Trial · NCT00988221
A Study of Tocilizumab in Patients With Active Polyarticular Juvenile Idiopathic Arthritis
NCT00988221, Phase 3, Completed, Hoffmann-La Roche; results first posted 2012-11-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Tocilizumab in Patients With Active Polyarticular Juvenile Idiopathic Arthritis. Trials, record NCT00988221. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00988221
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Tocilizumab in Patients With Active Polyarticular Juvenile Idiopathic Arthritis
- NCT number
- NCT00988221
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 188 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Juvenile Idiopathic Arthritis
- Interventions
- Tocilizumab, Placebo
- First posted
- 2009-10-02
- Last updated
- 2017-07-26
- Other registries' IDs
- eudract:2009-011593-15
- Results first posted
- 2012-11-01
Source ClinicalTrials.gov
Registered outcomes42
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent of Patients With a Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30 (ACR30) Flare in Part II of the Study (Weeks 16-40) | Week 16 through Week 40 | JIA ACR30 flare is defined as a ≥ 30% worsening of 3 of 6 variables and no more than 1 of the remaining variables improving \> 30%. The 6 variables are physician global assessment of disease activity (worsening of 20 units minimum on a 0-100 visual analog scale \[VAS\]), parent/patient global assessment of overall well-being (worsening of 20 VAS units minimum), number of joints (minimum of 2 worse) with active arthritis (swelling, or pain and limitation of motion), number of joints (minimum of 2 worse) with limitation of movement, erythrocyte sedimentation rate, and functional ability assessed using the disability index of the Childhood Health Assessment Questionnaire (CHAQ, 30 questions, 8 domains, 0\[best\]-3\[worst\]). Patients who withdrew or who took escape medication are classified as flared. The analysis used the Cochran-Mantel-Haenszel test with the stratification variables background use of methotrexate and oral corticosteroids applied at Week 16. |
| Secondary | Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses in Part I of the Study (Baseline to Week 16) | Baseline to Week 16 | A JIA ACR30/50/70/90 response is defined as a ≥ 30/50/70/90% response on 3 of 6 variables and no more than 1 of the remaining variables worsening \> 30%. The 6 variables are physician global assessment of disease activity (20 units minimum on a 0-100 visual analog scale \[VAS\]), parent/patient global assessment of overall well-being (20 VAS units minimum), number of joints (minimum of 2 worse) with active arthritis (swelling, or pain and limitation of motion), number of joints (minimum of 2 worse) with limitation of movement, erythrocyte sedimentation rate, and functional ability assessed using the disability index of the Childhood Health Assessment Questionnaire (CHAQ, 30 questions, 8 domains, 0\[best\]-3\[worst\]). |
| Secondary | Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Physician Global Assessment of Disease Activity at the End of Part I of the Study (Week 16) | Baseline to Week 16 | The patient's treating physician provides a rating of the patient's arthritis disease activity on a 0 to 100 mm horizontal scale. The extreme left end of the line represents 'arthritis inactive' (ie, symptom-free and no arthritis symptoms) and the extreme right end represents 'arthritis very active'. A higher score indicates more disease activity. A negative change score indicates improvement. |
| Secondary | Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Patient/Parent Global Assessment of Overall Well-being at the End of Part I of the Study (Week 16) | Baseline to Week 16 | The patient or parent/guardian, as appropriate, provides a rating of the patient's well-being on a 0 to 100 mm horizontal scale. The extreme left end of the line represents 'very well' (ie, symptom-free and no arthritis disease activity) and the extreme right end represents 'very poor' (ie, maximum arthritis disease activity). A higher score indicates poorer well-being. A negative change score indicates improvement. |
| Secondary | Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Number of Joints With Active Arthritis at the End of Part I of the Study (Week 16) | Baseline to Week 16 | Joints with active arthritis are defined as joints with swelling present or pain present and limitation of motion. The maximum number of joints with active arthritis is 71. The joint assessment is performed by an independent assessor who is not the treating physician and who is blinded to all other aspects of the patient's efficacy and safety data. A negative change score indicates improvement. |
| Secondary | Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Number of Joints With Limitation of Movement at the End of Part I of the Study (Week 16) | Baseline to Week 16 | Joints with limitation of movement are defined as joints with limitation of motion. The maximum number of joints with limitation of movement is 67. The joint assessment is performed by an independent assessor who is not the treating physician and who is blinded to all other aspects of the patient's efficacy and safety data. A negative change score indicates improvement. |
| Secondary | Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Erythrocyte Sedimentation Rate (ESR) at the End of Part I of the Study (Week 16) | Baseline to Week 16 | Erythrocyte sedimentation rate, an acute phase protein, was measured using a kit furnished by the study central laboratory. A negative change score indicates improvement. |
| Secondary | Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Functional Ability at the End of Part I of the Study (Week 16) | Baseline to Week 16 | Functional ability is assessed with the Childhood Health Assessment Questionnaire (CHAQ-DI) disability index which consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. If aids and devices listed in the questionnaire or assistance from a person are required to perform a task, a domain score of 0 or 1 is increased to 2; if the domain score is 2 or 3, the domain score is not adjusted. To calculate the overall score, the patient must have a domain score in at least 6 of the 8 domains. The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A higher score indicates less ability. A negative change score indicates improvement. |
| Secondary | Juvenile Arthritis Disease Activity Score (JADAS-27) at the End of Part I of the Study (Week 16) | Week 16 | The JADAS-27 is derived from the following components: Physician's global assessment of disease activity on a 0-100 mm visual analog scale (VAS)/10, patient/parent's global assessment of overall well-being on a 0-100 mm VAS/10, normalized erythrocyte sedimentation rate (ESR) (if ESR is ≤ 20 then set to 0, if ≥ 120 then set to 10, and if \> 20 and \< 120 then apply formula \[ESR-20\]/10), and number of joints (maximum of 27) with active arthritis (cervical spine, left/right elbow, left/right wrist, left/right MCP1-3, left/right PIP1-5, left/right hips, left/right knee and left/right ankle). The scores for the first 3 components range from 0-10; the score for the final component ranges from 0-27. The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity. |
| Secondary | Pain Visual Analogue Scale (VAS) Score at the End of Part I of the Study (Week 16) | Week 16 | The patient or parent/guardian, as appropriate, provides a rating of the patient's pain (also called a discomfort index) on a 0 to 100 mm horizontal scale. The extreme left end of the line represents 'no pain' and the extreme right end represents 'very extreme pain'. A higher score indicates more pain. |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 registered outcomesOutcomes42
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent of Patients With a Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30 (ACR30) Flare in Part II of the Study (Weeks 16-40) | Week 16 through Week 40 | Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II. | Percent of patients | NUMBER |
| SECONDARY | Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses in Part I of the Study (Baseline to Week 16) | Baseline to Week 16 | Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab. | Percent of patients | NUMBER |
| SECONDARY | Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Physician Global Assessment of Disease Activity at the End of Part I of the Study (Week 16) | Baseline to Week 16 | Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Patient/Parent Global Assessment of Overall Well-being at the End of Part I of the Study (Week 16) | Baseline to Week 16 | Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Number of Joints With Active Arthritis at the End of Part I of the Study (Week 16) | Baseline to Week 16 | Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Number of Joints With Limitation of Movement at the End of Part I of the Study (Week 16) | Baseline to Week 16 | Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Erythrocyte Sedimentation Rate (ESR) at the End of Part I of the Study (Week 16) | Baseline to Week 16 | Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Functional Ability at the End of Part I of the Study (Week 16) | Baseline to Week 16 | Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab. | Percent change | MEAN |
| SECONDARY | Juvenile Arthritis Disease Activity Score (JADAS-27) at the End of Part I of the Study (Week 16) | Week 16 | Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab. | Units on a scale | MEAN |
| SECONDARY | Pain Visual Analogue Scale (VAS) Score at the End of Part I of the Study (Week 16) | Week 16 | Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab. | Units on a scale | MEAN |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 outcomesResults by group543
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent of Patients With a Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30 (ACR30) Flare in Part II of the Study (Weeks 16-40) | Placebo | 48.1 | 95% Confidence Interval 37.0 to 59.0 | Percent of patients | |
| Percent of Patients With a Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30 (ACR30) Flare in Part II of the Study (Weeks 16-40) | Tocilizumab 8 or 10 mg/kg | 25.6 | 95% Confidence Interval 16.0 to 35.0 | Percent of patients | |
| Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses in Part I of the Study (Baseline to Week 16) | Tocilizumab 10 mg/kg in Patients Weighing < 30 kg | ACR30 response | 88.6 | Percent of patients | |
| Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses in Part I of the Study (Baseline to Week 16) | Tocilizumab 8 mg/kg in Patients Weighing < 30 kg | ACR30 response | 76.5 | Percent of patients | |
| Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses in Part I of the Study (Baseline to Week 16) | Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg | ACR30 response | 93.3 | Percent of patients | |
| Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses in Part I of the Study (Baseline to Week 16) | Tocilizumab 8 or 10 mg/kg | ACR30 response | 89.4 | Percent of patients | |
| Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses in Part I of the Study (Baseline to Week 16) | Tocilizumab 10 mg/kg in Patients Weighing < 30 kg | ACR50 response | 80.0 | Percent of patients | |
| Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses in Part I of the Study (Baseline to Week 16) | Tocilizumab 8 mg/kg in Patients Weighing < 30 kg | ACR50 response | 70.6 | Percent of patients | |
| Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses in Part I of the Study (Baseline to Week 16) | Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg | ACR50 response | 87.4 | Percent of patients | |
| Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses in Part I of the Study (Baseline to Week 16) | Tocilizumab 8 or 10 mg/kg | ACR50 response | 83.0 | Percent of patients |
1 to 10 of 543Source ClinicalTrials.gov
See all 543 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part I | STARTED | Tocilizumab 10 mg/kg in Patients Weighing < 30 kg | 35 | |
| Part I | STARTED | Tocilizumab 8 mg/kg in Patients Weighing < 30 kg | 34 | |
| Part I | STARTED | Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg | 119 | |
| Part I | STARTED | Placebo | 0 | |
| Part I | COMPLETED | Tocilizumab 10 mg/kg in Patients Weighing < 30 kg | 31 | |
| Part I | COMPLETED | Tocilizumab 8 mg/kg in Patients Weighing < 30 kg | 24 | |
| Part I | COMPLETED | Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg | 111 | |
| Part I | COMPLETED | Placebo | 0 | |
| Part I | NOT COMPLETED | Tocilizumab 10 mg/kg in Patients Weighing < 30 kg | 4 | |
| Part I | NOT COMPLETED | Tocilizumab 8 mg/kg in Patients Weighing < 30 kg | 10 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events490
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 | Nasopharyngitis | Infections and infestations | Tocilizumab 10 mg/kg in Patients Weighing < 30 kg | 7 | 22 | |
| other | Nasopharyngitis | Infections and infestations | Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg | 1 | 13 | |
| other | Nasopharyngitis | Infections and infestations | Tocilizumab 8 mg/kg in Patients Weighing < 30 kg | 5 | 34 | |
| other | Nasopharyngitis | Infections and infestations | Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg | 32 | 119 | |
| other | Nasopharyngitis | Infections and infestations | All Tocilizumab Patients | 45 | 188 | |
| other | Upper respiratory tract infection | Infections and infestations | Tocilizumab 10 mg/kg in Patients Weighing < 30 kg | 2 | 22 | |
| other | Upper respiratory tract infection | Infections and infestations | Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg | 0 | 13 | |
| other | Upper respiratory tract infection | Infections and infestations | Tocilizumab 8 mg/kg in Patients Weighing < 30 kg | 4 | 34 | |
| other | Upper respiratory tract infection | Infections and infestations | Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg | 17 | 119 | |
| other | Upper respiratory tract infection | Infections and infestations | All Tocilizumab Patients | 23 | 188 |
1 to 10 of 490Source ClinicalTrials.gov
See all 490 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tocilizumab 10 mg/kg in Patients Weighing < 30 kg | ||
| Total, all-cause mortality | Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg | ||
| Total, all-cause mortality | Tocilizumab 8 mg/kg in Patients Weighing < 30 kg | ||
| Total, all-cause mortality | Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg | ||
| Total, all-cause mortality | All Tocilizumab Patients | ||
| Total, other adverse events | Tocilizumab 10 mg/kg in Patients Weighing < 30 kg | 19 | 22 |
| Total, other adverse events | Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg | 11 | 13 |
| Total, other adverse events | Tocilizumab 8 mg/kg in Patients Weighing < 30 kg | 25 | 34 |
| Total, other adverse events | Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg | 102 | 119 |
| Total, other adverse events | All Tocilizumab Patients | 157 | 188 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers4
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/NCT00988221
GET https://conductscience.org/api/trials/v1/NCT00988221/registered?page=2