Trial · NCT03669861
Safety and Efficacy of Abatacept in IgG4-Related Disease
NCT03669861, Phase 2, Completed, Massachusetts General Hospital; results first posted 2021-08-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Abatacept in IgG4-Related Disease. Trials, record NCT03669861. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03669861
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Abatacept in IgG4-Related Disease
- NCT number
- NCT03669861
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- IgG4-related Disease
- Interventions
- Abatacept
- First posted
- 2018-09-13
- Last updated
- 2021-08-24
- Results first posted
- 2021-08-24
- Limitations and caveats
- The trial also comes with additional limitations, specifically the small number of patients, the lack of a comparator group, and the open-label design.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Response | 24 weeks | Effect of weekly subcutaneous (SC) administration of abatacept on complete remission |
| Secondary | Disease Response | 12 weeks | Assess the effect of abatacept on disease response at week 12 |
| Secondary | Disease Response at Week 24 | disease response at 24 weeks | Percentage of patients achieving disease response at week 24 |
| Secondary | Disease Remission: Flares Over Time Per Subject | 24 weeks | number of disease flares per subject |
| Secondary | Decline in Serum IgG4 Concentration of Responders | 24 Weeks | Serum IgG4 measured at baseline and week 24 |
| Secondary | Decline in Serum IgE Concentration of Responders | 24 weeks | Serum IgE concentration was measured at baseline and Week 24 |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment Response | 24 weeks | The primary outcome, complete remission at week 24 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disease Response | 12 weeks | All 10 patients were treated initially with abatacept | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disease Response at Week 24 | disease response at 24 weeks | disease response at week 24 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disease Remission: Flares Over Time Per Subject | 24 weeks | Subjects with reported disease flare on treatment. Disease flare was defined as recurrence of disease activity or demonstration of a disease exacerbation such that additional therapy beyond the trial protocol was indicated | units on a scale | MEAN |
| SECONDARY | Decline in Serum IgG4 Concentration of Responders | 24 Weeks | serum IgG4 concentration can be used as a surrogate marker for disease activity | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Decline in Serum IgE Concentration of Responders | 24 weeks | Serum IgE concentrations declined in all 6 patients (100%) who demonstrated a disease response with abatacept | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment Response | Abatacept | 3 | Participants | ||
| Disease Response | Abatacept | 6 | Participants | ||
| Disease Response at Week 24 | Abatacept | 5 | Participants | ||
| Disease Remission: Flares Over Time Per Subject | Abatacept | 0.2 | Full Range 0 to 2 | units on a scale | |
| Decline in Serum IgG4 Concentration of Responders | Abatacept | 3 | Participants | ||
| Decline in Serum IgE Concentration of Responders | Abatacept | 6 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Abatacept | 10 | |
| Overall Study | COMPLETED | Abatacept | 3 | |
| Overall Study | NOT COMPLETED | Abatacept | 7 |
Source ClinicalTrials.gov
Adverse events4
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 | thrombocytopenia | Blood and lymphatic system disorders | Abatacept | 1 | 10 | 1 |
| other | episcleritis | Eye disorders | Abatacept | 1 | 10 | 1 |
| other | abdominal pain | Gastrointestinal disorders | Abatacept | 1 | 10 | 1 |
| serious | Myocardial Infarction | Cardiac disorders | Abatacept | 1 | 10 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Abatacept | 0 | 10 |
| Total, other adverse events | Abatacept | 3 | 10 |
| Total, serious adverse events | Abatacept | 1 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT03669861
GET https://conductscience.org/api/trials/v1/NCT03669861/registered