Trial · NCT01584388
Rituximab in IgG4-RD: A Phase 1-2 Trial
NCT01584388, Phase 1, Phase 2, Completed, Massachusetts General Hospital; results first posted 2017-07-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Rituximab in IgG4-RD: A Phase 1-2 Trial. Trials, record NCT01584388. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01584388
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rituximab in IgG4-RD: A Phase 1-2 Trial
- NCT number
- NCT01584388
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Retroperitoneal Fibrosis, Autoimmune Pancreatitis, Sialadenitis, Pseudotumor
- Interventions
- Rituximab
- First posted
- 2012-04-25
- Last updated
- 2017-07-02
- Results first posted
- 2017-07-02
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | IgG4-RD RI Score at Baseline and Six Months After Rituxan Treatment | 6 months | The IgG4-RD RI is then calculated by adding the individual organ scores.At each assessment, the physician enters a 0-4 score after the organ/site listed with: 0 = Normal or resolved 1. = Improved but still present 2. = Persistent (still active; unchanged from previous visit) 3. = New or recurrent disease activity while patient is off treatment 4. = Worsened or new disease despite treatment Definitions Organ/Site score: The overall level of IgG4-RD activity within a specific organ system Symptomatic: Is the disease manifestation in a particular organ system symptomatic? (Y = yes; N = no) Urgent disease: Disease that requires treatment immediately to prevent serious organ dysfunction (Y = yes; N = no) (Presence of urgent disease within an organ leads to DOUBLING of that organ system score) Damage: Organ dysfunction that has occurred as a result of IgG4-RD and is considered permanent (Y = yes; N = no) The Responder Index ranges from 0-60. |
| Primary | Cumulative Glucocorticoid Use at Baseline and 6 Months | 6 months | Cumulative glucocorticoid therapy between baseline and 6 months. |
| Primary | No Disease Flares During Rituximab Treatment Phase | Month 6 | Disease flare measured by responder Index score: At each assessment, the physician enters a 0-4 score after the organ/site listed with: 0 = Normal or resolved 1. = Improved but still present 2. = Persistent (still active; unchanged from previous visit) 3. = New or recurrent disease activity while patient is off treatment 4. = Worsened or new disease despite treatment Definitions Organ/Site score: The overall level of IgG4-RD activity within a specific organ system Symptomatic: Is the disease manifestation in a particular organ system symptomatic? (Y = yes; N = no) Urgent disease: Disease that requires treatment immediately to prevent serious organ dysfunction (Y = yes; N = no) (Presence of urgent disease within an organ leads to DOUBLING of that organ system score) Damage: Organ dysfunction that has occurred as a result of IgG4-RD and is considered permanent (Y = yes; N = no) |
| Secondary | Retreatment With Rituximab for Disease Relapse | 12 months | Number of subjects that relapsed during the course of the trial |
| Secondary | Disease Response at 6 Months | 6 months | Decline of IgG4-RD Responder Index by at least two points for at least 6 months |
| Secondary | Sustained Disease Response | 12 months | Decline of the IgG4-RD RI by at least two points and maintained for 12 months. |
| Secondary | Complete Remission | 6 months | IgG4-RD RI (including serum IgG4) of 0 at six months |
| Secondary | Complete Remission IgG-RD RI (Exclusive of Serum IgG4) of 0 at 6 Months. | 6 months | IgG-RD RI (exclusive of serum IgG4) of 0 at 6 months. |
| Secondary | Complete Remission at Any Timepoint | 12 months | IgG4-RD RI = 0 at any point in the trial |
| Secondary | Complete Remission (Any Timepoint), Exclusive of Serum IgG4 | 12 months | IgG4-RD RI = 0 (exclusive of serum IgG4) at any point in the trial |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | IgG4-RD RI Score at Baseline and Six Months After Rituxan Treatment | 6 months | units on a scale | MEAN | |
| PRIMARY | Cumulative Glucocorticoid Use at Baseline and 6 Months | 6 months | cumulative glucocorticoid use at 6 and compare them to baseline using paired T tests. | mg | MEAN |
| PRIMARY | No Disease Flares During Rituximab Treatment Phase | Month 6 | number of subjects without disease flares during baseline to 6 month of treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Retreatment With Rituximab for Disease Relapse | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Disease Response at 6 Months | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Sustained Disease Response | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Complete Remission | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Complete Remission IgG-RD RI (Exclusive of Serum IgG4) of 0 at 6 Months. | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Complete Remission at Any Timepoint | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Complete Remission (Any Timepoint), Exclusive of Serum IgG4 | 12 months | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| IgG4-RD RI Score at Baseline and Six Months After Rituxan Treatment | IgG4-RD Responder Index | 11 | Standard Deviation 7 | units on a scale | |
| IgG4-RD RI Score at Baseline and Six Months After Rituxan Treatment | 6 Months | 1 | Standard Deviation 2 | units on a scale | |
| Cumulative Glucocorticoid Use at Baseline and 6 Months | Glucocorticoid Treatment (Baseline) | 42 | Full Range 0 to 850 | mg | |
| Cumulative Glucocorticoid Use at Baseline and 6 Months | Glucocorticoid Use (6 Months) | 15 | Full Range 0 to 280 | mg | |
| No Disease Flares During Rituximab Treatment Phase | Disease Flare | 23 | Participants | ||
| Retreatment With Rituximab for Disease Relapse | Relapse Treatment | 4 | Participants | ||
| Disease Response at 6 Months | Disease Response at 6 Months | 29 | Participants | ||
| Sustained Disease Response | Disease Response at 12 Months | 22 | Participants | ||
| Complete Remission | Complete Remission at 6 Months | 14 | Participants | ||
| Complete Remission IgG-RD RI (Exclusive of Serum IgG4) of 0 at 6 Months. | Complete Remission at 6 Months, Exclusive of Serum IgG4 | 18 | Participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rituximab | 30 | |
| Overall Study | COMPLETED | Rituximab | 30 | |
| Overall Study | NOT COMPLETED | Rituximab | 0 |
Source ClinicalTrials.gov
Adverse events6
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 |
|---|---|---|---|---|---|---|
| serious | Legionella pneumophila pneumonia | Infections and infestations | Open Label Treatment With Rituximab | 1 | 30 | 1 |
| serious | Klebsiella urinary tract infection | Infections and infestations | Open Label Treatment With Rituximab | 1 | 30 | 1 |
| serious | cold agglutininmediated | Blood and lymphatic system disorders | Open Label Treatment With Rituximab | 1 | 30 | 1 |
| serious | Amaurosis fugax | Vascular disorders | Open Label Treatment With Rituximab | 1 | 30 | 1 |
| serious | unstable angina | Cardiac disorders | Open Label Treatment With Rituximab | 1 | 30 | 1 |
| serious | Surgery for pseudotumor | Eye disorders | Open Label Treatment With Rituximab | 1 | 30 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Open Label Treatment With Rituximab | ||
| Total, other adverse events | Open Label Treatment With Rituximab | 0 | 30 |
| Total, serious adverse events | Open Label Treatment With Rituximab | 5 | 30 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25667206 | 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 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/NCT01584388
GET https://conductscience.org/api/trials/v1/NCT01584388/registered