Trial · NCT01750697
A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis
NCT01750697, Phase 2, Completed, Hoffmann-La Roche; results first posted 2019-06-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis. Trials, record NCT01750697. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01750697
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis
- NCT number
- NCT01750697
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Granulomatosis With Polyangiitis
- Interventions
- Rituximab
- First posted
- 2012-12-17
- Last updated
- 2019-06-26
- Other registries' IDs
- eudract:2012-002062-13
- Results first posted
- 2019-06-26
- Limitations and caveats
After Month 6, participants could receive treatment for GPA/MPA in accordance with local standard of care, and this could include additional rituximab infusions and/or other immunosuppressive therapies. Low participant numbers (e.g., 1 subject = 4%).
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Adverse Events (AEs), Including Serious AEs | Baseline (Day 1) up to last visit (1.5-5 years) | An AE is any unfavourable and unintended sign (including abnormal laboratory finding), symptom, or disease temporarily associated with the use of a study drug, whether or not considered related to the study drug. A SAE is any experience that results in death, is life-threatening, requires in-patient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is medically significant. |
| Primary | Pharmacokinetics: Rituximab Clearance (CL) | From Day 1 to Day 180 | CL is a quantitative measure of the rate at which a drug substance is removed from the body. The following allometric scaling equation was used for the estimation of CL in children: CL= qCL X (BSA/1.9) 0.92 X 1.31\*ADA where qCL is a typical value of clearance in millilitres per day (mL/day) for a typical participant (i.e., Body Surface Area (BSA) of 1.9 m\^2 and absence of anti-rituximab antibodies (ADA)) and is equal to 258 mL/day; BSA is in m\^2 and ADA is 1 when anti-rituximab antibodies are present (0 otherwise). The allometric scaling factor was 0.92. CL was calculated in millilitres per day (mL/day). |
| Primary | Pharmacokinetics: Volume of Distribution (Vd) of Rituximab | From Day 1 to Day 180 | Vd is defined as the theoretical central volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vd was calculated in millilitres (mL). |
| Secondary | Pharmacokinetics: Area Under the Concentration-Time Curve From Time 0 to 180 Days (AUC-180) of Rituximab | From Day 1 to Day 180 | The AUC0-180 is a measure of the plasma concentration of rituximab over time. The AUC0-180 was calculated in micrograms per millilitres times day (mcg/mL\*day). |
| Secondary | Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Rituximab | From Day 1 to Day 180 | Cmax is the maximum observed plasma rituximab concentration. Cmax was assessed at each visit following 1st, 2nd, 3rd, and 4th IV dose of rituximab 375 mg/m\^2 on Days 1, 8, 15, and 22. Cmax was calculated in micrograms per millilitre (mcg/mL). |
Source ClinicalTrials.gov
Outcomes5
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 Adverse Events (AEs), Including Serious AEs | Baseline (Day 1) up to last visit (1.5-5 years) | The safety population included all participants who received at least part of one infusion of rituximab. | percentage of participants | NUMBER |
| PRIMARY | Pharmacokinetics: Rituximab Clearance (CL) | From Day 1 to Day 180 | The PK analysis population included all participants in the safety population who provided at least one evaluable PK sample. | mL/day | GEOMETRIC_MEAN |
| PRIMARY | Pharmacokinetics: Volume of Distribution (Vd) of Rituximab | From Day 1 to Day 180 | The PK analysis population included all participants in the safety population who provided at least one evaluable PK sample. | mL | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics: Area Under the Concentration-Time Curve From Time 0 to 180 Days (AUC-180) of Rituximab | From Day 1 to Day 180 | The PK analysis population included all participants in the safety population who provided at least one evaluable PK sample. | mcg/mL*day | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Rituximab | From Day 1 to Day 180 | The PK analysis population included all participants in the safety population who provided at least one evaluable PK sample. | mcg/mL | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group11
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 Adverse Events (AEs), Including Serious AEs | Remission Induction Phase (up to 6 Mos.) Rituximab | Percentage of Participants with AEs | 100 | percentage of participants | |
| Percentage of Participants With Adverse Events (AEs), Including Serious AEs | Overall Follow-up Phase (up to 4.5 Yrs) Rituximab | Percentage of Participants with AEs | 100 | percentage of participants | |
| Percentage of Participants With Adverse Events (AEs), Including Serious AEs | Remission Induction Phase (up to 6 Mos.) Rituximab | Percentage of Participants with SAEs | 28 | percentage of participants | |
| Percentage of Participants With Adverse Events (AEs), Including Serious AEs | Overall Follow-up Phase (up to 4.5 Yrs) Rituximab | Percentage of Participants with SAEs | 48 | percentage of participants | |
| Pharmacokinetics: Rituximab Clearance (CL) | Rituximab (Experimental) | 204 | Geometric Coefficient of Variation 0.414 | mL/day | |
| Pharmacokinetics: Volume of Distribution (Vd) of Rituximab | Rituximab (Experimental) | 2220 | Geometric Coefficient of Variation 0.212 | mL | |
| Pharmacokinetics: Area Under the Concentration-Time Curve From Time 0 to 180 Days (AUC-180) of Rituximab | Rituximab (Experimental) | 10120 | Geometric Coefficient of Variation 0.42 | mcg/mL*day | |
| Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Rituximab | Rituximab (Experimental) | 1st Dose | 230 | Geometric Coefficient of Variation 0.166 | mcg/mL |
| Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Rituximab | Rituximab (Experimental) | 2nd Dose | 305 | Geometric Coefficient of Variation 0.181 | mcg/mL |
| Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Rituximab | Rituximab (Experimental) | 3rd Dose | 353 | Geometric Coefficient of Variation 0.183 | mcg/mL |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rituximab | 25 | |
| Overall Study | Completed | Rituximab | 25 | |
| Overall Study | Follow-up Phase | Rituximab | 24 | |
| Overall Study | COMPLETED | Rituximab | 16 | |
| Overall Study | NOT COMPLETED | Rituximab | 9 |
Source ClinicalTrials.gov
Adverse events152
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 | Remission Induction Phase: Rituximab | 0 | 25 | |
| other | Neutropenia | Blood and lymphatic system disorders | Overall Follow-up Phase: Rituximab | 2 | 25 | |
| other | Deafness unilateral | Ear and labyrinth disorders | Remission Induction Phase: Rituximab | 0 | 25 | |
| other | Deafness unilateral | Ear and labyrinth disorders | Overall Follow-up Phase: Rituximab | 2 | 25 | |
| other | Abdominal pain | Gastrointestinal disorders | Remission Induction Phase: Rituximab | 2 | 25 | |
| other | Abdominal pain | Gastrointestinal disorders | Overall Follow-up Phase: Rituximab | 3 | 25 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Remission Induction Phase: Rituximab | 3 | 25 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Overall Follow-up Phase: Rituximab | 4 | 25 | |
| other | Constipation | Gastrointestinal disorders | Remission Induction Phase: Rituximab | 3 | 25 | |
| other | Constipation | Gastrointestinal disorders | Overall Follow-up Phase: Rituximab | 3 | 25 |
1 to 10 of 152Source ClinicalTrials.gov
See all 152 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Remission Induction Phase: Rituximab | 0 | 25 |
| Total, all-cause mortality | Overall Follow-up Phase: Rituximab | 0 | 25 |
| Total, other adverse events | Remission Induction Phase: Rituximab | 22 | 25 |
| Total, other adverse events | Overall Follow-up Phase: Rituximab | 24 | 25 |
| Total, serious adverse events | Remission Induction Phase: Rituximab | 7 | 25 |
| Total, serious adverse events | Overall Follow-up Phase: Rituximab | 12 | 25 |
Source ClinicalTrials.gov
Papers2
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Remission Induction Phase: Rituximab vs Overall Follow-up Phase: Rituximab: deaths from any cause | Trial comparisons |
| Remission Induction Phase: Rituximab vs Overall Follow-up Phase: Rituximab: 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/NCT01750697
GET https://conductscience.org/api/trials/v1/NCT01750697/events?page=2