Trial · NCT01904279
A Study of Subcutaneously (SC) Administered Tocilizumab (TCZ) in Participants With Polyarticular-Course Juvenile Idiopathic Arthritis (pJIA)
NCT01904279, Phase 1, Completed, Hoffmann-La Roche; results first posted 2017-03-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Subcutaneously (SC) Administered Tocilizumab (TCZ) in Participants With Polyarticular-Course Juvenile Idiopathic Arthritis (pJIA). Trials, record NCT01904279. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01904279
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Subcutaneously (SC) Administered Tocilizumab (TCZ) in Participants With Polyarticular-Course Juvenile Idiopathic Arthritis (pJIA)
- NCT number
- NCT01904279
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 52 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Juvenile Idiopathic Arthritis
- Interventions
- Tocilizumab
- First posted
- 2013-07-22
- Last updated
- 2017-06-14
- Other registries' IDs
- eudract:2012-003486-18
- Results first posted
- 2017-03-16
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Minimum Serum Concentration (Cmin) of TCZ at Steady State | Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section) | Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016, 2022, 2064, 2112, 2160, 2520 hours post Day 1 dose (additionally at 6, 12, 48, 120, 2028 hours post Day 1 dose in participants \>/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016, 2022, 2028, 2040, 2064, 2112, 2160, 2520 hours post Day 1 dose. |
| Primary | Area Under the Curve at Steady-state Over a 12-week Interval (AUC12weeks) of TCZ Treatment | Pre-dose (Hour 0) up to 2016 hours post Day 1 dose (detailed timeframe is provided in outcome description section) | Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016 hours post Day 1 dose (additionally at 6, 12, 48, 120 hours post Day 1 dose in participants \>/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016 post Day 1 dose. |
| Primary | Maximum Serum Concentration (Cmax) of TCZ at Steady State | Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section) | Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016, 2022, 2064, 2112, ,2160, 2520 hours post Day 1 dose (additionally at 6, 12, 48, 120, 2028 hours post Day 1 dose in participants \>/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016, 2022, 2028, 2040, 2064, 2112, 2160, 2520 hours post Day 1 dose. |
| Secondary | Change From Baseline in Serum Interleukin-6 (IL-6) Levels | Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52 | IL-6 is a cytokine associated with disease activity in juvenile idiopathic arthritis (JIA) including the polyarticular juvenile idiopathic arthritis (pJIA) subset. It is found in high levels in the synovial fluid and is associated with indicators of inflammatory activity. |
| Secondary | Change From Baseline in Soluble IL-6 Receptor Levels | Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52 | |
| Secondary | Change From Baseline in C-Reactive Protein (CRP) Levels | Baseline, Weeks 4, 6, 9, 12,18, 20, 27, 28, 36, 44, 45, 51, 52 | |
| Secondary | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) | Baseline, Week 4, 6, 9, 12, 18, 20, 27, 28, 36, 44, 45, 51, 52 | The ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline indicates improvement. |
| Secondary | Percentage of Participants With Anti-TCZ Antibodies of Neutralizing Potential | Baseline up to Week 52 |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Minimum Serum Concentration (Cmin) of TCZ at Steady State | Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section) | Pharmacokinetic population included all enrolled participants who were adherent to the protocol. | Micrograms/milliliter (mcg/mL) | MEDIAN |
| PRIMARY | Area Under the Curve at Steady-state Over a 12-week Interval (AUC12weeks) of TCZ Treatment | Pre-dose (Hour 0) up to 2016 hours post Day 1 dose (detailed timeframe is provided in outcome description section) | Pharmacokinetic population. | mcg*day/mL | MEAN |
| PRIMARY | Maximum Serum Concentration (Cmax) of TCZ at Steady State | Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section) | Pharmacokinetic population | mcg/mL | MEDIAN |
| SECONDARY | Change From Baseline in Serum Interleukin-6 (IL-6) Levels | Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52 | Safety population. Here Number of participants analyzed represents participants evaluable for this outcome measure. Number Analyzed represents participants evaluable for the specified category. | picograms/milliliter (pg/mL) | MEAN |
| SECONDARY | Change From Baseline in Soluble IL-6 Receptor Levels | Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52 | Safety population. Here Number of participants analyzed represents participants evaluable for this outcome measure. Number Analyzed represents participants evaluable for the specified category. | nanograms per milliliter (ng/mL) | MEAN |
| SECONDARY | Change From Baseline in C-Reactive Protein (CRP) Levels | Baseline, Weeks 4, 6, 9, 12,18, 20, 27, 28, 36, 44, 45, 51, 52 | Safety population. Number Analyzed represents participants evaluable for the specified category. | mg/L | MEAN |
| SECONDARY | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) | Baseline, Week 4, 6, 9, 12, 18, 20, 27, 28, 36, 44, 45, 51, 52 | Safety population. Number Analyzed represents participants evaluable for the specified category. | millimeters per hour (mm/h) | MEAN |
| SECONDARY | Percentage of Participants With Anti-TCZ Antibodies of Neutralizing Potential | Baseline up to Week 52 | Safety population. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group121
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Minimum Serum Concentration (Cmin) of TCZ at Steady State | TCZ SC 162 mg Q3W | 13.35 | Full Range 0.21 to 52.25 | Micrograms/milliliter (mcg/mL) | |
| Minimum Serum Concentration (Cmin) of TCZ at Steady State | TCZ SC 162 mg Q2W | 12.71 | Full Range 0.19 to 23.75 | Micrograms/milliliter (mcg/mL) | |
| Area Under the Curve at Steady-state Over a 12-week Interval (AUC12weeks) of TCZ Treatment | TCZ SC 162 mg Q3W | 2998 | Full Range 1465 to 7708 | mcg*day/mL | |
| Area Under the Curve at Steady-state Over a 12-week Interval (AUC12weeks) of TCZ Treatment | TCZ SC 162 mg Q2W | 1933 | Full Range 324 to 3098 | mcg*day/mL | |
| Maximum Serum Concentration (Cmax) of TCZ at Steady State | TCZ SC 162 mg Q3W | 62.44 | Full Range 39.37 to 121.13 | mcg/mL | |
| Maximum Serum Concentration (Cmax) of TCZ at Steady State | TCZ SC 162 mg Q2W | 29.74 | Full Range 7.56 to 50.3 | mcg/mL | |
| Change From Baseline in Serum Interleukin-6 (IL-6) Levels | TCZ SC 162 mg Q3W | Baseline | 77.569 | Standard Deviation 278.376 | picograms/milliliter (pg/mL) |
| Change From Baseline in Serum Interleukin-6 (IL-6) Levels | TCZ SC 162 mg Q2W | Baseline | 10.567 | Standard Deviation 11.24 | picograms/milliliter (pg/mL) |
| Change From Baseline in Serum Interleukin-6 (IL-6) Levels | TCZ SC 162 mg Q3W | Day 0.25 | -15.309 | Standard Deviation 108.157 | picograms/milliliter (pg/mL) |
| Change From Baseline in Serum Interleukin-6 (IL-6) Levels | TCZ SC 162 mg Q2W | Day 0.25 | 4.575 | Standard Deviation 7.555 | picograms/milliliter (pg/mL) |
1 to 10 of 121Source ClinicalTrials.gov
See all 121 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TCZ SC 162 mg Q3W | 27 | |
| Overall Study | STARTED | TCZ SC 162 mg Q2W | 25 | |
| Overall Study | COMPLETED | TCZ SC 162 mg Q3W | 24 | |
| Overall Study | COMPLETED | TCZ SC 162 mg Q2W | 22 | |
| Overall Study | NOT COMPLETED | TCZ SC 162 mg Q3W | 3 | |
| Overall Study | NOT COMPLETED | TCZ SC 162 mg Q2W | 3 |
Source ClinicalTrials.gov
Adverse events98
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 | Neutropenia | Blood and lymphatic system disorders | TCZ SC 162 mg Q3W | 3 | 27 | |
| other | Neutropenia | Blood and lymphatic system disorders | TCZ SC 162 mg Q2W | 1 | 25 | |
| other | Ear Pain | Ear and labyrinth disorders | TCZ SC 162 mg Q3W | 2 | 27 | |
| other | Ear Pain | Ear and labyrinth disorders | TCZ SC 162 mg Q2W | 1 | 25 | |
| other | Abdominal Pain | Gastrointestinal disorders | TCZ SC 162 mg Q3W | 3 | 27 | |
| other | Abdominal Pain | Gastrointestinal disorders | TCZ SC 162 mg Q2W | 3 | 25 | |
| other | Aphthous Ulcer | Gastrointestinal disorders | TCZ SC 162 mg Q3W | 1 | 27 | |
| other | Aphthous Ulcer | Gastrointestinal disorders | TCZ SC 162 mg Q2W | 3 | 25 | |
| other | Constipation | Gastrointestinal disorders | TCZ SC 162 mg Q3W | 2 | 27 | |
| other | Constipation | Gastrointestinal disorders | TCZ SC 162 mg Q2W | 1 | 25 |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TCZ SC 162 mg Q3W | ||
| Total, all-cause mortality | TCZ SC 162 mg Q2W | ||
| Total, other adverse events | TCZ SC 162 mg Q3W | 23 | 27 |
| Total, other adverse events | TCZ SC 162 mg Q2W | 22 | 25 |
| Total, serious adverse events | TCZ SC 162 mg Q3W | 1 | 27 |
| Total, serious adverse events | TCZ SC 162 mg Q2W | 2 | 25 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33506875 | DERIVED |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| TCZ SC 162 mg Q3W vs TCZ SC 162 mg Q2W: serious adverse events |
Source 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/NCT01904279
GET https://conductscience.org/api/trials/v1/NCT01904279/results?page=2