-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of Early Aggressive Drug Therapy in Juvenile Idiopathic Arthritis. Trials, record NCT00443430. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00443430
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Early Aggressive Drug Therapy in Juvenile Idiopathic Arthritis
- NCT number
- NCT00443430
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 85 participants, actual
- Lead sponsor
- Seattle Children's Hospital
- Conditions
- Juvenile Chronic Polyarthritis, Juvenile Idiopathic Arthritis, Juvenile Rheumatoid Arthritis
- Interventions
- methotrexate, methotrexate - etanercept - prednisolone arm
- First posted
- 2007-03-06
- Last updated
- 2013-05-31
- Results first posted
- 2013-05-31
- Limitations and caveats
- small number of participants with recent onset poly JIA
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants Who Attain Inactive Disease by 6 Months | 6 months after initiation of study intervention | |
| Secondary | Safety Profiles, Including the Number of Treatment-emergent, Serious, or Unexpected Adverse Events and Other Important Medical Events | Over 12 months maximum study participation per subject | |
| Secondary | Clinical Remission on Medication | 12 months or end of study | 6 months of clinical inactive disease |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Participants Who Attain Inactive Disease by 6 Months | 6 months after initiation of study intervention | all participants receiving study medications | participants | NUMBER |
| SECONDARY | Safety Profiles, Including the Number of Treatment-emergent, Serious, or Unexpected Adverse Events and Other Important Medical Events | Over 12 months maximum study participation per subject | all participants that received study medications | events | NUMBER |
| SECONDARY | Clinical Remission on Medication | 12 months or end of study | all participants receiving study medications | participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Participants Who Attain Inactive Disease by 6 Months | Methotrexate Arm | 10 | participants | ||
| Proportion of Participants Who Attain Inactive Disease by 6 Months | Methotrexate-Prednisolone-Etanercept Arm | 17 | participants | ||
| Safety Profiles, Including the Number of Treatment-emergent, Serious, or Unexpected Adverse Events and Other Important Medical Events | Methotrexate Arm | 1 | events | ||
| Safety Profiles, Including the Number of Treatment-emergent, Serious, or Unexpected Adverse Events and Other Important Medical Events | Methotrexate-Prednisolone-Etanercept Arm | 2 | events | ||
| Clinical Remission on Medication | Methotrexate Arm | 3 | participants | ||
| Clinical Remission on Medication | Methotrexate-Prednisolone-Etanercept Arm | 9 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Methotrexate Arm | 43 | |
| Overall Study | STARTED | Methotrexate-Prednisolone-Etanercept Arm | 42 | |
| Overall Study | COMPLETED | Methotrexate Arm | 39 | |
| Overall Study | COMPLETED | Methotrexate-Prednisolone-Etanercept Arm | 38 | |
| Overall Study | NOT COMPLETED | Methotrexate Arm | 4 | |
| Overall Study | NOT COMPLETED | Methotrexate-Prednisolone-Etanercept Arm | 4 |
Source ClinicalTrials.gov
Adverse events8
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 | liver function test elevation | Hepatobiliary disorders | Methotrexate Arm | 0 | 43 | 0 |
| other | liver function test elevation | Hepatobiliary disorders | Methotrexate-Prednisolone-Etanercept Arm | 3 | 42 | 3 |
| serious | pneumonia | Infections and infestations | Methotrexate Arm | 0 | 43 | 0 |
| serious | pneumonia | Infections and infestations | Methotrexate-Prednisolone-Etanercept Arm | 1 | 42 | 1 |
| serious | psychosis | Psychiatric disorders | Methotrexate Arm | 1 | 43 | 1 |
| serious | psychosis | Psychiatric disorders | Methotrexate-Prednisolone-Etanercept Arm | 0 | 42 | 0 |
| serious | septic hip | Infections and infestations | Methotrexate Arm | 0 | 43 | 0 |
| serious | septic hip | Infections and infestations | Methotrexate-Prednisolone-Etanercept Arm | 1 | 42 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Methotrexate Arm | ||
| Total, all-cause mortality | Methotrexate-Prednisolone-Etanercept Arm | ||
| Total, other adverse events | Methotrexate Arm | 0 | 43 |
| Total, other adverse events | Methotrexate-Prednisolone-Etanercept Arm | 3 | 42 |
| Total, serious adverse events | Methotrexate Arm | 1 | 43 |
| Total, serious adverse events | Methotrexate-Prednisolone-Etanercept Arm | 2 | 42 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01AR049762 | Early Aggressive Therapy in Juvenile Idiopathic Arthritis | WALLACE, CAROL A | SEATTLE CHILDREN'S HOSPITAL | NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES | 2006 to 2009 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Methotrexate Arm vs Methotrexate-Prednisolone-Etanercept Arm: Clinical Remission on Medication | Trial comparisons |
| Methotrexate Arm vs Methotrexate-Prednisolone-Etanercept Arm: Proportion of Participants Who Attain Inactive Disease by 6 Months | Trial comparisons |
| Methotrexate Arm vs Methotrexate-Prednisolone-Etanercept Arm: serious adverse events | Trial comparisons |
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/NCT00443430
GET https://conductscience.org/api/trials/v1/NCT00443430/registered