Trial · NCT00468208
Abatacept in Treating Adults With Mild Relapsing Wegener's Granulomatosis
NCT00468208, Phase 1, Phase 2, Completed, University of Pennsylvania; results first posted 2013-11-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Abatacept in Treating Adults With Mild Relapsing Wegener's Granulomatosis. Trials, record NCT00468208. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00468208
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Abatacept in Treating Adults With Mild Relapsing Wegener's Granulomatosis
- NCT number
- NCT00468208
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- University of Pennsylvania
- Conditions
- Wegener's Granulomatosis
- Interventions
- Abatacept
- First posted
- 2007-05-02
- Last updated
- 2016-01-18
- Results first posted
- 2013-11-26
- Limitations and caveats
- The main limitation of this trial is the small sample size and the open-label, uncontrolled design.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety of Abatacept - Number of Participants With Adverse Events | Measured continuously from the screening visit through to the 6 month post-treatment study visit, up to 3 years and 4 months. | This study examined the safety profile of this agent when used in Wegener's granulomatosis. Information was gathered on all adverse events with specific events being identified in the protocol for analysis that included the following: * Infection * Infusion reactions * Cytopenias * Transaminase elevation * Skin reactions * GI side effects * Malignancy All adverse events were reportable for this study. |
| Secondary | Disease Remission | Measured monthly until common closing or early termination,up to 3 years and 4 months. | Disease remission was measured by a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) of 0. The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63. |
| Secondary | Disease Improvement | Measured monthly until common closing or early termination, up to 3 years and 4 months. | Disease improvement was measured by a reduction in the Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG). The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63. |
| Secondary | Meeting Common Closing | Number assessed at the time of common closing, up to 3 years and 4 months. | The number of subjects that reached the common closing date. |
| Secondary | Disease Relapse | Measured monthly until common closing or early termination, up to 3 years and 4 months. | Disease relapse was measured by a rise in the Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) of greater than or equal to 1 after achieving remission. The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63. |
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 | Safety of Abatacept - Number of Participants With Adverse Events | Measured continuously from the screening visit through to the 6 month post-treatment study visit, up to 3 years and 4 months. | This study intended to examine safety and to explore preliminary signal for efficacy of abatacept in Wegener's granulomatosis. The sample size of 20 was based upon a sufficient number of subjects to begin such pilot explorations. | participants | NUMBER |
| SECONDARY | Disease Remission | Measured monthly until common closing or early termination,up to 3 years and 4 months. | This study intended to examine safety and to explore preliminary signal for efficacy of abatacept in Wegener's granulomatosis. The sample size of 20 was based upon a sufficient number of subjects to begin such pilot explorations. | participants | NUMBER |
| SECONDARY | Disease Improvement | Measured monthly until common closing or early termination, up to 3 years and 4 months. | This study intended to examine safety and to explore preliminary signal for efficacy of abatacept in Wegener's granulomatosis. The sample size of 20 was based upon a sufficient number of subjects to begin such pilot explorations. | participants | NUMBER |
| SECONDARY | Meeting Common Closing | Number assessed at the time of common closing, up to 3 years and 4 months. | This study intended to examine safety and to explore preliminary signal for efficacy of abatacept in Wegener's granulomatosis. The sample size of 20 was based upon a sufficient number of subjects to begin such pilot explorations. | participants | NUMBER |
| SECONDARY | Disease Relapse | Measured monthly until common closing or early termination, up to 3 years and 4 months. | This study intended to examine safety and to explore preliminary signal for efficacy of abatacept in Wegener's granulomatosis. The sample size of 20 was based upon a sufficient number of subjects to begin such pilot explorations. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety of Abatacept - Number of Participants With Adverse Events | Open-label Abatacept | Serious adverse events | 7 | participants | |
| Safety of Abatacept - Number of Participants With Adverse Events | Open-label Abatacept | Non-serious adverse events | 16 | participants | |
| Safety of Abatacept - Number of Participants With Adverse Events | Open-label Abatacept | Infection | 14 | participants | |
| Safety of Abatacept - Number of Participants With Adverse Events | Open-label Abatacept | Infusion related (systemic) | 1 | participants | |
| Safety of Abatacept - Number of Participants With Adverse Events | Open-label Abatacept | Infusion related( intravenous site reaction) | 1 | participants | |
| Safety of Abatacept - Number of Participants With Adverse Events | Open-label Abatacept | Cytopenia | 4 | participants | |
| Disease Remission | Open-label Abatacept | 16 | participants | ||
| Disease Improvement | Open-label Abatacept | 18 | participants | ||
| Meeting Common Closing | Open-label Abatacept | 14 | participants | ||
| Disease Relapse | Open-label Abatacept | 3 | 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 | Open-label Abatacept | 20 | |
| Overall Study | COMPLETED | Open-label Abatacept | 20 | |
| Overall Study | NOT COMPLETED | Open-label Abatacept | 0 |
Source ClinicalTrials.gov
Adverse events45
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 | Allergy/immunology - Allergic reaction/hypersensitivity | Immune system disorders | Open-label Abatacept | 1 | 20 | 9 |
| other | Allergy/immunology | Immune system disorders | Open-label Abatacept | 1 | 20 | 1 |
| other | Auditory/Ear | Ear and labyrinth disorders | Open-label Abatacept | 1 | 20 | 1 |
| other | Auditory/Ear - Otitis | Ear and labyrinth disorders | Open-label Abatacept | 1 | 20 | 1 |
| other | Blood/Bone marrow - Hemoglobin | Blood and lymphatic system disorders | Open-label Abatacept | 2 | 20 | 2 |
| other | Blood/Bone marrow - Leukocytes | Blood and lymphatic system disorders | Open-label Abatacept | 2 | 20 | 2 |
| other | Blood/Bone marrow - Lymphopenia | Blood and lymphatic system disorders | Open-label Abatacept | 1 | 20 | 1 |
| other | Dermatology/Skin - Other | Skin and subcutaneous tissue disorders | Open-label Abatacept | 5 | 20 | 10 |
| other | Dermatology/Skin - Injection site reaction | Skin and subcutaneous tissue disorders | Open-label Abatacept | 1 | 20 | 2 |
| other | Dermatology/Skin - Photosensitivity | Skin and subcutaneous tissue disorders | Open-label Abatacept | 1 | 20 | 1 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Open-label Abatacept | ||
| Total, other adverse events | Open-label Abatacept | 16 | 20 |
| Total, serious adverse events | Open-label Abatacept | 7 | 20 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U54AR057319 | Vasculitis Clinical Research Consortium (VCRC) | MERKEL, PETER A | UNIVERSITY OF PENNSYLVANIA | NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES | 2009 to 2020 |
Source NIH RePORTER
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/NCT00468208
GET https://conductscience.org/api/trials/v1/NCT00468208/events?page=2