Trial · NCT00048542
Study of Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Idiopathic Arthritis (JIA)
NCT00048542, Phase 3, Completed, Abbott; results first posted 2010-01-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Idiopathic Arthritis (JIA). Trials, record NCT00048542. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00048542
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Idiopathic Arthritis (JIA)
- NCT number
- NCT00048542
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 171 participants, actual
- Lead sponsor
- Abbott
- Conditions
- Arthritis, Juvenile Idiopathic
- Interventions
- Double-Blind Adalimumab/Placebo + MTX, Double-Blind Adalimumab/Placebo, OLE BSA Adalimumab +/- MTX, OLE FD Adalimumab +/- MTX
- First posted
- 2002-11-05
- Last updated
- 2011-08-22
- Results first posted
- 2010-01-11
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects in the Non-MTX Stratum With Disease Flare During the Double-Blind Phase | Week 16 to Week 48 (32 weeks) | The primary efficacy endpoint was the number of adalimumab-treated subjects in the non-MTX stratum with disease flare during the Double-Blind Phase compared with the number of placebo-treated subjects in the non-MTX stratum with disease flare during the double-blind phase. Subjects met the criteria for disease flare if they had 1) \>= 30% worsening in at least 3 of the 6 Juvenile Rheumatoid Arthritis (JRA) core set criteria and a minimum of 2 active joints, and 2) \>= 30% improvement in not more than 1 of the 6 JRA core set criteria. |
| Secondary | Number of Subjects Meeting Pediatric American College of Rheumatology 30% (PedACR30) Response Criteria at the End of the Open-Label Lead-In Phase | Week 16 | Responders met the following criteria: \>= 30% improvement in \>= 3 of 6 JRA core set criteria, and \>= 30% worsening in not more than 1 JRA criterion, compared with the open-label baseline. JRA core set criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with limitation of motion \[LOM\] and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. |
| Secondary | Number of Subjects in the MTX Stratum With Disease Flare During the Double-Blind Phase | Week 16 to Week 48 (32 Weeks) | Subjects met criteria for disease flare if they had \>= 30% worsening in at least 3 of 6 JRA core set criteria and a minimum of 2 active joints, and \>= 30% improvement in not more than 1 JRA criterion. JRA core set criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with LOM and with pain, tenderness or both); number of joints with LOM; physical function of Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. |
| Secondary | Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the Non-MTX Stratum | Week 16 to Week 48 (32 weeks) | A log rank test was performed and the Kaplan-Meier curve for time to disease flare from double-blind baseline (Week 16) to Week 48 was generated. Disease flare was defined as a \>= 30% worsening in at least 3 of 6 JRA core set criteria and a minimum of 2 active joints, and \>= 30% improvement in not more than 1 JRA criterion. The percentage of subjects without disease flare at each time point is presented. |
| Secondary | Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the MTX Stratum | Week 16 to Week 48 (32 weeks) | A log rank test was performed and the Kaplan-Meier curve for time to disease flare from double-blind baseline (Week 16) to Week 48 was generated. Disease flare was defined as a \>= 30% worsening in at least 3 of 6 JRA core set criteria and a minimum of 2 active joints, and \>= 30% improvement in not more than 1 JRA criterion. The percentage of subjects without disease flare at each time point is presented. |
| Secondary | Number of Subjects Meeting PedACR30 Response Criteria at the End of the Double-Blind Phase | Week 48 | Responders met the following criteria: \>= 30% improvement in \>= 3 of 6 JIA core set criteria, and \>= 30% worsening in not more than 1 JIA criterion, compared with the OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with LOM and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core criteria are included in PedACR criteria. |
| Secondary | Number of Subjects Meeting PedACR50 Response Criteria at the End of the Double-Blind Phase | Week 48 | Responders met the following criteria: \>= 50% improvement in \>= 3 of 6 JIA core set criteria, and \>= 30% worsening in not more than 1 JIA criterion, compared with the OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with LOM and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core variables are included in PedACR criteria. |
| Secondary | Number of Subjects Meeting PedACR70 Response Criteria at the End of the Double-Blind Phase | Week 48 | Responders met the following criteria: \>= 70% improvement in \>= 3 of 6 JIA core set criteria, and \>= 30% worsening in not more than 1 JIA criterion, compared with the OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with LOM and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core variables are included in PedACR criteria. |
| Secondary | Mean Change From Baseline in Physician's Global Assessment of Disease Activity at Week 48 of the Double-Blind Phase | Baseline and Week 48 | A 100 mm horizontal visual analog scale (VAS) was used to assess the Physician Global Assessment of Disease Activity. The left end of the VAS scale (0 mm) signified the absence of symptoms and the right end (100 mm) maximum disease activity. The mean change from open-label baseline to Week 48 was determined. Negative mean changes indicated improvement. |
| Secondary | Mean Change From Baseline in Parent's/Patient's Global Assessment of Disease Activity at Week 48 of the Double-Blind Phase | Baseline and Week 48 | A 100 mm horizontal visual analog scale (VAS) was used to assess the Parent's/Patient's Global Assessment of Disease Activity. The left end of the VAS (0 mm) signified the absence of symptoms and the right end (100 mm) maximum disease activity. The mean change from open-label baseline to Week 48 was determined. Negative mean changes indicated improvement. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects in the Non-MTX Stratum With Disease Flare During the Double-Blind Phase | Week 16 to Week 48 (32 weeks) | All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, in the non-MTX stratum. Missing values were treated as disease flare. | Participants | NUMBER |
| SECONDARY | Number of Subjects Meeting Pediatric American College of Rheumatology 30% (PedACR30) Response Criteria at the End of the Open-Label Lead-In Phase | Week 16 | All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug. Missing values were treated as non-responders. | Participants | NUMBER |
| SECONDARY | Number of Subjects in the MTX Stratum With Disease Flare During the Double-Blind Phase | Week 16 to Week 48 (32 Weeks) | All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, in the MTX stratum. Missing values were treated as disease flare. | Participants | NUMBER |
| SECONDARY | Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the Non-MTX Stratum | Week 16 to Week 48 (32 weeks) | All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, in the non-MTX stratum. | Percent participants w/o disease flare | NUMBER |
| SECONDARY | Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the MTX Stratum | Week 16 to Week 48 (32 weeks) | All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, in the MTX stratum. | Percent participants w/o disease flare | NUMBER |
| SECONDARY | Number of Subjects Meeting PedACR30 Response Criteria at the End of the Double-Blind Phase | Week 48 | All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug. Missing values were treated as non-responders. | Participants | NUMBER |
| SECONDARY | Number of Subjects Meeting PedACR50 Response Criteria at the End of the Double-Blind Phase | Week 48 | All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug. Missing values were treated as non-responders. | Participants | NUMBER |
| SECONDARY | Number of Subjects Meeting PedACR70 Response Criteria at the End of the Double-Blind Phase | Week 48 | All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug. Missing values were treated as non-responders. | Participants | NUMBER |
| SECONDARY | Mean Change From Baseline in Physician's Global Assessment of Disease Activity at Week 48 of the Double-Blind Phase | Baseline and Week 48 | All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, who completed Week 48. Observed data of subjects who remained in the study at Week 48 were analyzed. | Units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Parent's/Patient's Global Assessment of Disease Activity at Week 48 of the Double-Blind Phase | Baseline and Week 48 | All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, who completed Week 48. Observed data of subjects who remained in the study at Week 48 were analyzed. | Units on a scale | MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group116
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects in the Non-MTX Stratum With Disease Flare During the Double-Blind Phase | Double-Blind Adalimumab | 13 | Participants | ||
| Number of Subjects in the Non-MTX Stratum With Disease Flare During the Double-Blind Phase | Double-Blind Placebo | 20 | Participants | ||
| Number of Subjects Meeting Pediatric American College of Rheumatology 30% (PedACR30) Response Criteria at the End of the Open-Label Lead-In Phase | Adalimumab + MTX | 80 | Participants | ||
| Number of Subjects Meeting Pediatric American College of Rheumatology 30% (PedACR30) Response Criteria at the End of the Open-Label Lead-In Phase | Adalimumab | 64 | Participants | ||
| Number of Subjects in the MTX Stratum With Disease Flare During the Double-Blind Phase | Double-Blind Adalimumab + MTX | 14 | Participants | ||
| Number of Subjects in the MTX Stratum With Disease Flare During the Double-Blind Phase | Double-Blind Placebo + MTX | 24 | Participants | ||
| Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the Non-MTX Stratum | Double-Blind Adalimumab | Week 20 | 90.0 | Percent participants w/o disease flare | |
| Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the Non-MTX Stratum | Double-Blind Placebo | Week 20 | 78.6 | Percent participants w/o disease flare | |
| Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the Non-MTX Stratum | Double-Blind Adalimumab | Week 24 | 83.3 | Percent participants w/o disease flare | |
| Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the Non-MTX Stratum | Double-Blind Placebo | Week 24 | 64.3 | Percent participants w/o disease flare |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 results by groupParticipant flow72
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Phase | STARTED | Double-Blind Adalimumab + MTX | 38 | |
| Double-Blind Phase | STARTED | Double-Blind Placebo + MTX | 37 | |
| Double-Blind Phase | STARTED | Double-Blind Adalimumab | 30 | |
| Double-Blind Phase | STARTED | Double-Blind Placebo | 28 | |
| Double-Blind Phase | STARTED | Open-Label Extension BSA Adalimumab + MTX | 0 | |
| Double-Blind Phase | STARTED | Open-Label Extension BSA Adalimumab | 0 | |
| Double-Blind Phase | STARTED | Open-Label Extension FD Adalimumab + MTX | 0 | |
| Double-Blind Phase | STARTED | Open-Label Extension FD Adalimumab | 0 | |
| Double-Blind Phase | COMPLETED | Double-Blind Adalimumab + MTX | 35 | |
| Double-Blind Phase | COMPLETED | Double-Blind Placebo + MTX | 36 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 participant flowAdverse events840
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 | Double-Blind Adalimumab + MTX | 0 | 38 | |
| other | Abdominal pain | Gastrointestinal disorders | Double-Blind Placebo + MTX | 0 | 37 | |
| other | Abdominal pain | Gastrointestinal disorders | Double-Blind Adalimumab | 0 | 30 | |
| other | Abdominal pain | Gastrointestinal disorders | Double-Blind Placebo | 2 | 28 | |
| other | Abdominal pain | Gastrointestinal disorders | Open-Label Extension BSA Adalimumab + MTX | 0 | 71 | |
| other | Abdominal pain | Gastrointestinal disorders | Open-Label Extension BSA Adalimumab | 0 | 57 | |
| other | Abdominal pain | Gastrointestinal disorders | Open-Label Extension FD Adalimumab + MTX | 5 | 59 | |
| other | Abdominal pain | Gastrointestinal disorders | Open-Label Extension FD Adalimumab | 4 | 47 | |
| other | Acne | Skin and subcutaneous tissue disorders | Double-Blind Adalimumab + MTX | 1 | 38 | |
| other | Acne | Skin and subcutaneous tissue disorders | Double-Blind Placebo + MTX | 0 | 37 |
1 to 10 of 840Source ClinicalTrials.gov
See all 840 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Double-Blind Adalimumab + MTX | ||
| Total, all-cause mortality | Double-Blind Placebo + MTX | ||
| Total, all-cause mortality | Double-Blind Adalimumab | ||
| Total, all-cause mortality | Double-Blind Placebo | ||
| Total, all-cause mortality | Open-Label Extension BSA Adalimumab + MTX | ||
| Total, all-cause mortality | Open-Label Extension BSA Adalimumab | ||
| Total, all-cause mortality | Open-Label Extension FD Adalimumab + MTX | ||
| Total, all-cause mortality | Open-Label Extension FD Adalimumab | ||
| Total, other adverse events | Double-Blind Adalimumab + MTX | 27 | 38 |
| Total, other adverse events | Double-Blind Placebo + MTX | 19 | 37 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers2
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Double-Blind Adalimumab vs Double-Blind Placebo: Number of Subjects in the Non-MTX Stratum With Disease Flare During the Double-Blind Phase | Trial comparisons |
| Double-Blind Adalimumab + MTX vs Double-Blind Placebo + MTX: Number of Subjects in the MTX Stratum With Disease Flare During the Double-Blind Phase | Trial comparisons |
| Adalimumab + MTX vs Adalimumab: Number of Subjects Meeting Pediatric American College of Rheumatology 30% (PedACR30) Response Criteria at the End of the Open-Label Lead-In Phase | 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/NCT00048542
GET https://conductscience.org/api/trials/v1/NCT00048542/registered?page=2